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, MD23,
- Deborah E. Sellmeyer, MD4 and
- Jennifer L. Kelsey, PHD1
- 1Division of Epidemiology, Stanford University School of Medicine, Stanford, California
- 2Department of Epidemiology and Biostatistics, University of California–San Francisco, San Francisco, California
- 3Division of General Internal Medicine, University of California–San Francisco, San Francisco, California
- 4Division 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
Abstract
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.
- 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
Footnotes
-
D.C.B. has received support for clinical studies from Merck, Procter and Gamble, and SmithKline Beecham.
A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances.
-
- Accepted March 23, 2004.
- Received January 13, 2004.
- DIABETES CARE
