date fosamax goes off patent
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Business Editors/Health & Medical Writers
SAN ANTONIO–(BUSINESS WIRE)–Sept. 23, 2002
In the longest study of a non-hormonal osteoporosis therapy to date, Fosamax(R) (alendronate sodium) continued to help build spinal bone through 10 years of treatment of osteoporosis in postmenopausal women.
The results were presented today at the annual meeting of the American Society for Bone Mineral Research (ASBMR) in San Antonio, Texas.
“Having clinical data on the long-term effectiveness and safety of osteoporosis therapies is very important,” said Henry G. Bone III, M.D., of the Michigan Bone and Mineral Clinic in Detroit. “The results of this study extend our knowledge about treatment of osteoporosis with alendronate over a period of 10 years and were consistent with our earlier findings.”
Fosamax continues to help build spinal bone over 10 years
The study originally began as a three-year trial with 994 osteoporotic, postmenopausal women between the ages of 45 and 82. The multi-center, double-blind, randomized, placebo-controlled study was extended, so that patients were studied over 10 consecutive years of treatment. Patients originally were randomized into four groups, receiving 5 mg, 10 mg or 20 mg of Fosamax, or placebo. The groups taking Fosamax 5 mg and 10 mg remained on these doses for the entire 10 years.
The study showed that treatment with daily oral alendronate 10 mg for 10 years in 86 patients resulted in:
— one 70 mg tablet once weekly or — one 10 mg tablet once daily
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The safety and tolerability profile of Fosamax was similar to that seen in other studies with Fosamax 5 mg and 10 mg.
About osteoporosis
Menopause is a key factor contributing to the development of osteoporosis, caused when there is an imbalance in bone-building cycles and more bone is broken down than is replaced.(1) This can lead to osteoporosis, a silent disease that causes bones to become more porous, gradually making them weaker, more brittle and prone to fracture.
“Physicians have been concerned about the long-term effects of bisphosphonates like risedronate and alendronate. This study is the first to show that alendronate was generally well-tolerated over a 10-year period of time, while at the same time it helped to provide continuous increases in bone mass,” said Ronald Emkey, M.D., medical director, Radiant Research in Reading, PA.
Important information about Fosamax
Fosamax, like other bisphosphonates, should be used with caution in people with certain stomach or digestive problems. Fosamax should not be used if the patient has certain disorders of the esophagus that delay emptying or if the patient is unable to stand or sit upright for at least 30 minutes. In addition, Fosamax should not be used in patients with severe kidney disease or low levels of calcium in their blood, in patients who are allergic to Fosamax or in patients who are pregnant or nursing.
Some patients may develop severe digestive reactions including irritation, inflammation or ulceration of the esophagus. The risk of sevStudies done in germany on fosamax
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