FDA clears wearable vibration belt for postmenopausal women with osteopenia
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Key takeaways:
- The FDA cleared a vibration belt to treat postmenopausal women with osteopenia.
- The device slowed the loss of bone strength and density in a double-blinded sham-controlled trial.
The FDA cleared a wearable vibration belt device as a non-pharmacologic treatment for postmenopausal women with osteopenia, according to an industry press release.
The Osteoboost vibration belt (Bone Health Technologies) is a device that delivers a targeted, calibrated vibration to the lumbar spine and hips. The device has been indicated to reduce bone strength and density declines for postmenopausal women. As Healio previously reported, the FDA granted breakthrough device designation to the vibration belt in December 2020.
“There are millions of American women with low bone density or osteopenia,” David B. Karpf, MD, adjunct clinical professor of endocrinology, gerontology and metabolism at Stanford University School of Medicine and attending physician in the osteoporosis and metabolic bone disease clinic, said in the release. “This is often the precursor to osteoporosis. We have little to offer those women other than calcium and vitamin D supplements. The field of bone health right now is missing innovative approaches — there are no new agents in clinical trials for osteoporosis and nothing for women who have osteopenia. With the aging of our population, we need new ways to effectively prevent the decline in bone mass and strength that affects all women in the perimenopause or postmenopausal stage.”
The vibration belt’s clearance was based on data from a double-blinded sham-controlled study. The primary outcome of the study was change in vertebral strength as measured by CT scan at 1 year. Women who used the vibration belt least 3 times per week lost 0.48% of their bone strength compared with a bone strength decline of 2.84% in the sham group (P = .014). The sham group also had a 1.68% greater decline in vertebral bone density compared with women using the vibration belt. (P = .008). There were no serious adverse events reported.
“The well-being and ability of postmenopausal women to maintain an active lifestyle is threatened when loss of estrogen causes rapid loss of bone,” Laura Bilek, PhD, associate dean for research and associate professor at the University of Nebraska, and principal investigator of the study, said in the release. “Although lifestyle interventions such as exercise and diet are beneficial to bone, the effect is small. The Osteoboost shows promise in slowing the loss of bone density and strength and may fill the treatment gap.”
Perspective
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For many years, clinical trials testing whether low-magnitude mechanical signals to the skeleton can preserve bone mass have been inconsistent. With funding from a National Institute on Aging Small Business Innovation Research Grant, Bone Health Technologies tested a wearable belt with an incorporated motor transmitting low-amplitude, high-frequency (20 to 40 Hz) vibration to the spine and hips.
Results of a 1-year randomized, sham-controlled study have been presented only as an abstract, reporting vertebral bone strength derived from CT-based finite element analysis in 126 postmenopausal women with osteopenia wearing the belt for 5 days per week for 30 minutes per session. The primary intent-to-treat analysis showed no differences between active and sham groups. However, post hoc per-protocol analyses that included only 50% of the subjects revealed a significant advantage of the intervention in a single age 50 to 60 years subgroup.
The active group maintained spine bone mineral density and strength relative to declines in the sham group. On the basis of these results, the company submitted to the FDA’s De Novo classification request process, designed to test products that provide reasonable assurance of safety and effectiveness for the intended use. They received breakthrough device designation, which is intended to provide timely access to medical devices by speeding up development, assessment and review for premarket approval. The device is indicated “to reduce the decline in bone strength and volumetric BMD in postmenopausal women with osteopenia of the hip or spine.”
This story is an odd juxtaposition given that to date, trials of new anti-osteoporosis drugs have required fractures as primary endpoints, requiring large trials. The lack of a surrogate endpoint for fractures has led to a drying of the drug pipeline to prevent age-related bone loss. Current efforts by the FNIH-ASBMR Study to Approve BMD as a Regulatory Endpoint (SABRE) project to develop an FDA-approved biomarker for clinical trials of bone active drugs has taken millions of dollars and several years to approach a goal of permitting BMD to serve as a valid endpoint for new drug development. It is therefore remarkable to me that a prescription-requiring device like Osteoboost can be approved within the FDA with a single small randomized trial showing no significant effect in the intent-to-treat analysis. No one has ever claimed that the FDA process is a consistent one across the Center for Devices and Radiological Health and the Center for Drug Evaluation and Research. In the end, we expect evidence-based decisions to drive both drug and device approval — a belt and suspenders approach.
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