MON-802 Wearable Vibration Therapy for Low Bone Density: High Adherence and Usability Scores in a 12-Month Clinical Trial

Abstract Disclosure: L.D. Bilek: Bone Health Technologies, Inc.. L.E. Flores: None. N. Waltman: None. K. Smith: None. D. Hillstrom: Bone Health Technologies, Inc. L. Yecies: Bone Health Technologies, Inc. M.J. Jaasma: Bone Health Technologies, Inc.. Following menopause, women experience a rapid reduction in bone density and bone strength.1 Given the low adherence and high discontinuation rates for pharmacotherapies for low bone density,2 there is a need for new solutions that are more acceptable to patients. Mechanical stimulation via targeted vibration therapy provides a non-drug intervention for low bone density, and as a wearable, home-use treatment, it is also convenient for patients. Previously, we reported on effectiveness results from a 12-month randomized, sham-controlled trial in postmenopausal women with osteopenia, in which targeted vibration therapy provided significant reductions in the loss of vertebral bone strength and density.3 Here, we present adherence results and device usability scores from this study. The study evaluated Osteoboost, a home-use, wearable medical device that is worn like a belt and delivers vibration therapy (30 minutes/day treatment) targeted to the spine and hips. Treatment is delivered while doing activities of daily living that involve standing or walking. We enrolled postmenopausal women with a diagnosis of osteopenia. Participants were randomized (1:1) to the Active treatment (Osteoboost device providing vibration therapy) or Sham treatment (inactive device, emitted a buzzing sound but no vibration) and instructed to use their device 30 minutes/day for at least 5 days/week over the 12-month study. For the compliance analysis, completion of at least 24 minutes of treatment in a calendar day was considered a full treatment session for that day. In the modified intention-to-treat (mITT) population, 88% of participants (110 of 125) completed the 12-month study. These participants completed 4.1 ± 1.5 treatment sessions/week (mean ± SD), which represents 82% compliance with the recommended treatment regimen. At study completion, when asked if the device was easy to use, 72% agreed or strongly agreed (n=99 mITT participants who completed the usability assessment). When asked how easy it was to schedule time to use the device at least 5 days/week, participants rated it 7.9 ± 2.1 on a 10-point scale. Participants reported using the device while conducting activities of daily living, including going for a walk, getting ready in the morning, cooking, doing the dishes, and watching TV. These results demonstrate that postmenopausal women found the Osteoboost wearable vibration therapy device to have high usability and found the daily 30-minute treatment easy to incorporate into their daily schedules. Taken together with previously reported results, Osteoboost’s wearable vibration therapy provides a safe, effective, and convenient therapy for the treatment of osteopenia in postmenopausal women. References: 1Finkelstein JS et al. (2008), J Clin Endocrinol Metab 93(3):861. 2Lindsay BR et al. (2016), Arch Osteoporos 11(1):19. 3Bilek LD et al. (2023), J Endocrine Soc 7(S1):bvad114.449. Presentation: Monday, July 14, 2025