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In December 1996, a group of investigators reported the results of the Fracture Intervention Trial, a randomized controlled trial that compared the effect of alendronate plus calcium or calcium supplementation alone on the risk of fractures in women who already had evidence of vertebral fractures. The results showed that in patients managed with alendronate, there was a 51% decrease in the risk of hip fractures, a 46% decrease in the risk of vertebral fractures, and a 44% decrease in the risk of distal radial fractures when compared with patients managed with calcium alone. These results, as well as those from several other reports, supported the regulatory approval of alendronate (marketed under the trade name Fosamax) for the treatment of postmenopausal osteoporosis in the United States and many countries abroad.
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