A new vibrating belt designed to reduce bone loss in women is attracting attention after the U.S. Food and Drug Administration cleared it.
That is, instead of approving it. The distinction is important, says Dr. Suzanne Jan de Beur of the University of Virginia.
“FDA approval is usually for drugs and biologics. You have to show safety and efficacy. For FDA clearance ... manufacturers do not usually need to conduct new clinical trials,” she said. FDA approval requires evidence of both safety and efficacy.
UVA Health endocrinologist Dr. Suzanne Jan de Beur cares for patients with osteoporosis, metabolic bone disease and rare bone disorders. (Contributed photo)
The belt, called Osteoboost, is marketed for people with osteopenia, a condition marked by lower-than-normal bone density that has not progressed to osteoporosis. Worn around the hips and lower back, the device sends vibrations through the skeleton, mimicking the small stresses muscles and bones experience during walking or exercise. The goal is not to build new bone, but to help slow bone loss.
Osteoboost, which costs about $1,000, is currently on back order. It is the latest in a string of vibration-based devices that researchers and companies have explored as bone-health interventions for more than two decades.
Osteoboost points to a randomized, sham-controlled trial of 126 postmenopausal women with osteopenia. Researchers found no statistically significant benefit in the overall study population, though a subgroup of women who used the device regularly showed significantly less loss of vertebral bone strength as measured by biomechanical computed tomography over 12 months.
“It’s a small trial of postmenopausal women with close to normal bone density at baseline that demonstrated no difference in the treatment versus a placebo group in DXA-scanning after 12 months, which is our gold standard for measuring bone density and assessing fracture risk,” Jan de Beur said.
“I don’t recommend it because it’s expensive and the data supporting its effectiveness are limited,” she said.
