Effect of alendronate on bone mineral density and biochemical markers of bone turnover in type 2 diabetic women: the fracture intervention trial.
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.


METHODS
We used data from the Fracture Intervention Trial, a randomized blinded placebo-controlled trial conducted at 11 centers in which 6458 women aged 54-81 years with a femoral neck BMD of <or=0.68 g/cm(2) 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 >or=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.
Keegan
Theresa H M
TH
Division of Epidemiology, Stanford University School of Medicine, Stanford, CA 94305-5405, USA. tkeegan@nccc.org
Schwartz
Ann V
AV
Bauer
Douglas C
DC
Sellmeyer
Deborah E
DE
Kelsey
Jennifer L
JL
D000368:Aged; D000369:Aged, 80 and over; D019386:Alendronate / Q000009:adverse effects / Q000627:therapeutic use*; D015415:Biomarkers / Q000097:blood; D015992:Body Mass Index; D015519:Bone Density / Q000187:drug effects*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000503:physiopathology*; D004311:Double-Blind Method; D005260:Female; D050723:Fractures, Bone / Q000517:prevention & control*; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000517:prevention & control; D010919:Placebos; D013131:Spine / Q000033:anatomy & histology
D015415:Biomarkers; D007004:Hypoglycemic Agents; D010919:Placebos; D019386:Alendronate