FIT Women Reveal Alendronate Benefits

2 June 1996

Post-menopausal women with osteoporosis, who have already suffered a spinal fracture, have 51% lower risk of hip fractures and a 46% lower risk of new spinal fractures if they receive treatment with Merck & Co's new bisphosphonate drug Fosamax (alendronate), according to initial results from the placebo-controlled Fracture Intervention Trial (FIT).

The new data come from the first arm of the FIT study, called the Vertebral (Spinal) Fracture study, which included 2,027 women and was stopped by the Data & Safety Monitoring Board in October 1995 as there was already clear evidence of the benefits of alendronate treatment. VFS was scheduled to conclude in mid-1996.

A second arm, the Clinical Fracture Study, is looking at 4,432 women who have low bone mineral density but no prior fractures and is due to end sometime in 1997.

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