In a first for the treatment of osteopenia, the Osteoboost — a wearable device that delivers precise vibrations to the spine and hips — promises to offer a new form of therapy for clinicians treating postmenopausal women dealing with a loss of bone density.
At the beginning of 2024, the U.S. Food and Drug Administration granted clearance for the first non-pharmacological device-based prescription treatment for postmenopausal women diagnosed with osteopenia — a wearable belt device, worn on the hips, that delivers targeted, calibrated vibration to the lumbar spine and hips that Bone Health Technologies is marketing as Osteoboost.
Osteoboost was reviewed through the FDA’s De Novo classification process and received Breakthrough Device Designation. The Osteoboost clearance creates a class of therapeutics for low bone density outside of pharmacological intervention. The belt also represents the first therapeutic mechanism specifically designed and cleared for intervention during the osteopenia stage.
Until recently, patients with osteopenia lacked effective therapeutic options; the standard of care for osteopenia focused on regular weight-bearing exercise and calcium supplementation — neither of which have been proven to significantly slow the loss of bone density.
The clearance comes on the heels of a study presented at ENDO 2023 in Chicago: a double-blind, sham-controlled study enrolled 126 postmenopausal women with low bone mass who were not on bone-active medications. The data showed strong evidence that supports the efficacy of the Osteoboost in reducing the decline of bone strength and bone density.
“The well-being and ability of postmenopausal women to maintain an active lifestyle is threatened when loss of estrogen causes rapid loss of bone,” says Laura Bilek, PhD, associate dean for research and professor at the University of Nebraska and principal investigator for this study. “Although lifestyle interventions such as exercise and diet are beneficial to bone, the effect is small. The Osteoboost shows promise in slowing the loss of bone density and strength and may fill the treatment gap.”
Finding the Right Target
The road to a wearable vibrationdevice on the hips to treat osteopenia is pretty straightforward. Bilek tells Endocrine News that a lot of research has looked at bone changes in patients who would stand on a platform that vibrates. These vibrations travel up through the skeleton and have been shown to be effective at improving bone density – decreasing osteoclasts and increasing osteoblasts. “But the results were inconclusive, and looking at the hip and spine, they weren’t seeing as great of effect size as was needed,” Bilek says. “That’s where this novel idea came in. What happens if we apply this modality directly to the pelvis, the sacrum, so that we can target the dose to the areas that we really need to have an effect?”
“The well-being and ability of postmenopausal women to maintain an active lifestyle is threatened when loss of estrogen causes rapid loss of bone. Although lifestyle interventions such as exercise and diet are beneficial to bone, the effect is small. The Osteoboost shows promise in slowing the loss of bone density and strength and may fill the treatment gap.” — Laura Bilek, PhD, associate dean for research, associate professor, University of Nebraska, Omaha, Nebraska
For the study presented at ENDO in Chicago, participants underwent a thorough screening process, including DXA scans and a comprehensive blood workup. The participants were divided into two randomized groups: the Active group received Osteoboost treatment five times per week for 12 months, while the Sham group used the same device but received a placebo treatment that simulated vibration. Compressive strength and volumetric density of the first lumbar vertebrae (L1) were measured using Finite Element Analysis of computed tomography (CT) scans of the lumbar spine by ON Diagnostics.
The primary outcome measurement was the change in vertebral strength, as measured by Biomechanical Computed Tomography using finite element analysis. Per Protocol (PP) —subjects (those who used the device a minimum of three times per week throughout the year) in the Active Treatment group lost, on average, 0.48% bone strength, while those in the Sham group lost 2.84%, with a relative difference of 2.36% (P=0.014) — an 82% reduction in the rate of bone strength loss. Additionally, CT measurement of vertebral bone density was conducted and showed a 1.68% relative benefit for those using the Osteoboost — an 85% reduction in loss of bone density (P=0.008) in the PP group. Zero serious adverse events were reported.
Filling the Treatment Gap
But while the road may be straightforward, it had its share of potential potholes. The COVID-19 pandemic hit during the study, threatening to disrupt it as it did with so many other things. Still, the study was funded, and Bilek says her institution helped the study proceed. What’s more is that the women who participated did so without any trepidation. “The women are so excited about having an option for their health, that really anyone who pre-screened and qualified to come in for a DEXA, did so without any hesitation, even during COVID-19,” Bilek says. “To me, that was evidence of the enthusiasm for women looking for something they could do for their bone health.”
Bilek praises the participants’ compliance, even as their family members got sick and amidst all the other challenges of the past few years. “All these women are busy, even the ones that aren’t working,” she says. “They’re active in their late middle-aged years. I didn’t have anyone say, ‘I can’t do that.’”
Laura Yecies, CEO of Bone Health Technologies, says that while compliance rates were lower for the studies with the whole-body platforms, the participants in the Osteoboost study were drawn to the idea of getting treatment while walking the dog or cooking. “They just get into a habit at a particular time of day, maybe in the morning when they’re doing their chores or going for their walk, they put the belt on,” Yecies says. “I think that idea of being able to incorporate it into daily activities is what helped us get the compliance, and the compliance helped us get the great result.”
“[Osteoboost] was very easy to incorporate into a lifestyle, which is critical,” Bilek says. “There’s a lot of medications that have low uptake or compliance, because they have symptoms and side effects, so I was really excited to see that the compliance was high.”
Flattening the Curve
Approximately 52 million Americans have osteopenia, a much bigger population that those with osteoporosis. According to Bilek and Yecies, the average American woman’s bone density peaks in her 30s, then declines, with the sharpest dip coming in the immediate menopausal timeframe. Bilek and Yecies both stress the importance of intervening during the osteopenia stage — the earlier the better. And again, until now, there haven’t been many tools to delay bone loss.
“[Osteoboost] was very easy to incorporate into a lifestyle, which is critical. There’s a lot of medications that have low uptake or compliance, because they have symptoms and side effects, so I was really excited to see the compliance was high.” — Laura Bilek, PhD, associate dean for research, associate professor, University of Nebraska, Omaha, Nebraska
They liken the belt’s effects to that ubiquitous phrase during the beginning of COVID – “flattening the curve.” “If someone is losing on average, 3% to 4% of their bone per year, and you slow it to 2% through something safe — there’s no reason why they can’t use it for 10 years, the medications now even have holidays,” Yecies says. “So, it’s this flattening of the bone loss curve.”
Bilek also points out that this belt isn’t meant to replace exercise to help prevent bone loss; they hope women incorporate the device into their routines, to help with consistency. “I’m an exercise researcher, and we know exercise is helpful, but it’s really hard for women who are still in their working years — maybe in the sandwich generation, caring for their parents — to truly do the exercise level that’s needed for effectiveness,” she says. “So, to have a tool that’s simple, safe, and accessible is really exciting.”
That access is another thing Bilek and Yecies hope to remedy as well. Bilek lives in Nebraska, and she says there are a lot of therapies that are out of reach for many individuals. For instance, some people might not be able to afford a gym membership or even get to a gym if they live in rural or remote areas. Older adults may have difficulty with high-impact exercise or heavy lifting. “This belt can be a really great adjunct,” Bilek says.
Bilek goes on to say that she has seen a lot of excitement among endocrinologists when it comes to this device. “There’s been greater enthusiasm for the belt with the endocrinologist than I even anticipated,” she says. “It tells me that, in their profession, they’re really struggling at that area where they know they need to prevent bone loss during osteopenia, and there aren’t any approved tools, other than lifestyle.”
Bagley is the senior editor of Endocrine News. In the April issue, he wrote about the ENDO2024 sessions, “Endocrine Care for Incarcerated Individuals” and “Artificial Intelligence in Health and Biomedical Research: The Future Is Now.”
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