FRI681 OsteoboostTm Is Effective In Preserving Bone Strength And Density Of The Spine In Women With Low Bone Mass

Abstract

Abstract Disclosure: L.D. Bilek: Grant Recipient; Self; Bone Health Technologies. Stock Owner; Self; Bone Health Technologies. L.E. Flores: Employee; Self; Bone Health Technologies. N. Waltman: None. L.R. Mack: None. K. Smith: None. D. Hillstrom: Employee; Self; Bone Health Technologies. M. Griffin: Consulting Fee; Self; Bone Health Technologies. Stock Owner; Self; Bone Health Technologies. L. Yecies: Employee; Self; Bone Health Technologies. Stock Owner; Self; Bone Health Technologies. M. Jaasma: Consulting Fee; Self; Bone Health Technologies. Stock Owner; Self; Bone Health Technologies. Introduction: Fragility fractures result in significant morbidity and mortality, which is of particular concern in postmenopausal women who are at high risk of fractures due to loss of estrogen. Pharmaceutical interventions are effective but have low uptake and adherence and are generally not indicated for patients with osteopenia. Vibration has the potential to prevent bone loss and holds promise as an effective, yet minimal risk, treatment. The Osteoboost, a novel wearable device delivering targeted vibration to the lumbar spine and hips, is designed to improve bone strength and bone density. Thus, this study aims to evaluate the efficacy of a 12-month intervention with the OsteoboostTM on preserving strength of the first lumbar vertebrae in postmenopausal women with low bone mass. Methods: This double-blinded, randomized controlled trial enrolled postmenopausal women with low bone mass who were not taking bone-active medications. Women had a bone density DXA and assessment of thyroid function to screen for eligibility Those who qualified were randomized to receive Osteoboost treatment 5x/week for 12 months with the belt in either the active or sham setting. The sham device created a sound but did not deliver vibration. Compressive strength (N) and volumetric density of the 1st lumbar vertebra (L1) was analyzed using Finite Element Analysis (FEA) of computed tomography (CT) scans of lumbar spine by ON Diagnostics. Results: 126 women (64 Active, 62 Sham) with low bone mass participated in the study, with an average age of 62.1 years (SD ± 5.8) and 60.6 years (± 5.3) in the Active and Sham groups, respectively. Most participants were of White race (98%) and non-Hispanic (96%). There were no significant differences in baseline demographics between the sham and active groups. Intent to treat analysis revealed no significant difference in percent change in vertebral bone strength between the Active and Sham groups over time (baseline to 12 months). When stratified by age category, significant differences in percent change in vertebral bone strength were present in the 50-60 year old category; the Sham group lost 3.4% of their vertebral bone strength compared to a 0.5% loss in the Active group (p=0.018). While bone was preserved in the active group relative to the sham in the women over 60, it was not significant (p=0.20). With analysis of those who met the compliance criterion of 3x/week, the Sham group lost 2.84% compared to 0.48% in the Active group (p=0.014); representing a 5 times greater loss in the Sham group. Additionally, the Osteoboost treatment preserved volumetric bone density of L1, with the Active treatment group losing 0.29% BMD relative to a 1.97% loss in the Sham group; representing a 6.8 times greater loss in the Sham group (p=0.008). Conclusion: The Osteoboost holds promise as a therapeutic intervention for women with low bone mass to prevent decline to osteoporosis and reduce fracture risk. Presentation: Friday, June 16, 2023