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

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.