Concerns about the paper, “Benefits of targeted vibration for bone strength and bone density in postmenopausal women with osteopenia: a randomized, sham-controlled trial”

We write to raise serious concerns regarding the clinical significance and conclusions of a paper recently published in JBMR Plus, “Benefits of Targeted Vibration for Bone Strength and Bone Density in Postmenopausal Women With Osteopenia: A Randomized, Sham-Controlled Trial.”¹ First, it is important to recognize that we, the undersigned, are staunch supporters of the role of exercise in general, and mechanical signals in particular, as part of any strategy to improve bone quality and quantity in osteopenia and osteoporosis. With that perspective, we were interested that the authors evaluated the ability of low-magnitude vibrations, transmitted focally to the pelvis via a wearable vibration belt device secured around the waist, to modulate bone loss in postmenopausal women with T-scores between –1.0 and –2.5 at the spine and hip. Following 1 year of treatment, neither primary bone outcome differed between active and sham device groups as measured in the spine and hip using DXA and CT.

In a secondary analysis, the authors built person-specific finite element models (FEMs) from CT images of the first lumbar vertebra (L1) at baseline and 1 year, subjecting these FEMs to virtual loading of that singular vertebral body. Evident in only a subgroup of highly compliant participants, this computational simulation demonstrated that the derived strength at L1 fell less in the device group than in the sham control. It is noteworthy that the study failed to report benefits of treatment at the spine or the femur. While we recognize that there could be potential benefits to slowing bone loss at a singular site directly beneath a wearable device, the investigators’ conclusion that such a focal treatment could be prescribed as a treatment strategy for osteopenia, a systemic—not a local—disease, is not supported by the study results. Based on these results, the manufacturers received “breakthrough device” designation by the Food and Drug Administration (FDA), a designation intended to provide timely access to medical devices by speeding up development, assessment, and review for premarket approval. The FDA’s De Novo classification request process is designed to test products that provide reasonable assurance of safety and effectiveness for the intended use. In our opinion, the results do not provide evidence of effectiveness for preventing or treating osteopenia or osteoporosis.

A principal pillar of the ASBMR has been to improve our understanding of the cause of bone disease. The global medical community depends on our society to carefully evaluate benefits versus risks of new modalities to treat bone loss. In part, this is done by publishing important research findings after careful peer review. At the same time, the aging population, with ready access to medical information, eagerly searches web-based information sources for novel ways to improve bone health. We are concerned that patients diagnosed with bone loss will be misled by the sweeping conclusions made from the study’s limited results, building false expectations that such a site-targeted device can slow osteopenia/osteoporosis, or reduce major fragility fractures in the hip or spine.

On the basis of this paper, the Osteoboost device is being aggressively marketed by the manufacturer, Bone Health Technologies, as therapy for osteopenia. Those of us practicing in an endocrinology clinic have already been hearing from our patients about using this device to treat osteoporosis! The failure of the Osteoboost device to treat the general systemic condition of osteopenia must be made clear, if only to open the door to doctors to discuss with their patients the many efficacious treatments—including exercise—that have been reliably shown to slow and reverse bone loss across the weight-bearing skeleton.

Author contributions

Douglas P. Kiel (Conceptualization, Writing—original draft, Writing—review & editing), Theresa A. Guise (Writing—review & editing), Maya Styner (Writing—review & editing), Janet Rubin (Conceptualization, Writing—original draft, Writing—review & editing).

Funding

None declared.

Conflicts of interest

D.P.K. has previously performed a clinical trial using a high-frequency, low-magnitude mechanical stimulation platform for increasing bone density. He is nonpaid member of Solarea Bio Scientific Advisory Board and his institution received a grant to conduct research funded by Solarea Bio. The other authors report no potential conflicts.