Fosamax Cleared For Osteoporosis Prevention

10 March 1997

An advisory committee to the US Food and Drug Administration hasunanimously recommended that a new 5mg dose of Merck & Co's aminobisphosphonate Fosamax (alendronate) be cleared for the prevention of osteoporosis in postmenopausal women. If approved it will be the first nonhormonal drug to be cleared for this indication. The committee additionally recommended that the existing formulation of Fosamax (10mg) be approved for the prevention of fractures and hospitalization in postmenopausal osteoporotic women.

These recommendations were based on prevention studies involving 2,347 postmenopausal women between 40 and 60 years of age who did not show signs of the disease. Furthermore, data from the Fracture Intervention Trial (Marketletter December 16, 1996), a treatment study which enrolled 2,027 women aged 55 to 81 who had both osteoporosis and history of spinal fracture, were also taken into consideration.

Trial Results Over a period of 24 months, bone loss in women receiving Fosamax 5mg was prevented and significant increases in bone mass at the spine and hip and total body were recorded. In contrast, placebo-treated patients in the prevention studies experienced significant losses in bone mass at these sites (Marketletter June 3, 1996).

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