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Merck Fosamax

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

A two-year study of 10 mg alendronate daily in 241 men with osteoporosis shows mean bone mineral density increases of 7.1±0.3% at the lumbar spine, 2.5±0.4% at the femoral neck, and 2.0±0.2% for the total body. Placebo patients saw a 1.8±0.5% increase in BMD at the lumbar spine and no significant changes in femoral neck or total body BMD, investigators reported in the New England Journal of Medicine Aug. 31. The results were similar to one-year data announced last fall. Merck has an sNDA with priority review status pending at FDA for treatment of male osteoporosi

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