© 2004 by the American Diabetes Association, Inc.
Effect of Alendronate on Bone Mineral Density and Biochemical Markers of Bone Turnover in Type 2 Diabetic WomenThe Fracture Intervention Trial
1 Division of Epidemiology, Stanford University School of Medicine, Stanford, California Address correspondence and reprint requests to Dr. Theresa Keegan, Department of Health ResearchPolicy, Division of Epidemiology, HRP Redwood Building, T224, Stanford University School of Medicine, Stanford, CA 94305-5405. E-mail: tkeegan{at}nccc.org OBJECTIVEAlendronate sodium (ALN) increases bone mineral density (BMD) in heterogeneous populations of postmenopausal women, but its effect is unknown in women with type 2 diabetes. The objective of this project was to compare changes in BMD during 3 years of ALN treatment versus placebo in diabetic women.
RESEARCH DESIGN AND METHODSWe used data from the Fracture Intervention Trial, a randomized blinded placebo-controlled trial conducted at 11 centers in which 6,458 women aged 5481 years with a femoral neck BMD of RESULTSIn diabetic women, 3 years of ALN treatment was associated with increased BMD at all sites studied, including 6.6% at the lumbar spine and 2.4% at the hip, whereas women in the placebo group experienced a decrease in BMD at all sites except the lumbar spine. The safety/tolerability of ALN was similar to placebo, except for abdominal pain, which was more likely in the ALN group. CONCLUSIONSALN increased BMD relative to placebo in older women with type 2 diabetes and was generally well tolerated as a treatment for osteoporosis. Increases in BMD with ALN therapy compared with placebo were similar between women with and without diabetes.
Abbreviations: ALN, alendronate sodium BMD, bone mineral density BSAP, bone-specific alkaline phosphatase CTx, COOH-terminal telopeptide of type I collagen FIT, Fracture Intervention Trial NTx, NH2-terminal propeptide of type I collagen
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