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« on: September 15, 2006, 08:39:13 am »

Public Awareness Fuels Dramatic Rise in Osteoporosis Diagnosis

The number of diagnosed cases of osteoporosis in the US jumped from about half a million in 1994 to more than 3.6 million in 2003, according to a recent study by researchers at Stanford University. The authors attributed the dramatic increase in large part to the development and consumer marketing of new drugs to treat the bone-thinning condition that in turn fueled greater public awareness and an emphasis on prevention.

Osteoporosis is characterized by decrease in bone mass, with low bone density and enlargement of spaces producing porosity and fragility. The condition can devastate the quality of life of older people, resulting in greatly increased likelihood of bone fractures. In the case of hip fractures, death from complications is likely in as many as 20% of victims within a year of the fracture.

"I think the increase is due to the fact that we are looking for osteoporosis and that we can diagnose it," said M. E. Csuka, MD, FACP, Medical College of Wisconsin Associate Professor of Medicine. "I'm not so sure that reports of a sevenfold increase represent an absolute increase. Prior to 1995, when alendronate (sold as Fosamax) became approved, I do not think we were looking for osteoporosis in our patients."

Alendronate, calcitonin, raloxifene, and risedronate are the primary drug treatments for osteoporosis. A new drug, ibandronate sodium, was approved for osteoporosis treatment by the Food and Drug Administration in March 2005 and is expected to enter the market in April. The manufacturers are touting the new drug for both treatment and prevention of postmenopausal osteoporosis and selling the point that it is only taken once a month, unlike others that are taken weekly.

Treatment Options Encourage Diagnosis
"Once you have a treatment, then you start looking," said Dr. Csuka. "When you have a disease but no treatment, you do not always diagnose it until it's really in front of your face because someone fractured a hip.

"When I went to medical school, this was considered 'normal' aging. The line of thought was 'this is osteoporosis, this is what happens when you get old.' It was more or less considered in terms of 'that's the way it is.'"

Estimates of the number of people over age 50 with osteoporosis in the US run as high as 10 million, mostly women, meaning that the vast majority of cases are still not diagnosed and the disease is still undertreated.

"I think that when you start doing epidemiological studies and you start looking at increased incidences, you have to put in the mix that we are much better at diagnosing it now," said Dr. Csuka. "The way we used to diagnose it was when a person presented with a fracture. Now we can diagnose it with bone densitometry before a fracture occurs.

"And you have to do a proportional analysis, too. There are a lot more people making it to old age. People used to die earlier, and now they're living long enough to get this diagnosis. Even with that said, I think it is a significant entity and I do think there are increased numbers. We are still way behind in treating people."

The Role of Marketing
Rules that offer drug manufacturers more leeway in directly marketing drugs to consumers through television, radio and print have been a boon to pharmaceutical companies. The newer osteoporosis drugs sold since the mid-1990s are among those widely advertised.

"People's awareness of osteoporosis has been greatly elevated by direct consumer marketing, but I do not necessarily translate that as a negative," said Dr. Csuka. "This really is a significant epidemic in many ways. It robs people of so much of their quality of life.

"This is an instance where I'm willing to make an exception; a lot of the direct consumer advertising for drugs is just crazy. With osteoporosis, as with the marketing of statin drugs to lower cholesterol, the advertising has done a lot for raising people's awareness and bringing them in for screening and diagnosis.

"I find it much easier when a patient is already interested in osteoporosis than when I bring up one more topic" for discussion, Dr Csuka added.

Universal Screening Recommended
The Stanford study authors supported new guidelines for universal osteoporosis screening of women over age 65 as part of a growing effort to emphasize prevention.

"I agree with that," said Dr. Csuka. "It is important that you do screening to identify the patients at risk. I'm oftentimes amazed at patients who, if I look at just their risk factors - they are on chronic steroids, have low body weight (less than 127 pounds) , and have poor diets - then you do bone densitometry and they're fine. They have very good genes!

"A simple screening test is a good idea; I'd even suggest that we should probably do it around age 60, a little bit earlier than that magical age 65. Because we want to prevent a clinical problem that is going to occur ten or fifteen years down the road. You have to have people's awareness up, including primary care physicians.

"The primary care physician has to be involved. How long did it take cholesterol screening to become routine? It's taken maybe ten to fifteen years. Now, patients want to know their cholesterol level. We do screenings for cholesterol and for colorectal cancer. Recommendations on osteoporosis screening come from the regulatory bodies that tell us what we need to do. Now the physicians and their patients will have to follow through."

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« Reply #1 on: September 18, 2006, 11:26:53 am »

Study: Osteoporosis Shot Reduces Breaks

Saturday, September 16, 2006


An experimental treatment for bone-thinning osteoporosis appears to prevent spine and hip fractures even though it is given only once a year, eliminating the need for a strict daily pill regimen, preliminary data show.


Reclast, given as an annual, 15-minute infusion, reduced risk of new spine fractures by 70 percent and of hip fractures by 40 percent, according to data supplied by maker Novartis Pharmaceuticals Corp. The drug, chemically known as zoledronic acid, also reduced the risk of fractures elsewhere, according to a just-completed, international study of 7,736 postmenopausal women with osteoporosis.


Side effects were generally minor and short-lived, said Novartis, of East Hanover, N.J.


The data, from final-stage human testing, was presented Saturday at the annual meeting of the American Society of Bone and Mineral Research in Philadelphia.


"This is very good news," said Dr. Ethel Siris (SEYE' riss), president of the National Osteoporosis Foundation and director of the Osteoporosis Center at Columbia University.


"Because it can be given once a year, it's going to be terrific for women who like that option," said Siris, who has consulted for Novartis and other drug companies.


Novartis plans to apply for U.S. approval to sell Reclast early next year.


Lead researcher Dennis Black, a professor of epidemiology at University of California-San Francisco, said that like Fosamax and other pills, Reclast slows down the speed at which cells called osteoclasts break down bone while other cells build it back up.


"If you take Fosamax every week for a year, you'll get a similar effect on bone density," Black said.


He noted that Reclast is part of a decade-long trend of researchers developing osteoporosis drugs taken less and less frequently: Some pills are taken only once a month, and one drug is available as a shot every three months.


Dr. Thomas Cavalieri, director of the New Jersey Institute for Successful Aging, said Reclast will be very significant, if approved, because many osteoporosis patients stop taking their medicine in the first year. One reason is that the pills can cause irritation and ulcers in the esophagus; to limit that, people must take them first thing on an empty stomach, with a large glass of water, then stay upright for 30 to 60 minutes.


That could make nursing home residents and patients with acid reflux disease, among others, good candidates for the shot.


In the United States, about 10 million people have osteoporosis and 34 million others have low bone density, putting them at risk for it, according to the National Osteoporosis Foundation. Half of women over age 50 with the disorder will suffer a fracture, which can trigger overall health decline and premature death.


Roughly one-third of the people with osteoporotic fractures don't know it, but as their vertebrae crack and compress they stoop forward, lose height and can suffer pain.


Treatment — when the fracture is caught — focuses on medicines to relieve pain, hot or cold packs, physical therapy and steps to prevent another fracture. Those steps include taking an osteoporosis drug and increasing calcium and vitamin D intake, either through diet or supplements.


For women entering menopause, it's better to try to prevent fractures by using those steps, weight-bearing exercise and getting bone density screenings.


Reclast is in the same category of osteoporosis drugs, bisphosphonates, as Fosamax from Merck & Co. of Whitehouse Station, N.J.; Actonel by Procter & Gamble Pharmaceuticals of Cincinnati; and Boniva from Hoffmann-La Roche Inc. of Nutley, N.J. Another drug, Forteo from Eli Lilly & Co. of Indianapolis, is a form of human parathyroid hormone and must be injected in the thigh or abdomen daily.


Competition is so fierce that P&G unsuccessfully sued Hoffmann-La Roche over claims in its advertising campaign that Boniva is as effective as Fosamax and Actonel.


Merck has long been the market leader but loses patent protection in February 2008 on Fosamax, which had $3.2 billion in 2005 sales. The company has two potential osteoporosis drugs in human testing, said spokesman Chris Loder. He said Merck research shows Fosamax can reduce spine fractures by about 85 percent and hip fractures by about 50 percent.

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« Reply #2 on: September 23, 2006, 06:43:26 am »

Buprenorphine Patches Improve Quality of Life in Patients With Severe Pain Due to Osteoarthritis
ISTANBUL, TURKEY -- September 15, 2006 -- Data presented today show that the once-a-week transdermal buprenorphine patch, BuTrans(TM), is able to provide the same level of pain relief as 8-hourly doses of sub-lingual buprenorphine tablets, without any increase in side-effects or tolerability.

Dr. C. McDonald, explained the background to this new research, "Around a hundred million patients across Europe suffer with painful arthritic diseases such as osteoarthritis.

The option of this low dose transdermal opioid treatment offers a substantial improvement in convenience for these patients with severe pain. In addition, the transdermal route of drug administration, provides a constant - albeit reduced - concentration of opiate which reduces many of the side-effects associated with the use of strong opioid therapy, whilst offering continuous analgesia.

However, the particular significance of this research is that it demonstrates buprenorphine patches provide an equivalent efficacy in terms of pain relief to traditional oral medication, with the added benefits of transdermal administration."

The data was acquired through a double-blind, parallel group study1, conducted by Napp Pharmaceuticals, in which patients with moderate to severe pain caused by hip and/or knee osteoarthritis (OA) were randomised to receive either treatment with BuTrans(TM) transdermal patch (BTP) or sublingual buprenorphine (SLB). Doses of both drugs were titrated up to a maintained level of pain relief over 21 days (BTP doses: 5 mcg/h to 20 mcg/h; SLB doses: 200 mcg to 400 mcg 8-hourly). Those patients who achieved effective pain control were entered into a 28-day assessment period during which their quality of life; sleep; overall pain and severity of OA symptoms were all evaluated*.

The BuTrans(TM) patch provided comparable symptom relief to STP in every category measured. Before the trial, 79% of patients in the STP group and 73% of the BTP group reported being woken at least twice a night by their pain. At its conclusion, those figures had been reduced to 24% and 20%, respectively. Both groups also showed equitable improvements in all the categories for assessment of pain intensity and of the interference from pain on normal daily living. The occurrence of other OA symptoms such as stiffness and impaired physical function were also greatly reduced by both treatments to a similar degree.

Dr. McDonald concluded that "the 7-day BuTrans(TM) patch gives a comparable improvement in quality of life to 8-hourly sublingual buprenorphine in patients with severe OA pain".

Buprenorphine patches are only registered in the following European countries: AT, DK, CZ, DE, IS, IE, HU, LU, NO, PT, SK, SE and UK
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« Reply #3 on: September 29, 2006, 08:10:24 am »

Study Suggests Vitamin K Deficiency as an Osteoporosis Risk Factor

ANN ARBOR, MI -- September 22, 2006 -- A new study by Jane Lukacs of the University of Michigan School of Nursing suggests that the impairment of vitamin K function could compromise bone health and contribute to the development of osteoporosis.

The study found that one of the early effects of declining estrogen is the impairment of vitamin K function in bone even before any bone loss that could be attributed to menopause can be measured.

"Our study suggests that the generally accepted level of vitamin K in healthy women is inadequate to maintain bone health just at the onset of menopause," Lukacs said.

Vitamin K is essential for making a bone protein called osteocalcin fully functional. This protein is part of the bone structure when it is "carboxylated" (a chemical modification of the protein that changes its shape making it easy to bind to calcium) in the presence of sufficient vitamin K. With adequate vitamin K, this protein can bind to calcium in the bone environment -- sort of like glue, Lukacs said.

The study involved volunteer human subjects of whom 80 percent were white with the remainder of African-American, Hispanic and Asian heritage. All were healthy middle-aged women or young adult women. The study included blood tests, interviews to determine dietary habits and calculation of the body mass index and measurement of bone mineral density of the lumbar spine and the non-dominant hip. If right handed, left hip.

While vitamin K comes from green leafy vegetables, green vegetables and vegetable oils, most individuals don't consume amounts on a consistent basis that are sufficient to promote bone health. Few multivitamins contain vitamin K, and those that do have minimal amounts of vitamin K. Anyone considering vitamin K supplements should consult with their medical adviser first; people on blood thinners should not be taking vitamin K.

So, what's a woman to do? For now, Lukacs suggests getting back to basics. "In early menopause, increase your intake of dark green vegetables and vegetable oils on a daily basis," she said. "In adolescence and early adulthood, the incorporation of weight-bearing exercise is crucial because we also observed lower bone density in the hip of premenopausal women in their late 40's well before the onset of menopause.

"Many factors contribute to the development of osteoporosis and fracture risk," Lukacs said. "Part of our effort in this study was to examine vitamin K as a novel nutritional factor that may play a role in bone health in a group of women well characterized for their vitamin nutriture, reproductive status and age, something that is rarely attempted in descriptive studies."

She said it will be important to explore whether vitamin K supplementation in the early postmenopause will offer an additional intervention for women concerned about their future risk of fracture.

Lukacs's study was funded by Pfizer. Her findings have been presented at the Endocrine Society meetings and are published in the September/October 2006 issue of Menopause (volume 13, issue 5.)

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« Reply #4 on: September 29, 2006, 09:02:48 am »


Data Demonstrate Benefits of Once-Yearly Zoledronic Acid for Infusion in Treatment of Postmenopausal Osteoporosis

For the first time, a once-yearly infusion has shown significant bone fracture reduction in postmenopausal osteoporosis patients1

Additional data confirm patients can be directly switched from weekly oral alendronate to Aclasta* and maintain bone benefits for a full year2

A majority of women being treated for postmenopausal osteoporosis (PMO) prefer a once- yearly infusion to a once-weekly pill3

DORVAL, CANADA -- September 21, 2006 -- Phase 3 data presented for the first time demonstrated that Aclasta* (zoledronic acid 5 mg solution for infusion), the only once-yearly bisphosphonate, was highly effective in reducing the incidence of bone fracture in women with postmenopausal osteoporosis (PMO)†.

Benefits were shown across the most common fracture sites -- hip, spine and non-spine‡ -- with the effect sustained over three years1.

Further data demonstrated that PMO patients currently taking oral alendronate can be switched to Aclasta* and maintain the beneficial bone effects for a full 12 months after a single dose2. These studies were presented recently at the annual meeting of the American Society of Bone and Mineral Research (ASBMR) in Philadelphia.

Aclasta* (zoledronic acid 5 mg solution for infusion) is the only once-yearly bisphosphonate being studied for the treatment of PMO. As a once-yearly infusion, this treatment has clearly been shown to be the preferred choice of patients over a once-weekly pill3.

PMO is a serious condition affecting one in four Canadian women over the age of 50.4 An estimated 50 per cent of women with PMO will suffer an osteoporotic fracture in her lifetime5. Of those women age 65 or older who suffer a hip fracture, 21% will die within one year6. Although osteoporosis affects more women, men can also suffer from the disease.

In fact, one in eight Canadian men1 over the age of 50 also has the disease.4 The number of osteoporosis patients is estimated at 1.4 million in Canada.4 The incidence of hip fracture in women is projected to rise by 240% worldwide by 2050, as populations grow and age8. Osteoporosis can result in disfigurement, lower self-esteem, reduction or loss of mobility and decreased independence.

An interim analysis encompassing 99% of data from the now-completed three-year HORIZON Pivotal Fracture Trial showed that patients taking Aclasta* experienced a 70% risk reduction in new spine fractures (p<0.0001) and a 40% risk reduction in hip fractures (p=0.0032) over three years compared to placebo1. This met the study's two primary endpoints. Additionally, the study met all secondary endpoints, including risk reduction in clinical spine fractures and non-spine fractures1.

"The efficacy and safety data show for the first time that women may have the option of a once-yearly treatment for osteoporosis," said Dr. Jonathan D. Adachi, a principal investigator of the clinical trial from McMaster University, Hamilton, Ontario. "The results show Aclasta* effectively protects women against fractures including those of the hip, which can be devastating."

In the study, the overall incidence of adverse events experienced with Aclasta* were comparable to placebo. The study included a careful examination of key safety parameters, including kidney and jaw safety, which found Aclasta* to be comparable to placebo. The most common adverse events associated with intravenous infusion of Aclasta* were the following post-dose symptoms: fever, muscle pain, flu-

like symptoms, headache and bone pain. The majority of these occurred within the first three days following Aclasta* administration and were resolved within the first three days of the event onset. The incidence decreased markedly with subsequent doses of Aclasta*1.

Additional Phase III data presented at the meeting from a study of 225 women with PMO demonstrated that patients treated with weekly alendronate can directly switch to Aclasta*. In the study, the beneficial effects of alendronate on bone mineral density (BMD) in postmenopausal women were maintained for 12 months after a single infusion of Aclasta*. At 12 months, BMD values for patients randomised to receive Aclasta* were similar to those for patients randomised to continued treatment with alendronate, meeting the study's primary endpoint. In patients taking Aclasta*, bone turnover remained within the normal pre-menopausal range at 12 months after an infusion2. The most common adverse events reported in this study were similar to those observed in the pivotal fracture trial1,2,6.

"We believe once-yearly Aclasta* may offer advantages for the thousands of women suffering from osteoporosis, and potentially provide the most comprehensive protection across the most common osteoporotic fracture sites," said Jean-Marie Leclerc, MD, Chief Scientific Officer and Senior Vice President of Clinical and Regulatory Affairs, at Novartis Pharmaceuticals Canada Inc.

Aclasta* in PMO: study designs
The Health Outcomes and Reduced Incidence with Zoledronic acid Once yearly (HORIZON) Pivotal Fracture Trial is a multi-national, multi-centre, randomized, placebo-controlled trial of 7,736 women. The study evaluated the potential of a yearly infusion of Aclasta* 5 mg to decrease the risk of fracture in postmenopausal women with osteoporosis. Primary endpoints were incidence of new vertebral fractures and hip fractures at three years compared to placebo. All participants received elemental calcium (1000-1500 mg per day) and vitamin D (400-1200 IU per day).

The second phase 3 Aclasta* study presented at ASBMR investigated the safety and efficacy of treating patients with Aclasta* who were previously taking alendronate. This randomised, double-blind, double-dummy, multi-center trial evaluated a single infusion of 5 mg Aclasta* vs. continuation of therapy with oral alendronate 70 mg weekly for 52 weeks. The study included postmenopausal women with low bone mineral density (n=225). The women must have been treated with alendronate for at least one year prior to randomisation. The primary endpoint of the study was change in lumbar spine BMD from baseline to one year.

About Aclasta*
Aclasta* is being studied in a series of multi-national and multi-centre clinical trials called HORIZON – one of the most comprehensive drug evaluation programs ever undertaken in the area of metabolic bone diseases. This clinical development program involves once-yearly dosing with Aclasta* for osteoporosis. It also includes studies in the prevention of clinical fractures following a hip fracture in men and women, male osteoporosis, corticosteroid-induced osteoporosis, prevention of osteoporosis, treatment of Paget's disease of the bone, and treatment of osteogenesis imperfecta in children.

Approximately 13,000 patients have participated in the ongoing HORIZON program in more than 400 trial centres worldwide. In June 2005, Novartis Pharmaceuticals Canada Inc. received marketing approval for Aclasta* in Paget's disease of bone, and Aclasta* is available across Canada. Aclasta* has been approved in approximately 50 countries, including the EU and Canada, for the treatment of Paget's disease.

Zoledronic acid, the active ingredient of Aclasta*, is also available under the brand name Zometa* for use in other indications, in a different patient population and a dosage of 4 mg every 3 to 4 weeks. In the USA, Novartis is working with the FDA to gain approval for Paget's disease of bone, and the tradename Reclast is currently under review by FDA. Aclasta* is not approved for osteoporosis in Canada. Disclaimer

* Aclasta is a registered trademark

† Aclasta is not yet approved for the treatment of PMO

‡ Non-spine fractures include all sites with the exception of face, fingers and toes

REFERENCES:
1. Black DM, et al. Effect of once-yearly infusion of Zoledronic Acid 5 mg on spine and hip fracture reduction in postmenopausal women with osteoporosis: the HORIZON pivotal fracture trial. Presented at 28th Annual meeting of the American Society for Bone and Mineral Research (ASBMR), 15-19 September 2006, Philadelphia.
2. McClung M, et al. Single infusion of zoledronic acid 5 mg provides sustained benefits in BMD and biomarkers at 12 months in postmenopausal women with low bone mineral density and prior alendronate therapy. Presented at 28th Annual meeting of the American Society for Bone and Mineral Research (ASBMR), 15-19 September 2006, Philadelphia, USA.
3. Lindsay R, et al. A single zoledronic acid 5 mg infusion is preferred over weekly 70 mg oral alendronate in a clinical trial of postmenopausal women with osteoporosis/osteopenia. Presented at Sixth European Congress on Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ECCEO), 15-18 March 2006, Vienna, Austria.
4. Osteoporosis Society of Canada website. http://www.osteoporosis.ca Accessed Sept 20, 2006.
5. National Institutes of Health Osteoporosis and Related Bone Diseases – National Resource Center. Osteoporosis Overview. Department of Health and Human Services. Available at http://www.niams.nih.gov/bone/hi/overview.htm.
6. US Congress, Office of Technology Assessment, Hip Fracture Outcomes in People Age 50 and Over – Background Paper, OTA-BP-H-120 (Washington, DC: US Government Printing Office, July 1994.
7. Recker R, et al. Bone histomorphometry demonstrates normal bone remodeling in postmenopausal women with osteoporosis/osteopenia switched from oral alendronate to IV zoledronic acid. Presented at 28th Annual meeting of the American Society for Bone and Mineral Research (ASBMR), 15-19 September 2006, Philadelphia, USA.
8. Gullberg B, et al. World-wide projections for hip fracture. Osteoporosis Int 1997; 7:407-13.


SOURCE: Novartis Pharmaceuticals Canada Inc.

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« Reply #5 on: October 06, 2006, 06:44:07 pm »

The phrase "degenerative changes in the spine" refers to osteoarthritis of the spine. Osteoarthritis is the most common form of arthritis. Doctors may also refer to it as degenerative arthritis or degenerative joint disease.

Osteoarthritis may affect any joint in your body. When it affects your back, it causes slow deterioration of the disks between the bones (vertebrae) in your spine. This results in narrowing of the spaces between the vertebrae. Bone spurs often form. When bone surfaces rub together, the vertebral joints (facets) and areas around the cartilage become inflamed and painful. Gradually, your spine stiffens and loses flexibility. Once these changes appear on X-rays, osteoarthritis has already started.

If you have osteoarthritis, your doctor will work with you to develop a treatment and pain management plan, which may include exercise, medications and measures to protect your joints. Your doctor may also refer you to a rheumatologist, physical therapist or orthopedic surgeon.

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« Reply #6 on: October 09, 2006, 05:49:49 pm »

Cola Causes Bone Loss
Study: Scientists Link Cola Consumption to Osteoporosis Risk in Women over 60


Too many cans of cola might mean bad news for your bones.

Some women drink diet cola to help keep the weight off, but a new study suggests that drinking diet, regular and decaffeinated cola can actually lower bone density and put women at increased risk for osteoporosis.

According to the National Osteoporosis Foundation, roughly 55 percent of Americans, mostly women, are at risk of developing the brittle-bone disease, which leaves bones dry, weak, and more likely to fracture.

Cola drinks -- such as Pepsi-Cola or Coca-Cola -- seem to increase that risk, according to research published in today's American Journal of Clinical Nutrition.

Researchers from the U.S. Department of Agriculture Human Nutrition Research Center on Aging at Tufts University looked at data from 2,500 men and women who were part of the Framingham Osteoporosis Study. The average age of those studied was just under 60.

The scientists compared how much cola and other sodas people drank to bone mineral density measurements taken from the spine and from three different spots on the hips.

"The more cola that women drank, the lower their bone mineral density was," said Katherine Tucker, study author and director of the Epidemiology and Dietary Assessment Program at Tufts University, in a press release.

Women who drank more cola had reduced bone mineral density at all three hip sites but not at the spine. The link between cola consumption and women's bone loss was unaffected by age, menopausal status, cigarettes, alcohol, or total calcium and vitamin D intake.

Cola consumption did not affect men in the same way. Also, other carbonated drinks were not associated with bone loss.

Previous studies suggested that women who drank more cola had reduced bone density because the cola replaced milk in their diets, meaning the women got less calcium. But in this study, the women who drank the most cola still drank enough milk. However, women who drank cola had less calcium in their diet overall, so that lack of calcium could explain the finding here. Researchers said they'll continue to study the link between cola consumption and bone loss.

In the meantime, women concerned about osteoporosis might want to put down that can of cola.

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« Reply #7 on: November 16, 2006, 08:11:00 am »

WASHINGTON, Nov. 14 -- For overweight patients with osteoarthritis of the knee, even a relatively minor weight loss can make a significant long-term difference in improving quality of life, a researcher said here. Action Points

Explain to patients who ask that excess weight worsens the symptoms and outcomes for patients with osteoarthritis of the knee.


Explain that that this study suggests even a small weight loss, through minimal lifestyle changes, will lessen pain and improve other aspects of quality of life over the long term.


This study was published as an abstract and presented orally at a conference. These data and conclusions should be considered to be preliminary as they have not yet been reviewed and published in a peer-reviewed publication.
A weight loss of about 15 pounds can be enough to lead to significant improvements in quality of life for moderately overweight or mildly obese patients, according to Steffany Haaz, a doctoral candidate at the Johns Hopkins School of Public Health.


And improvements in pain scores during and after losing the weight are sufficient motivation to keep the pounds off, Haaz said before presenting data from a 16-month study at the American College of Rheumatology meeting.


The take-home message is "doctors can now tell their patients they will feel better if you only lose a little weight," Haaz said. The message is less overwhelming for patients than being told they have to get down to a normal weight range.


Haaz noted that many medical societies recommend weight loss for overweight people with osteoarthritis, but the message is often transmitted as urging a fitness program that may be difficult or painful for patients.


She and colleagues tried a four-month behavioral intervention, in which patients attended weekly meetings to learn how to control calories, how to make their lives more physically active, and how to develop strategies for weight loss.


At the end of the four months, the patients had lost an average of 14.9 pounds, with significant improvements (at P<0.001) in physical function, physical limitations, and bodily pain, as measured by the standardized SF-36 test.


"The concern was that they would regain the weight and be as badly off as before," Haaz said.


But in a year of follow-up, that was not the case, she reported here. On average, the participants regained 5.5 pounds, but remained significantly below (P<0.05) their baseline weight, and the improvements on the SF-36 were maintained (P<0.01).


Neither the initial weight loss nor the magnitude of weight gain was associated with age, race, sex, education, baseline physical function, or initial weight.


"No matter how you were doing when you came in the door," Haaz said, "you had an equal shot at improvement with the program."


On the other hand, weight loss was significantly associated with improvements in bodily pain (P<0.05) and improvements in pain after the four-month intervention were significantly associated with keeping the weight off during follow-up (P<0.01).


Weight loss was also associated with improved blood pressure (r=0.34, P<0.05). In turn, low post-intervention blood pressure was the most robust predictor of keeping weight off during follow-up (r=0.46, P=0.01).

"The better they felt at the end of the program, the more likely they were to be able to keep the weight off," Haaz said. The relationship was "reciprocal," she said -- the less weight patients carried, the better they felt.


The study finding was "interesting," because obesity is an important risk factor for a poor outcome in cases of osteoarthritis of the knee, commented Robert Wortmann, M.D., of the University of Oklahoma College of Medicine in Tulsa, who was not part of the research team.


In essence, he said, the study demonstrated that losing less weight than it would take to get a normal body weight could lead to significant improvements in the symptoms of osteoarthritis of the knee.


"I was surprised by that a little bit," Dr. Wortmann said.

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« Reply #8 on: November 16, 2006, 08:18:44 am »

Botox May Cut Knee Osteoarthritis Pain

Nov. 14, 2006 (Washington) -- Botox shots may do more than get rid of wrinkles. A new study shows Botox may decrease the pain of knee osteoarthritis (OA) and potentially prevent or forestall the need for knee replacement surgery.

The preliminary research was presented at the 2006 annual meeting of the American College of Rheumatology.

Injecting Botox directly into the knee joint relieved pain and improved function among people with severe knee osteoarthritis after one month, says researcher Maren Mahowald, MD. She is the rheumatology section chief at the Minneapolis Veteran's Affairs Medical Center and professor of medicine at the University of Minnesota in Minneapolis. Mahowald now plans to evaluate the participants after three and six months.

Botox is a purified form of botulinum toxin type A and has been used to treat wrinkles and creases on the face. It is currently FDA-approved to treat other conditions including excessive sweating, eye disorders, and certain neurologic conditions. Botox is being studied for treatment of headache, ringing in the ears, overactive bladder, diabetic nerve pain, and more.

Pain Reduction

The new study comprised 37 people with moderate and severe knee osteoarthritis. Participants received 100 units of Botox with the anesthetic lidocaine or a dummy injection with lidocaine directly into their knee joints.

After one month, people with severe pain showed a 28% decrease in pain and a 25% improvement in function. By contrast, people with severe knee pain who received a placebo did not show a significant decrease in pain.

Botox injections had almost no effect among people with moderate pain, the study found.

But it's still early, Mahowald points out. "Patients often have continued decreases in pain and improvements in function after one to two months. And I think there will be more improvements at the three-month evaluation."

Exactly how long the effect lasts will be determined at the six-month evaluation, she says. "People may require one to three injections per year to control knee pain, but these injections may obviate the need for knee surgery."

The new findings came about when researchers noticed that people with limb weakness from a stroke or polio did not develop arthritis.

They also noticed that when people with cervical dystonia -- neck muscle stiffness and spasms -- received shots of Botox, their pain improved before their muscle contractions stopped, suggesting that Botox may have a soothing effect on pain nerves.

How Safe Is Botox?

Safe treatments are desperately needed for people with knee osteoarthritis.

"This is an exciting new approach to knee pain due to OA," she says. "Total joint replacement has been the single greatest advance for relieving the pain of OA, but not all patients are candidates."

Some people with knee osteoarthritis are too young for the surgery and others are too old. In addition, nonsteroidal anti-inflammatory drugs, which are commonly taken to relieve the pain of knee osteoarthritis, are not without risks, such as gastrointestinal problems and increased risk of heart attack or stroke. There are also risks from long-term use of opioid pain killers, including risk of addiction.

The Botox treatment seems to be extremely safe, she says.

Muscle weakness can occur when Botox shots are used to treat cervical dystonia, but such effects were not seen when the toxin was injected into the knee joint. "Since we are not injecting it into the muscle, we do not see any weakness to the limb," she says. "We use a very small dose and there are no significant adverse effects due to injection."

'Intriguing Finding'

Shreyasee Amin, MD, an assistant professor of medicine at the Mayo Clinic in Rochester, Minn., tells WebMD that "this is an intriguing finding and Botox could have a role in patients who have risk factors or contraindications to knee surgery. And if it doesn't have side effects to knee strength, it would be very helpful."

Robert L. Wortmann, MD, professor and chairman of the department of rheumatology at the University of Oklahoma in Tulsa, agrees. "It's too early to say for sure what role injections of Botox may play in knee OA," he says. "But having the possibility of something that may alter the course or pain levels for a disease to which there is no known cure is really exciting."

He adds that "if it does have a positive effect in knee OA, it will likely have an effect in hip OA as well."

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« Reply #9 on: November 29, 2006, 08:08:56 am »

Is Degenerative Arthritis The Same As Osteoarthritis?

Osteoarthritis, also called degenerative arthritis is the most common type of arthritis. Degenerative arthritis increases in frequency as people age. Degenerative arthritis may commonly develop years after an injury.

What Is Osteoarthritis?: Osteoarthritis, also referred to as degenerative joint disease, DJD, or wear-and-tear arthritis, is the most common form of arthritis and is caused by the breakdown of cartilage in one or more joints. Cartilage acts as a cushion between the bones of joints. When there is cartilage loss, a joint can become bone-on-bone, which is very painful for the patient.

What Causes Osteoarthritis?: Osteoarthritis which is considered "primary" is mostly a consequence of aging. Water content of cartilage increases while protein composition of cartilage degenerates.

Besides aging, factors which may increase the risk of developing osteoarthritis include:

injury to joints
repetitive use of joints
being overweight
stressing the joints
family history

Secondary osteoarthritis can develop as a consequence of another disease or condition.

What Symptoms Are Associated With Osteoarthritis?: Osteoarthritis only affects the joints, unlike other types of arthritis which may have systemic effects. The most common symptom associated with osteoarthritis is pain in the affected joint after repeated use.

Joint pain is often worse later in the day. The affected joints can swell, feel warm, and become stiff after prolonged inactivity. Osteoarthritis can occur with other forms of arthritis simultaneously. Bone spurs and bony enlargements (nodes) are also characteristic of osteoarthritis.


How Is Osteoarthritis Diagnosed? : X-rays of affected joints can show joint damage associated with osteoarthritis (i.e. cartilage loss, narrowing of joint space, bone spurs).

Blood tests are not used to diagnose osteoarthritis, but may be used to rule out other conditions. Arthrocentesis, joint fluid removal, and joint fluid analysis are possible procedures to assess osteoarthritis. If necessary, arthroscopy, a surgical technique can allow doctors to visualize the joint space and abnormalities which can possibly be repaired.

How Is Osteoarthritis Treated?: Treatment options for osteoarthritis focus on pain relief and restoring function to the affected joint.


Physical treatments - weight reduction, exercise, supports, heat, rest
Medication - topical, oral, or injectible medications to relief pain and inflammation
Alternative treatments or dietary supplements - massage therapy, acupuncture, etc.
Surgical treatments - arthroscopy or joint replacement
Osteoarthritis Prevalence: Osteoarthritis is a common condition associated with aging.


Osteoarthritis affects over 21 million people in the United States.
Osteoarthritis occurs more frequently in males before age 45.
After age 55, osteoarthritis occurs more frequently in females.
All races in the United States appear to be affected equally.

According to the American College of Rheumatology, 70 percent of people over the age of 70 have x-ray evidence of osteoarthritis.

Points Of Interest About Osteoarthritis: Maintaining healthy weight is important. According to the Arthritis Foundation, for every pound of weight lost, there is a four pound reduction in the load exerted on the knee for each step taken.



Another interesting fact concerns the correlation between level of pain and visible damage on x-rays. It's possible for a patient to have a lot of joint damage on x-ray yet have minimal symptoms. Conversely, a patient may have a lot of pain but not much damage observed on x-ray.

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« Reply #10 on: December 06, 2006, 09:04:28 am »



Know Your Organs - Hip Joint-IV
Tuesday December 5 2006

Rheumatoid Arthritis (R.A.): Rheumatoid arthritis starts in the synovium and is mainly inflammatory in nature. The cause is not known. It destroys the joint cartilage damaging the bone next to the cartilage and making it very soft. This is probably the reason why attempts for uncemented implants become impracticable. Rheumatoid arthritis affects multiple joints simultaneously. Unlike in osteoarthritis, rheumatoid arthritis also affects internal organs. Another form of arthritis of the hip joint which is mainly inflammatory in nature is ‘Lupus’. There are other forms of arthritis affecting the hip joint which are basically of inflammatory type but are very rare. Though X-ray changes are similar in both osteoarthritis and rheumatoid arthritis, the distinguishing feature in rheumatoid arthritis is loss of bone density. Unlike in osteoarthritis, blood tests are available in the diagnosis of rheumatoid arthritis. However, they are not accurate. Rheumatoid factor is present in 80 percent of patients with rheumatoid arthritis of longer duration. The percentage of presence of rheumatoid factor in earlier cases of rheumatoid arthritis is much lower. Incidentally it is unfortunate that about 7 percent of people above the age of 70 test positive for rheumatoid factor without the presence of rheumatoid arthritis. The test by itself is, therefore, not very reliable. Anti-inflammatory drugs like NSAIDs are commonly used in both types of arthritis of the hip joint.

Though pain is the most common symptom in both types of arthritis, there is one condition known as ‘osteonecrosis’ which is not an arthritis type but yet presents with severe pain. In osteonecrosis, blood flow to an area of bone is restricted. If inadequate amount of blood flow reaches the bone, the cells will die and the bone may collapse. One of the most common places for osteonecrosis to occur is in the hip joint. In this condition, a part of the femoral head dies and the dead bone cannot withstand the stress of walking. The necrosed head collapses and this leads to irregular shape of the bone. The collapse of the dead bone leads to severe pain. Though the cause is not known, it is believed that excessive use of alcohol and drugs containing cortisone are the common causes.

There are few more conditions which can affect the hip joint and they are: Lumbar pain-referred symptoms:

Many problems in the back and spine can mimic a hip joint problem leading to confusion in diagnosis. Herniated disc and sciatica are the two common conditions which can mimic hip joint pain though in effect the hip joint is free from any problem. Snapping hip syndrome: This condition includes three distinct problems: 1. IT (intertrochantric) band snaps over the outside of the thigh, 2. The deep hip flexor snaps over the front of the hip joint and 3. Tears of the cartilage and the labrum, around the hip socket can cause a snapping sensation. Muscle Strains: Any strain in the muscles around the hip and pelvis can cause pain and spasm. The most common strains are a groin pull and strain in the hamstring muscles of the thigh. Hip Fracture: A fracture in the hip is most common in elderly patients especially if associated with osteoporosis, a condition in which the bone becomes brittle due to low density. Treatment of a broken hip requires surgery to either replace the broken portion or repair it. Childhood hip problems: These are yet another category which needs detailed description of problems affecting a hip from childhood.

Some of the possible problems in this category include: 1. Developmental dysplasia, a condition characterised by dislocation of the hip joint during infancy which might not have pain but might lead to early arthritis at a later period including problems in walking. 2. Leg-calve-perthes disease also known as perthes disease is almost similar to osteonecrosis affecting adults. If it is severe, it can lead to permanent damage to the hip joint and early arthritis.

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« Reply #11 on: December 12, 2006, 01:29:37 pm »



Osteoarthritis is the most common joint disorder with symptoms in the hands, knees, hips, back, and neck. It is unclear exactly how excess weight influences OA. Clearly, being overweight increases the load placed on the joints such as the knee, which increases stress and could possibly hasten the breakdown of cartilage.

For example, it is estimated that a force of nearly three to six times one's body weight is exerted across the knee while walking; an increase in body weight increases the force by this amount.(
 However, overweight has also been associated with higher rates of hand OA in some studies  suggesting the involvement of a circulating systemic factor as well.


Being overweight is a clear risk factor for developing OA. Population-based studies have consistently shown a link between overweight or obesity and knee OA. Estimating prevalence across populations is difficult since definitions for obesity and knee OA vary among investigators.
 Data from the first National Health and Nutrition Examination Survey (HANES I) indicated that obese women had nearly 4 times the risk of knee OA as compared with non-obese women; for obese men, the risk was nearly 5 times greater.

 In a study from Framingham MA, overweight individuals in their thirties who did not have knee OA were at greater risk of later developing the disease. Other investigations, which performed repeated x-rays over time also, have found that being overweight significantly increases the risk of developing knee OA.  It is estimated that persons in the highest quintile of body weight have up to 10 times the risk of knee OA than those in the lowest quintile.

Weight/Height Tables.

 Determining whether a patient would benefit from weight loss involves making some informed decisions. One method that offers general guidelines is to determine whether a patient's weight falls into the "healthy weight ranges" currently recommended for adults. These ranges, which were revised and updated in 1995, are presented in the Optimal Weight/Height Table below. In general, within each range the lower weights are for women, while the higher weights are for men.

**Obesity Is a Risk Factor for Osteoarthritis
Overweight women have nearly 4 times the risk of knee OA; for overweight men the risk is 5 times greater.
**The Benefits of Weight Loss
Even small amounts of weight loss reduce the risk of developing knee OA. Preliminary studies suggest weight loss decreases pain substantially in those with knee OA.
**Being only 10 pounds overweight increases the force on the knee by 30-60 pounds with each step.

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« Reply #12 on: December 30, 2006, 10:05:28 am »


Osteoarthritis, sometimes called degenerative joint disease or osteoarthrosis, is the most common form of arthritis. Osteoarthritis is characterized by the breakdown of joint cartilage and may affect any joint in your body, including those in your fingers, hips, knees, lower back and feet. Initially osteoarthritis may strike only one joint. But if your fingers are affected, multiple hand joints may become arthritic.

The word "arthritis" is a blend of the Greek words "arthron," for joint, and "itis," for inflammation. In other words, arthritis literally means "joint inflammation." Although arthritis is often referred to as one disease, it's not. Arthritis has more than 100 forms and is common cause of disability.

There's no cure for osteoarthritis, but available treatments can relieve pain and help you remain active. In addition, how well you live with osteoarthritis often depends on your behaviors and attitude. If you actively manage your osteoarthritis, you may be able to gain control over your pain.


~Signs and symptoms~

Osteoarthritis often develops slowly, and some people may not experience any signs or symptoms. However, osteoarthritis can cause the following signs and symptoms:

Pain in a joint during or after use, or after a period of inactivity
Discomfort in a joint before or during a change in the weather
Swelling and stiffness in a joint, particularly after using it
Bony lumps on the middle or end joints of your fingers or the base of your thumb
Loss of joint flexibility
The acute pain of early osteoarthritis often tends to fade within a year of its appearance, but it may return if you overuse the affected joint — this is especially true of fingers affected by osteoarthritis.

Areas osteoarthritis typically affects include:

Fingers.
Bony knobs called nodes can enlarge your finger joints, creating a gnarled appearance. Early in the course of the disease, your joints may feel painful or stiff and numb. Eventually, the pain often subsides, leaving just bony nodes that affect the mobility of the joints at the end of your fingers. These nodes tend to run in families and affect more women than men.
Spine. Slow deterioration of disks between the bones along your spine can lead to back and neck pain and stiffness.

Weight-bearing joints.
The parts of your body that bear the majority of your weight — your hips, knees and feet — are more susceptible to osteoarthritis. As cartilage slowly deteriorates over the years, you can develop chronic pain or varying amounts of discomfort when you stand and walk. Swelling also may occur, especially in your knees.
Unless you've been injured or placed unusual stress on a joint, it's uncommon for osteoarthritis to affect your jaw, shoulder, elbows, wrists or ankles.


Causes

With osteoarthritis the problem lies in the cartilage that cushions the ends of bones in your joints. Over time, the cartilage deteriorates, and its smooth surface roughens. Eventually, if the cartilage wears down completely, you may be left with bone rubbing on bone — causing the ends of your bones to become damaged and your joints to become painful.

The exact cause of osteoarthritis isn't known. Researchers suspect that it's a combination of factors, including being overweight, the aging process, joint injury or stress, heredity, and muscle weakness.

Some scientists believe the cartilage damage may be due to a mechanical stress that results in an imbalance of enzymes released from the cartilage cells or from the lining of the joint. When balanced, these enzymes allow for the natural breakdown and regeneration of cartilage. But too much of the enzymes can cause the joint cartilage to break down faster than it's rebuilt. The exact cause of this enzyme imbalance is unclear.

Your body goes to work repairing the damage, but the repairs may be inadequate, resulting instead in growth of new bone along the sides of the existing bone, which produces prominent lumps, most noticeable on hands and feet. Each of the steps in this repair process produces pain. The pain and tenderness over the bony lumps may be most marked early in the course of the disease and less evident later on.

Osteoarthritis commonly occurs in the fingers, neck or lower back. Hips and knees also are frequently affected because they bear most of your weight. You can have chronic pain or varying amounts of discomfort when you stand and walk. Swelling also may occur, especially in your knees.


~Risk factors~

The exact causes of osteoarthritis are unclear, but these factors increase your risk:

*Being 45 years old or older
*Being female
*Having certain hereditary conditions, including defective cartilage and malformed joints
*Having joint injuries caused by physical activity or sports
*Being obese
*Having diseases that change the normal structure and function of cartilage, such as rheumatoid arthritis, hemochromatosis, gout or pseudogout
*Having weak thigh (quadriceps) muscles, which may lead you to develop osteoarthritis in your knees

~When to seek medical advice~

If you have swelling or stiffness in your joints that lasts for more than two weeks, seek medical advice. If your doctor determines that you have osteoarthritis, he or she can work with you to develop a pain management and treatment plan. Also seek medical advice if you experience side effects from arthritis medications, such as nausea, abdominal discomfort, black or tarry stools, constipation, and drowsiness.


~Screening and diagnosis~

Your doctor may use a variety of methods to diagnose osteoarthritis, including a physical examination, blood tests and certain imaging techniques. Doctors use blood tests to diagnose or rule out specific types of arthritis. Fluid may be withdrawn from a joint for analysis (joint aspiration).

Imaging techniques may include X-rays, bone scans, computerized tomography (CT) scans, magnetic resonance imaging (MRI) scans and arthrography — an image taken after dye has been injected into your joint. Imaging techniques can reveal bone spurs, worn-down cartilage and loss of joint space, indicating the presence of osteoarthritis.


~Complications~

The major complication of osteoarthritis is pain. The degree of pain can vary greatly, from being a mild inconvenience to being debilitating. Although arthritis doesn't go away, for many people the acute pain of early osteoarthritis often diminishes within a year. However, it can return if you overuse affected joints. Your doctor can help you determine how to adjust your activities to reduce stress on those joints. People with very painful osteoarthritic joints may require joint replacement surgery for pain relief.


~Treatment~

There's no known cure for osteoarthritis, but treatments can help to reduce pain and maintain joint movement. Your doctor may recommend a combination of treatments that may include medication, self-care, physical therapy and occupational therapy. In some cases, surgical procedures may be necessary.

~Medications~
Medications are used to treat the pain and mild inflammation of osteoarthritis and to improve your joints' functioning. They include both topical medications and oral medications. Over-the-counter (OTC) medications may be sufficient to treat milder osteoarthritis, but stronger prescription medications also are available.

Topical pain relievers.

 Various OTC products are available as creams, gels, ointments and sprays to temporarily relieve arthritis pain. Products containing the pain reliever trolamine salicylate include Aspercreme and Sportscreme. Products containing one or more of the counterirritant medications methyl salicylate, menthol and camphor include Icy Hot and Ben-Gay. Capsaicin, a cream made from the seeds of hot chili peppers, may relieve pain in joints close to your skin surface, such as your fingers, knees and elbows.

Acetaminophen.
Acetaminophen (Tylenol, others) can relieve pain but doesn't reduce inflammation. It has been shown to be effective for people with osteoarthritis who have mild to moderate pain. Taking more than the recommended dosage of acetaminophen can cause liver damage, especially if you consume three or more alcoholic drinks a day. Ask your doctor for guidance on limiting or abstaining from alcohol if you take acetaminophen regularly. Acetaminophen can also affect other medications you may be taking, so be sure to inform your doctor if you're taking it.

NSAIDs.
Nonsteroidal anti-inflammatory drugs (NSAIDs) work in two ways. They relieve pain (such as from osteoarthritis and sore muscles), and they fight inflammation (such as from rheumatoid arthritis). NSAIDs range from OTC aspirin, ibuprofen (Advil, Motrin IB, others) and naproxen sodium (Aleve) — which are also available at higher dosages by prescription — to others that are only available by prescription, such as ketoprofen (Orudis), diclofenac (Cataflam, Voltaren) and nabumetone (Relafen). NSAIDs have risks of side effects that increase when used at high dosages for long-term treatment. Side effects may include ringing in your ears, gastric ulcers, cardiovascular problems, gastrointestinal bleeding, and liver and kidney damage. Consuming alcohol or taking corticosteroids while using NSAIDs also increases your risk of gastrointestinal bleeding.

COX-2 inhibitors.
 Considered as effective for managing pain and inflammation as other NSAIDs, COX-2 inhibitors — such as celecoxib (Celebrex) — may not have the same stomach-damaging effects. But side effects may include fluid retention and causing or exacerbating high blood pressure. Furthermore, this class of drugs has been linked to an increased risk of heart attack and stroke.
Tramadol. Tramadol (Ultram) is a centrally acting analgesic that's available by prescription. Tramadol has no anti-inflammatory effect, but can provide effective pain relief with fewer side effects — such as stomach ulcers and bleeding — than those of NSAIDs. However, tramadol may cause nausea and constipation. It's generally used for short-term treatment of acute flare-ups. Your doctor may recommend using tramadol in combination with acetaminophen to increase pain relief.

Antidepressants.
Independent of their antidepressant properties, antidepressants, especially tricyclics, can help reduce chronic pain. Some people with arthritis also experience symptoms of depression. Antidepressant medications can treat the sleep disturbance that can accompany arthritis. Antidepressants used for arthritis pain and nonrestorative sleep include amitriptyline and nortriptyline (Pamelor, Aventyl).

Injections of pain relievers. Occasionally, your doctor may suggest injecting a joint space with a corticosteroid, which can offer some pain relief and reduce inflammation. Injecting hyaluronic acid derivatives into knee joints (viscosupplementation) can relieve pain from osteoarthritis. Hyaluronic acid is a component of joint fluid, and hylan G-F20 (Synvisc) and sodium hyaluronate (Hyalgan, Supartz, Nuflexxa) are derivatives made from cockscomb.
 
Surgical or other procedures
Surgical procedures can help relieve disability and pain caused by osteoarthritis.

Joint replacement.
In joint replacement surgery (arthroplasty), your surgeon removes your damaged joint and replaces it with a plastic or metal device called a prosthesis. The hip and knee joints are the most commonly replaced joints. But today implants can replace your shoulder, elbow, finger or ankle joints. Joint replacement is most successful in large joints, such as hips and knees — these replacement joints last at least 20 years in about 80 percent of those who receive them. Joint replacement surgery can help you resume an active, pain-free lifestyle. In smaller hand joints, it also can improve appearance and comfort and may improve your joint's mobility.

Arthroscopic lavage and debridement.
 During arthroscopy, your surgeon makes a tiny incision in the area around your joint and then inserts a tubular instrument called an arthroscope. The arthroscope contains a light and a small camera, which projects an enlarged image of the interior of your joint onto a video monitor so that your surgeon can view it. Your surgeon may recommend performing lavage, debridement or both during arthroscopy. Lavage involves using saline to flush out blood, fluid or loose debris inside your joint. Debridement removes loose fragments of bone or cartilage inside your joint. These procedures may provide short-term pain relief and improved joint function for some people. However, recent studies have questioned their effectiveness for certain people with osteoarthritis, including those for whom knee pain is their only symptom and those with severe osteoarthritis.
Repositioning bones. Surgeons can also reposition your bones to help correct deformities (osteotomy).

Fusing bones.
Surgeons also can permanently fuse bones in a joint (arthrodesis) to increase stability and reduce pain. The fused joint, such as an ankle, can then bear weight without pain, but has no flexibility.

~Self-care~

Fortunately, you can relieve much of the discomfort associated with osteoarthritis through healthy-living strategies and self-care techniques, such as the following:

Exercise regularly.
 Different types of exercise achieve different goals. Check with your doctor before beginning a regular exercise program. Your doctor may recommend working with a physical therapist who can design an exercise program to meet your specific needs, and who may also perform manual exercises that stretch and strengthen the muscles around your arthritic joints.

 If you can walk, walking is a good starter exercise. If you can't walk, try a stationary bicycle using no resistance or do hand or arm exercises. Aquatic exercise is another option, and many health clubs with pools offer classes. If you don't have access to a pool, tai chi may be a good alternative. It teaches strengthening, range of motion exercises and relaxation techniques, and can improve balance.

It's good to move each joint in its full range of motion every day. As you move, maintain a slow, steady rhythm. Don't jerk or bounce. Also don't hold your breath, as this can temporarily deprive your muscles of oxygen and tire them. Maintain good posture while you exercise. Avoid exercising tender, injured or severely inflamed joints. If you feel new joint pain, stop. New pain that lasts more than two hours after you exercise probably means you've overdone it. If pain persists for more than a few days, call your doctor.

Control your weight.
Excess weight puts added stress on joints in your back, hips, knees and feet — places where arthritis pain is commonly felt. Excess weight can also make joint surgery more difficult and risky.

Eat a healthy diet.
A healthy diet emphasizing fruit, vegetables and whole grains can help you control your weight and maintain your overall health, allowing you to deal better with your arthritis. However, there's no special diet effective for treating arthritis. It hasn't been proved that eating any particular food will make your joint pain or inflammation better or worse.

Apply heat.
Heat will ease your pain, relax tense, painful muscles and increase the regional flow of blood.
You may find it especially helpful to apply heat before exercising. One of the easiest and most effective ways to apply heat is to take a 15-minute hot shower or bath. Other options are a hot pack, an electric heating pad on its lowest setting or a radiant heat lamp with a 250-watt reflector heat bulb. If your skin has poor sensation or if you have poor circulation, don't use heat treatment.

Choose appropriate footwear.
Wearing comfortable cushioned shoes that properly support your weight is especially important if you have arthritis in your weight-bearing joints or back.

Apply cold for occasional flare-ups.
Cold may dull the sensation of pain during the first day or two. Cold also has a numbing effect and decreases muscle spasms. Don't use cold treatments if you have poor circulation or numbness.
Practice relaxation techniques. Hypnosis, guided imagery, deep breathing and muscle relaxation can all be used to control pain.
Take your medications as recommended. By taking medications regularly instead of waiting for pain to build, you will lessen the overall intensity of your discomfort.

~Coping skills~

Osteoarthritis can affect your everyday activities and overall quality of life. As a result, it's important to adopt coping strategies for dealing with the disease. You might consider the following:

Keep a positive attitude.
Make a plan with your doctor for managing your arthritis. This will help you feel that you're in charge of your disease, rather than vice versa. Studies show that people who take control of their treatment and actively manage their arthritis experience less pain and function better.
 
Use assistive devices.
Your painful knee may need a brace for support. You might also opt for a cane to take weight off the joint as you walk. The cane should be used in the hand opposite the affected joint. If your hands are affected, various helpful tools and gadgets are available to help you maintain an active lifestyle. Contact your pharmacy or doctor's office for information on ordering the items that may help you the most.

Know your limits.
 Rest when you're tired. Arthritis can make you prone to fatigue and muscle weakness — a deep exhaustion that makes everything you do a great effort. A rest or short nap that doesn't interfere with nighttime sleep may help.
Avoid grasping actions that strain your finger joints.
*For example, instead of a clutch-style purse, select one with a shoulder strap.
 
*Use hot water to loosen a jar lid and pressure from your palm to open it, or use a jar opener. Don't twist or use your joints forcefully.

*Spread the weight of an object over several joints. Use both hands, for example, to lift a heavy pan.

*Try using a walking stick or cane.

*Take a break. Periodically relax and stretch.

*Maintain good posture. Poor posture causes uneven weight distribution and may strain ligaments and muscles. The easiest way to improve your posture is by walking. The faster you walk, the harder your muscles must work to keep you upright. Some people find that swimming also helps improve their posture.

*Use your strongest muscles and favor large joints. Don't push open a heavy glass door. Lean into it. To pick up an object, bend your knees and squat while keeping your back straight.

~Complementary and alternative medicine~

Because many complementary medicine methods haven't been studied extensively by researchers using mainstream scientific methods, it's difficult for the scientific community to evaluate their effectiveness and safety.

And with much of today's research funding coming from the pharmaceutical industry, some "low-tech," nontraditional approaches to manage diseases such as arthritis may not get as much attention from the research community as they deserve.
 For these reasons, many Western physicians just don't know enough about these methods to endorse them. Nonetheless a growing body of evidence indicates that complementary medicine practices could have a role in treating and managing some diseases.

Common forms of complementary and alternative medicine for treatment of osteoarthritis include:

*Acupuncture
*Copper jewelry
*Homeopathy
*Magnets
*Some studies have shown positive effects of nutritional supplements such as glucosamine and chondroitin sulfate preparations on osteoarthritis. Studies are ongoing in people who have osteoarthritis to compare results of using glucosamine with those of using chondroitin sulfate and of using a mixture of the two. Don't use glucosamine if you're allergic to shellfish. Glucosamine may raise your blood insulin level if you have diabetes. Chondroitin sulfate may affect blood levels of warfarin (Coumadin) if you're taking that medication.

Be careful when considering alternative therapies. Many are expensive, and some may be harmful. Before taking any complementary medications or dietary supplements, talk with your doctor to learn about potential dangers, particularly if you're taking other medications.

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« Reply #13 on: January 08, 2007, 10:43:54 am »

Dental X-Rays May Warn of Osteoporosis



Jan. 8, 2007 -- Osteoporosis screening may be helped by dental X-rays, British dental experts report.

They've developed computer software that checks routine dental X-rays for possible warning signs of osteoporosis, in which bones become too thin and are more likely to fracture.

The software developers include Keith Horner, PhD, MSc. He's a professor of oral and maxillofacial surgery at England's University of Manchester.

Horner's team tested the software on 652 women aged 45-70 in Belgium, Greece, Sweden, and the U.K.

The women got bone density scans of their hip and spine using a special type of X-ray called dual-energy X-ray absorptiometry (DEXA).

The women also got routine dental X-rays that were analyzed with the computer software.

The DEXA scans showed that 140 women had osteoporosis. The computerized dental X-ray analysis didn't flag all of those cases.

But the dental X-ray analysis showed that 119 women were candidates for further bone tests, which later showed that 72 of those women indeed had osteoporosis.

Tapping Useful Information

The dental X-ray software "should not been seen as a replacement" for DEXA, Horner tells WebMD in an email.

Instead, the software may help dentists note patients who might be candidates for further osteoporosis screening, based on their risk factors and medical history.

"The value of our method is that dentists take millions of these X-rays every year for ordinary dental reasons and they contain useful information that isn't being used," Horner says.

"People may be apparently healthy and never visit their family doctor, but often regularly go to their dentist for checkups."

Horner says the analysis could be done without the software, but not as well.

"The software does it automatically and is free from observer errors," Horner says.

The software isn't available yet.

"We are currently negotiating with an industrial partner to get the software out from the laboratory into the dental offices," Horner says.

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« Reply #14 on: January 29, 2007, 09:00:40 am »

new folder for just Osteoporosis
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« Reply #15 on: February 02, 2007, 09:20:06 am »

Normal Bone

Osteoporosis Bone


It is important to understand that bone is not a hard and lifeless structure; it is, in fact, complex, living tissue. Our bones provide structural support for muscles, protect vital organs, and store the calcium essential for bone density and strength.
Because bones are constantly changing, they can heal and may be affected by diet and exercise. Until the age of about 30, you build and store bone efficiently. Then, as part of the natural aging process, your bones begin to break down faster than new bone can be formed. In women, bone loss accelerates after menopause, when your ovaries stop producing estrogen - the hormone that protects against bone loss.

Think of your bones as a savings account. There is only as much bone mass in your account as you deposit. The critical years for building bone mass are from prior to adolescence to about age 30. Some experts believe that young women can increase their bone mass by as much as 20 percent - a critical factor in protecting against osteoporosis.

~Assessing Your Bone Health
 

To determine if you have osteoporosis or may be at risk for the disease, your doctor will ask you a variety of questions about your lifestyle and medical history. Your doctor will want to know if anyone in your family has suffered from osteoporosis or if they have fractured bones. Based on a comprehensive medical assessment, your doctor may recommend that you have your bone mass measured.
A bone mass measurement is the only way to tell if you have osteoporosis. Specialized tests called bone density tests can measure bone density in various sites of the body. A bone density test can:

Detect osteoporosis before a fracture occurs
Predict your chances of fracturing in the future
Determine your rate of bone loss and/or monitor the effects of treatment if the test is conducted at intervals of a year or more.
 

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« Reply #16 on: February 02, 2007, 09:58:48 am »

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« Reply #17 on: September 23, 2007, 11:08:55 am »

Cautious Optimism for Sufferers of Joint Pain



For decades patients with osteoarthritis resigned themselves to what seemed to be the body’s inevitable breakdown. People grow old, doctors told them. Hips and knees wear out. What can you do?

But advances in the last decade, particularly in genetics, have led to a fundamental rethinking of osteoarthritis. “The way we think about and research osteoarthritis now is to not be nihilistic or totally negative,” said Dr. Steven Abramson, director of rheumatology at the Hospital for Joint Diseases at New York University. “This is a disease you can intervene in.”

Intervention is increasingly needed. Osteoarthritis is incurable, and treatments for it are inadequate. Currently 21 million Americans are coping with the disease, and it is the leading cause of disability in people ages 65 and older. Those numbers are likely to explode as the baby boomers age and as obesity rates rise.

Most patients must rely on oral pain relievers, which provide only temporary or partial relief, or invasive surgery to replace stiff and damaged joints.

New therapies have been slow to arrive, partly because osteoarthritis has been thought of as the result of mechanical wear and tear on the joints. “What we’ve learned in the last 5 or 10 years is that that’s not entirely true,” said Dr. Abramson. “There are abnormal chemicals and molecules being produced by these joints that are causing the joint to self-destruct.”

The joint damage occurring in osteoarthritis resembles that in rheumatoid arthritis: much of it results from the immune system’s misdirected attack on the body’s own cells. Screening of rheumatoid arthritis patients for genetic mutations contributing to the process has led to effective medicines that provide relief by inhibiting inflammatory proteins like tumor necrosis factor and interleukin-1.

Osteoarthritis researchers have been quick to see the possibilities. “Those drugs have revolutionized treatment,” Dr. Abramson said. “There are similar molecules in osteoarthritis that might be amenable to drug therapy.” At Brigham and Women’s Hospital in Boston, Dr. Christopher Evans, director of the Center for Molecular Orthopedics, is injecting a therapeutic gene directly into arthritic knees. Cells within the knee absorb the gene and incorporate it into their own DNA, then begin to express it locally as a sustained release of beneficial proteins that block the action of interleukin-1 and other cartilage-degrading compounds. The procedure, still highly experimental, essentially turns the joint into, as Dr. Evans puts it, “a factory that makes its own medicine.”

Genetic studies are providing a number of other clues to potential treatments. After using magnetic resonance imaging to evaluate the joints of 115 siblings from 48 families with a history of osteoarthritis, a British research team recently discovered that certain characteristic lesions were as much as 99 percent likely to be inherited -- likely to result from a defective gene, that is, rather than from wear on the joint. Once the gene is found, scientists may be able to block the damaging proteins it encodes.

In 2006, scientists at Brown Medical School and Rhode Island Hospital found that the loss of just a single gene, called matrilin-3, greatly increased rates of osteoarthritis in aging lab mice. Among other functions, the gene controls bone mineral density in adults. “In the long term, it helps us understand the mechanism of human osteoarthritis development,” said Dr. Qian Chen, head of orthopaedic biology research at Rhode Island Hospital. “Very few molecules have even been associated with osteoarthritis, so this is a huge deal.”

These types of findings may be preliminary, but they do mark a new beginning. As scientists peer deeper into the genetic underpinnings of osteoarthritis, they are finding something completely unexpected. Hope.
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« Reply #18 on: September 23, 2007, 11:12:25 am »

Looking for Alternatives to Ligament Replacement Surgery


ANTERIOR cruciate ligaments are stubborn healers. Once one is torn playing basketball or soccer, its ends don't rejoin, form a blood clot or mend — possibly because lubricating fluid in the knee makes it difficult. So to be able to return to pivoting sports, as many as 250,000 patients undergo surgery to reconstruct their ligaments each year with grafts harvested from their hamstrings or patella tendons.

New research from the Children's Hospital Boston suggests that one day it may be possible to regenerate damaged anterior cruciate ligaments rather replace them, offering hundreds of thousands of patients a less invasive surgery and a shot at slowing the onset of osteoarthritis. Scientists recently demonstrated that inserting a collagen gel mixed with platelet-rich blood plasma into a wound site of a canine model provides a bridge so that the torn fiber ends can reconnect. The procedure leads to a 40 percent increase of mechanical strength at six weeks compared with 14 percent for untreated tears, according to their results, published this month in the Journal of Orthopaedic Research.

The study is one of the first to challenge the widely held belief among orthopedic doctors that anterior cruciate ligaments are incapable of repair. Its lead author, Dr. Martha Murray, an orthopedic surgeon at Children's Hospital Boston, found that cells in the ligaments do try to migrate to the wound, secrete growth factors and create new tissue, but to get the job done they need a bridge to unite frayed ends that is resistant to getting washed away by knee fluid.

"Those cells clearly have the potential to heal," said Dr. Jo A. Hannafin, a sports medicine clinician-scientist at the Hospital for Special Surgery in Manhattan. In fact, Dr. Hannafin said she has even seen the ligaments of a few lucky patients mend without surgery, as did a 13-year-old patient that Dr. Beth Shubin Stein, a colleague from the hospital, treated. Two M.R.I.'s showed that the teenager had ruptured her anterior cruciate ligament, but surgery was put off because she was still growing. She spent three months in physical therapy and double that in a functional brace, after which another M.R.I. showed she had an intact ligament. It doesn't happen often, Dr. Hannafin noted, but that it happens at all suggests that the ligaments can regenerate given favorable conditions.

Some doctors argue that alternatives to reconstruction should be researched because although the surgery gives most athletes enough stability to return to pivoting sports, it doesn't fully restore knee mechanics or prevent osteoarthritis. One study found that 14 years after surgery, 78 percent of participants with torn anterior cruciate ligaments — those who had them reconstructed and those who didn't — had osteoarthritis. (But skeptics say that surgical technique has vastly improved and that today's patients won't suffer the same fate.)

"The problem is in the long term when you replace the ligament, you don't make the knee normal again," Dr. Murray said. "You've taken something that's triangular and complex in shape and replaced it with something that looks more like a rope." Different parts of an anterior cruciate ligament are put to use when a knee with an uninjured ligament bends. But that doesn't happen with a reconstructed ligament. Dr. Murray hypothesizes this peculiarity may cause the knee to break down over time.

"What God gave us is not exactly what we get in the knee when we reconstruct it," said Dr. Henry Goitz, an orthopedic surgeon at the Henry Ford Hospital in Detroit. "We don't know to the extent we return the injured A.C.L. to preinjury status."

The National Institutes of Health is financing studies of regeneration of the anterior cruciate ligament because repairing the damage to the original ligament would retain its precise structure as well as its nerves, which provide feedback to the brain. "You wouldn't need a graft, perhaps it might heal faster and it would certainly be a more anatomical scenario," said Dr. David McAllister, an orthopedic surgeon at U.C.L.A. Medical Center in Los Angeles.

Regeneration surgery is years away from patient use. To date, Dr. Murray has tried her gel only on partial tears, not the far more common total rupture. And it would need to be demonstrated that regenerated ligaments were durable over time.

Even with the study's limitations, Dr. Goitz acknowledged, "the fact that you can show some kind of healing is exciting."


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« Reply #19 on: September 23, 2007, 11:21:19 am »

Obesity's Hidden Toll on Joints



Dr. Joan Bathon is director of the Johns Hopkins Arthritis Center and co-deputy director of the division of rheumatology at the Johns Hopkins Bayview Medical Center in Baltimore.

Q. Osteoarthritis is more common in younger men and strikes women at older ages. Why?

A. Osteoarthritis is thought to be more common in men in their younger years because of trauma — meniscal tears, sports-related injuries. And then it shifts over to women as aging and obesity take over — the big risk factors in women. It is probably in the mid-40s to mid-50s that it transitions.

Q. Are menopause and decreased hormone levels to blame?

A. Osteoarthritis is more common in everybody as we get older. But in the knee and some of the joints in the hands, it is more common in women than in men. Whether that’s hormonal or not is controversial; there are some studies suggesting that lack of estrogen is a predisposing factor for it, but that’s not corroborated in other studies. So I think that still needs further study, whether hormones are really playing a role or not. Some people have argued that women’s thighbones come off at a sharper angle from the wider pelvis, and that that may be a contributor as well. It might not be hormonal.

Q. Is it possible to know whether someone is at risk for osteoarthritis?

A. Most of the risk factors that have been studied are knee-related, and most of the risk factors for knee osteoarthritis are relatively weak. We don’t have an overwhelming array of risk factors that really tell us who’s going to get it. And it’s so common as people age -- that’s far and away the biggest predictor.

Q. Do women and men develop osteoarthritis in different joints?

A. Men get it in the hip a little bit more than women; women get it in the knee more than men. Hand osteoarthritis is more common in women as well, in what we call the distal joints at the very end of the fingers. But, of course, the entire spine can be affected by osteoarthritis, and the big toes, which form bunions. There’s this reigning theory that bunions are a problem for women who wear tight shoes. But whether that’s really ever borne out in data, I don’t know. I see a lot of men with bunions, too. The spine is pretty equal: just about everybody who reaches 70 or so — or even younger — is going to have osteoarthritis of the spine in some area. And most of those are going to have some degree of osteoarthritis in the knee as well.

Q. How has the aging of the boomer generation affected osteoarthritis care?

A. Well, first of all, it’s the aging process plus obesity. People are living longer and are more obese, so it’s affecting people at both ends of the age spectrum. They’re living long enough so that everybody’s getting osteoarthritis; and then because of obesity starting so early, we anticipate that people are going to start developing osteoarthritis at a much earlier age. So that where one might have had 10 or 20 years of osteoarthritis in the knee, maybe now what we’re going to see is 30 or 40 years. And I don’t think we know the full implications of this yet.

Q. Are you seeing more knee replacements?

A. We definitely are seeing increasing numbers of people coming in for knee replacement. And revisions: if people live longer with their osteoarthritis, they’re going to need total knee replacements earlier. How many times can you revise a knee replacement? If somebody gets her first knee replacement at 40 instead of 60, and the replacement lasts about 10 or 15 years, is there enough good bone in the system to be able to have three and four and five revisions? I think the health-care costs are going to be astronomical, from a surgical point of view, because we still don’t have any good treatment for this illness.

Q. Will a younger age at onset affect productivity?

A. As people develop osteoarthritis earlier, they’re going to drop out of the workforce earlier, because it is very difficult to do full-time work, especially if there’s any physical component to it, when you have chronic knee pain. So people could be spending more and more time on disability at an earlier age.

Q. How have newer scanning techniques, like magnetic resonance imaging, affected understanding of osteoarthritis?

A. The M.R.I. offers us the opportunity to find some markers of the disease much earlier. And also in the blood, we’re looking for biomarkers that would tell us if somebody has early osteoarthritis years before they develop the severe radiographic findings. If there’s a biomarker or an M.R.I. marker that’s more sensitive and changes with treatment, then drug companies would be much more interested in doing work in this area. If they have to do a study, like they do now, using X-rays over two to three years — because that’s the time you have to look at to see changes — they just get really discouraged. It’s too expensive. So the National Institutes of Health’s Osteoarthritis Initiative study is using the latest and greatest M.R.I. machine, the 3-tesla, which is the most powerful magnet now available. It’s an attempt to really stimulate some interest in moving treatment of this disease forward.

Q. Do you advise patients to take glucoasmine?

A. Glucosamine doesn’t seem to be harmful, and it might have some analgesic effect. But as far as slowing the cartilage degradation, there have been two big studies in Europe showing that glucosamine does slow the progression of the disease, but they’re both funded by the company that makes it. And there are independent studies that are smaller that suggest that glucosamine is not disease-modifying. So we don’t push it. If patients want to take it, we say sure, it can’t hurt. However, there was a study a few years ago that showed that the amount of glucosamine that was claimed to be in the preparation was nowhere near the amount that was actually in the preparation. These are over-the-counter, nonregulated compounds. So one has to be careful.

Q. What needs to happen in order for treatments to improve?

A. Trying to find a better way to diagnose the disease, and then identifying some therapeutics that really work for people to decrease pain. We need better markers to diagnose the disease — that’ll stimulate pharmaceutical research. We need more investigators in the field to understand the molecules and the stresses that cause osteoarthritis, and therefore treatments that would make it better. But we also need a real tremendous social change in the way we live, because we’re just heading in all the wrong directions. We have reached a point where we have this incredible longevity and health, and now we’re counteracting it with obesity, which is then going to turn around and reduce our lifespan.

Q. So obesity is the big issue in osteoarthritis today?

A. It is right now; it really is. Because even if we come up with a great drug, it’s not likely to be able to counteract 300 pounds of force on your knee. The thing to remember is, every pound that a person gains puts about three to four times that amount of weight on the knee. It can’t withstand all this tremendous weight. So the new drugs are important, but really, lifestyle modification is absolutely critical. The most important thing is to adopt a very healthy lifestyle: continue to get exercise, daily if possible; watch the weight; eat healthily. Those are your best defenses against getting osteoarthritis.
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« Reply #20 on: October 16, 2007, 11:19:44 am »

Cautious Optimism for Sufferers of Joint Pain



For decades patients with osteoarthritis resigned themselves to what seemed to be the body’s inevitable breakdown. People grow old, doctors told them. Hips and knees wear out. What can you do?

But advances in the last decade, particularly in genetics, have led to a fundamental rethinking of osteoarthritis. “The way we think about and research osteoarthritis now is to not be nihilistic or totally negative,” said Dr. Steven Abramson, director of rheumatology at the Hospital for Joint Diseases at New York University. “This is a disease you can intervene in.”

Intervention is increasingly needed. Osteoarthritis is incurable, and treatments for it are inadequate. Currently 21 million Americans are coping with the disease, and it is the leading cause of disability in people ages 65 and older. Those numbers are likely to explode as the baby boomers age and as obesity rates rise.

Most patients must rely on oral pain relievers, which provide only temporary or partial relief, or invasive surgery to replace stiff and damaged joints.

New therapies have been slow to arrive, partly because osteoarthritis has been thought of as the result of mechanical wear and tear on the joints. “What we’ve learned in the last 5 or 10 years is that that’s not entirely true,” said Dr. Abramson. “There are abnormal chemicals and molecules being produced by these joints that are causing the joint to self-destruct.”

The joint damage occurring in osteoarthritis resembles that in rheumatoid arthritis: much of it results from the immune system’s misdirected attack on the body’s own cells. Screening of rheumatoid arthritis patients for genetic mutations contributing to the process has led to effective medicines that provide relief by inhibiting inflammatory proteins like tumor necrosis factor and interleukin-1.

Osteoarthritis researchers have been quick to see the possibilities. “Those drugs have revolutionized treatment,” Dr. Abramson said. “There are similar molecules in osteoarthritis that might be amenable to drug therapy.”

At Brigham and Women’s Hospital in Boston, Dr. Christopher Evans, director of the Center for Molecular Orthopedics, is injecting a therapeutic gene directly into arthritic knees. Cells within the knee absorb the gene and incorporate it into their own DNA, then begin to express it locally as a sustained release of beneficial proteins that block the action of interleukin-1 and other cartilage-degrading compounds. The procedure, considered highly experimental, essentially turns the joint into, as Dr. Evans puts it, “a factory that makes its own medicine.”

Such unproven treatments, however, are not without their dangers. An experimental gene therapy trial was halted in 1999 following the death of a teenager at the University of Pennsylvania. And investigators are looking into an incident in July in which a 36-year-old woman with rheumatoid arthritis died after genetically engineered viruses were injected into her knee.

Genetic studies are providing a number of other clues to potential treatments. After using magnetic resonance imaging to evaluate the joints of 115 siblings from 48 families with a history of osteoarthritis, a British research team recently discovered that certain characteristic lesions were as much as 99 percent likely to be inherited -- likely to result from a defective gene, that is, rather than from wear on the joint. Once the gene is found, scientists may be able to block the damaging proteins it encodes.

In 2006, scientists at Brown Medical School and Rhode Island Hospital found that the loss of just a single gene, called matrilin-3, greatly increased rates of osteoarthritis in aging lab mice. Among other functions, the gene controls bone mineral density in adults. “In the long term, it helps us understand the mechanism of human osteoarthritis development,” said Dr. Qian Chen, head of orthopaedic biology research at Rhode Island Hospital. “Very few molecules have even been associated with osteoarthritis, so this is a huge deal.”

These types of findings may be preliminary, but they do mark a new beginning. As scientists peer deeper into the genetic underpinnings of osteoarthritis, they are finding something completely unexpected. Hope.
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« Reply #21 on: January 29, 2009, 04:22:17 pm »

Knee osteoarthritis study needs volunteers

Jan. 28, 2009
 The Arthritis Research Institute of America, Barry University and the University of Kentucky are collaborating on an exercise study that will provide tests, X-rays and five training sessions free to participants who have knee osteoarthritis.

The eight-week study is home-based and does not involve any drugs. Study volunteers are not compensated. The study is seeking volunteers who are 50 years of age or older and haven’t exercised in six months or more.

The study is limited to volunteers with osteoarthritis only. Researchers are not studying those with rheumatoid arthritis, fibromyalgia, gout, lupus or other rheumatic diseases.

For information, call Matt Rogers at 461-4054 or e-mail mrogers@preventarthritis.org.
Tampa Bay,FL Areas
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« Reply #22 on: January 31, 2009, 10:06:43 pm »

Eli Lilly tests antidepressant for osteoarthritis


Drugmaker Eli Lilly said Friday its antidepressant Cymbalta showed some effectiveness at relieving osteoarthritis pain of the knees.

The company said patients taking Cymbalta over 13 weeks had less pain, as measured on a questionnaire, than patients taking a dummy pill. In the study, 65 percent of Cymbalta patients reported significantly less pain, compared with 44 percent of those taking placebo.

However, patients taking the drug did show significant improvement in walking ability, mood or overall enjoyment of life.

Thirty one Cymbalta patients dropped out of the study due to adverse reactions, which included nausea, constipation and excessive sweating.

Cymbalta is already approved to treat depression, anxiety disorder, diabetic nerve pain and fibromyalgia. It is Lilly's second-best-selling drug.

Shares of Eli Lilly & Co. fell 73 cents to $37.24 in morning trading.
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« Reply #23 on: March 19, 2009, 12:36:05 pm »

Osteoarthritis, sometimes called degenerative joint disease or osteoarthrosis, is the most common form of arthritis. Osteoarthritis occurs when cartilage in your joints wears down over time.

Osteoarthritis can affect any joint in your body, though it most commonly affects joints in your hands, hips, knees and spine. Osteoarthritis typically affects just one joint, though in some cases, such as with finger arthritis, several joints can be affected.

Osteoarthritis gradually worsens with time, and no cure exists. But osteoarthritis treatments can relieve pain and help you remain active. Taking steps to actively manage your osteoarthritis may help you gain control over your osteoarthritis pain.


Causes:
Osteoarthritis occurs when the cartilage that cushions the ends of bones in your joints deteriorates over time. The smooth surface of the cartilage becomes rough, causing irritation. Eventually, if the cartilage wears down completely, you may be left with bone rubbing on bone — causing the ends of your bones to become damaged and your joints to become painful.

It isn't clear what causes osteoarthritis in most cases. Researchers suspect that it's a combination of factors, including being overweight, the aging process, joint injury or stress, heredity, and muscle weakness.

Osteoarthritis occurs when the cartilage that cushions the ends of bones in your joints deteriorates over time. The smooth surface of the cartilage becomes rough, causing irritation. Eventually, if the cartilage wears down completely, you may be left with bone rubbing on bone — causing the ends of your bones to become damaged and your joints to become painful.

It isn't clear what causes osteoarthritis in most cases. Researchers suspect that it's a combination of factors, including being overweight, the aging process, joint injury or stress, heredity, and muscle weakness.

Factors that increase your risk of osteoarthritis include:

    * Older age. Osteoarthritis typically occurs in older adults. People under 40 rarely experience osteoarthritis.
    * Sex. Women are more likely to develop osteoarthritis, though it isn't clear why.
    * Bone deformities. Some people are born with malformed joints or defective cartilage, which can increase the risk of osteoarthritis.
    * Joint injuries. Injuries, such as those that occur when playing sports or from an accident, may increase the risk of osteoarthritis.
    * Obesity. Carrying more body weight places more stress on your weight-bearing joints, such as your knees. But obesity has also been linked to an increased risk of osteoarthritis in the hands, as well.
    * Other diseases that affect the bones and joints. Bone and joint diseases that increase the risk of osteoarthritis include gout, rheumatoid arthritis, Paget's disease of bone and septic arthritis.

When to seek medical advice
If you have swelling or stiffness in your joints that lasts for more than two weeks, make an appointment with your doctor.

If you're already taking medication for osteoarthritis, contact your doctor if you're experiencing side effects from arthritis medications. Tell your doctor if you experience side effects such as nausea, abdominal discomfort, black or tarry stools, constipation, or drowsiness.

Tests and diagnosis
If your doctor suspects you have osteoarthritis, he or she will examine your affected joint and ask you questions about your joint pain. To better understand the cause of your pain, he or she may also recommend:

    * X-rays. X-ray images of your affected joint may reveal a narrowing space within a joint, which indicates that the cartilage is breaking down. An X-ray may also show bone spurs around a joint.
    * Blood tests. Blood tests may help rule out other causes of joint pain, such as rheumatoid arthritis.
    * Joint fluid analysis. Your doctor may use a long needle to draw fluid out of the affected joint. Examining and testing the fluid around your joint can determine if your pain is caused by gout or an infection.
    * Examining the joint with a tiny camera (arthroscopy). In some cases, your doctor may recommend arthroscopy to see inside your joint in order to determine the cause of your pain. During arthroscopy, small incisions are made around your joint and a tiny camera is inserted to see inside your joint. Your doctor watches a video screen to look for abnormalities within your joint.

Osteoarthritis is a degenerative disease that worsens over time. As many as a third of people with osteoarthritis will eventually experience significant disability. Joint pain and stiffness may become severe enough to make getting through the day difficult, if not impossible. Some people are no longer able to work. When joint pain is this severe, doctors typically suggest joint replacement surgery. For those who aren't able to undergo surgery, pain medications and assistive devices can make daily tasks more manageable.


Treatments and drugs

There's no known cure for osteoarthritis, but treatments can help to reduce pain and maintain joint movement so that you can go about your daily tasks. While medications and joint replacement surgery are key components of treatment for osteoarthritis, your doctor will likely recommend you try all other possible solutions before you consider those options. Eventually the pain may become severe so that medications and surgery may be necessary.

Initial treatment options for mild osteoarthritis
For mild osteoarthritis pain that is bothersome, but not enough to have a great impact on your daily activities, your doctor may recommend that you:

    * Rest. If you're experiencing pain or inflammation in your joint, rest it for 12 to 24 hours. Find activities that don't require you to use your joint repetitively. Try taking a 10-minute break every hour.
    * Exercise. With your doctor's approval, get regular exercise when you feel up to it. Stick to gentle exercises, such as walking, biking or swimming. Exercise can increase your endurance and strengthen the muscles around your joint, making your joint more stable. Avoid exercising tender, injured or swollen joints. If you feel new joint pain, stop. New pain that lasts more than two hours after you exercise probably means you've overdone it.
    * Lose weight. Being overweight or obese increases the stress on your weight-bearing joints, such as your knees and your hips. Even a small amount of weight loss can relieve some pressure and reduce your pain. Aim to lose 1 or 2 pounds a week, at most. Talk to your doctor about healthy ways to lose weight. Most people combine changes in their diet with increased exercise.
    * Use heat and cold to manage pain. Both heat and cold can relieve pain in your joint. Heat also relieves stiffness and cold can relieve muscle spasms. Soothe your painful joint with heat using a heating pad, hot water bottle or warm bath. Heat should be warm, not hot. Apply heat for 20 minutes several times a day. Cool the pain in your joint with cold treatments, such as with ice packs. You can use cold treatments several times a day, but don't use cold treatments if you have poor circulation or numbness.
    * Work with a physical therapist. Ask your doctor for a referral to a physical therapist. The physical therapist can work with you to create an individualized exercise plan that will strengthen the muscles around your joint, increase your range of motion in your joint and reduce your pain.
    * Find ways to avoid stressing your joints. Find ways to go about your day without stressing your joints. An occupational therapist can help you discover ways to do everyday tasks or do your job without putting extra stress on your already painful joint. For instance, a toothbrush with a large grip could make brushing your teeth easier if you have finger osteoarthritis. A special seat in your shower could help relieve the pain of standing if you have knee osteoarthritis.
    * Apply over-the-counter pain creams. Creams and gels available at the drugstore may provide temporary relief from osteoarthritis pain. Some creams numb the pain by creating a hot or cool sensation. Other creams contain medications, such as aspirin-like compounds, that are absorbed into your skin. Read the label so you know what you're using. Pain creams work best on joints that are close the surface of your skin, such as your knees and fingers.
    * Try braces or shoe inserts. Consider trying special splints, braces, shoe inserts or other medical devices that can help reduce your pain. These devices can immobilize or support your joint to help you keep pressure off it.
    * Take a chronic pain class. The Arthritis Foundation and some medical centers have classes for people with osteoarthritis or chronic pain. Ask your doctor about classes in your area or check with the Arthritis Foundation. These classes teach skills that help you manage your osteoarthritis pain. And you'll meet other people with osteoarthritis and learn their tips for reducing joint pain or coping with your pain.

Treatment options for moderate osteoarthritis
Osteoarthritis pain that persists despite initial treatment may require medications in addition to initial treatment options. Don't assume that taking a medication is all you need. In order to get the most from your treatment, continue exercising when possible and resting when you need to. If you're overweight, continue working to lose weight.

Medications that may be useful for moderate arthritis include:

    * Acetaminophen. Acetaminophen (Tylenol, others) can relieve pain, but doesn't reduce inflammation. It has been shown to be effective for people with osteoarthritis who have mild to moderate pain. Taking more than the recommended dosage of acetaminophen can cause liver damage, especially if you consume three or more alcoholic drinks a day. Ask your doctor for guidance on limiting or abstaining from alcohol if you take acetaminophen regularly. Acetaminophen can also affect other medications you may be taking, so be sure to inform your doctor if you're taking it.
    * NSAIDs. Nonsteroidal anti-inflammatory drugs (NSAIDs) can relieve pain and reduce inflammation. Over-the-counter NSAIDs include ibuprofen (Advil, Motrin, others) and naproxen sodium (Aleve). Stronger versions of these NSAIDs and others are available by prescription. NSAIDs have risks of side effects that increase when used at high dosages for long-term treatment. Side effects may include ringing in your ears, gastric ulcers, cardiovascular problems, gastrointestinal bleeding, and liver and kidney damage. Consuming alcohol or taking corticosteroids while using NSAIDs also increases your risk of gastrointestinal bleeding.
    * Tramadol. Tramadol (Ultram) is a centrally acting analgesic that's available by prescription. Tramadol has no anti-inflammatory effect, but can provide effective pain relief with fewer side effects - such as stomach ulcers and bleeding - than those of NSAIDs. However, tramadol may cause nausea and constipation. It's generally used for short-term treatment of acute flare-ups. Your doctor may recommend using tramadol in combination with acetaminophen to increase pain relief.

Treatment options for severe osteoarthritis
If you've tried other treatments but are still experiencing severe pain and disability, you and your doctor can discuss other treatments including:

    * Stronger painkillers. Prescription pain pills, such as codeine and propoxyphene (Darvon), may provide relief from more severe osteoarthritis pain. These stronger medications carry a risk of dependence, though that risk is thought to be small in people who have severe pain. Side effects may include nausea, constipation and sleepiness.
    * Cortisone shots. Injections of corticosteroid medications may relieve pain in your joint. During this procedure your doctor numbs the area around your joint and then inserts a needle into the space within your joint and injects medication. It isn't clear how or why corticosteroid injections work in people with osteoarthritis. Your doctor may limit the number of injections you can have each year, since too many corticosteroid injections may cause joint damage.
    * Visco-supplementation. Injections of hyaluronic acid derivatives (Hyalgan, Synvisc) may offer pain relief by providing some cushioning in your knee. These treatments are made of rooster combs and are similar to a component normally found in your joint fluid. Visco-supplementation is only approved for knee osteoarthritis, though researchers are studying its use in other joints. Injections are typically given weekly over several weeks. Pain relief may last for a few months. Possible risks include infection, swelling and joint pain. People who are sensitive to birds, feathers or eggs shouldn't undergo visco-supplementation treatments.

Surgery for osteoarthritis
Surgery is generally reserved for severe osteoarthritis that isn't relieved by other treatments. You may consider surgery if your osteoarthritis makes it very difficult to go about your daily tasks. Surgical treatments include:

    * Joint replacement. In joint replacement surgery (arthroplasty), your surgeon removes your damaged joint surfaces and replaces them with plastic and metal devices called prostheses. The hip and knee joints are the most commonly replaced joints. But today implants can replace your shoulder, elbow, finger or ankle joints. How long your new joint will last depends on how you use it. Some knee and hip joints can last 20 years. Joint replacement surgery can help you resume an active, pain-free lifestyle. In smaller hand joints, it can also improve appearance and comfort and may improve your joint's mobility. Joint replacement surgery carries a small risk of infection and bleeding. Artificial joints can wear or come loose, and may need to eventually be replaced.
    * Cleaning up the area around the joint (debridement). Your surgeon may recommend removing loose pieces of cartilage and bone from around your joint to relieve your pain. Debridement is most useful if you're experiencing a locking sensation from a torn cartilage or loose debris in your knee joint. Debridement is typically done arthroscopically, meaning only small incisions are made in your body. A tiny video camera is inserted through the incision to allow your surgeon to see inside your joint. The surgeon uses special surgical tools to clean out any debris pieces from your joint.
    * Realigning bones. Surgery to realign bones may relieve pain. These types of procedures are typically used when joint replacement surgery isn't an option, such as in younger people with osteoarthritis. During a procedure called an osteotomy, the surgeon cuts across the bone either above or below the knee to realign the leg. Osteotomy can reduce knee pain by transferring the force of the joint away from the worn-out part of the knee.
    * Fusing bones. Surgeons also can permanently fuse bones in a joint (arthrodesis) to increase stability and reduce pain. The fused joint, such as an ankle, can then bear weight without pain, but has no flexibility. Arthrodesis may be an option if you experience severe pain in your joint, but can't undergo joint replacement surgery.

Osteoarthritis pain may flare from time to time. In order to prevent and cope with these flares in pain and stiffness, try self-care techniques. Try to:

    * Eat a healthy diet. A healthy diet emphasizing fruit, vegetables and whole grains can help you control your weight and maintain your overall health, allowing you to deal better with your arthritis. However, there's no special diet effective for treating arthritis. It hasn't been proved that eating any particular food will make your joint pain or inflammation better or worse.
    * Take your medications as recommended. By taking medications regularly instead of waiting for pain to build, you will lessen the overall intensity of your discomfort.
    * Use assistive devices. Assistive devices can make it easier to go about your day without stressing your painful joint. A cane may take weight off your knee or hip as you walk. Gripping and grabbing tools may make it easier to work in the kitchen if you have osteoarthritis in your fingers. Your doctor or occupational therapist may have ideas about what sorts of assistive devices may be helpful to you. Catalogs and medical supply stores may also be places to look for ideas.
    * Avoid grasping actions that strain your finger joints. For example, instead of a clutch-style purse, select one with a shoulder strap. Use hot water to loosen a jar lid and pressure from your palm to open it, or use a jar opener. Don't twist or use your joints forcefully.
    * Spread the weight of an object over several joints. Use both hands, for example, to lift a heavy pan. Try using a walking stick or cane.
    * Maintain good posture. Poor posture causes uneven weight distribution and may strain ligaments and muscles. The easiest way to improve your posture is by walking. The faster you walk, the harder your muscles must work to keep you upright. Some people find that swimming also helps improve their posture.
    * Use your strongest muscles and favor large joints. Don't push open a heavy glass door. Lean into it. To pick up an object, bend your knees and squat while keeping your back straight.
    * Choose appropriate footwear. Wearing comfortable cushioned shoes that properly support your weight is especially important if you have arthritis in your weight-bearing joints or back.


Medications and other treatments are key to managing pain and disability, but another major component to treatment is your own attitude. Your ability to cope despite pain and disability caused by osteoarthritis often determines how much of an impact osteoarthritis will have on your everyday life. Talk to your doctor if you're feeling frustrated. He or she may have ideas about how to cope or refer you to someone who can help. In the meantime, try to:

    * Keep a positive attitude. Make a plan with your doctor for managing your arthritis. This will help you feel that you're in charge of your disease, rather than vice versa. Studies show that people who take control of their treatment and actively manage their arthritis experience less pain and function better.
    * Practice relaxation techniques. Hypnosis, guided imagery, deep breathing and muscle relaxation can all be used to control pain.
    * Know your limits. Rest when you're tired. Arthritis can make you prone to fatigue and muscle weakness - a deep exhaustion that makes everything you do a great effort. A rest or short nap that doesn't interfere with nighttime sleep may help.


Alternative medicine

People who aren't helped by medications for osteoarthritis pain sometimes turn to complementary and alternative medicine practices for relief. Mainstream doctors are becoming more open to discussing these options with their patients. But, since few of these treatments have been extensively studied in clinical trials, it's difficult to assess whether these treatments are helpful for osteoarthritis pain. In some cases, the risks of these treatments aren't known.

If you're interested in trying complementary and alternative medicine therapies for your osteoarthritis pain, discuss these treatments with your doctor first. He or she can help you weigh the benefits and risks and tell you if the treatments will interfere with your current osteoarthritis medications.

Some common complementary and alternative treatments that have shown some promise for osteoarthritis include:

    * Acupuncture. During acupuncture, tiny needles are inserted into your skin at precise spots. Practitioners believe the needles free or redirect your body's energy in order to relieve pain. Studies of acupuncture for knee osteoarthritis have been mixed. Most studies haven't found a benefit, though some have found some short-term relief of pain. Acupuncture can be safe if you select a reputable practitioner — ask your doctor to suggest someone. Risks include infection, bruising and some pain where needles are inserted into your skin.
    * Ginger. The ginger plant is best known for its use in cooking, but some research has found ginger extract may be helpful in reducing osteoarthritis pain. Limited studies have been conducted with ginger in people with osteoarthritis, and results have been mixed. Side effects of ginger supplements can include heartburn and diarrhea. Talk to your doctor before taking ginger supplements, since they can interfere with prescription medications such as warfarin (Coumadin).
    * Glucosamine and chondroitin. Studies have been mixed on these nutritional supplements. Some have found benefits for people with osteoarthritis, while others haven't. Tell your doctor if you're considering taking these supplements. Don't use glucosamine if you're allergic to shellfish. Chondroitin sulfate may affect blood levels of warfarin if you're taking that medication.
    * Magnets. Some people believe placing magnets near your affected joint can relieve osteoarthritis pain. Some small studies have found magnets can provide temporary pain relief, though others haven't found any benefit from magnets. It isn't clear how magnet therapy might work. Still, a variety of magnetic products, such as bracelets, are available. Magnets appear to be safe.
    * Tai chi and yoga. These movement therapies involve gentle exercises and stretches combined with deep breathing. Many people use these therapies to abate stress in their lives, though small studies have found that tai chi and yoga may reduce osteoarthritis pain. More study is needed to understand whether tai chi and yoga can relieve osteoarthritis pain. Talk to your doctor if you'd like to give tai chi or yoga a try. When led by a knowledgeable instructor, these therapies are safe. But don't do any moves that cause pain in your joints.


SOURCE: MAYO
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« Reply #24 on: July 08, 2009, 12:36:19 pm »



FDA approves low-level laser for osteoarthritis

Billions of dollars equal a staggering loss in the United States economy due to medical costs and decrease in productivity. The culprit, osteoarthritis. However, the United States Food and Drug Administration (FDA) cleared a new therapy for home use that alleviates pain and inflammation with no side effects. This therapy is the Q Laser System, a low level laser. This marks the first low level laser to be cleared by the FDA for over the counter use treating Osteoarthritis of the hand.

Osteoarthritis cannot currently be cured, but effective treatments can improve the quality of life of millions of people. To many people, it comes as exciting news that the FDA has recently approved a low-level laser treatment, the QLaser, for treating osteoarthritis in the hands. The Q1000 is a Class I laser device that has been classified by the FDA as a non-significant risk device as related to eye injuries, yet helps the body release endorphins (natural painkillers) reduce inflammation, increase circulation, help heal damaged cell membranes and boost cells’ energy levels, resulting in less pain and more healing.

The clinical, placebo controlled study, that led to the FDA clearance of this low level laser, saw statistically significant improvements in pain, range of motion, and patient satisfaction by using the Q1000 low level laser and Flash Probe. These hand held devices are applied to 10 treatment points over a 9 day schedule. Subjects in the study reported a 60 percent decrease in pain, and an 82 percent increase in range of motion over the “sham laser” group. Furthermore, every subject reported having no side effects from the low level laser treatment.

In the book Universal Healer: Book 1 Osteoarthritis, Dr. Larry Lytle proclaims, “For osteoarthritis of the hand, in particular, we will present amazing evidence of the ability of low level laser therapy to alleviate pain that often cripples hands and restricts their use.”
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« Reply #25 on: July 24, 2009, 10:08:22 am »

Osteoarthritis of the Hip or Knee

This study is for people with osteoarthritis of the hip or knee. You must be at least 18, have joint pain caused by arthritis, and meet other criteria to participate in this study.

The research site is in Mesa, Ariz.

More information

Please see http://www.clinicalconnection.com/clinical_trials/condition/osteoarthritis.aspx.
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« Reply #26 on: June 25, 2010, 09:00:07 am »

Pfizer Suspends Tanezumab Osteoarthritis Clinical Trial Program

 Jun. 23, 2010

Tanezumab Trials in Other Disease Areas Under Review by FDA

 Pfizer Inc. (NYSE: PFE) announced today the suspension of the osteoarthritis clinical program for the investigational compound tanezumab following a request by the U.S. Food and Drug Administration (FDA). The worldwide suspension – which is effective immediately – follows a small number of reports of tanezumab patients experiencing the worsening of osteoarthritis leading to joint replacement. To date, this adverse event has not been observed in non-osteoarthritis patient populations taking tanezumab.

The clinical hold includes both the suspension of recruitment of new patients and the dosing of existing patients in the osteoarthritis program, as well as patients with osteoarthritis in other studies. The FDA as asked that, later this week, the company present its assessment of the potential implications of the adverse events in the osteoarthritis program for the other tanezumab clinical programs involving non-osteoporosis patients, which include patients with cancer pain, interstitial cystitis, chronic low back pain and painful diabetic peripheral neuropathy. The company is actively working with the FDA, to determine the appropriate course of action, which will serve the best interest of patients.

Pfizer Inc.: Working together for a healthier world™

At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world's best-known consumer products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world's leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more about our commitments, please visit us at www.pfizer.com


SOURCE Pfizer Inc.

 
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« Reply #27 on: October 26, 2010, 08:46:55 am »

Unigene Reports Top-Level Results on Phase III Study of Oral Calcitonin in Osteoarthritis Patients


-Oct 21, 2010 - Unigene Laboratories, Inc. (OTCBB: UGNE, http://www.unigene.com) announced today that Novartis has released information on the first of two studies on oral calcitonin for the treatment of osteoarthritis conducted by its license partner Nordic Bioscience. The recently completed Study 2301, which assesses the safety and efficacy of oral calcitonin in the treatment of knee osteoarthritis, had three co-primary endpoints. Top-level results indicate that the study did not meet the first of three co-primary endpoints, joint space width narrowing. Results from the other two co-primary endpoints indicated clinical efficacy related to symptom modification (WOMAC scale for pain and function). MRI analyses suggested an effect on cartilage.

Novartis and its license partner Nordic Bioscience will continue to work together to further analyze and evaluate the results of this study and determine the appropriate next steps. More detailed information on this clinical trial program will be shared appropriately as it is made available to Unigene from its license partner Novartis.

The second two-year, Phase III Study 2302, which also assesses safety and efficacy of oral calcitonin in patients with osteoarthritis of the knee, is currently ongoing.

Novartis and Nordic Bioscience also have confirmed that a concurrent three-year Phase III study 2303 of oral calcitonin for the treatment of osteoporosis is proceeding as planned.

Novartis has a worldwide license to produce recombinant calcitonin under Unigene's patented E. coli manufacturing technology. Calcitonin manufactured under the Unigene license is currently being used for all three of the oral calcitonin studies being conducted by Novartis and Nordic Bioscience. The commercial products also will use calcitonin manufactured with Unigene's licensed process. Unigene's Chief Executive Officer Ashleigh Palmer commented that “Unigene continues to be positive about the potential of calcitonin for the treatment of osteoporosis and osteoarthritis. Unigene is eligible to receive milestones and royalties on the sale of the Novartis calcitonin product for both indications. We anticipate that the launch of oral calcitonin would be a significant revenue driver for the Company.”

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About Unigene

Unigene Laboratories, Inc. is a leader in the design, delivery, manufacture and development of peptide-based therapeutics. The Company is building a robust portfolio of proprietary partnerships in this expanding drug class based on its Peptelligence™ platform. Peptelligence encompasses extensive intellectual property covering delivery and manufacturing technologies, unsurpassed research and development expertise, and proprietary know-how representing a genuine distinctive competence. Core Peptelligence assets include proprietary oral and nasal peptide delivery technologies, and proprietary, high-yield, scalable and reproducible E. coli-based manufacturing technologies.

Unigene's technologies have extensive clinical and partner validation. The Company's first product to market, Fortical®, a nasal calcitonin product, received FDA approval in 2005 and is marketed in the U.S. by Upsher-Smith for the treatment of postmenopausal osteoporosis. Pivotal clinical programs include an oral calcitonin licensed to Tarsa Therapeutics, now in Phase 3 testing for the treatment of osteoporosis. Other validating relationships include an oral parathyroid hormone nearing Phase 2 and licensed to GlaxoSmithKline. In addition, Unigene has a manufacturing license agreement with Novartis, which recently completed a Phase 3 study of oral calcitonin for the treatment of osteoarthritis of the knee and is completing two additional Phase 3 studies of oral calcitonin for the treatment of osteoporosis and osteoarthritis.

For more information about Unigene, please visit http://www.unigene.com. For information about Fortical, please visit http://www.fortical.com.

Safe Harbor statements under the Private Securities Litigation Reform Act of 1995: This press release contains forward-looking statements, including with respect to clinical studies of one of our licensees. We have based these forward-looking statements on our current expectations and projections about future events. These forward-looking statements are not guarantees of future performance and are subject to certain risks, uncertainties, and assumptions that are difficult to predict. Therefore, our actual results could differ materially and adversely from those expressed in any forward-looking statements as a result of various risk factors. These known and unknown risk factors include, but are not limited to: the delay in obtaining or the failure to obtain regulatory approvals for our products and the products of our licensees that may generate royalty and milestone payments to us, our ability to achieve product sales and royalties, competition, our dependence on other companies to commercialize, manufacture and sell products using our technologies, the ability of our products to gain market acceptance and increase market share, the uncertainty of results of animal and human testing, the risk of product liability and liability for human clinical trials, our dependence on patents and other proprietary rights and the risks associated with patent litigation, dependence on key management officials, the availability and cost of capital, the availability of qualified personnel, changes in, or the failure to comply with, governmental regulations, general economic and business conditions, our history of losses and ability to achieve profitability, litigation and other risk factors discussed in our Securities and Exchange Commission ("SEC") filings, including our annual report on Form 10-K and our quarterly reports on Form 10-Q. Words such as "anticipates," "expects," "intends," "plans," "predicts," "believes," "seeks," "estimates," "may," "will," "should," "would," "potential," "continue," and variations of these words (or negatives of these words) or similar expressions, are intended to identify forward-looking statements, but are not the exclusive means of identifying forward-looking statements. In addition, any statements that refer to expectations, projections, contingencies, goals, targets or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements and are not statements of historical fact. Except as required by applicable law, including the securities laws of the United States and the rules and regulations of the SEC, we are under no obligation to publicly update or revise any forward-looking statements after the date of this release.

 



Contact: Unigene Laboratories, Inc.
William Steinhauer
VP of Finance
973-265-1100
or
Burns McClellan
Justin Jackson (media)
212-213-0006
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