Wearable to treat osteopenia is authorized in the USA

Postmenopausal women diagnosed with osteopenia (low bone density) now have a wearable device to help with treatment, already authorized by the Food and Drug Administration (FDA), the US agency responsible for protecting public health.

Developed by Bone Health Technologies, the new Osteoboost is a non-pharmacological treatment that uses a belt to generate targeted and calibrated vibrations in the direction of the lumbar spine and hips, indicated to reduce the decline in bone density in women. The device uses low-amplitude, high-frequency vibrations in the range between 20 Hz and 40 Hz. The vibration level is controlled by an internal microprocessor, and the vibrating parts are fixed laterally, monitored and regulated by means of multiple accelerometers. The Osteoboost also includes an automatic shut-off feature that ends the treatment after 30 minutes.

According to the company, the technology is drug-free and easy to use at home, making it suitable for a wide range of patients with bone density loss.

It is estimated that 52 million Americans have osteopenia, the stage before osteoporosis, which represents an addressable market of more than $30 billion in the United States and $100 billion worldwide. Half of all women suffer fractures in their lifetime, and most of these occur during the osteopenia phase.

“This is the first non-pharmacological therapy approved by the FDA to treat this widespread disease. With Osteoboost, we have a new treatment option, with no serious adverse effects, that exploits the body’s natural mechanism to stimulate bone growth,” explains Laura Yecies, CEO of Bone Health Technologies. “Women’s health has been poorly treated for too long, which makes Osteoboost a huge step forward for those without effective treatment options and who are looking to protect their bone health.”

According to Bone Health Technologies, after the review process, the FDA classified Osteoboost as an innovative device, creating an entirely new class of therapy for low bone density, without pharmacological intervention. Osteoboost is also the first therapy specifically designed and authorized for intervention during the osteopenia phase. Before Osteoboost, the standard of care for osteopenia was based on regular weight lifting exercises and calcium supplementation.

According to David B. Karpf, associate clinical professor of endocrinology, gerontology and metabolism at Stanford University School of Medicine and member of the osteoporosis and metabolic bone disease clinic, there are millions of women in the United States with low bone density or osteopenia, which are often precursors to osteoporosis. And little has been offered to these women beyond calcium and vitamin D supplements. “The field of bone health currently lacks innovative approaches, with no new agents in clinical trials for osteoporosis and nothing for women with osteopenia. With an ageing population, we need new ways to effectively prevent the decline in bone mass and strength that affects all women during or after the menopause,” Karpf points out.

Osteoboost received clearance based on data from a double-blind, simulation-controlled study conducted at the University of Nebraska Medical Center. The data demonstrated the effectiveness of Osteoboost in directly stimulating bone density growth and preserving bone mineral density and strength by sending low-frequency vibrations directly to the lumbar spine and hips.

The primary outcome was the change in vertebral strength measured by computed tomography. Individuals who used the device at least three times a week lost an average of 0.48% of bone strength, while the other group, with simulated use, lost 2.84%. In addition, measurement of vertebral bone density by CT scan showed a relative benefit of 1.68% for those who used the Osteoboost. These results represent a significant reduction in the loss of bone strength and density. Bone Health Technologies has not reported any serious adverse events.

In December 2023, Bone Health Technologies (BHT) received the fourth patent for the Osteoboost device, which recognizes the product as a wearable device for the treatment or prevention of osteopenia or osteoporosis.