The US Food and Drug Administration (FDA) has approved a portable belt device for postmenopausal women with osteopenia, the precursor to osteoporosis, according to Bone Health Technologies, the company’s manufacturer.
The device (Osteoboost) is the first non-pharmacological, device-based, prescription treatment for postmenopausal women with low bone density. It has not been tested for its ability to reduce fracture risk.
The device is worn around the hips and emits calibrated, gentle vibrations to the hips and lumbar spine to maintain bone strength and density. A vibration pack is mounted on the back of the belt.
The FDA approval announced on January 18 was based on results from a double-blind, placebo-controlled study of 126 women with low bone density, funded by the National Institutes of Health and conducted at the University of Nebraska Medical Center in Omaha, Nebraska. The data was presented at the 2023 annual meetings of the Endocrine Society and the American Society for Bone and Mineral Research and published in the Journal of the Endocrine Society.
Lead researcher Laura Bilek, PT, PhD, Deputy Dean for Research and Associate Professor at the University of Nebraska, and colleagues wrote that the primary outcome measure was the change in vertebral strength measured by CT scans in women who used the device at least three times per week compared to a sham group wearing a belt emitting noise but no vibrations.
Bone strength and volumetric density of the first lumbar spine were analyzed.
In the active belt group, women lost an average of 0.48% in bone strength, while women in the sham group lost almost 2.84% (P = .014), about five times as much. The 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 to 1.97% BMD in the control group. No adverse events were reported in the study.
Sonali Khandelwal, MD, Rheumatologist at Rush University in Chicago, Illinois, told Medical News from Medscape that some patients have great fear of long-term medication for bone health, „so any non-therapeutic method—no pill—is always exciting.“
The study endpoints are a good measure, she said, but emphasized that it will be important to show that the improved bone density from the belt described in this study is „a true indicator of reduced fracture risk.“
Currently available osteoporosis medications have been shown to improve bone strength and reduce fracture risk, she noted.
„It could help. I just don’t believe we have enough evidence that it can fully address bone loss,“ Khandelwal said.
She said she sees the potential target population for the belt being women before menopause with a family history of bone loss who may not reach the degree of bone loss requiring medical treatment, but are interested in prevention.
„I also think of individuals who may already be covering their medication needs but are completely averse to medication intake,“ she said. The majority of her practice is treating bone loss, she said, estimating that 20% of her patients do not want medications.
Laura Yecies, MBA, CEO of Bone Health Technologies, told Medical News from Medscape that the company has not yet set the price for the device and noted that copayments and deductibles will vary as it will only be available by prescription. She said the company expects to begin shipping later this year. Requests for update notifications can be made on the company’s website.
Bilek told Medical News from Medscape that the device was tested for a year, so it is unclear how long people with osteopenia would need to wear the belt to achieve 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 only postmenopausal women with osteopenia were included in the study, Bilek said she would like to test the device in other groups, such as men with prostate cancer receiving testosterone blocker therapy, which can lead to bone loss. An estimated 34 million people in the United States suffer from osteopenia.
Bilek said a next step for the study would be to enroll a more diverse cohort at another center to test the device, as most women at this center are white.
She noted that women’s bone mass reaches its peak at the age of 30 and then declines.
„When women go through menopause, there is a very rapid decline [in bone strength] for the next 5-7 years and then the decline levels off. If we can slow this decline, hopefully a woman’s bone density will remain at a higher level for a lifetime,“ Bilek said.
Bilek is a scientific advisor to Bone Health Technologies. She and many co-authors of the study received grants or fees from the company and own shares in the company or are employees of the company. Yecies is the founder and CEO of Bone Health Technologies. Khandelwal had no relevant financial relationships.