Study Details

Long-Term Safety and Efficacy of Oral Alendronate in Postmenopausal Women from the Fracture Intervention Trial—FLEX

Adrianne C. Feldstein, Principal Investigator
Emily L. Harris, Co-Investigator

This double-blind, randomized, placebo-controlled extension study examines the long-term efficacy, safety, and tolerability of oral alendronate sodium in postmenopausal women who were treated with alendronate for 3-6 years in the Fracture Intervention Trial, 1992-1998. FIT was an 11-center trial that examined alendronate's effectiveness in preventing fractures secondary to osteoporsis.

Randomization will be stratified by fracture risk, and eligible patients will be randomly assigned to receive one of two doses of alendronate, or placebo. Patient height and bone mineral density of the hip will be measured at baseline and annually thereafter. Other measurements of bone mineral density (lumbar spine, total body, and forearm) will be taken at varying intervals; radiographs will be taken at baseline and at months 36 and 60; and biochemical markers of bone turnover will be measured at baseline and at months 12, 36, and 60.
Funding source: Merck Research Laboratories

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