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FDA clears Osteoboost, first drug-free medical device for postmenopausal women with osteoporosis
January 25, 2024

On January 18, the FDA announced clearance of Bone Health Technologies’ Osteoboost, the first non-pharmacologic medical device for the treatment of postmenopausal women diagnosed with low bone density.
What’s the potential patient impact?
According to the National Institutes of Health, osteopenia, which is often the precursor to osteoporosis, affects nearly 34 million Americans and that incidence is expected to exponentially increase as the population ages. Women have a four-fold higher overall prevalence of osteopenia compared to males. The current standard of care is limited to calcium and vitamin D supplementation and regular weight-bearing exercise, neither of which have been proven to significantly slow the loss of bone density.
How does it work?
Osteoboost is worn around the waist and delivers calibrated vibrations to the lower lumbar spine and hips. Treatment sessions last about 30 minutes and are administered during routine activities like walking and standing.
What’s the evidence?
The FDA clearance comes on the heels of a randomized controlled NIH-funded study that showed that Osteoboost could alter the course of vertebral strength.
All participants wore the Osteoboost and were randomly assigned to either the active group (Osteoboost with vibration, n=64) or the control group (Osteoboost with noise but no vibration, n=62). The primary outcome measurement was the change in vertebral strength as measured by CT scan.
Participants in the active treatment group used the device a minimum of three times per week and 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). Additionally, CT measurement of vertebral bone density showed a 1.68% relative benefit for those using the Osteoboost (P=0.008). No serious adverse events were reported.
According to Bone Health Technologies’ press release, the findings demonstrate the efficacy of Osteoboost in directly stimulating bone growth and preserving bone mineral density and strength by sending low-frequency vibrations directly to the lumbar spine and hips.
Sources:
(2024, January 18). Bone Health Technologies. Bone Health Technologies Announces FDA Clearance of Osteoboost, the First Prescription Medical Device to Treat Low Bone Density.[Press release]. https://www.bonehealthtech.com/news/press-release/1007/
Ernst, D. (2024, January 18). Prescription belt device gets FDA clearance for postmenopausal women with osteopenia. Medical Professionals Reference. https://www.empr.com/home/news/medical-technology/prescription-belt-device-gets-fda-clearance-for-postmenopausal-women-with-osteopenia/
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