Post-menopausal women may soon have a new weapon in the fight against bone loss.
The U.S. Food and Drug Administration (FDA) recently granted clearance for a vibration belt known as Osteoboost.
The prescription device is intended for post-menopausal women who have low bone density, a condition called osteopenia, according to the company’s manufacturer, Bone Health Technologies.
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“A study conducted at the University of Nebraska Medical Center showed the efficacy of Osteoboost in directly stimulating bone growth and preserving bone mineral density and strength in postmenopausal women with osteopenia by sending low-frequency vibrations directly to the lumbar spine and hips,” Laura Yecies, CEO of Bone Health Technologies in Redwood City, California, told Fox News Digital.
Fewer than 10% of patients who meet the criteria for osteoporosis medications are taking them — and many others are not compliant with taking them on a regular basis, Yecies noted.
The Osteoboost technology is “safe, medication-free and easy to use at home, making it suitable for a wide variety of patients with bone density loss,” she said.
The FDA approved the device on Jan. 18 based on National Institutes of Health (NIH)-funded research.
The NIH’s findings were presented at last year’s annual scientific meeting of the Endocrine Society in Chicago as well as the American Society of Bone and Mineral Research in Vancouver, British Columbia, Canada.
The findings are currently under peer review for publication.
“There are some studies that are as much as 15 years old that have found whole-body vibratory stimulation can have a beneficial effect on bone strength,” Chris Morris, M.D., a rheumatologist at Arthritis Associates in Kingsport, Tennessee, told Fox News Digital. Morris is not affiliated with Osteoboost.
In 2013, Dr. Shane Mangrum, a physician who is also a co-founder of Bone Health Technologies, saw a need for preventing spine fractures in patients with osteoporosis after treating many patients with compression fractures, Yecies said.
The doctor aimed to find a treatment that did not involve taking medications.
After learning about research by NASA that showed mechanical stimulation of bones through whole-body vibration could improve bone density, Mangrum pursued grant funding to develop and test the initial prototype of the Osteoboost belt.
This led to additional funding that supported a study that Yecies calls “pivotal.”
The study, led by Dr. Laura Bilek, a researcher from the University of Nebraska Medical Center and a clinical adviser to Bone Health Technologies, included 126 post-menopausal women who had low bone mass but did not have osteoporosis.
The participants were 62 years old, on average; 98% were White and 96% were non-Hispanic.
The women were randomly assigned to a treatment group or a control group, but were not told which treatment they were receiving, according to Bilek, who spoke to Fox News Digital.
The treatment group used a vibration belt, while the control group used a “sham device” that created a sound but did not deliver vibration.
Both treatments were administered five times a week for 12 months, and the researchers ensured that all participants met the daily recommended amount of calcium intake.
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The researchers evaluated CT scans for each group to gauge changes in the strength of the lower spine, Bilek said.
They found no significant differences in the change of lower spine vertebrae between the active group and the control group.
But when comparing the different age categories, the researchers found that women between 50 and 60 years old who received the active treatment had significantly less bone loss compared to the control group, the researcher noted.
Among those who used the belt a minimum of three times a week, the control group had approximately five times less bone strength and almost seven times less bone mineral density compared to the active treatment group, the researchers found.
“This is especially important for women during the menopause transition, when women lose bone rapidly,” Bilek told Fox News Digital.
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Morris agreed, noting that “this new therapy has the potential to be a non-medication approach to the improvement of bone density and reduction of fracture risk.”
The technology has the potential to “improve balance and mobility in people who are at a greater risk of fracture,” he added.
Menopause accelerates bone loss in women due to the loss of estrogen, with up to 20% of bone loss occurring during and after menopause, according to The Endocrine Society’s website.
“The Osteoboost has the potential to help millions of women with low bone mass who are at risk of progressing to osteoporosis,” said Bilek.
While Morris called the research “promising,” he noted that it did not look at whether the participants had a reduced risk of fractures after using the vibration belt.
Bilek’s research team looked at “surrogate markers” (substitute values) for bone strength, because directly determining fracture risk would have required following the participants over a number of years.
The research also did not compare Osteoboost with standard medication therapies that have shown to be effective in reducing the risk of a fracture, Morris added.
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“Additionally, I would be interested in whether this might be something to add to the currently available medications to provide even more benefit,” he said.
As Yecies told Medscape Medical News, a price has not yet been set for the Osteoboost device, and out-of-pocket costs are expected to differ by patient.
The company aims to begin shipping the device later this year, she noted.
“Osteopenia and osteoporosis both refer to a medical condition in which there has been a loss of calcium and the protein framework of our bones,” Morris told Fox News Digital.
Bone mass peaks during the early 30s and then starts to decline, according to Healthline.
Osteopenia occurs when the body breaks down bone faster than it builds new bone.
Someone has osteopenia, or low bone mass, if the T-score is -1 to -2.5. With osteoporosis, the T-score is below -2.5.
“This number is important, because the lower the score, the higher the risk of fractures due to worsening bone weakness,” noted Morris.
Approximately 34 million people in the United States have osteopenia, as Cleveland Clinic stated.
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The condition increases the risk of osteoporosis, which is the most common bone disease in the U.S., per the CDC.
Doctors diagnose both bone conditions based on a test called a DEXA scan, which measures bone density.
“The test compares a person’s bone density to that seen in a 30-year-old with similar height, weight and gender,” Morris said.
Approximately half of all women will have a fracture during their lifetime, primarily occurring during the osteopenia stage.
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