The Fracture Intervention Trial, the largest randomized study to assess drug efficacy in reducing the incidence of osteoporotic fractures at all sites in post-menopausal women, has found that Merck Sharp & Dohme's bisphosphonate Fosamax (alendronate) is highly effective. Full results of the trial are published in The Lancet (December 7).
The three-year, placebo-controlled trial was conducted at 11 centers in the USA and involved 2,027 post-menopausal women with low bone mass and a history of spinal fracture. Patients initially received either 5mg of Fosamax or placebo. After two years this dose was increased to 10mg following the release of data from separate dose-ranging efficacy trials. Participants who had a dietary calcium intake of less than 1000mg per day (80% in both placebo- and Fosamax-treated groups) were also given calcium and vitamin D supplements.
Postitive Trial Results Findings showed that the incidence of hip fracture was reduced by 51%, new vertebral fracture by 47%, and wrist fracture by 48%. In addition, a 90% reduction of two or more spinal fractures, a 55% reduction in painful spinal fractures and a 34% reduction in height loss was noted in the treated group compared to placebo.
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