Randomized Trial of Effect of Alendronate Continuation Versus Discontinuation in Women With Low BMD: Results From the Fracture Intervention Trial Long-Term Extension

作者：Kristine E. Ensrud, Elizabeth L Barrett-Connor, Ann V. Schwartz, Arthur C. Santora, Douglas C. Bauer, Shailaja Suryawanshi, Adrianne C. Feldstein, William L. Haskell, Marc C. Hochberg, James C. Torner, Antonio Lombardi, Dennis M. Black · 发表于：Journal of Bone and Mineral Research · 年份：2004 · DOI：10.1359/jbmr.040326 · 被引用次数：277 · 研究领域：Bone health and osteoporosis research、Bone health and treatments、Bone and Joint Diseases

UNLABELLED: To determine the effects of continuation versus discontinuation of alendronate on BMD and markers of bone turnover, we conducted an extension trial in which 1099 older women who received alendronate in the FIT were re-randomized to alendronate or placebo. Compared with women who stopped alendronate, those continuing alendronate for 3 years maintained a higher BMD and greater reduction of bone turnover, showing benefit of continued treatment. However, among women who discontinued alendronate and took placebo in the extension, BMD remained higher, and reduction in bone turnover was greater than values at FIT baseline, showing persistence of alendronate's effects on bone. INTRODUCTION: Prior trials including the Fracture Intervention Trial (FIT) have found that therapy with alendronate increases BMD and decreases fracture risk for up to 4 years in postmenopausal women with low BMD. However, it is uncertain whether further therapy with alendronate results in preservation or further gains in BMD and if skeletal effects of alendronate continue after treatment is stopped. MATERIALS AND METHODS: We conducted a follow-up placebo-controlled extension trial to FIT (FIT long-term extension [FLEX]) in which 1099 women 60-86 years of age who were assigned to alendronate in FIT with an average duration of use of 5 years were re-randomized for an additional 5 years to alendronate or placebo. The results of a preplanned interim analysis at 3 years are reported herein. Participants...