A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of Alendronate on Bone Mineral Density and Bone Remodelling in Perimenopausal Women With Low Bone Mineral Density

BACKGROUND: Perimenopausal women can experience rapid bone loss at skeletal sites with both cortical and cancellous bone, increasing the prevalence of osteoporosis following menopause. METHODS: We conducted a 12-month randomized placebo-controlled trial evaluating the effects of alendronate 70 mg with 2800 IU cholecalciferol administered once per week for 12 months in comparison with placebo and cholecalciferol. The primary end-point was the percentage change in the lumbar spine bone mineral density (BMD) from baseline to 12 months. Secondary end-points were the change in BMD at the femoral neck and changes in biochemical markers of bone turnover. RESULTS: Forty-five women were recruited to participate in the study. Five subjects withdrew from the study before randomization for unrelated reasons. Forty subjects were randomly allocated to the alendronate and placebo groups. The mean lumbar spine MD in women treated with alendronate increased by 3.66% (mean paired difference, μd = 0.032; ± 0.008 SE) at 12 months, compared with a reduction of 3.33% (μd = -0.030; ± 0.008 SE) in the control group (P < 0.001). In the femoral neck, the mean BMD in the alendronate group increased by 2.07% (μd = 0.014; ± 0.009 SE) at 12 months, compared with a reduction of 1.87% (μd = -0.014; ± 0.008 SE) in the control group (P = 0.046). There were no differences in BMD between the alendronate and placebo groups at the total hip sites after 12 months. At 12 months, both bone-specific alkaline phosphatase and urinary N-telopeptide were significantly reduced, by 37.79% (μd = -9.90; ± 1.92 SE) and 27.21% (μd = -11.68; ± 4.80 SE) respectively, in the alendronate group; in the control group, these levels increased (P < 0.001). CONCLUSION: Weekly treatment with alendronate 70 mg and cholecalciferol 2800 IU increases BMD and decreases bone turnover in perimenopausal women.