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Diabetes Care 27:1547-1553, 2004
© 2004 by the American Diabetes Association, Inc.


Clinical Care/Education/Nutrition
Original Article

Effect of Alendronate on Bone Mineral Density and Biochemical Markers of Bone Turnover in Type 2 Diabetic Women

The Fracture Intervention Trial

Theresa H.M. Keegan, PHD1, Ann V. Schwartz, PHD2, Douglas C. Bauer, MD2,3, Deborah E. Sellmeyer, MD4 and Jennifer L. Kelsey, PHD1

1 Division of Epidemiology, Stanford University School of Medicine, Stanford, California
2 Department of Epidemiology and Biostatistics, University of California–San Francisco, San Francisco, California
3 Division of General Internal Medicine, University of California–San Francisco, San Francisco, California
4 Division of Endocrinology, University of California–San Francisco, San Francisco, 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

OBJECTIVE—Alendronate 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 METHODS—We used data from the Fracture Intervention Trial, a randomized blinded placebo-controlled trial conducted at 11 centers in which 6,458 women aged 54–81 years with a femoral neck BMD of ≤0.68 g/cm2 were randomly assigned to either placebo or 5 mg/day ALN for 2 years, followed by 10 mg/day for the remainder of the trial. BMD was measured by dual-energy X-ray absorptiometry. Type 2 diabetes (n = 297) was defined by self-report, use of insulin or other hypoglycemic agents, or a random nonfasting glucose value ≥200 mg/dl.

RESULTS—In 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.

CONCLUSIONS—ALN 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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