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Fosamax.

(alendronate, Merck)

A bisphosphonate to increase bone mass in men with osteoporosis. The first drug approved to treat osteoporosis in men.

* Recommended Dosage: 10 mg once a day (the same dose approved for post-menopausal osteoporosis).

* Special Considerations: To avoid esophageal side effects and maximize absorption, must be taken with 6-8 ounces of plain water when arising, at least 30 minutes before ingesting the first food, beverage, or medication of the day. Patient should also sit up for at least 30 minutes after taking Fosamax.

Generally well tolerated; no significant differences between serious or drug-related adverse effect in the related or placebo groups.

* Comments: Approval was based on a Merck-funded, placebo-controlled multi-center study of 241 men with osteoporosis, aged 31-87 (36% had low serum free testosterone, and men with other secondary causes of osteoporosis were excluded). After 2 years, those treated with Fosamax had mean increases in bone mineral density (BMD) of the lumbar spine (7%), the femoral neck (2.5%), and total body BMD (2%) that were significantly greater than increases seen among those on placebo.

Increases were similar in men under age 65 and those 65 and older, and were similar regardless of gonadal function or baseline BMD. The rate of vertebral fractures was higher in those on placebo (7% vs. 0.8%); at the end of the study those on Fosamax were 0.6 mm shorter and those on placebo were 2.4 mm shorter (N. Engl. J. Med. 343[9]:604-10, 2000).

On the basis of this study and others, including those that found benefits of the drug in men with steroid-induced osteoporosis, the authors concluded that Fosamax "appears to be effective in the majority of men with osteoporosis."
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Author:Mechcatie, Elizabeth
Publication:OB GYN News
Date:Nov 15, 2000
Words:282
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