Issue: March 2024
Fact checked byJill Rollet

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January 18, 2024
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FDA clears wearable vibration belt for postmenopausal women with osteopenia

Issue: March 2024
Fact checked byJill Rollet
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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.
Perspective from Douglas P. Kiel, MD, MPH

The FDA cleared a wearable vibration belt device as a non-pharmacologic treatment for postmenopausal women with osteopenia, according to an industry press release.

David B. Karpf

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.

Generic FDA News infographic
The FDA has cleared the Osteoboost vibration belt for use among postmenopausal women with osteopenia.

“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.”