Osteoporosis

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Osteoporosis

~Definition
 Osteoporosis, or porous bone, is a disease characterized by low bone mass and structural deterioration of bone tissue, leading to bone fragility and an increased susceptibility to fractures, especially of the hip, spine and wrist, although any bone can be affected.
 
~Prevalence
 Osteoporosis is a major public health threat for an estimated 44 million Americans, or 55 percent of the people 50 years of age and older. In the U.S., 10 million individuals are estimated to already have the disease and almost 34 million more are estimated to have low bone mass, placing them at increased risk for osteoporosis.

Of the 10 million Americans estimated to have osteoporosis, eight million are women and two million are men.

Significant risk has been reported in people of all ethnic backgrounds.

While osteoporosis is often thought of as an older person's disease, it can strike at any age.

~Women

Eighty percent of those affected by osteoporosis are women.

Twenty percent of non-Hispanic white and Asian women aged 50 and older are estimated to have osteoporosis, and 52 percent are estimated to have low bone mass.

Five percent of non-Hispanic black women over age 50 are estimated to have osteoporosis; an estimated additional 35 percent have low bone mass that puts them at risk of developing osteoporosis.

Ten percent of Hispanic women aged 50 and older are estimated to have osteoporosis, and 49 percent are estimated to have low bone mass.

Osteoporosis is under-recognized and under-treated not only in Caucasian women, but in African-American women as well.

 ~Men

Twenty percent of those affected by osteoporosis are men.

Seven percent of non-Hispanic white and Asian men aged 50 and older are estimated to have osteoporosis, and 35 percent are estimated to have low bone mass.

Four percent of non-Hispanic black men aged 50 and older are estimated to have osteoporosis, and 19 percent are estimated to have low bone mass.

Three percent of Hispanic men aged 50 and older are estimated to have osteoporosis, and 23 percent are estimated to have low bone mass.

~Fractures

One in two women and one in four men over age 50 will have an osteoporosis-related fracture in her/his remaining lifetime.

Osteoporosis is responsible for more than 1.5 million fractures annually, including:

over 300,000 hip fractures; and approximately

700,000 vertebral fractures;

250,000 wrist fractures; and

300,000 fractures at other sites.

Hip fracture risk is increasing most rapidly among Hispanic women. 

Women with a hip fracture are at a four-fold greater risk of a second one, and the risk factors are similar to those for the first hip fracture.

Osteoporotic fractures lower a patient’s quality of life. 
 
Cost The estimated national direct care expenditures (including hospitals, nursing homes, and outpatient services) for osteoporotic fractures is $18 billion per year in 2002 dollars, and costs are rising.
 
Symptoms Osteoporosis is often called a "silent disease" because bone loss occurs without symptoms.  People may not know that they have osteoporosis until their bones become so weak that a sudden strain, bump or fall causes a fracture or a vertebra to collapse.  Collapsed vertebrae may initially be felt or seen in the form of severe back pain, loss of height, or spinal deformities such as kyphosis or stooped posture.
 
Risk Factors Certain people are more likely to develop osteoporosis than others.  Factors that increase the likelihood of developing osteoporosis and fractures are called "risk factors."  These risk factors include: 

Personal history of fracture after age 50

Current low bone mass

History of fracture in a 1° relative

Being female

Being thin and/or having a small frame

Advanced age

A family history of osteoporosis

Estrogen deficiency as a result of menopause, especially early or surgically induced

Abnormal absence of menstrual periods (amenorrhea)

Anorexia nervosa

Low lifetime calcium intake

Vitamin D deficiency

Use of certain medications (corticosteroids, chemotherapy, anticonvulsants and others)

Presence of certain chronic medical conditions

Low testosterone levels in men

An inactive lifestyle

Current cigarette smoking

Excessive use of alcohol

Being Caucasian or Asian, although African Americans and Hispanic Americans are at significant risk as well

Women can lose up to 20 percent of their bone mass in the five to seven years following menopause, making them more susceptible to osteoporosis.
 
Detection Specialized tests called bone mineral density (BMD) tests can measure bone density in various sites of the body.  A BMD test can:

Detect osteoporosis before a fracture occurs

Predict chances of fracturing in the future

Determine rate of bone loss and/or monitor the effects of treatment if a DXA BMD test is conducted at intervals of one year or more 

Medicare reimburses for BMD testing every two years.

An increase in BMD testing and osteoporosis treatment was associated with a decrease in hip fracture incidence.

Bone density is an important determinant of fracture risk even in nursing home patients.

There has been a five-fold increase in office visits for osteoporosis (from 1.3 to 6.3 million) in the  past 10 years.
 
Prevention By about age 20, the average woman has acquired 98 percent of her skeletal mass.  Building strong bones during childhood and adolescence can be the best defense against developing osteoporosis later. There are five steps, which together can optimize bone health and help prevent osteoporosis.  They are:

A balanced diet rich in calcium and vitamin D

Weight-bearing and resistance-training exercises

A healthy lifestyle with no smoking or excessive alcohol intake

Talking to one’s healthcare professional about bone health

Bone density testing and medication when appropriate

A study of disease management in a rural healthcare population demonstrated that a preventive program was able to reduce hip fractures and save money.
 
Fractures The most typical sites of fractures related to osteoporosis are the hip, spine, wrist and ribs, although the disease can affect any bone in the body. 

The rate of hip fractures is two to three times higher in women than men; however, the one year mortality following a hip fracture is nearly twice as high  for men as for women.

A woman's risk of hip fracture is equal to her combined risk of breast, uterine and ovarian cancer.

In 2001, about 315,000 Americans age 45 and over were admitted to hospitals with hip fractures. Osteoporosis was the underlying cause of most of these injuries.

An average of 24 percent of hip fracture patients aged 50 and over die in the year following their fracture.

One in five of those who were ambulatory before their hip fracture requires long-term care afterward.

At six months after a hip fracture, only 15 percent of hip fracture patients can walk across a room unaided.

Not just hip fractures, but vertebral fractures are also linked with an increased risk of death.

One in five hip fracture patients ends up in a nursing home, a situation that participants in one study described as less desirable than death.

White women aged 65 or older have twice the incidence of fractures as African-American women.
 Medications Although there is no cure for osteoporosis, the following medications are approved by the FDA for postmenopausal women to prevent and/or treat osteoporosis:

~ANTIRESORPTIVE MEDICATIONS – BISPHOSPHONATES


Alendronate and alendronate plus vitamin D (brand names Fosamax® and Fosamax® plus D)

Alendronate is approved as a treatment for osteoporosis in men and is approved for treatment of glucocorticoid (steroid)-induced osteoporosis in men and women.
Ibandronate (brand name Boniva®)


Ibandronate is approved for the prevention and treatment of osteoporosis in postmenopausal women.
Risedronate and risedronate with calcium (brand names Actonel® and Actonel® with Calcium)

Risedronate is approved for prevention and treatment of glucocorticoid-induced osteoporosis in men and women.
Zoledronic Acid (brand name Reclast®)

Zoledronic acid is approved for the treatment of osteoporosis in postmenopausal women. It is the first and only once-a-year osteoporosis medication.
OTHER ANTIRESORPTIVE MEDICATIONS

Calcitonin (brand names Fortical® and Miacalcin®)

Calcitonin is approved for the treatment of osteoporosis in postmenopausal women who are at least five years beyond menopause.
Estrogen/Hormone Therapy
Multiple brand names available

Estrogen therapy (ET) and estrogen with progesterone hormone therapy (HT) are approved for the prevention of osteoporosis in postmenopausal women.
Because of side effects, the FDA recommends that women consider other medications for the prevention of osteoporosis. According to the FDA, estrogen should not be prescribed for the prevention of postmenopausal osteoporosis unless a woman is at significant risk of osteoporosis and cannot take non-estrogen medications. The FDA also recommends prescribing the lowest possible dose of ET/HT for the shortest period of time.
Selective Estrogen Receptor Modulators (SERMs)
Raloxifene (brand name Evista®)

Raloxifene is approved for the prevention and treatment of osteoporosis in postmenopausal women.
BONE FORMING (ANABOLIC) MEDICATIONS
Teriparatide – Parathyroid Hormone (brand name - Forteo®)

Teriparatide, a type of parathyroid hormone, is approved for the treatment of osteoporosis in postmenopausal women and in men who are at high risk for a fracture. [/size]

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Osteoporosis is a debilitating disease that can usually be prevented.

OSTEOPOROSIS is a disease people often do not know they have until they break a bone.

Bone thinning due to osteoporosis affects millions of people around the world. While 80% of those affected are women, men are also at risk, and the disease can strike at any age.

Osteoporosis literally means “porous bones” and it is a condition characterised by calcium-depleted bones that become fragile and weak.

Between 2-4% of a person’s skeleton is remodelled every year. This means that calcium and other minerals (magnesium, zinc, copper, boron, manganese) leave the bone in a process called resorption and then must be “remodelled” or replaced.

If not prevented or if left untreated, osteoporosis can progress painlessly until a bone breaks. These broken bones, also known as fractures, occur typically in the hip, spine, and wrist.

Any bone can be affected, but of special concern are fractures of the hip and spine. A hip fracture almost always requires hospitalisation and major surgery. It can impair a person’s ability to walk unassisted and may cause prolonged or permanent disability or even death. 

Spinal or vertebral fractures also have serious consequences, including loss of height, severe back pain, deformity and so on.

Whether due to poor nutrition or reduced hormone levels with the onset of ageing, the loss of calcium and other minerals from the bone creates tiny holes that make bones weak and brittle, particularly if collagen is lost. This is how osteoporosis develops.

Building and maintaining bone mass is paramount to avoiding osteoporosis. By about age 20, the average woman has acquired 98% of her skeletal mass.

Building strong bones during childhood and adolescence can be the best defence against developing osteoporosis later. 

There are five steps, which together, can optimise bone health and help prevent osteoporosis. They are:

Diet: Eating foods rich in calcium, magnesium, zinc, manganese, boron and copper such as milk, broccoli, fish and dark green vegetables.

Weight-bearing and resistance-training exercises: Bones, like muscles, grow stronger when regularly stressed.

A healthy lifestyle with no smoking or excessive alcohol intake.

If you are not meeting the required intake of calcium and other minerals through diet, you should consider taking supplements.

The importance of calcium supplementation has long been recognised in bone health. However, as important as calcium is to bone health, it is found that in the US, only 25% of women with osteoporosis are calcium deficient.

New evidence clearly shows that vitamin D, magnesium, copper, zinc, boron and manganese are also vital for maintaining strong and healthy bone.

These nutrients should all be consumed together for optimal bone metabolism. Even the absence of one nutrient can result in weak bones and osteoporosis.

Calcium plays an important role in maintaining bone. Calcium alone cannot prevent or cure osteoporosis, but it is an important part of an overall prevention or treatment program. The US RDA (recommended daily allowances) for calcium is as follows:

Adults and teenagers – 800 to 1200mg per day.

Pregnant and breast-feeding females – 1200mg per day.

Children four to 10 years of age – 800mg per day.

Children from birth to 3 years of age – 400 to 800mg per day.

Vitamin D helps body absorb calcium. Low levels of vitamin D are common in women, especially the elderly. Deficiencies of vitamin D can lead to calcium deficiencies, leading to soft bones (osteomalacia). Experts recommend a daily intake of between 400 and 800 international units (IU). 

Magnesium is essential for both the preservation and mobilisation of calcium in the bone and is required for the utilisation of vitamin D.

Magnesium deficiency is common and is a leading risk factor for osteoporosis. The US RDA for magnesium is 400mg per day.

Manganese is a trace mineral required for the synthesis of connective tissue that form the matrix upon which mineral deposition occurs. The recommended daily intake for manganese is 2mg.

Boron is needed to convert vitamin D into its active form, which explains why boron deficiency affects calcium metabolism and bone formation.

Boron reduces calcium loss from bones. Although there is no official RDA for boron, a dosage of 1.5 to 3.0mg daily is safe and adequate (Murray, 1996).

Zinc supports bone formation by enhancing the action of vitamin D. Zinc helps maintain bone structure and is involved in bone development.

Copper deficiency may lead to abnormal bone deposition. Copper helps form the building blocks of bone.

When shopping for a calcium supplement, do ensure that it also contains the other essential nutrients mentioned above in adequate amounts to support strong and healthy bones.

Prevention of osteoporosis should begin at birth by meeting the human dietary requirements for calcium and other nutrients and should continue thereafter.
 

Reference:

1. National Osteoporosis Foundation (nof.org

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Proton pump inhibitors and osteoporosis-related fractures
Laura E. Targownik, MD MSHS* and William D. Leslie, MD

*Assistant Professor of Medicine, Section of Gastroenterology; Professor of Medicine and Radiology, Sections of Endocrinology and Metabolism and Nuclear Medicine, University of Manitoba, Winnipeg, Man.

Two of the authors respond:

We thank Mathieu Forster for his interest in our article.1 He expressed concern about the possible influence of unmeasured variables, specifically smoking status, alcohol use and body mass index, on the association that we observed between use of proton pump inhibitors and the development of osteoporosis-related fractures. For an unmeasured variable to influence the results of the study, it would have to be associated both with the outcome of interest in the unexposed cohort and with the exposure of interest. It has previously been established that smoking, excessive alcohol use and low body mass index are associated with higher risk for osteoporosis and osteoporosis-related fractures,2–4 but for these factors to influence (positively or negatively) the relation between proton pump inhibitor use and osteoporosis-related fractures, they would also have to be independently associated with the use of proton pump inhibitors.

There are currently very little data available to confirm a relation between proton pump inhibitor use and any of the above factors. A recently published analysis of long-term use of proton pump inhibitors suggests a lack of a relation between use of proton pump inhibitors and both smoking and body mass index.5 However, smoking and alcohol use are both positively associated with gastresophageal reflux disease, the most common indication for proton pump inhibitor therapy. Conversely, gastresophageal reflux disease is also strongly associated with obesity,6 which is in fact protective against osteoporosis and osteoporosis-related fractures. Given the likelihood that these influences have opposing effects, it is very likely that the overall effect of these unmeasured variables on the detected association is minimal. We agree that further studies are required to determine whether the association between use of proton pump inhibitors and the development of osteoporosis and osteoporosis-related fractures is truly causal.

Footnotes

Competing interests: Laura Targownik has served on the national advisory board for AstraZeneca Canada. None declared for William Leslie.

REFERENCES

   1. Targownik LE, Lix LM, Metge CJ, et al. Use of proton pump inhibitors and risk of osteoporosis-related fractures. CMAJ 2008;179:319-26.[Abstract/Free Full Text]
   2. De Laet C, Kanis JA, Oden A, et al. Body mass index as a predictor of fracture risk: a meta-analysis. Osteoporos Int 2005;16:1330-8.[CrossRef][Medline]
   3. Kanis JA, Johansson H, Johnell O, et al. Alcohol intake as a risk factor for fracture. Osteoporos Int 2005;16:737-42.[CrossRef][Medline]
   4. Kanis JA, Johnell O, Oden A, et al. Smoking and fracture risk: a meta-analysis. Osteoporos Int 2005;16:155-62.[CrossRef][Medline]
   5. Raghunath AS, Hungin AP, Mason J, et al. Symptoms in patients on long-term proton pump inhibitors: prevalence and predictors. Aliment Pharmacol Ther 2009;29:431-9.[CrossRef][Medline]
   6. El-Serag H. The association between obesity and GERD: a review of the epidemiological evidence. Dig Dis Sci 2008;53:2307-12.[CrossRef][Medline]
SOURCE:CMAJ

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May 14, 2009
Governor David A. Paterson has designated May as Osteoporosis Prevention Month in New York State to remind all New Yorkers to protect their bone health. Nearly three million New Yorkers over age 50 have osteoporosis or are at significant risk of developing osteoporosis. May is also National Osteoporosis Prevention Month.

"Maintaining strong bones should be a lifetime commitment," said State Health Commissioner Richard F. Daines, M.D. "Prevention through diet and exercise, along with early diagnosis and treatment can reduce the prevalence and debilitating affects of this disease."

Osteoporosis is a disease that causes bones to become thin and weak. This "silent disease" progresses without symptoms until a fracture occurs. If left untreated, osteoporosis can lead to debilitating pain, reduced mobility and a loss of quality of life. In 2006, more than 75,000 New Yorkers were hospitalized for falls, many of whom suffered bone fractures related to osteoporosis.

"An astonishing number of adults who break a bone -- as many as 95 percent -- are being treated without being evaluated for osteoporosis," said Commissioner Daines. "Too often, people believe that once they have osteoporosis or a fracture, there is nothing they can do to protect their bones. But there are steps everyone can take at any age to help prevent and treat osteoporosis."

The following steps are recommended to protect bone health:

* Maintain a balanced diet rich in calcium and vitamin D.

* Engage in regular physical activity, including weight-bearing exercise.

* Avoid smoking and excessive alcohol consumption.

* Have a bone mineral density test. Consult with your health care provider as to when and how often.

* Take osteoporosis medications as prescribed by your health care provider.

Nationally, nearly one in two women of Caucasian or Asian/Pacific Island descent, one in four women of African-American, Hispanic/Latina or American Indian/Alaskan Native descent, and one in four men over 50 years of age will have an osteoporosis-related fracture during their lifetime. It is projected that by the year 2020, the number of New Yorkers with either osteoporosis or low bone mass will increase by 25 percent to more than 3.7 million people.

Each year, the New York State Department of Health provides funding to support New York State Osteoporosis Prevention and Education Programs. These not-for-profit organizations and hospitals conduct outreach campaigns, provide education and information, and training and support to the general public and health professionals about the disease.

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Key Mechanism In Pathogenesis Of Osteoporosis Unraveled

May 20, 2009~
Osteoporosis, or bone loss, is a disease that is most common in the elderly population, affecting women more often than men. Until now, it was not clear exactly how the disease develops. Researchers of the Max Delbrück Center for Molecular Medicine (MDC) Berlin-Buch, Germany, have now elucidated a molecular mechanism which regulates the equilibrium between bone formation and bone resorption. Dr. Jeske J. Smink, Dr. Valérie Bégay, and Professor Achim Leutz were able to show that two different forms of a gene switch – a short isoform and a long isoform – determine this process.

The MDC researchers hope these findings will lead to new therapies for this bone disease.

In osteoporosis, excessive bone resorption occurs. The bones lose their density and are therefore prone to breakage. Even minor falls can lead to serious bone fractures. The interplay between two cell types determines bone density: bone forming cells (osteoblasts) and bone resorbing cells (osteoclasts). The equilibrium between these two cell types is strictly regulated to prevent the formation of either too much or too little bone.

LAP and LIP maintain the balance

Dr. Smink, Dr. Bégay, and Professor Leutz have now elucidated a complicated mechanism which maintains the equilibrium between bone formation and bone resorption. Here, the gene switch C/EBPbeta plays a major role. It exists in different forms, differing in length and number of building blocks. LAP is the term researchers use to denote the full-length isoform of C/EBPbeta, and LIP is the term for the short isoform.

LAP activates another gene switch (MafB) which suppresses the formation of bone resorbing osteoclasts. In contrast, LIP, suppresses this gene switch and thus enhances the proliferation and activity of the osteoclasts. As a result, the osteoclasts resorb more bone substance than is built by the osteoblasts. The researchers suspect that imbalance in the ratio between LAP and LIP plays a role in osteoporosis.

The activity of a signaling molecule – mTOR – determines which of the two isoforms LAP and LIP is formed. The abbreviation mTOR stands for mammalian Target of Rapamycin. The drug rapamycin inhibits mTOR and thus suppresses the formation of bone resorbing osteoclasts. Unfortunately, rapamycin has severe side-effects on the immune system. "In the future, it may be possible to develop new drugs that regulate the activity of mTOR and, thus, remedy the disturbance in osteoclast function," Professor Leutz said.
Journal reference:

   1. Smink et al. Transcription factor C/EBPβ isoform ratio regulates osteoclastogenesis through MafB. The EMBO Journal, 2009; DOI: 10.1038/emboj.2009.127

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Bone disorder doesn't discriminate by gender

Posted: May. 25, 2009


Judging from the TV ads for drugs that treat osteoporosis, you would think that the bone-thinning disorder is something only women have to worry about, and that men can simply ignore what Sally Field and other talking heads have to say about the disease.

You would be wrong.

Though osteoporosis is less common in men than in women, it still takes a toll on men.

It's a painless illness in which bones become fragile and are more likely to break, and its first sign may be a fracture of the hip, spine or wrist.

The disease can progress silently, according to Neil Binkley, a physician and researcher with the University of Wisconsin-Madison School of Medicine and Public Health.

In the same way that cholesterol accumulates, leading to a heart attack, bone density decreases, leading to "a bone attack" - a fracture for no apparent reason, he said.

While a 50-year-old woman faces a lifetime risk of 50% for an osteoporotic fracture, anywhere from one in eight to one in four 50-year-old men face that risk.

And the disease may even be more serious in men than in women, said Felicia Cosman, medical director of the nonprofit National Osteoporosis Foundation.

In hip fractures, "the complication rate is higher, the death rate is higher," she said.

The death rate for women is between 15% and 20% and for men it is between 20% and 25%. The reason for the difference isn't clear, but Cosman said men who fracture their hips are typically older than women and may be in poorer health initially.

Risk factors include medications
Nevertheless, the disease doesn't have a very high profile, said Binkley, who co-authored a 2002 article on the condition in the Wisconsin Medical Journal.

"It's basically unrecognized," he said. "The word on the street is that this is not a disease that guys get, and that is clearly incorrect."

Binkley ticked off numerous risk factors for osteoporosis - low calcium, deficient vitamin D levels, smoking, low testosterone, not enough exercise and certain medications.

He and other physicians point to steroid drugs such as prednisone and other corticosteroid drugs that are used to treat inflammatory diseases such as severe asthma and autoimmune diseases such as rheumatoid arthritis.

Antidepressants known as SSRIs also are a risk factor, as well as widely advertised drugs to combat digestive problems because they inhibit calcium absorption, Cosman said.

She does not suggest abandoning these drugs, but said men who take them should be alert to the risks.

Key study
Much about osteoporosis remains to be understood, even though medications to treat it are available.

Since 2000, researchers funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases have been studying 6,000 men age 65 and older to better understand the disease. The study, dubbed Mr. OS, is being conducted in six U.S. medical centers and has expanded to several foreign medical centers.

"We're trying to understand the mechanism between age and rates of bone loss and fractures. We're also imaging the bone trying to understand the bone geometry and bone strength and structure," said Kristine Ensrud, one of the study researchers and a physician with the University of Minnesota and the Minneapolis VA Hospital.

Clifford Rosen, a professor of medicine at Tufts University School of Medicine and the Maine Medical Research Institute, called the study extremely important.

"I don't think we have a good understanding of the epidemiology of this disease," Rosen said. "Men tend to come to physicians later, and we don't understand what the natural history of this disease is in males."

Understanding that history is crucial in finding ways to treat the disorder, Ensrud said. While the Mr. OS study doesn't offer participants any treatment, it does provide information about the disease.

Mind nutrition, exercise
Men can take specific steps to lower their risk.

Binkley and other physicians recommend that men make sure their diet contains calcium and vitamin D. It's also recommended that men engage in load-bearing exercises such as walking or jogging.

And osteoporosis is yet another reason to cut out tobacco because it is a risk factor.

Medicare does cover bone density screening for people who are at known risk for losing bone mass. That would include people at "clinical risk for osteoporosis based on medical history and findings," people with vertebral fractures or abnormalities and those taking steroid drugs.

Given the current state of evidence, routine mass screening doesn't make sense, said Rosen, because not enough is known about the disease.
SOURCE:
National Osteoporosis Foundation

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Monday, May 26, 2009

Osteologix Inc has received a Notice of Allowance from the US Patent and Trademark Office for its US Patent Application Number 11/579,773 titled 'High Yield and Rapid Synthesis Methods for Producing Metallo-Organic Salts' reporting allowance of claims covering certain manufacturing processes for NB S101 (strontium malonate), the company's lead osteoporosis drug candidate. The company expects the patent will issue in the second half of 2009; the patent's 20-year term would expire in 2025.

This patent allowance expands the company's patent portfolio that also includes the recently upheld European patent in which the European Patent Office (EPO) maintained the validity of the company's European Patent No. EP 1,534,305 B9, 'Treating Cartilage and Bone Conditions with Water Soluble Strontium Salts'. This patent offers protection for the use of NB S101 (strontium malonate) for the treatment of osteoporosis and related conditions while confirming that the innovative product, NB S101, demonstrated a significant increase in bioavailability over the EMEA approved Protelos (strontium ranelate).

Osteologix is a specialty biopharmaceutical company committed to improving the health of those afflicted with musculoskeletal diseases, such as osteoporosis.

SOURCE: Google

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Zoledronic Acid Okayed for Two-Year Treatment of Osteoporosis

WASHINGTON, June 1, 2009
 The FDA has approved zoledronic acid (Reclast) to prevent postmenopausal osteoporosis for two years with a single injection.

The drug is currently approved as a once-yearly infusion for treating the disease.

The approval comes after a two-year randomized controlled trial of 581 postmenopausal women, which found that the drug significantly increased lumbar spine bone mineral density compared with placebo -- by 6.3% in women who were in early menopause and by 5.4% in those in later stages.

"The dosing of [zoledronic acid] for the prevention of postmenopausal osteoporosis offers an advance over existing therapies since it can be given once every two years instead of daily, weekly, or monthly, Mone Zaidi, M.D., Ph.D., of Mount Sinai School of Medicine in New York, said in a statement.

According to the FDA, the drug should not be given to patients with low blood calcium, kidney problems, or an allergy to zoledronic acid. It also should not be given to women who are pregnant or nursing.

Common side effects include flu-like symptoms, fever, muscle or joint pain, headache, nausea, vomiting, and diarrhea. Jaw problems have also been reported with use of the drug, the FDA said.

Zoledronic acid is also approved to treat Paget's disease.

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Sally Field Shares Her Osteoporosis Story on EmpowHer
Hollywood Legend and Women's Health Web Site Heighten Bone Health Awareness

Scottsdale, AZ (PRWEB) June 26, 2009 -- EmpowHer, the home of women's health online, (http://www.empowher.com) announced today that Academy Award winning actress and bone health advocate Sally Field is sharing her osteoporosis story with the web site's audience. Field joins EmpowHer's large group of women who are sharing their health stories to help other women.

To view Sally Field's videos, click here: http://www.empowher.com/community/herstory/video-herstory-sally-field-shares-how-it-felt-be-recognized-national-osteoporosis

Sally Field is a powerful advocate in the area of osteoporosis. By sharing her story on EmpowHer, Sally is making a tremendous impact on the bone health of women around the country. It is an honor to help spread her message.   
 I have been very proud to … help bring about this awareness to the women of my generation and the women to come after us.   
Sally Field is a two-time Academy Award winning actress who has tirelessly helped educate women on the importance of osteoporosis awareness and prevention. Since being diagnosed with osteoporosis six years ago, Field has launched a national "Rally With Sally for Bone Health" campaign and has participated in a Capitol Hill briefing co-sponsored by the National Osteoporosis Foundation.

EmpowHer Founder and Chairman, Michelle King Robson, said about Sally Field's presence on EmpowHer, "Sally Field is a powerful advocate in the area of osteoporosis. By sharing her story on EmpowHer, Sally is making a tremendous impact on the bone health of women around the country. It is an honor to help spread her message."

Commenting on how integral osteoporosis awareness is, Sally Field said, "I have been very proud to … help bring about this awareness to the women of my generation and the women to come after us."
About EmpowHer
EmpowHer, the home of women's health online, is a unique resource dedicated to improving women's health and well-being. EmpowHer provides up-to-date medical information, access to leading medical experts, advocates, and a devoted community of women who ask questions, share stories, and connect with one another in a safe and supportive environment.

Useful Information on Osteoporosis & Bone Health
Dr. Robert P. Heaney, M.D.
Internationally recognized expert in the field of bone biology and calcium nutrition, father of the groundbreaking 40+ year nun study on osteoporosis and calcium physiology. http://www.empowher.com/users/rheaney

Dr. Ethel S. Siris, M.D.
Immediate past-President for the National Osteoporosis Foundation and the Director of the Toni Stabile Osteoporosis Center at Columbia University http://www.empowher.com/users/dr-ethel-siris

For additional information on EmpowHer, please contact Todd Hartley or visit http://www.empowher.com.



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Once-yearly Aclasta® approved in EU to treat osteoporosis caused by steroid treatment in men and postmenopausal women

London, June , 26, 2009


 * Steroids, widely used to treat inflammatory conditions, can cause
    bone loss and increase risk of fractures in up to 50% of patients
    on long-term therapy[1]

  * European approval based on data showing Aclasta better at
    increasing bone mass than oral risedronate, a current established
    therapy[2],[3]

  * Clinical trial results also reaffirm efficacy and safety of
    Aclasta, used in more than 500,000 patients worldwide since
    launch in 2007[4],[5]

  * Approval is fifth indication for once-yearly Aclasta, already
    approved worldwide to treat postmenopausal osteoporosis[6]

Basel, June 26, 2009 -  Once-yearly Aclasta® (zoledronic acid 5  mg)*
has  been  approved  in   the  European  Union   to  treat  men   and
postmenopausal women  with osteoporosis  caused by  long-term use  of
glucocorticoids, commonly known  as steroids[6]. Glucocorticoids  are
widely used  to  treat inflammatory  conditions  such as  asthma  and
rheumatoid arthritis, but also cause  bone loss and can increase  the
risk of fracture in up to 50% of patients on long-term glucocorticoid
therapy[1].

The new  indication for  men  and women  with  glucocorticoid-induced
osteoporosis (GIO) is based on study data showing that Aclasta, given
once a year as  a 15-minute infusion, is  more effective at  treating
bone  loss  than  daily  oral  risedronate,  a  current   established
therapy[2],[3].

The study  results,  recently  published in  The  Lancet,  show  that
Aclasta produced  a significantly  greater increase  in bone  mineral
density (BMD) than  risedronate at  six months,  indicating a  faster
onset of efficacy[2].

"Oral bisphosphonates have been used for many years for the treatment
of GIO,  but they  are associated  with poor  compliance as  patients
frequently fail to take them as prescribed," said Professor David  M.
Reid, Head of the Division of  Applied Medicine at the University  of
Aberdeen, UK. "Available data show that patients who remember to take
their  medicines  only  half  of  the  time  receive  little  or   no
protection[7]."

He added: "The approval of Aclasta is a significant step forward,  as
it is more  effective and  faster-acting than  a current  established
therapy for the treatment of GIO  and has the advantage of  year-long
compliance and sustained osteoprotection."

This is the fifth indication for Aclasta, which is approved to  treat
osteoporosis in  men and  postmenopausal women,  including those  who
have experienced  a  low-trauma hip  fracture.  Aclasta is  the  only
bisphosphonate approved  in the  EU  and US  to  reduce the  risk  of
fractures at  all  key osteoporotic  fracture  sites, like  the  hip,
spine,  and   other  bones   in  the   treatment  of   postmenopausal
osteoporosis[8].  It is also approved to treat Paget's disease of the
bone.

In the US, the same medicine  under the trade mark Reclast® has  also
been approved by the Food and Drug Administration (FDA) to treat  and
prevent GIO in men and women. In May it was approved in the US as the
only  therapy  to  prevent  postmenopausal  osteoporosis  with   less
frequent dosing (i.e. a single dose every two years)[9].

The GIO indication is important because it is estimated that  between
700,000 and 1.3 million adults in Western Europe, and between 1.5 and
2.7 million adults in the US, are receiving prolonged courses of oral
glucocorticoids[10],[11]. Up to 50%  of patients receiving  long-term
glucocorticoid therapy are  at increased risk  of fracture, as  their
use  is  associated  with  side   effects  such  as  bone  loss   and
consequently osteoporosis[1].

"This European  approval  marks  another  important  achievement  for
Aclasta by adding to  the broad spectrum of  patients who can now  be
treated with this therapy,"  said Trevor Mundel,  MD, Global Head  of
Development at Novartis Pharma AG. "Aclasta has a strong efficacy and
safety profile  established during  eight years  of clinical  trials.
Since its launch in 2007, Aclasta has been used in more than  500,000
patients, demonstrating that an annual infusion has become a valuable
treatment option."

The latest approval was based on a  study of 833 men and women  which
investigated both the prevention  and treatment of  GIO (288 and  545
patients respectively)[2].  The  study had  several  advantages  over
previous trials studying the effects of bisphosphonate drugs on  GIO,
including the large sample size, the inclusion of both prevention and
treatment subgroups, and an excellent retention rate.

The study showed that over one year, a single intravenous infusion of
Aclasta produced increases  in BMD  of the lumbar  spine and  femoral
neck, trochanter and total hip  that were significantly greater  than
those seen with once-daily oral risedronate (Actonel®)[2].

The greater efficacy of Aclasta was evident at six months in both the
treatment group  (Aclasta  4.03%, risedronate  2.70%;  P=0.0002)  and
prevention group  (Aclasta  2.34%, risedronate  0.36%;  P<0.0001)[2].
Aclasta was better than risedronate at increasing lumbar spine BMD at
12 months  in both  the treatment  group (Aclasta  4.1%,  risedronate
2.7%; P=0.0001) and prevention group (Aclasta 2.6%, risedronate 0.6%;
P<0.0001)[2].

Results from the study showed that Aclasta is generally safe and well
tolerated[2], supporting previous clinical  trial evidence from  more
than 14,000 patients[4].  The most common  adverse events  associated
with Aclasta  were transient  post-dose symptoms  such as  fever  and
muscle pain. Most of these symptoms occurred in the first three  days
after Aclasta administration and resolved  within the same period  of
time. Post-dose  symptoms can  be reduced  by taking  paracetamol  or
ibuprofen shortly after the Aclasta infusion[2],[6],[8].

In this trial  there were  no cases of  osteonecrosis of  the jaw  or
delayed fracture healing,  and no  evidence of an  increased risk  of
atrial fibrillation[2].

Zoledronic acid, the  active ingredient in  Aclasta/Reclast, is  also
available  under  the  trade  name   Zometa®  for  use  in   oncology
indications.
Disclaimer
The foregoing release contains forward-looking statements that can be
identified by  terminology such  as  "can," "risk,"  "estimated,"  or
similar expressions, or by  express or implied discussions  regarding
potential new  indications  or  labeling  for  Aclasta  or  regarding
potential future revenues  from Aclasta. You  should not place  undue
reliance on these statements. Such forward-looking statements reflect
the current views of management regarding future events, and  involve
known and unknown  risks, uncertainties  and other  factors that  may
cause actual results with Aclasta to be materially different from any
future results, performance or  achievements expressed or implied  by
such statements.  There can  be  no guarantee  that Aclasta  will  be
approved for any  additional indications or  labeling in any  market.
Nor can  there  be  any  guarantee  that  Aclasta  will  achieve  any
particular  levels  of   revenue  in  the   future.  In   particular,
management's expectations  regarding Aclasta  could be  affected  by,
among other  things,  unexpected  regulatory  actions  or  delays  or
government regulation generally;  unexpected clinical trial  results,
including unexpected  new  clinical data  and  unexpected  additional
analysis of existing clinical data;  the company's ability to  obtain
or  maintain  patent  or  other  proprietary  intellectual   property
protection; competition in general; government, industry and  general
public pricing pressures; the impact that the foregoing factors could
have on  the values  attributed to  the Novartis  Group's assets  and
liabilities as recorded  in the Group's  consolidated balance  sheet,
and other risks and factors referred to in Novartis AG's current Form
20-F on file with the  US Securities and Exchange Commission.  Should
one or more of  these risks or  uncertainties materialize, or  should
underlying assumptions  prove  incorrect,  actual  results  may  vary
materially from those anticipated,  believed, estimated or  expected.
Novartis is providing  the information  in this press  release as  of
this date  and  does  not  undertake any  obligation  to  update  any
forward-looking statements  contained  in  this press  release  as  a
result of new information, future events or otherwise.

About Novartis
Novartis AG provides healthcare  solutions that address the  evolving
needs of  patients  and  societies.  Focused  solely  on  healthcare,
Novartis offers a  diversified portfolio  to best  meet these  needs:
innovative medicines, cost-saving generic pharmaceuticals, preventive
vaccines, diagnostic tools and consumer health products. Novartis  is
the only company with leading positions in these areas. In 2008,  the
Group's continuing operations achieved net sales of USD 41.5  billion
and net income of USD 8.2 billion. Approximately USD 7.2 billion  was
invested in  R&D activities  throughout the  Group. Headquartered  in
Basel, Switzerland,  Novartis  Group companies  employ  approximately
98,000 full-time-equivalent associates and  operate in more than  140
countries around  the  world.  For  more  information,  please  visit
www.novartis.com.

References
[1.] Sambrook PN. Corticosteroid Osteoporosis: Practical Implications
of Recent Trials. JBMR 2000; 15:1645-1649.
[2.] Reid DM, Devogelaer J-P, Saag K, Roux C, et al. Zoledronic acid
and risedronate in the prevention and treatment of
glucocorticoid-induced osteoporosis (HORIZON): a multicenter,
double-blind, double-dummy, randomized controlled trial. Lancet 2009;
373: 1253-63.
[3.] Actonel 5mg Film Coated Tablets SPV. Available at:
emc.medicines.org.uk/document.aspx?documentId=3340. Last
accessed June 8, 2009.
[4.] Novartis data on file. Novartis Pharma AG; June, 2009.
[5.] Novartis - NPMR, May 2009, based on vials sold (retreatments
taken into account).
[6.] Aclasta Summary of Product Characteristics. West Sussex, United
Kingdom: Novartis Europharm Limited, 2009.
[7.] Siris SE, Harris ST, Rosen CT et al. Adherence to Bisphosphonate
Therapy and Fracture Rates in Osteoporotic Women: Relationship to
Vertebral and Nonvertebral Fractures From 2 US Claims Databases. Mayo
Clin Proc., August 2006;81(8):1013-1022.
[8.] Black D, Delmas S, Eastell R et al for the HORIZON Pivotal
Fracture Trial Group. Once-Yearly Zoledronic Acid for Treatment of
Postmenopausal Osteoporosis. NEJM 2007; 356(18): 1809-22.
[9.] Reclast® (zoledronic acid) Injection [Prescribing Information].
East Hanover, NJ: Novartis Pharmaceuticals Corporation; May 2009.
[10.] Gluck O, Colic G. Recognizing and Treating
Glucocorticoid-Induced Osteoporosis in Patients with Pulmonary
Diseases. CHEST 2004; 125: 1859-1876.
[11.] United Nations. Department of Economic and Social Affairs.
Population Division. The 2008 Revision. Western Europe and United
States of America Population Statistics. Available at:
esa.un.org/unpp. Last accessed 30 March, 2009. The estimated
figures for glucocorticoid use in Western Europe and the US were
calculated by extrapolating the percentage of UK adults receiving
oral glucocorticoids at any given time (between 0.5% and 0.9% of the
adult population) to the populations of Western Europe (145 million
adults) and the US (300 million adults).

• The tradename is Reclast® in the  US and Aclasta® in the rest  of

the world.

[Adminஐﻬ]

FDA OKs new use for Lilly osteoporosis drug Forteo

  July 28, 2009

 Drugmaker Eli Lilly and Co. said Thursday regulators have approved a new use for its osteoporosis treatment Forteo.

The Food and Drug Administration approved the drug to be used as a treatment for patients taking medications for inflammatory conditions like rheumatoid arthritis and obstructive pulmonary disease.

BuzzLilly said the glucocorticoid medications patients take in these cases are the most common cause of secondary osteoporosis and can lead to an increased risk of bone fractures.

Forteo has already been approved to treat osteoporosis in men and women.

The drug was launched in 2002 and generated $203 million in the recently completed second quarter.

Source:Press Release

[Adminஐﻬ]

Pfizer To Explore Sale Or Licensing Of Fablyn Bone Drug

August 08, 2009

Pfizer Inc. (PFE) plans to explore the sale or licensing of osteoporosis drug Fablyn, which has been approved for sale in Europe but held up by regulators in the U.S., possibly due to safety concerns.

The New York-based drug giant disclosed its plan to pursue strategic options for Fablyn in regulatory filings Thursday and in May, but the plans haven't been widely publicized. Wall Street expectations for the drug's financial performance were already low because of Pfizer's past difficulties in getting the drug approved.

The European Commission approved Fablyn earlier this year for the treatment of osteoporosis in post-menopausal women at increased risk of fracture.

But in January, the U.S. Food and Drug Administration issued a so-called " complete response" letter to Pfizer's application to market Fablyn in the U.S., requesting additional information before it could make a final decision.

The FDA delay followed a September 2008 recommendation by an FDA advisory committee that the drug had benefits for certain post-menopausal women, though it should be restricted to those at high risk of fracture or those who fail other treatments. FDA staff had raised concerns that Fablyn puts patients at higher risk of death than a fake drug, but outside advisers said there weren't enough definitive data on that issue.

After the FDA's letter in January, and "following a strategic review, we decided to explore strategic options for Fablyn, including out-licensing or sale," Pfizer said in its regulatory filing.

Pfizer representatives weren't immediately available Friday to elaborate.

Pfizer executives signaled earlier this year the company was seeking to license out dozens of its experimental drugs because they were in disease areas that are no longer top Pfizer priorities.

In addition, Pfizer is in the process of acquiring Wyeth (WYE), which has developed a similar osteoporosis drug, bazedoxifene, that received European regulatory approval in April. The drug is being marketed as Conbriza in Europe. Wyeth also is pursuing U.S. regulatory approval for the drug under the brand Viviant.

Pfizer had been seeking FDA approval of Fablyn for years. In 2005 and 2006, the FDA rejected Pfizer's applications to market the drug for the prevention of post-menopausal osteoporosis and for treatment of vaginal atrophy.

Both Pfizer and Wyeth co-developed their respective osteoporosis drugs under collaborations with Ligand Pharmaceuticals Inc. (LGND).

[Adminஐﻬ]

August 14, 2009
A Partial Approval for Amgen’s Osteoporosis Drug
Amgen’s new bone drug, the company’s best hope for future growth, won a partial endorsement Thursday from a federal advisory committee despite concerns about the product’s safety.

The committee, which advises the Food and Drug Administration, voted 15 to 0 that the drug, called denosumab, should be approved to treat postmenopausal women with osteoporosis, a condition marked by weak bones that are prone to fracture.

But the committee voted 12 to 3 that denosumab should not be approved to prevent osteoporosis in women with moderately low bone mineral density. And it voted against three of four possible uses for breast and prostate cancer patients whose therapy can weaken bones.

Panel members expressed concern about a slight increase in certain infections and cancers in patients getting denosumab compared with those getting a placebo in clinical trials. While the differences could have been by chance in many cases, some committee members argued in favor of caution.

“I feel that the committee’s consensus is that the drug should be limited to a high-risk subgroup, high risk for fracture,” said Dr. Sandra Carson, the committee’s chairwoman and a professor of obstetrics and gynecology at Brown University.

The F.D.A. is scheduled to decide by Oct. 19 whether to approve the drug, though such deadlines can be missed. The agency usually follows the advice of its advisory committees.

Shares of Amgen fell $1.30, or 2 percent, to $60.86. Still, some analysts said the biggest commercial opportunity by far was treatment of osteoporosis, and that vote was positive for the company.

“They got what they needed,” said Geoffrey Porges, a biotechnology analyst at Sanford C. Bernstein & Company. “They didn’t emerge unscathed, but what they lost wasn’t particularly meaningful.”

But Eric Schmidt, an analyst at Cowen & Company, said the committee did express some support, without a vote or much discussion, for having all patients getting denosumab entered into a registry and tracked over time. If the F.D.A. were to require that, he said, the extra paperwork would discourage doctors from using denosumab. “That would be a real death knell,” he said.

Amgen declined to comment beyond a statement saying that it “looks forward to collaborating with the F.D.A. to arrive at the best possible approach to making Prolia available to appropriate patients.” Prolia is the brand name Amgen will use.

Amgen, the world’s largest biotechnology company, needs a big success. Sales of its anemia drug Aranesp have been declining because of safety concerns. Sales of Neulasta and Neupogen, which prevent infections that result from chemotherapy, have flattened. Enbrel, the arthritis drug, faces increased competition.

Some analysts predict denosumab sales could reach $2 billion a year for treatment of osteoporosis. In a clinical trial involving 8,000 women, only 2.3 percent of those getting denosumab had a vertebral fracture over three years, compared with 7.2 percent of women getting a placebo. Those who got the drug also had fewer hip fractures.

There are an estimated 10 million women with osteoporosis in the United States, according to the National Osteoporosis Foundation. Another 34 million women have low bone mineral density that puts them at risk of getting osteoporosis, but the committee voted against use of the drug for those women.

The main treatments now for osteoporosis are drugs called bisphosphonates, like Actonel, Boniva and alendronate, the generic version of Merck’s Fosamax.

Many analysts expect that doctors, prodded by insurance companies, will try bisphosphonates first, in part because denosumab is expected to be more expensive. But many patients stop taking bisphosphonates because the drugs can be hard to tolerate. Denosumab, which is given only once every six months by an injection, might be an attractive alternative for such patients.

Denosumab is a type of protein called a monoclonal antibody that blocks a molecule in the body called RANK ligand, which spurs the formation and activity of cells that break down bone.

Women with breast cancer getting estrogen-deprivation therapy and men with prostate cancer getting androgen-deprivation therapy can experience bone weakness similar to osteoporosis.

The panel, meeting in Gaithersburg, Md., voted in favor of using denosumab to treat bone loss, but not to prevent it, in men with prostate cancer. It voted against use of the drug for either treatment or prevention of bone loss in women with breast cancer.

“Bone loss is not the major thing,” said Dr. Aman U. Buzdar, an oncologist at the M. D. Anderson Cancer Center and a panel member, said. “The patients already have a fatal disease.”


Source:Press release

[Adminஐﻬ]

Immune System's Role In Bone Loss Uncovered; Finding Could Lead To New Therapies For Osteoporosis
Aug. 24, 2009

Got high cholesterol? You might want to consider a bone density test.
A new UCLA study sheds light on the link between high cholesterol and osteoporosis and identifies a new way that the body's immune cells play a role in bone loss.

Published Aug. 20 in the journal Clinical Immunology, the research could lead to new immune-based approaches for treating osteoporosis. Affecting 10 million Americans, the disease causes fragile bones and increases the risk of fractures, resulting in lost independence and mobility.

Scientists have long recognized the relationship between high cholesterol and osteoporosis, but pinpointing the exact mechanism connecting the two has proved elusive.

"We've known that osteoporosis patients have higher cholesterol levels, more severe clogging of the heart arteries and increased risk of stroke. We also knew that drugs that lower cholesterol reduce bone fractures, too," explained Rita Effros, professor of pathology at the David Geffen School of Medicine at UCLA. "What we didn't understand was why."

Effros suspected a clue to the mystery involved oxidation -- cell and tissue damage resulting from exposure of the fatty acids in cholesterol to molecules known as free radicals.

In the study, UCLA researchers focused on low-density lipoprotein (LDL), the so-called "bad" cholesterol. They examined how high levels of oxidized LDL affect bone and whether a type of immune cell called a T cell plays a role in the process.

Using blood samples from healthy human volunteers, the team isolated the participants' T cells and cultured them in a dish.

Half of the T cells were combined with normal LDL– the rest was combined with oxidized LDL. The scientists stimulated half of the T cells to mimic an immune response and left the other half alone.

"Lo and behold, both the resting and the activated T cells started churning out a chemical that stimulates cells whose sole purpose is to destroy bone," said Effros. Called RANKL, the chemical is involved in immune response and bone physiology.

To investigate further how the immune system participates in bone loss, the scientists repeated the experiment in a mouse model.

Half the animals were fed a high-fat diet starting at one month of age, while the control group ate a normal diet. At 11 months, the mice on the high-fat diet showed elevated cholesterol and thinner bones.

When Effros and her colleagues tested the T cells of the mice on the high-fat diet, they discovered that the cells acted differently than those of the mice on the normal diet.

The T cells switched on the gene that produces RANKL. The chemical also appeared in the animals' bloodstream, suggesting that the cellular activity contributed to their bone loss.

"It's normal for our T cells to produce small amounts of RANKL during an immune response," explained Effros. "But when RANKL is manufactured for long periods or at the wrong time, it results in excessive bone damage."

"That's exactly what happened to the mice on the high-fat diet," she said. "The animals' high cholesterol increased their levels of oxidized LDL, which told the T cells to keep generating RANKL. This discovery revealed to us how the immune system might play an entirely new role in bone loss."

The next step will be exploring methods to control T cell response to oxidized LDL in an effort to develop immune-based approaches to prevent or slow bone loss, Effros says.

The study was funded by the National Institute on Aging, the National Institute of Allergy and Infectious Diseases and the National Heart, Lung and Blood Institute.

Effros' coauthors were Lucia Graham, Farhad Parhami, Yin Tintut, Christina Kitchen and Linda Demer, all of UCLA.


Adapted from materials provided by University of California - Los Angeles.
Source:Science Daily

[Adminஐﻬ]

Buyer beware: No easy bone fixes

Sept. 5,2009
A U.S. researcher says it is buyer beware when it comes to postmenopausal women using plant-derived isoflavones to promote bone health.

"We found that some plant-derived isoflavones -- soy cotyledon, soy germ, red clover and kudzu -- have a modest effect on suppressing bone loss during post-menopause," Connie Weaver of Purdue University says in a statement.

"It's buyer beware. Some of the supplements in our study claimed to be substitutes for estrogen, yet they weren't effective at all or weren't as effective as some of the current treatments for osteoporosis."

Estrogen hormone replacement therapy -- the traditional osteoporosis treatment -- is no longer recommended long term because of links to stroke, embolism and breast cancer. However, the current main class of osteoporosis treatment drugs -- biphosphonates -- cause harmful side effects in some individuals, Weaver says.

"This is a reminder that it's better to build up a good healthy skeleton than to rely on a drug to fix it later," Weaver says in a statement. "Healthy bones can be maintained by a good diet that is rich in calcium and regular exercise that includes strength training."

The findings are scheduled to be published in the October edition of the Journal of Clinical Endocrinology and Metabolism.

[Adminஐﻬ]

Amgen Highlights Data to be Presented at American Society for Bone and Mineral Research (ASBMR) Meeting

 Sept. 10, 2009 /PRNewswire-FirstCall/ -- Amgen (Nasdaq: AMGN) today announced that new data will be presented on the burden of osteoporosis, current osteoporosis treatment challenges and Prolia(TM) (denosumab) at the 2009 American Society for Bone and Mineral Research (ASBMR) annual meeting in Denver from Sept. 11-15, 2009. Prolia currently is being evaluated by regulatory bodies in the United States (U.S.), the European Union, Switzerland, Australia and Canada as a potential therapy for postmenopausal osteoporosis and bone loss in patients undergoing hormone ablation for prostate and breast cancer.


"The continued need for new alternatives to treat postmenopausal osteoporosis is reinforced by data that will be presented at this year's ASBMR meeting. These data highlight challenges with adherence to therapy and show the link between adherence and fracture outcomes," said Roger M. Perlmutter, M.D., Ph.D., executive vice president for Research and Development at Amgen. "Clinical data that will be presented at the meeting include a Phase 3 study sub-analysis showing Prolia's effect on fracture reduction in woman at a greater risk for fracture, 6-year efficacy and safety data from a Phase 2 study, and bone histology data."


ASBMR abstracts are available and can be viewed online at www.asbmr.org. Identified below are selected abstracts of interest on Amgen research.


Prolia(TM) (denosumab)

-- Effects of Denosumab on Bone Mineral Density and Biochemical Markers of Bone Turnover: 6 Year Results of a Phase 2 Clinical Trial

Lead Author: Miller P

Abstract No. 1026 (Saturday, Sept. 12, 2009, 10:15am MT)


-- Effects of Denosumab on Bone Histomorphometry: the FREEDOM and STAND Studies Lead Author: Reid IR

Abstract No. 1027 (Saturday, Sept. 12, 2009, 10:30am MT)


-- Effect of Denosumab on the Incidence of Hip, New Vertebral, and Nonvertebral Fractures Over 3 Years Among Postmenopausal Women with Higher Fracture Risk: A Subgroup Analysis From the FREEDOM Study

Lead Author: Boonen S

Abstract No. 1199 (Monday, Sept. 14, 2009, 3:00pm MT)


-- Effects of Denosumab Treatment and Discontinuation on Bone Mineral Density and Bone Turnover Markers in Postmenopausal Women With Low Bone Mass

Lead Author: Bone H

Abstract No. 1243 (Monday, Sept. 14, 2009, 5:30pm MT)


-- Baseline Remodeling Intensity and Greater Suppression by Denosumab Than Alendronate: Effects on HR-pQCT Parameters at the Radius

Lead Author: Seeman SE

Abstract No. 1244 (Monday, Sept. 14, 2009, 5:45pm MT)


-- Evaluation of Health-Related Quality of Life in Postmenopausal Women Who Participated in the FREEDOM Trial

Lead Author: Siris E

Abstract No. 1282 (Tuesday, Sept. 15, 2009, 11:15am MT)


-- Increases in BMD on Denosumab Explains Much of the Reduction in Fracture Risk

Lead Author: Cummings SR

Abstract No. 1284 (Tuesday, Sept. 15, 2009, 11:45am MT)



Osteoporosis Burden and Treatment Challenges

-- Impact of Treatment Satisfaction (Perceived Benefits, Convenience, Side Effects) on Persistence with Postmenopausal Osteoporosis (PMO) Therapy

Lead Author: Do T

Abstract No. SA0317 (Saturday, Sept. 12, 2009, 11:30 am MT)


-- Impact of Adherence to Osteoporosis Medication on Risk of Fracture

Lead Author: Halpern R.

Abstract No. SA0368 (Saturday, Sept. 12, 2009, 11:30 am MT)


-- Association Between Adherence to Osteoporosis Medication and Inpatient Stays and Medical Services Costs

Lead Author: Iqbal SU

Abstract No. SU0387 (Sunday, Sept. 13, 2009, 11:30 am MT)


-- Comorbidities, Bone Loss and Concomitant Medication Use in European Postmenopausal Women: POSSIBLE EU

Lead Author: Freemantle N

Abstract No. MO0369 (Monday, Sept. 14, 2009, 12:00pm MT)


-- Assessment of Patient Preference, Satisfaction, and Bother with Two Treatments For Postmenopausal Bone Loss

Lead Author: Gold DT

Abstract No. MO0369 (Monday, Sept. 14, 2009, 12:00pm MT)




About Prolia(TM) (denosumab)

Prolia is the first fully human monoclonal antibody in late stage clinical development that specifically targets RANK Ligand, an essential regulator of osteoclasts (the cells that break down bone). Prolia is being investigated for its potential to inhibit all stages of osteoclast activity through a targeted mechanism. Prolia is being studied in a range of bone loss conditions including postmenopausal osteoporosis and bone loss in patients undergoing hormone ablation for prostate and breast cancer.


In February 2009, the U.S. Food and Drug Administration (FDA) accepted the Biologics License Application (BLA), submitted by Amgen for Prolia for the treatment and prevention of osteoporosis in postmenopausal women and cancer treatment-induced bone loss in women and men receiving hormone therapy for either breast cancer or prostate cancer based on these studies and a parallel trial in women with breast cancer. The FDA has provisionally approved the trade name Prolia in these proposed indications, for which denosumab is administered twice yearly subcutaneously at a 60mg dose. The trade name is only for these indications and may not apply for other indications of denosumab.


Amgen has also submitted marketing applications for use of Prolia in the European Union, Canada, Switzerland, and Australia.


Osteoporosis: Impact and Prevalence

Often referred to as the "silent epidemic," osteoporosis is a global problem that is increasing in significance as the population of the world both increases and ages. The World Health Organization (WHO) has recently identified osteoporosis as a priority health issue along with other major non-communicable diseases.


The economic burden of osteoporosis is comparable to that of other major chronic diseases; for example, in the U.S., the costs associated with osteoporosis-related fractures are equivalent to those of cardiovascular disease and asthma.(i,ii,iii) It has been reported that osteoporosis results in more hospital bed-days than stroke, myocardial infarction or breast cancer.(iv)


About Amgen

Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.com.


Forward-Looking Statements

This news release contains forward-looking statements that are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission (SEC) reports filed by Amgen, including Amgen's most recent annual report on Form 10-K and most recent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen's most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to our business. Unless otherwise noted, Amgen is providing this information as of Sept. 9, 2009 and expressly disclaims any duty to update information contained in this news release.


No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation and products liability claims. We depend on third parties for a significant portion of our manufacturing capacity for the supply of certain of our current and future products and limits on supply may constrain sales of certain of our current products and product candidate development.


In addition, sales of our products are affected by the reimbursement policies imposed by third-party payors, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others' regulations and reimbursement policies may affect the development, usage and pricing of our products. In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. We believe that some of our newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Our products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with our products. In addition, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors and there can be no guarantee of our ability to obtain or maintain patent protection for our products or product candidates. We cannot guarantee that we will be able to produce commercially successful products or maintain the commercial success of our existing products. Our stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of our products or product candidates. Further, the discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations.


The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration (FDA), and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Only the FDA can determine whether the product candidates are safe and effective for the use(s) being investigated. Further, the scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration (FDA) for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses. Only the FDA can determine whether the products are safe and effective for these uses. Healthcare professionals should refer to and rely upon the FDA-approved labeling for the products, and not the information discussed in this news release.


i. Burge R, et al. J Bone Miner Res. 2007; 22:465-475


ii. "Osteoporosis Fast Facts." National Osteoporosis Foundation. Accessed on August 19, 2009 at http://www.nof.org/osteoporosis/diseasefacts.htm


iii. "Economic Cost of Cardiovascular Diseases." American Heart Association. Accessed on February 24, 2009 at http://www.americanheart.org/statistics/10econom.html.


iv. Lippuner K, et al. "Incidence and direct medical costs of hospitalisations due to osteoporotic fractures in switzerland." Osteoporosis International.1997;7:414-25.



    CONTACT: Amgen, Thousand Oaks
    Sarah Reines: (805) 447-9783 (U.S. media)
    Arvind Sood: (805) 447-1060 (investors)


(Logo:http://www.newscom.com/cgi-bin/prnh/20081015/AMGENLOGO)






 
SOURCE : Amgen
 

[Adminஐﻬ]

Positive Data from Wyeth Drug

Wyeth Pharmaceuticals, a division of Wyeth (WYE), announced data from a placebo-controlled late-stage study of its drug candidate bazedoxifene 20 mg in postmenopausal women with osteoporosis. The results indicated that women who took bazedoxifene had a lower risk of new fractures to their vertebrae.

As a reminder, 20 mg and 40 mg doses of the drug were initially tested, along with raloxifene 60 mg and a placebo, over a three-year period in 7,492 postmenopausal women aged between 55 and 85 and with moderate to severe osteoporosis. The results were disclosed in 2007. They revealed that the three-year incidences of new vertebral fracture were 2.3%, 2.5%, 2.3% and 4.1% in the bazedoxifene 20 mg, bazedoxifene 40 mg, raloxifene 60 mg and placebo groups, respectively. On conclusion of the three-year study, a total of 4,216 subjects were enrolled in the extension to five years.

The raloxifene 60 mg arm was discontinued in the extended version of the trial. Some of the subjects took 20 mg of bazedoxifene per day during the entire trial period. Others took 40 mg per day for four years and were switched to the 20 mg group in the last year of the study. Both groups had fewer new vertebral fractures than patients who only took a placebo.

About 4.5% of women who took 20 mg of the drug exclusively had new fractures, compared with 3.9% who started off on the larger dose, and 6.8% of placebo patients.

Bazedoxifene was approved for sale in the European Union under the name Conbriza in April 2009. However, it is still under review by the U.S. Food and Drug Administration.

The osteoporosis market represents a huge commercial potential with global sales of osteoporosis medications coming in at about $8.4 billion in 2008. The indication, which results in bone fragility coupled with an increased risk of fractures, affects approximately 75 million people in the United States, Europe and Japan. It is estimated that a significant amount of a woman's expected bone loss occurs in the postmenopausal years. Consequently, the effective treatment of postmenopausal osteoporosis could lead to significant improvement in the overall health.

We note that Amgen (AMGN - Analyst Report) is currently seeking approval for denosumab for the treatment and prevention of postmenopausal osteoporosis and bone loss in patients undergoing hormone ablation for either prostate or breast cancer. We believe the candidate has the potential to capture a major share of the osteoporosis market once launched.

[Adminஐﻬ]

The Chautauqua County Osteoporosis Support group will meet at 10:30 a.m. Thursday in the Jamestown Boys and Girls Club main lobby, 62 Allen St., Jamestown.

Members attending should take a bathing suit and towel if planning to use the pool and gym shoes for walking the track. The public is invited and new members are welcome.

The group focuses on education for prevention and understanding of osteoporosis. There is no cost to attend.

[Adminஐﻬ]

FRAX - Identifying people at high risk of fracture
WHO Fracture Risk Assessment Tool, a new clinical tool for informed treatment decisions

This 16-page report, issued on World Osteoporosis Day 2009, aims to bring understanding of FRAX® to health professionals, policy makers, and interested laypersons. The report is authored by Dr. Eugene McCloskey of the University of Sheffield, a key developer of the calculation tool.

As a freely accessible online clinical tool, FRAX® helps clinicians make informed treatment decisions, based on fracture risk rather than BMD values alone. The tool is available at
http://www.shef.ac.uk/FRAX/

[Adminஐﻬ]

Hope on World Osteoporosis Day – New Drug in Development 
Osteologix, Inc. (OTCBB:OLGX), a bio-pharmaceutical company announced today that the company will continue the clinical development for its osteoporosis drug, NB S101 (strontium malonate), in the United States and the rest of the world markets. Additionally, the company wants to recognize World Osteoporosis Day’s significance and make more people aware of its research dedicated to improving the lives of people with osteoporosis.

”We believe that NB S101 will bring a safe and effective new alternative therapy for the millions of patients with osteoporosis. Our product can be manufactured and commercialized in a way that should also appeal to the cost conscious patients, physicians and payers,” said Philip J. Young, CEO of Osteologix. “In addition, our recently expanded global patent estate will allow our shareholders a long window of opportunity to realize returns on their investments.”

Different from other drug therapies available in the U.S., NB S101 is a dual acting bone agent (DABA), designed to benefit patients by strengthening the bone in two ways. Unlike the aggressive actions of other therapies, which can sometimes lead to brittle bones after several years of therapy, strontium is a moderate anti resorptive drug that also works to enhance bone mineralization giving the patients stronger, more fracture-resistant bones. Another key advantage researchers note is that strontium therapy is an excellent choice for the significant number of women who cannot take or tolerate bisphosphonate treatment, (the largest class of drugs currently used to treat osteoporosis).

Currently, there is one prescription strontium therapy widely used in Europe and other parts of the world, Protelos® (strontium ranelate), which is marketed by a French pharmaceutical company. Protelos has been prescribed for five years and has demonstrated excellent efficacy and safety in patients of all ages. It is unavailable in the U.S. Strontium therapy with NB S101 should be preferred over the French product. First, NB S101 is a tablet, not a powder that needs to be suspended in water, which Osteologix believes will aid in compliance, as it is easier for patients to take. Second, studies conducted by the company have demonstrated that NB S101 has better bioavailability -- meaning the patients can take a lower dose of the active element, strontium, and obtain the same blood level. Osteologix believes that its drug will provide fracture reduction and safety on par with or better than the French product.

Osteologix has already conducted two human studies in hundreds of subjects with NB S101 (strontium malonate) and is in the planning stages of further clinical development that will be conducted here, in the U.S., and around the world.
About Osteoporosis

Osteoporosis is the most common bone disease in humans and, according to the National Osteoporosis Foundation (NOF), 10 million Americans are estimated to have the disease and almost 34 million more are estimated to have osteopenia or low bone mass, placing them at increased risk for osteoporosis. The most severe consequence of osteoporosis is skeletal fracture. Osteoporosis is responsible for more than 1.5 million fractures annually and direct expenditures for hip fractures are estimated to cost society more than $18 billion annually. According to NOF, one in two women and one in four men over age 50 can be expected to have an osteoporosis-related fracture at some time.

About Osteologix

Osteologix is a specialty pharmaceutical company committed to developing innovative therapies for the treatment and prevention of musculoskeletal diseases. The Company’s vision is to improve the health of those afflicted with musculoskeletal diseases such as osteoporosis. Its lead product candidate, NB S101, is a novel pharmaceutical agent for the treatment and prevention of osteoporosis. For more information please visit www.osteologix.com.

 
 

[Adminஐﻬ]

The National Osteoporosis Foundation is partnering with some big time Dallas eateries this Monday, October 26 at 6 p.m. for its second annual Gourmet for Good.

The twist from your usual fundraising foodie event? Guests start the night with wine and hors d'oeuvres at Samuel Lynne Galleries on Dragon Street and THEN discover which of eight participating restaurants they will be dining at. You can also get a ride to your destination via chauffeured limo.

Oh, and who all is involved? Chew on these names: Kenichi, Dragonfly, Nobu, Palomino, The Capital Grille, The Crescent Club, Nick & Sam's and Bolla at the Stoneleigh Hotel & Spa
 

Proceeds benefit the National Osteoporosis Foundation's programs of awareness, education, advocacy and research and you can still purchase tickets starting at $150 by calling Kelly Austin at 202-721-6342 or go online at www.nof.org/gourmetforgood

[Adminஐﻬ]

Register now for the 19th IOF Advanced Training Course on Osteoporosis in Lyon, France
The International Osteoporosis Foundation (IOF) invites you to attend its popular IOF Advanced Training Course on Osteoporosis, scheduled for February 2-4, 2010 in Lyon, France. Download program and registration form at http://www.iofbonehealth.org/ltc2010.html

Held annually in the beautiful city of Lyon since 1991, the two-and-a-half day course provides a concise and clinically-focused overview of the latest knowledge on the physiology, epidemiology, diagnosis and management of osteoporosis. A unique feature is the opportunity for direct interaction between delegates and faculty members during special Meet-the-Expert and Roundtable sessions.

The IOF Advanced Training Course on Osteoporosis is taught in English by an internationally renowned faculty which includes S. Boonen, M.L. Bouxsein, C. Cooper, W.H. Dere, J.A. Kanis, E.V. McCloskey, M.R. McClung, S.E. Papapoulos, J.Y. Reginster, and R. Rizzoli.

Participants are eligible for EACCME accreditation (also recognized by the American Medical Association).

Interested physicians, allied health professionals and industry representatives are encouraged to register quickly as spaces are limited to 250 participants. Take advantage of early bird registration rates until December 18, 2009.

Don't miss this informative training course - register now at http://www.iofbonehealth.org/ltc2010.html
Source: International Osteoporosis Foundation

[Adminஐﻬ]

Osteologix, Inc. (OTCBB:OLGX), a bio-pharmaceutical company announced today that the company will continue the clinical development for its osteoporosis drug, NB S101 (strontium malonate), in the United States and the rest of the world markets. Additionally, the company wants to recognize World Osteoporosis Day’s significance and make more people aware of its research dedicated to improving the lives of people with osteoporosis.

”We believe that NB S101 will bring a safe and effective new alternative therapy for the millions of patients with osteoporosis. Our product can be manufactured and commercialized in a way that should also appeal to the cost conscious patients, physicians and payers,” said Philip J. Young, CEO of Osteologix. “In addition, our recently expanded global patent estate will allow our shareholders a long window of opportunity to realize returns on their investments.”

Different from other drug therapies available in the U.S., NB S101 is a dual acting bone agent (DABA), designed to benefit patients by strengthening the bone in two ways. Unlike the aggressive actions of other therapies, which can sometimes lead to brittle bones after several years of therapy, strontium is a moderate anti resorptive drug that also works to enhance bone mineralization giving the patients stronger, more fracture-resistant bones. Another key advantage researchers note is that strontium therapy is an excellent choice for the significant number of women who cannot take or tolerate bisphosphonate treatment, (the largest class of drugs currently used to treat osteoporosis).

Currently, there is one prescription strontium therapy widely used in Europe and other parts of the world, Protelos® (strontium ranelate), which is marketed by a French pharmaceutical company. Protelos has been prescribed for five years and has demonstrated excellent efficacy and safety in patients of all ages. It is unavailable in the U.S. Strontium therapy with NB S101 should be preferred over the French product. First, NB S101 is a tablet, not a powder that needs to be suspended in water, which Osteologix believes will aid in compliance, as it is easier for patients to take. Second, studies conducted by the company have demonstrated that NB S101 has better bioavailability -- meaning the patients can take a lower dose of the active element, strontium, and obtain the same blood level. Osteologix believes that its drug will provide fracture reduction and safety on par with or better than the French product.

Osteologix has already conducted two human studies in hundreds of subjects with NB S101 (strontium malonate) and is in the planning stages of further clinical development that will be conducted here, in the U.S., and around the world.

About Osteoporosis

Osteoporosis is the most common bone disease in humans and, according to the National Osteoporosis Foundation (NOF), 10 million Americans are estimated to have the disease and almost 34 million more are estimated to have osteopenia or low bone mass, placing them at increased risk for osteoporosis. The most severe consequence of osteoporosis is skeletal fracture. Osteoporosis is responsible for more than 1.5 million fractures annually and direct expenditures for hip fractures are estimated to cost society more than $18 billion annually. According to NOF, one in two women and one in four men over age 50 can be expected to have an osteoporosis-related fracture at some time.

About Osteologix

Osteologix is a specialty pharmaceutical company committed to developing innovative therapies for the treatment and prevention of musculoskeletal diseases. The Company’s vision is to improve the health of those afflicted with musculoskeletal diseases such as osteoporosis. Its lead product candidate, NB S101, is a novel pharmaceutical agent for the treatment and prevention of osteoporosis. For more information please visit www.osteologix.com.


Read more: http://www.pharmiweb.com/pressreleases/pressrel.asp?ROW_ID=8910#ixzz0Uq4ikXNl

[Adminஐﻬ]

Study: Immune system may cause osteoporosis in celiac disease patients

Oct. 26,2009

People with celiac disease may be more likely to develop osteoporosis because their own immune system attacks their bone tissue, a recent study suggested.

About 20% of celiac patients produce antibodies that target a key protein called osteoprotegerin that maintains bone health, Scottish researchers reported in Oct. 8's New England Journal of Medicine. The result is rapid bone destruction and severe osteoporosis, Prof. Stuart Ralston of the Institute of Genetics and Molecular Medicine at the University of Edinburgh and his colleagues found.

People with celiac disease have a serious intolerance to gluten, found in wheat, rye, spelt, barley and other grains. Gluten can cause an immune system reponse that damages the small intensine in people with the disease. Initially, researchers believed that celiac disease patients may develop osteoporosis because their body lacked the ability to absorb calcium and vitamin D.

"Not only have we discovered a new reason to explain why osteoporosis occurs in celiac disease, but we have also found that it responds very well to drugs that prevent bone tissue removal," Ralston said.

[Adminஐﻬ]

Osteoporosis Still the Silent Epidemic
    Yoplait Asana(TM) with MBP(TM) first yogourt in Canada to offer
    clinically-proven fortified recipe for strong bones

 Nov. 3 , 2009~ Despite bone health being a major preoccupation for women, especially as they get older, more than 70% of Canadian women are still not consuming enough calcium on a daily basis to keep their bones strong and prevent osteoporosis. Known as the "silent epidemic", osteoporosis affects one in four Canadian women over the age of 50. The introduction of Yoplait Asana, the first and only yogourt to offer a unique fortified recipe for strong bones with two times more calcium than regular yogourt, now makes it easy for women to get the calcium that they need in the foods they eat every day.

Yoplait Asana(TM) is enriched with calcium, vitamin D and Milk Basic Protein (MBP ), an innovative dairy ingredient exclusive to Yoplait in Canada and clinically proven to suppress bone destruction and increase bone formation. Derived from bovine milk, it is a selected milk protein whose effectiveness on bone health has been proven in ten clinical studies, including five on humans. These three complementary ingredients work together to reinforce bones.

"I have had the opportunity to review and validate the scientific literature on from five different clinical trials on humans," said Dr. Jacques P. Brown, Head, Division of Rheumatology, Laval University, CHUL. "As a bone health expert, I believe that the MBP(TM) in Yoplait Asana(TM) can have a beneficial effect on osteoporosis."

Yoplait Asana(TM) delivers twice the calcium of regular yogourt: 20 per cent of the recommended daily intake (RDI) of calcium and 15 per cent of the RDI of vitamin D.

"Yoplait has responded to the consumer preference to get the calcium they need on a daily basis from their food," said Dr. Émilie Laurin, PhD, Yoplait R&D Manager, Scientific Affairs. "One serving (100g) of Yoplait Asana(TM) is enriched with 40 mg of MBP(TM) which contributes to the high calcium content" she added.

Yoplait Asana(TM) has 90 calories per serving and is made from 2% milk fat so it tastes great and has none of the chalky aftertaste typical in calcium enriched products.

Yoplait Asana(TM) will be available across Canada at grocery stores in November in a variety of formats and great flavours: 650g container in Vanilla, Strawberry and Plain flavours and two 8x100g packages with Strawberry/Fieldberry or Vanilla/Peach flavours. The 650g format retails for $3.99 and the eight-packs of 100g containers retail for $4.99-$5.49.

For more information, please visit www.yoplaitasana.com.

About Yoplait


At the forefront of Canada's yogourt and fresh cheese market for nearly 40 years, Yoplait products are synonymous with quality, diversity and innovation. Yoplait markets more than 100 products in Canada under such reputed brand names as Yoplait Minigo, Yoplait Tubes, Yoplait Source, Yop from Yoplait, Yoplait Creamy, Yoplait Basket Fat-Free, Yoptimal from Yoplait and new Yoplait Asana. Yoplait was the first yogourt manufacturer in Canada to offer a combination of vitamin D and calcium in all of its products, thereby helping Canadians achieve the daily recommended intake of these two nutrients. At Yoplait, eating healthfully and having fun is not a contradiction; it's a mission. That is why the company offers yogourts and other dairy products to make so many of life's moments more enjoyable. For more information about Yoplait products, visit www.yoplait.ca.

SOURCE: Press Release

[Adminஐﻬ]

New cause of osteoporosis: Mutation in a miroRNA

Many biological processes are controlled by small molecules known as microRNAs, which work by suppressing the expression of specific sets of genes. Xiang-Hang Luo and colleagues, at Second Xiangya Hospital of Central South University, People's Republic of China, have now identified a previously unknown microRNA (miR-2861) as crucial to bone maintenance in mice and humans. Of clinical importance, expression of functional miR-2861 was absent in two related adolescents with primary osteoporosis.

Several lines of evidence determined the key role of miR-2861 in maintaining bone. First, miR-2861 promoted the in vitro development of a mouse stromal cell line into the cells responsible for bone formation. Second, in mice, in vivo silencing of miR-2861 inhibited bone formation and decreased bone mass. Last, analysis of ten patients with primary osteoporosis revealed two related adolescents in whom disease was caused by a mutation in the miR-2861 precursor (pre-miR-2861) that blocked expression of miR-2861. These data led the authors to conclude that miR-2861 has an important role in controlling the generation of the cells responsible for bone formation and that defects in the processing of its precursor can cause osteoporosis.


TITLE: A novel microRNA targeting HDAC5 regulates osteoblast differentiation in mice and contributes to primary osteoporosis in humans

AUTHOR CONTACT:
Xiang-Hang Luo
Second Xiangya Hospital of Central South University, Changsha, Hunan, People's Republic of China.
Phone: 86-731-85292152; Fax: 86-731-85533525;

[Adminஐﻬ]

New NIH Website Offers Easy Access to Information on Bone Health

Aug. 12, 2010
A new Web resource providing people with the latest science-based information on bone health and bone disease is available through the NIH Osteoporosis and Related Bone Diseases ~ National Resource Center. The site is <www.bones.nih.gov>.

[Adminஐﻬ]

EffRx and Nycomed Announces First European Filing for Marketing Approval of Osteoporosis Drug Targeting Increased Convenience for Patients

Sep 21, 2010 - The Lausanne, Switzerland, based drug delivery company EffRx Pharmaceuticals SA (“EffRx”) and its partner, the global pharmaceutical company Nycomed, headquartered in Zurich, Switzerland, today announced that the first European filing for marketing approval of EX101, a once-a-week 70mg buffered effervescent alendronate, for the treatment of osteoporosis, has been submitted. The filing triggers a milestone payment to EffRx.

The licensing agreement for EX101 between Nycomed and EffRx was announced early 2009 and Nycomed recently amended its original licensing agreement with EffRx and holds now exclusive rights to develop, manufacture and commercialise the effervescent formulation of alendronate for the treatment of osteoporosis in all territories in the world except USA and Japan.

EX101 will complement Nycomed's osteoporosis portfolio, which consists of Preotact® (full-length parathyroid hormone [PTH 1-84]) for treatment of osteoporosis in post-menopausal women at high risk of fractures, and the company's broad Calcium D3 product range for the prevention and an adjunct of the condition.

“This is obviously a key step in getting EX101 to the market and shows Nycomed's commitment to get EX101 into their osteoporosis portfolio of products as soon as possible,” stated Christer Rosén, CEO of EffRx.
About EX101:

EX101 is a proprietary once weekly administration of a 70mg buffered effervescent formulation of alendronate (bisphosphonate) for treatment of post-menopausal osteoporosis. Product is addressing the complaints of inconvenience when taking bisphosphonates in tablet form. Alendronate reduces the risk of vertebral and hip fractures.

About Nycomed:

Nycomed is a privately owned global pharmaceutical company with a differentiated portfolio focused on branded medicines in gastroenterology, respiratory and inflammatory diseases, pain, osteoporosis and tissue management. An extensive range of OTC products completes the portfolio.

Its R&D is structured around partnerships and in-licensing is a cornerstone of the company's growth strategy.

Nycomed employs 12,000 associates worldwide, and its products are available in more than 100 countries. It has strong platforms in Europe and in fast-growing markets such as Russia/CIS and Latin America. While the US and Japan are commercialised through best-in-class partners, Nycomed plans to further strengthen its own position in key Asian markets.

Headquartered in Zurich, Switzerland, the company generated total sales of ‚¬3.2 billion in 2009 and an adjusted EBITDA of ‚¬1.1 billion.

For more information visit www.nycomed.com

About EffRx:

EffRx is a privately held drug delivery technology company specializing in utilizing advantages of effervescence to improve existing prescription drugs. In September 2010, the company moved its headquarters and operations to Epalinges Sur Lausanne, Switzerland. For more information, please go to the website www.effrx.com

[Adminஐﻬ]

Loyola Physician Helps Develop National Guidelines for Osteoporosis

Recommendations provide diagnosis, treatment guidance for postmenopausal women
Jan. 27, 2011 -- The American Association of Clinical Endocrinologists (AACE) has released new medical guidelines for the diagnosis and treatment of postmenopausal osteoporosis. Loyola physician Pauline Camacho, MD, was part of a committee that developed the guidelines to manage this major public health issue.

These recommendations were developed to reduce the risk of osteoporosis-related fractures and improve the quality of life for patients. They explain new treatment options and suggest the use of the FRAX tool (a fracture risk assessment tool developed by the World Health Organization) and the National Osteoporosis Foundation guide to identify candidates for treatment.

“Less than one-third of osteoporosis cases are diagnosed, and only one-seventh of American women with osteoporosis receive treatment,” said co-author Pauline Camacho, MD, director of the Loyola University Osteoporosis and Metabolic Bone Disease Center. “These guidelines use evidence to help physicians better identify and care for these women.”

More than 10 million Americans have osteoporosis and approximately 35 million more have low bone mass and are at increased risk for developing osteoporosis and fractures. Approximately 80 percent of these are women, most of them postmenopausal. AACE recommends that high-risk postmenopausal women should be screened immediately and all women ages 65 and older should be tested routinely for the disease.

Hip fractures are the most serious complication of osteoporosis. Half of all patients who could walk independently are unable to do so one year after a hip fracture. A hip fracture leads to an increased mortality rate for two years following the break. More than half of the survivors are unable to return to independent living and many require long-term nursing home care.

“These guidelines take into consideration the economic impact of the disease,” Dr. Camacho said. “They stress the need for efficient and effective evaluation and treatment of these women to prevent further complications from arising.”

Treatment involves ensuring adequate intake of calcium, vitamin D and prescription medications as well as lifestyle modification focusing on exercise and fall prevention.

The guidelines are available at www.aace.com. For more information, visit www.loyolahealth.org.


Contact:
Nora Plunkett
Media Relations

[Adminஐﻬ]

http://media.aace.com/article_display.cfm?article_id=5021