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

Abstract

BackgroundPerimenopausal women can experience rapid bone loss at skeletal sites with both cortical and cancellous bone, increasing the prevalence of osteoporosis following menopause. MethodsWe conducted a 12-month randomized placebo-controlled trial evaluating the effects of alendronate 70mg with 2800IU cholecalciferol administered once per week for 12months 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 12months. Secondary end-points were the change in BMD at the femoral neck and changes in biochemical markers of bone turnover. ResultsForty-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 BMD in women treated with alendronate increased by 3.66% (mean paired difference, d¯=0.032;±0.008SE) at 12months, compared with a reduction of 3.33% d¯=−0.030;±0.008SE in the control group (P<0.001). In the femoral neck, the mean BMD in the alendronate group increased by 2.07% d¯=0.014;±0.009SE at 12months, compared with a reduction of 1.87% d¯=−0.014;±0.008SE 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 12months. At 12months, both bone-specific alkaline phosphatase and urinary N-telopeptide were significantly reduced, by 37.79% d¯=−9.90;±1.92SE and 27.21% d¯=−11.68;±4.80SE respectively, in the alendronate group; in the control group, these levels increased (P<0.001). ConclusionWeekly treatment with alendronate 70mg and cholecalciferol 2800IU increases BMD and decreases bone turnover in perimenopausal women.