REDWOOD CITY, Calif. – Post-menopausal women have reason to be hopeful in the fight against bone loss as the U.S. Food and Drug Administration (FDA) recently approved a new prescription vibration belt known as Osteoboost. The belt, developed by Bone Health Technologies, is designed for post-menopausal women with low bone density, a condition known as osteopenia.
According to Laura Yecies, CEO of Bone Health Technologies, a study conducted at the University of Nebraska Medical Center demonstrated the efficacy of Osteoboost in stimulating bone growth and preserving bone mineral density and strength in postmenopausal women with osteopenia. The belt achieves this by sending low-frequency vibrations directly to the lumbar spine and hips.
Less than 10% of patients who are eligible for osteoporosis medications are actually taking them, and many are non-compliant with regular usage, Yecies noted. This has led to the need for alternative options to support bone health in menopausal women.
The technology behind Osteoboost is safe, medication-free, and easy to use at home, making it suitable for a wide variety of patients with bone density loss, Yecies added. The FDA approval was based on National Institutes of Health (NIH)-funded research, and the findings were presented at scientific meetings of the Endocrine Society and the American Society of Bone and Mineral Research.
The initial idea for Osteoboost was inspired by NASA research on whole-body vibratory stimulation and its beneficial effect on bone strength. Dr. Shane Mangrum, a physician and co-founder of Bone Health Technologies, identified the need for a non-medication approach to preventing spine fractures in patients with osteoporosis after witnessing many patients with compression fractures.
The FDA clearance was the result of a pivotal study led by Dr. Laura Bilek from the University of Nebraska Medical Center, which included 126 post-menopausal women with low bone mass. The women were randomly assigned to a treatment group that used the vibration belt or a control group that used a “sham device” without vibrations.
The study’s results indicated that women between the ages of 50 and 60 who received the active treatment with the belt had significantly less bone loss compared to the control group. This is significant, especially for women during the menopause transition, when bone loss occurs rapidly.
While the research is promising, it did not assess the participants’ reduced risk of fractures after using the belt, or compare Osteoboost with standard medication therapies that reduce fracture risk. The price of the Osteoboost device has not been set yet, and the company plans to begin shipping it later this year.
Osteopenia and osteoporosis both involve the loss of calcium and protein framework in the bones, with osteopenia occurring when bone breakdown exceeds new bone formation. Approximately 34 million people in the U.S. have osteopenia, which increases the risk of osteoporosis, a common bone disease.
The Osteoboost technology has the potential to help millions of women with low bone mass at risk of progressing to osteoporosis. Despite some limitations, the technology offers a non-medication approach to improving bone density, reducing fracture risk, and potentially enhancing balance and mobility in patients at a greater risk of fractures.