FDA Clears New Device Aimed at Reducing Bone Loss in Women
A recently introduced vibrating belt designed to tackle bone loss in women has been making headlines following its clearance by the U.S. Food and Drug Administration (FDA). This development has sparked interest due to the distinction between FDA clearance and approval, which is crucial, according to Dr. Suzanne Jan de Beur of the University of Virginia.
Dr. Jan de Beur explained, “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.” This highlights the difference in requirements for clearance, which does not necessitate the same level of evidence as approval.
The device, named Osteoboost, targets individuals with osteopenia—a condition characterized by bone density that is below normal but not low enough to be classified as osteoporosis. The belt is worn around the hips and lower back, delivering vibrations throughout the skeleton. These vibrations are intended to simulate the minor stresses that muscles and bones undergo during physical activities such as walking, with the aim of slowing down bone loss rather than generating new bone.
Currently priced at approximately $1,000 and facing back orders, Osteoboost is the latest in a series of vibration-based devices developed over the past twenty years to address bone health. A noteworthy aspect of Osteoboost is its reference to a randomized, sham-controlled trial involving 126 postmenopausal women with osteopenia. While the study did not reveal statistically significant benefits across the entire group, a particular subgroup of women who consistently used the device exhibited a marked reduction in vertebral bone strength loss, as assessed by biomechanical computed tomography over a 12-month period.
Dr. Jan de Beur commented on the trial, stating, “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.” This underscores the limited evidence supporting the device’s effectiveness.
Despite the innovation, Dr. Jan de Beur expressed skepticism about recommending the device, citing its high cost and the limited data backing its efficacy.
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