The FDA has granted clearance to a wearable belt that delivers targeted vibrations to the spine and hips as the first non-drug prescription medical device to treat low bone density, the precursor to osteoporosis. Shown to be effective in clinical trials, the novel device offers postmenopausal women an alternative treatment to vitamin and mineral supplements.
Postmenopausal women are at high risk of fractures due to loss of the hormone estrogen. Because estrogen helps maintain bone density, this loss can lead to osteopenia or low bone density. The precursor to osteoporosis, osteopenia affects 40.4% of people globally.
Developed by Bone Health Technologies (BHT), Osteoboost is a novel wearable belt device that delivers vibrations to the lumbar spine and hips to encourage bone growth. The FDA recently granted clearance for the device to treat osteopenia, making it the first non-drug prescription medical device to receive such clearance.
“Today’s groundbreaking decision represents the first non-pharmacological therapy approved to treat this widespread and serious condition,” said Laura Yecies, CEO of BHT, regarding the FDA’s announcement on the 18th of January. “With Osteoboost, we have a new treatment option – free of serious adverse events – that taps into the body’s natural mechanism to stimulate bone growth. Women’s health has been underserved for too long, making this a huge step forward for older women who have lacked effective treatment options and are seeking an effective way to protect their bone health.”
An offshoot of NASA technology designed to prevent bone loss in astronauts operating in zero gravity, whole-body vibration therapy (WBVT) stimulates bone growth by simulating the bones’ mechanical loading during high impact exercise. Previous studies have found that WBVT encourages bone growth and can prevent bone loss in the hips and lumbar spine in postmenopausal women. Ordinarily, WBVT is delivered by a stand-on oscillating platform. Osteoboost instead delivers targeted, low-intensity vibrations to the hips and lumbar spine, the most common areas for osteoporotic fractures.
The FDA based its decision on data from a clinical trial that evaluated Osteoboost’s effectiveness, published in the Journal of the Endocrine Society. The randomized controlled trial enrolled 126 postmenopausal women with low bone density who received Osteoboost treatment five times a week for 12 months with the belt in either the active or sham setting. In the sham setting, a sound was created, but the device didn’t deliver a vibration. When participants were stratified by age, there were significant differences in percent change in vertebral bone strength in 50-to-60-year-olds; the sham group lost 3.4% of their vertebral bone strength compared to a 0.5% loss in the active group. In those who met the compliance criterion of Osteoboost treatment three times per week, the sham group lost 2.84% of bone strength compared to 0.48% loss in the active group, representing a five times greater loss in the sham group. Additionally, the Osteoboost treatment preserved the bone density of the first lumbar vertebra (L1), with the active group losing 0.29% of bone mineral density (BMD) relative to a 1.97% loss in the sham group, representing a 6.8 times great loss in the sham group.
“The well-being and ability of postmenopausal women to maintain an active lifestyle is threatened when loss of estrogen causes rapid loss of bone,” said Laura Bilek, the study’s lead author. “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.”
The FDA applied the De Novo classification process, which provides a marketing pathway to classify novel medical devices, to BHT’s request for clearance for Osteoboost before it was designated a Breakthrough Device. This creates an entirely new class of therapeutics for low bone density outside of pharmaceutical intervention. Notably, Osteoboost also represents the first therapeutic device specifically designed and cleared for use in osteopenia.
Other than calcium and vitamin D supplements, no other treatments for osteopenia are currently available.
“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,” said David Karpf, Adjunct Clinical Professor of Endocrinology, Gerontology and Metabolism at Stanford University School of Medicine. “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.”
Source: Bone Health Technologies