Postmenopausal women may soon have a new weapon to fight bone loss.
The U.S. Food and Drug Administration (FDA) recently granted approval for a vibrating belt known as OsteoBoost.
The company’s manufacturer, Bone Health Technologies, says the prescription device is aimed at postmenopausal women who have low bone density, a condition called osteopenia.
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“A study conducted at the University of Nebraska Medical Center found that OsteoBoost directly stimulates bone growth and maintains bone density and strength in postmenopausal women with osteopenia by delivering low-frequency vibrations directly to the lumbar spine and hip joint. “It has been shown to be effective,” Laura Yesies said. , Bone Health Technologies CEO Speaking to Fox News Digital from Redwood City, California.
The U.S. Food and Drug Administration recently granted approval for a vibrating belt known as OsteoBoost. It works by sending low frequency vibrations directly to the lumbar spine and lower back. (Bone health technology)
Less than 10% of patients who meet the criteria for osteoporosis drugs are taking osteoporosis drugs, and many others do not follow their regular dosing regimen, Yesies points out.
OsteoBoost technology is “safe, requires no medication, and is easy to use at home, making it suitable for a variety of patients with reduced bone density,” she said.
The FDA approved the device on January 18 based on research funded by the National Institutes of Health (NIH).
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The NIH findings were presented last year at the Endocrine Society’s annual scientific meeting in Chicago and the American Society for Bone and Mineral Research in Vancouver, British Columbia, Canada.
The findings are currently under peer review for publication.
OsteoBoost technology is “safe, drug-free and easy to use at home,” the CEO said. (Bone health technology)
Chris Morris, M.D., a rheumatologist at Arthritis Associates in Kingsport, Tenn., says, “Several studies dating back 15 years have found that whole-body vibration stimulation can have beneficial effects on bone strength. Yes,” he told FOX News Digital. . Morris is not affiliated with OsteoBoost.
Research inspired by NASA
Dr. Shane Mangrum, an internist and co-founder of Bone Health Technologies, recognized the need to prevent vertebral fractures in patients with osteoporosis in 2013 after treating many patients with compression fractures, Yesies said. Told.
Doctors aimed to find a non-drug treatment.
After learning about a NASA study showing that mechanical stimulation of bones through whole-body vibration could improve bone density, Mangrum received a grant to develop and test the first prototype of the OsteoBoost Belt. I asked for
Doctors told the woman she was too young to undergo a colonoscopy. She was then diagnosed with stage 3 colon cancer.
This provided additional funding to support research that Yecies called “critically important.”
The study, led by Dr. Laura Bilek, a researcher at the University of Nebraska Medical Center and clinical consultant at Bone Health Technologies, involved 126 postmenopausal women who had low bone mass but did not have osteoporosis. .
The average age of participants was 62 years. 98% were white and 96% were non-Hispanic.
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In an interview with FOX News Digital, Bilek said the women were randomly assigned to treatment and control groups, but were not told which treatment they were receiving.
The treatment group used a vibrating belt, while the control group used a “sham device” that produced sound but did not transmit vibrations.
Both treatments were administered five times a week for 12 months, and the researchers ensured that all participants met the recommended daily calcium intake.
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Researchers evaluated CT scans of each group to measure changes in strength of the lower spine, Bilek said.
The researchers found no significant differences in lower spine changes between the active and control groups.
However, when comparing different age categories, researchers noted that women aged 50 to 60 who received active treatment had significantly less bone loss than the control group.
The researchers primarily used computed tomography (CT) images from each group to examine changes in strength in the lower spine, said the lead researcher (not pictured). (St. Petersburg)
Among the groups that used the belt at least three times a week, researchers found that the control group had about one-fifth less bone strength and almost one-seventh less bone density than the active treatment group. discovered.
“This is especially important for women during the menopausal transition, when women’s bone loss occurs rapidly,” Bilek told FOX News Digital.
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Dr. Morris agreed, noting that “this new treatment may provide a non-drug approach to improving bone mineral density and reducing fracture risk.”
He added that the technology has the potential to “improve balance and mobility in people at high risk of fractures.”
“This new treatment has the potential to be a non-drug approach to improving bone density and reducing fracture risk.”
According to the Endocrine Society website, menopause accelerates bone loss in women due to decreased estrogen, with up to 20% of bone loss occurring during and after menopause.
“OsteoBoost has the potential to help millions of women with low bone mass who are at risk of progressing to osteoporosis,” Bilek said.
Research limitations
Morris called the study “promising” but noted that it did not examine whether participants had a reduced risk of fractures after using the vibrating belt.
Bilek’s team focused on “surrogate markers” of bone strength, because directly determining fracture risk would require following participants over many years.
The study also did not compare OsteoBoost to standard drug therapy, which has been shown to be effective in reducing fracture risk, Morris added.
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“We’re also interested in whether this can be added to currently available drugs to achieve additional effects,” he said.
Prices for the OsteoBoost device have not yet been set, Yecies told Medscape Medical News, and out-of-pocket costs are expected to vary by patient.
The company aims to start shipping the device later this year, she said.
Osteopenia and osteoporosis
“Both osteopenia and osteoporosis refer to medical conditions in which the calcium and protein skeleton of bone is reduced,” Morris told Fox News Digital.
According to Healthline, bone mass peaks in your early 30s and then begins to decline.
According to the Cleveland Clinic, approximately 34 million people in the United States have osteopenia. (St. Petersburg)
Osteopenia occurs when the body breaks down bone faster than it can build new bone.
If the T-score is between -1 and -2.5, the person has osteopenia, or low bone mass. In osteoporosis, the T-score will be less than -2.5.
“This number is important because the lower the score, the worse the bone weakness and the higher the risk of fracture,” Morris points out.
According to the Cleveland Clinic, approximately 34 million people in the United States have osteopenia.
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According to the CDC, this condition increases the risk of osteoporosis, the most common bone disease in the United States.
Doctors diagnose both bone conditions based on a test called a DEXA scan, which measures bone density.
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“This test compares a person’s bone density to a 30-year-old person of similar height, weight, and gender,” Morris said.
Approximately half of all women will experience a fracture during their lifetime, but this primarily occurs during the osteopenic stage.
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