WEDNESDAY, Feb. 6 (HealthDay News) -- The U.S. Food and Drug Administration has approved the first generic equivalents of Fosamax (alendronate sodium), Merck & Co.'s osteoporosis drug.
In a statement, the Israeli firm Teva Pharmaceutical Industries Ltd. said the FDA had approved its new drug application to market the medication in doses of 5 milligrams, 10 milligrams, 35 milligrams, 40 milligrams, and 70 milligrams. Shipment will begin immediately.
The brand-name drug had annual U.S. sales of about $1.9 billion for the period ended Sept. 30, Teva said.
New Jersey-based Barr Pharmaceuticals Inc. also announced that it had received FDA approval to produce a 70-milligram dose of generic Fosamax.
More information
The FDA has more information about this medication.
TUESDAY, Nov. 27 (HealthDay News) -- Scientists have a developed a model to help doctors predict which postmenopausal women are likely to sustain a hip fracture over a five-year period.
The algorithm includes 11 different factors -- such as age and family history -- and applies to postmenopausal women of different ethnic backgrounds.
"Knowing the 5-year risk of fracture will permit patients to make informed choices when balancing ... lifestyle changes against undergoing medical interventions," explained a team led by Dr. John Robbins, of the department of internal medicine at the University of California School of Medicine, in Sacramento.
His group published their findings in the Nov. 28 issue of the Journal of the American Medical Association.
Some experts have predicted a coming epidemic of fractures among Americans over the next few decades as the population ages.
In particular, postmenopausal women are vulnerable to fractures resulting from osteoporosis, a degenerative weakening of the bones. About 329,000 hip fractures occur each year in the United States, according to the National Center for Health Statistics
The critical question is how to prevent such debilitating, and possibly fatal, fractures, and how to spot who's most at risk. Treatments that strengthen bone do exist, and might help shield people from fracture.
In devising the new algorithm, Robbins' team looked at data on almost 100,000 women who participated in the U.S. government-sponsored Women's Health Initiative (WHI).
The 11 predictors chosen were validated on 68,132 women and tested in 10,750 women who had undergone dual energy x-ray absorptiometry scans (DXA) to assess bone mass density.
The 11 factors that help predict hip fractures within five years are: age, self-reported health, weight, height, race/ethnicity, self-reported physical activity, history of fracture after age 54, parental history of hip fracture, current smoking, current corticosteroid use and treated diabetes.
The model still needs to be tested in diverse populations, the authors pointed out. And it doesn't identify which women would benefit from which specific prevention measures. "However, we believe [the] 11 readily available clinical variables offer a simple means of stratifying the 5-year risk of hip fracture in postmenopausal women," they concluded.
One outside expert thinks the model will help.
"This gives us a way to pinpoint which women need aggressive preventative therapy," said Paul Brandt, an associate professor of neuroscience and experimental therapeutics at Texas A&M Health Science Center College of Medicine in College Station.
More information
Find out more on osteoporosis at the American Academy of Orthopaedic Surgeons.