Health
To fight bone loss, FDA approves vibration belt shown to help post-menopausal women
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.
The U.S. Food and Drug Administration recently granted clearance for a vibration belt known as Osteoboost. It works by sending low-frequency vibrations directly to the lumbar spine and hips. (Bone Health Technologies)
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.
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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.
The Osteoboost technology is “safe, medication-free and easy to use at home,” the CEO said. (Bone Health Technologies)
“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.
Research inspired by NASA
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.
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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.
Bone mass peaks during the early 30s and then starts to decline. (iStock)
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.
The researchers were primarily looking for change in the strength in the lower spine by using images of computed tomography (CT) in each group, said the lead researcher (not pictured). (iStock)
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.
“This new therapy has the potential to be a non-medication approach to the improvement of bone density and reduction of fracture risk.”
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.
Study limitations
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 vs. osteoporosis
“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.
Approximately 34 million people in the United States have osteopenia, as Cleveland Clinic stated. (iStock)
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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A new study suggests that middle-aged men may be more vulnerable to faster biological aging, potentially linked to exposure to “forever chemicals.”
The research, published in the journal Frontiers in Aging, examined how perfluoroalkyl and polyfluoroalkyl substances, more commonly known as PFAS, could impact aging at the cellular level.
PFAS are synthetic chemicals commonly used in nonstick cookware, food packaging, water-resistant fabrics and other consumer products, the study noted.
Their chemical structure makes them highly resistant to breaking down, allowing them to accumulate in water, soil and the human body.
Chinese researchers analyzed blood samples from 326 adults enrolled in the U.S. National Health and Nutrition Examination Survey between 1999 and 2000.
A new study suggests that middle-aged men could face accelerated biological aging at the cellular level due to exposure to PFAS. (iStock)
The researchers measured levels of 11 PFAS compounds in participants’ blood and used DNA-based “epigenetic clocks” — tools that analyze chemical changes to DNA to estimate biological age — to determine how quickly their bodies were aging at the cellular level, the study stated.
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Two compounds, perfluorononanoic acid (PFNA) and perfluorooctanesulfonamide (PFOSA), were detected in 95% of participants.
Higher concentrations of those chemicals were associated with faster biological aging in men of certain age groups, but not in women.
“People should not panic.”
The compounds most strongly linked to accelerated aging were not the PFAS chemicals that typically receive the most public attention, the researchers noted.
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“The associations were strongest in adults aged 50 to 64, particularly in men,” Dr. Xiangwei Li, professor at Shanghai Jiao Tong University School of Medicine and the study’s corresponding author, told Fox News Digital.
“While this does not establish that PFAS cause aging, it suggests that these widely present ‘forever chemicals’ may be linked to molecular changes related to long-term health and aging.”
The study found that two of the compounds were detected in 95% of participants, and higher levels were linked to faster biological aging in men ages 50–64. (iStock)
Midlife may represent a more sensitive biological period, when the body becomes more vulnerable to age-related stressors, according to the researchers.
Lifestyle factors, such as smoking, may influence biological aging markers, potentially increasing vulnerability to environmental pollutants.
While Li said “people should not panic,” she does recommend looking for reasonable ways to reduce exposure.
That might mean checking local drinking water reports, using certified water filters designed to reduce PFAS, and limiting the use of stain- or grease-resistant products when alternatives are available.
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Meaningful reductions in PFAS exposure will likely depend on broader regulatory action and environmental cleanup efforts, Li added.
The researchers noted that midlife could be a particularly sensitive stage, when the body is more susceptible to stressors associated with aging. (iStock)
Study limitations
The researchers outlined several important limitations of the research, including that the findings show an association, but do not prove that PFAS directly causes accelerated aging.
“The study is cross-sectional, meaning exposure and aging markers were measured at the same time, so we cannot determine causality,” Li told Fox News Digital.
The study was also relatively small, limited to 326 adults age 50 or older, which means the findings may not apply to younger people or broader populations.
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Researchers measured PFAS levels using data collected between 1999 and 2000, and today’s exposure patterns may differ.
Li added that while PFAS is known to persist in the environment and the body, these results should be validated through larger, more recent studies that follow participants over time.
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A drug that has long been used to treat seizures has shown promise as a potential means of Alzheimer’s prevention, a new study suggests.
The anti-seizure medication, levetiracetam, was first approved by the FDA in November 1999 under the brand name Keppra as a therapy for partial-onset seizures in adults. The approval has since expanded to include children and other types of seizures.
Northwestern University researchers recently found that levetiracetam prevented the formation of toxic amyloid beta peptides, which are small protein fragments in the brain that are commonly seen in Alzheimer’s patients.
The medication was found to prevent the formation of amyloid-beta 42 in both animal models and cultured human neurons, according to the study findings, which were published in Science Translational Medicine.
The effect was also seen in post-mortem human brain tissue obtained from individuals with Down syndrome, who are at high risk for Alzheimer’s disease.
The medication was found to prevent the formation of amyloid-beta 42 in both animal models and cultured human neurons. (iStock)
“While many of the Alzheimer’s drugs currently on the market, such as lecanemab and donanemab, are approved to clear existing amyloid plaques, we’ve identified this mechanism that prevents the production of the amyloid‑beta 42 peptides and amyloid plaques,” said corresponding author Jeffrey Savas, associate professor of behavioral neurology at Northwestern University Feinberg School of Medicine, in a press release.
“Our new results uncovered new biology while also opening doors for new drug targets.”
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The brain is better able to avoid the pathway that produces toxic amyloid‑beta 42 proteins in younger years, but the aging process gradually weakens that ability, Savas noted.
“This is not a statement of disease; this is just a part of aging. But in brains developing Alzheimer’s, too many neurons go astray, and that’s when you get amyloid-beta 42 production,” he said.
The effect was also seen in post-mortem human brain tissue obtained from individuals with Down syndrome, who are at high risk for Alzheimer’s disease. (iStock)
That then leads to tau (“tangles”) — abnormal clumps of protein inside brain neurons — which can kill brain cells, trigger neuroinflammation and lead to dementia.
In order for levetiracetam to function as an Alzheimer’s blocker, high-risk patients would have to start taking it “very, very early,” Savas said — up to 20 years before elevated amyloid-beta 42 levels would be detected.
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“You couldn’t take this when you already have dementia, because the brain has already undergone a number of irreversible changes and a lot of cell death,” the researcher noted.
The researchers also did a deep dive into previous human clinical data to determine whether Alzheimer’s patients who were taking the anti-seizure drug had slower cognitive decline. They reported that the patients in that category had a “significant delay” in the span from cognitive decline to death compared to those not taking the drug.
“This analysis supports the positive effect of levetiracetam to slow the progression of Alzheimer’s pathology,” the researcher said. (iStock)
“Although the magnitude of change was small (on the scale of a few years), this analysis supports the positive effect of levetiracetam to slow the progression of Alzheimer’s pathology,” Savas said.
Looking ahead, the research team aims to find people who have genetic forms of Alzheimer’s to participate in testing, Savas said.
Limitations and caveats
The study had several limitations, including that it relied on animal models and cultured cells, with no human trials conducted.
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Because the study was observational in nature, it can’t prove that the medication caused the prevention of the toxic brain proteins, the researchers acknowledged.
Savas noted that levetiracetam “is not perfect,” cautioning that it breaks down in the body very quickly.
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The team is currently working to create a “better version” that would last longer in the body and “better target the mechanism that prevents the production of the plaques.”
“You couldn’t take this when you already have dementia, because the brain has already undergone a number of irreversible changes and a lot of cell death.”
The medication’s common documented side effects include drowsiness, weakness, dizziness, irritability, headache, loss of appetite and nasal congestion.
It has also been linked to potential mood and behavior changes, including anxiety, depression, agitation and aggression, according to the prescribing information. In rare cases, it could lead to severe allergic reactions, skin reactions, blood disorders and suicidal ideation.
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Funding for the study was provided by the National Institutes of Health and the Cure Alzheimer’s Fund.
Fox News Digital reached out to the drug manufacturer and the researchers for comment.
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