Bone Health Technologies to Present Clinical Data from Pivotal Trial of Wearable Treatment for Osteopenia in Post-Menopausal Women at Endo 2023
Per Protocol Participants saw an 85% Reduction in the Loss of Vertebral Bone Density in One Year
CHICAGO, June 16, 2023 (GLOBE NEWSWIRE) — Bone Health Technologies (BHT), a pioneer in health technologies for preventing and treating bone health diseases, is presenting pivotal trial data for Osteoboost, a novel treatment for low bone mass in postmenopausal women, at Endo 2023. The poster presentation will highlight the results of the study showing that Osteoboost is a promising intervention for postmenopausal loss of bone density and strength. The findings were chosen by a panel of experts as a “late-breaking abstract” for the annual meeting of the Endocrine Society, the largest and most prominent endocrinology conference. The majority of fragility fractures occur in patients with low bone mass or osteopenia who lack effective options to treat their condition.
Bone Health Technologies has filed for Class 2 Prescription De Novo Approval with the FDA and was previously awarded Breakthrough Device Status.
The double-blinded, sham-controlled study enrolled 126 postmenopausal women with low bone mass who were not on bone-active medications. The data being presented are strong evidence that supports the efficacy of the Osteoboost in reducing the decline of bone strength and bone density. The primary outcome measurement was the change in vertebral strength, as measured by Biomechanical Computed Tomography using finite element analysis. Per Protocol (PP) – subjects (those who used the device a minimum of 3 times per week throughout the year) in the Active Treatment group lost, on average, 0.48% bone strength, while those in the Sham group lost 2.84%, with a relative difference of 2.36% (P=0.014)– an 82% reduction in the rate of bone strength loss. Additionally, CT measurement of vertebral bone density was conducted and showed a 1.68% relative benefit for those using the Osteoboost– an 85% reduction in loss of bone density (P=0.008) in the PP group. Zero serious adverse events were reported.
Laura Bilek, Ph.D., the principal investigator for this study, emphasized the importance of understanding potential new mechanisms for reducing the bone loss that occurs after menopause. “The evidence of our study suggests that Osteoboost is a safe and effective option for the treatment of low bone density. By investing in the development of novel technology, we are empowering women and patients everywhere to maintain their bone health and the normalcy and independence of their daily lives.”
“The 53 million Americans with osteopenia lack clinically-proven effective interventions to slow or reverse their continued bone strength and bone density decline– we are excited by the pivotal trial results showing the first, non-pharmacological intervention to slow loss of bone strength as measured by CT,” said Laura Yecies, CEO of Bone Health Technologies.
The well-being of postmenopausal women is threatened by the increased risk of fragility fractures when loss of estrogen causes a rapid decline in bone strength. Pharmaceutical interventions, while effective, are generally not indicated for patients with osteopenia, and lifestyle interventions such as exercise and diet have small effect sizes. Osteoboost is a unique and easy-to-use intervention that combines clinically proven effectiveness with no serious adverse effects. Osteoboost is a wearable device that is designed to improve bone strength and density of the user. The belt delivers targeted vibration to the lumbar spine and hips and provides safe and effective treatment.
Study participants underwent a thorough screening process, including DXA scans and a comprehensive blood workup. The participants were divided into two randomized groups: the Active group received Osteoboost treatment five times per week for 12 months, while the Sham group used the same device but received a placebo treatment that simulated vibration. Compressive strength and volumetric density of the first lumbar vertebrae (L1) were measured using Finite Element Analysis of computed tomography (CT) scans of the lumbar spine by ON Diagnostics.
Bone Health Technologies is proud to have contributed to this groundbreaking study and will share findings with attendees at ENDO 2023. The conclusive findings of this study will revolutionize patient care and widen the discussion of osteoporosis treatment and fragility fractures.
ABOUT BONE HEALTH TECHNOLOGIES:
Bone Health Technologies is a San Francisco-based company that applies science and medical expertise to create better health outcomes for women and men at risk of developing osteoporosis and associated bone fractures. Bone Health Technologies is poised to become the new standard of care in treating both osteoporosis and osteopenia (the precursor to osteoporosis). Visit www.bonehealthtech.com for more information.
MEDIA CONTACT:
Michelle Kafka
407-603-5716
Michelle@kafkamediagroup.com
