Abstract
Purpose: This randomized controlled trial compared changes in bone mineral density (BMD) and bone turnover in postmenopausal women with low bone mass randomized to 12 months of either risedronate, exercise, or a control group. Methods: Two hundred seventy-six women with low bone mass, within 6 years of menopause, were included in analysis. Treatment groups were 12 months of (a) calcium and vitamin D supplements (CaD) (control), (b) risedronate + CaD (risedronate), or (c) bone-loading exercises + CaD (exercise). BMD and serum markers for bone formation (Alkphase B) and resorption (Serum Ntx) were analyzed at baseline, 6, and 12 months. Results: Using hierarchical linear modeling, a group by time interaction was found for BMD at the spine, indicating a greater improvement in the risedronate group compared to exercise (p ≤.010) or control groups (p ≤.001). At 12 months, for women prescribed risedronate, changes in BMD at the spine, hip, and femoral neck from baseline were + 1.9%, + 0.9%, and +.09%; in exercise group women, + 0.2%, + 0.5%, and − 0.4%; and in control group women, − 0.7%, + 0.5%, and − 0.5%. There were also significant differences in reductions in Alkphase B (RvsE, p <.001, RvsC, p <.001) and Serum Ntx (RvsE, p =.004, RvsC, p =.007) in risedronate women compared to exercise and control groups. For risedronate, 12-month changes in Alkphase B and Serum Ntx were − 20.3% and − 19.0%; for exercise, − 6.7% and − 7.0%; and for control, − 6.3% and − 9.0%. Conclusion: Postmenopausal women with low bone mass should obtain adequate calcium and vitamin D and participate in bone-loading exercises. Additional use of BPs will increase BMD, especially at the spine.