The US Food and Drug Administration (FDA) has approved a wearable belt device for postmenopausal women with osteopenia, the precursor to osteoporosis, according to the company's manufacturer, Bone Health Technologies.
According to the company, the device (Osteoboost) is the first nonpharmacologic device-based, prescription-only treatment for postmenopausal women with low bone density. It has not been tested for ability to reduce fracture risk.
The device is worn around the hips and delivers calibrated mild vibrations to the hips and lumbar spine to help preserve bone strength and density. A vibration pack is mounted to the back of the belt.
FDA approval, announced on January 18, was based on the findings of a National Institutes of Health–funded double-blinded, sham-controlled study of 126 women with low bone density conducted at the University of Nebraska Medical Center in Omaha, Nebraska. The data were shared at the 2023 Endocrine Society and American Society for Bone and Mineral Research annual meetings and published in the Journal of the Endocrine Society.
Lead investigator Laura Bilek, PT, PhD, associate dean for research and associate professor at the University of Nebraska, and colleagues wrote that the primary outcome measurement was the change in vertebral strength measured by CT scans for women who used the device a minimum of three times per week compared with a sham group who wore a belt that emitted sound but had no vibrations.
Compressive strength and volumetric density of the first lumbar vertebra were analyzed.
In the active-belt group, women lost, on average, 0.48% bone strength, while those in the sham group lost nearly 2.84% (P = .014), about five times as much. Results also showed that participants in the active treatment group who used the device three times per week lost 0.29% bone mineral density (BMD) compared with the 1.97% BMD lost in the control group. No adverse events were reported in the study.
Sonali Khandelwal, MD, a rheumatologist at Rush University in Chicago, Illinois, told Medscape Medical News there's considerable fear among some patients about long-term use of available medications for bone health, "so any modality that is nontherapeutic — not a pill — is always exciting."
The endpoints of the study are one good measure, she said, but she emphasized that it will be important to show that the improved bone density from the belt that is described in this study "is a true marker of decreased fracture risk."
Because there are no apparent side effects, she said it may be effective in combination with weight-bearing exercise, vitamin D and calcium, and/or medication, depending on severity of bone loss.
Current medications on the market for osteoporosis have been shown to improve bone strength and reduce fracture risk, she noted.
"It could help; I just don't think we have enough evidence that it will completely treat the bone loss," Khandelwal said.
She said she sees the potential population most interested in the belt as premenopausal women with a family history of bone loss who may not meet the level of bone loss for medical management but are interested in prevention.
"I also think of individuals who might already meet medication needs but are completely averse to being on medication," she said. The bulk of her practice is treating bone loss, she said, estimating that 20% of her patients do not want to be on medication.
Bone Health Technologies CEO Laura Yecies, MBA, told Medscape Medical News the company has not yet set the price for the device and noted that because it will be available by prescription only, out-of-pocket costs and copays will differ. She said the company expects to begin shipping later this year. Requests for update notifications can be made at the company's website.
Bilek told Medscape Medical News the device was tested for a year, so it's unclear how long people with osteopenia would need to wear the belt for maximum benefit.
The theory behind the mechanism of action, she said, "is that the vibration actually inhibits the cells [osteoclasts] that take away bone mass."
Although they only included postmenopausal women with osteopenia in the study, Bilek said she would like to test the device on other groups, such as men with prostate cancer getting testosterone-blocking therapy, which can result in loss of bone density. An estimated 34 million people in the United States have osteopenia.
Bilek said a next step for the study is to enroll a more diverse cohort at an additional center to test the device because most of the women in this one were White.
She noted that women's bone mass peaks at age 30 and then starts to decline.
"When women hit menopause, there's a really rapid decline [in bone strength] for the next 5-7 years and then the decline levels off. If we can slow that decline, hopefully that woman's bone density is maintained at a higher level throughout their life," Bilek said.
Bilek is a scientific adviser to Bone Health Technologies. She and many coauthors of the study received grants or fees from the company and own stock in or are employees of the company. Yecies is the founder and CEO of Bone Health Technologies. Khandelwal had no relevant financial relationships.