Benefits of Targeted Vibration for Bone Strength and Bone Density in Postmenopausal Women with Osteopenia: A Randomized, Sham-Controlled Trial

Abstract

Abstract Postmenopausal women are at increased risk of fractures due to higher bone turnover that accompanies reduced estrogen production. Vibration may be an effective intervention for maintaining bone strength and bone density. The Osteoboost Belt is a wearable, home-use device that delivers targeted vibration to the lumbar spine and hips. This randomized, sham-controlled trial evaluated the safety and effectiveness of targeted vibration on bone strength and density in postmenopausal women with osteopenia. Participants (n = 126) were randomized (1:1) to receive the Active (vibration therapy device) or Sham (inactive device) treatment for 30 minutes/day over 12 months. At baseline and 12 months, computed tomography scans of the lumbar spine were analyzed to measure finite element analysis-assessed vertebral bone compressive strength (vertebral strength) and volumetric bone mineral density (vBMD) of the L1 vertebra. The primary endpoint, the difference in percentage change of vertebral strength between the Active (-1.40%, [95% CI: -2.73, -0.08]) and Sham (-2.74% [-4.04, -1.43]) groups in the modified intent-to-treat population, did not reach statistical significance (relative benefit: +1.33% [-0.57, 3.24], P=.17). However, a statistically significant benefit of targeted vibration was observed for participants who met the prespecified per-protocol compliance criterion (averaged ≥3 treatment sessions/week): -0.48% [-2.12, 1.17]) and -2.84% [-4.21, -1.47] (n = 73, P=.028) for Active and Sham groups, respectively. Similarly, in this compliant cohort, targeted vibration provided a statistically significant benefit on vertebral bone density, with the percentage change in vBMD of -0.29% [-1.28, 0.70] and -1.97% [-2.92, -1.01] (P=.016) for the Active and Sham groups, respectively. The vibration therapy was well-tolerated, and there were no serious device-related adverse events. These results demonstrate that targeted vibration is safe and, in adherent individuals, can significantly mitigate the decline in vertebral bone strength and vertebral bone density in postmenopausal women with osteopenia.