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.

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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.

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“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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If painful leg cramps have woken you up in the middle of the night, the condition can be both scary and confusing.

You may think it’s due to the position you’re sleeping in — but there’s more to know about nighttime leg cramps than that. 

In original interviews, two physicians gave a “leg up” on the causes and treatments of nighttime leg cramps.

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Here’s what to know.

What are nighttime leg cramps? 

More commonly known as a charley horse, a nighttime leg cramp is when the muscles in a leg quickly tighten up.

A charley horse is a sudden, painful and involuntary muscle spasm or cramp, noted health.com. While it usually happens in your leg, especially the calf, it can actually happen in any muscle.

A person can be woken up as a result of painful leg cramp symptoms, said Mike Sevilla, M.D., a family physician with Family Practice Center of Salem in Salem, Ohio. 

“Sometimes the cramps last a few minutes, but I have had patients whose leg cramps lasted longer than that,” he said.

Who gets nighttime leg cramps? 

Nighttime cramps become more common as people get older and unfortunately, can become more frequent, Sara Austin, M.D., an associate professor of neurology at the Dell Medical School at the University of Texas at Austin, told Fox News Digital. 

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She is also a fellow of the American Academy of Neurology.

If you experience frequent leg cramps, your primary care doctor should test to make sure your thyroid hormone level is normal.

Most of the time, nighttime leg cramps just happen — but there are some causes, she said.

Being human. “That’s the most common cause. We all get them sometimes,” she said.

“If you notice that the cramps are associated with weakness in the extremity, or if they consistently interfere with the way you walk, you should bring that to your doctor’s attention.” (iStock)

Hypothyroidism. If you experience frequent cramps, she said, your primary care doctor should test to make sure your thyroid hormone level is normal.

Dehydration or very intense exercise. “Make sure if you sweat excessively or are dehydrated that you drink more fluids, preferably with some electrolytes,” she cautioned.

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Restless leg syndrome. Those who have restless leg syndrome seem to describe some of their symptoms as cramps, she said. 

“If you consistently feel like you wake up after being asleep for several hours and you feel symptoms in your leg — cramping, tingling, burning, aching — that are relieved by getting up and walking around, you might have restless leg syndrome,” Austin said. 

“If you find that you’re having two to three cramps every night for weeks to months, you should check in with a neurologist.”

Speak with your doctor for further evaluation.

Can leg cramps be a sign of serious conditions?

Some neuromuscular diseases are associated with more frequent muscle cramps, but this is not common, said Dr. Austin. 

“They are very rare,” she said.

There are also prescription medication options for nighttime leg cramps, “but patients should check with their family physician before considering prescription meds.” (iStock)

“But if you find that you are having two to three cramps every night for weeks to months, you should check in with a neurologist,” she advised. 

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“Or, if you notice that the cramps are associated with weakness in the extremity, or if they consistently interfere with the way you walk, you should bring that to your doctor’s attention.”

How can someone treat leg cramps?

When leg cramps begin, start with a gentle stretching of the muscles, said Sevilla of the Family Practice Center of Salem. 

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“In addition, what may help symptoms include massage of the area and application of a heating pad.”

When leg cramps begin, start with a gentle stretching of the muscles.  (iStock)

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Also, he said, “consider over-the-counter pain medication like acetaminophen or ibuprofen.”

There are also prescription medication options, “but patients should check with their family physician before considering prescription meds.”

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With some 70% of teenagers and children dropping out of organized sports by age 13, experts are chiming in on potential reasons for early burnout.

The dropout stat was revealed in a new report from the American Academy of Pediatrics (AAP) — “Overuse Injuries, Overtraining, and Burnout in Young Athletes” — published in the journal Pediatrics on Jan. 22.

Given the growing trend of young athletes participating on multiple teams at the same time while training year-round, pediatricians told Fox News Digital they’re seeing more cases of burnout and stress injuries at young age.

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“Burnout is real and it’s something that parents and coaches have to be attuned to,” Dr. James Barsi, a pediatric orthopedic surgeon at Stony Brook Children’s Hospital on Long Island, New York, who is not affiliated with the AAP report, said to Fox News Digital.

A current quarterback of a high school football team, who also plays travel baseball on Long Island, New York, said he sees burnout among some of his peers.

“[There’s] definitely pressure on kids these days because they’re trying to be the best athlete they can be and it’s just always on their shoulders, like, ‘I gotta train more and more to be the best,’” he said, adding that his former teammates told him they “just can’t do it anymore.”

The AAP report, which was an update to a previous report published in 2007, said overscheduling and excessive levels of training could lead to burnout, contributing to the high dropout rate in sports. 

This intense volume of training could also affect a young athlete’s sense of well-being and quality of life, the report noted.

There’s a growing trend of young athletes participating in multiple teams at the same time — and pediatricians say they are seeing more cases of burnout and stress injuries. (iStock)

“Whether training is specialized or multisport, it becomes a problem when an athlete no longer has any free play time or opportunity to engage in other non-sport-related activities,” Dr. Andrew Watson, M.D., co-author of the report, said in a news release. 

“The old saying ‘no pain, no gain’ doesn’t necessarily hold true.”

Some level of stress can be productive, experts agree — but excessive amounts can become a problem.

“Athletic competition and training will always prompt some stress that, when delivered in an appropriate way, leads to adaptation, success and enjoyment,” Watson said

“When that stress becomes excessive, it can lead to burnout.”

The new AAP report noted that overscheduling and excessive levels of training could lead to burnout, contributing to the high dropout rate in sports among young people. (iStock)

The AAP defines overtraining as “a decrease in performance due to an imbalance of training and recovery that is often accompanied by persistent fatigue, impaired sleep and alterations in mood.”

Dr. Kristin Hopkins, director of the Women’s Sports Medicine Center at Stony Brook Medicine and team physician at Stony Brook University athletics on Long Island, New York, was not affiliated with the report but commented on it. 

She said that in today’s sports landscape, there is “no off-season” for kids who are passionate about one sport and have aspirations to play that sport in college — which can leave young athletes at risk for burnout and injuries.

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“That sort of continuous play can put kids’ joints at risk for what we call overuse injuries, things we weren’t really seeing before, because a kid would play a sport for a season and then move on to another sport and use a different muscle group,” Hopkins told Fox News Digital. 

‘Micro-trauma’ to bone and soft tissue

An overuse injury typically occurs when the body is exposed to repetitive stress without enough recovery time, the AAP noted.

This can lead to “cumulative micro-trauma” to bone and soft tissue, such as muscles or tendons. 

Pain typically occurs after an activity and then progresses to occurring even at rest, the report said.

A New York pediatric orthopedic surgeon said he is seeing spine stress fractures about 10 times a month.

Children and adolescents are at an increased risk for these types of injuries because their bones are still growing and do not tolerate stress as well as adults’ bones, experts said.

“I’m seeing spine stress fractures about 10 times a month,” Barsi, the pediatric surgeon, told Fox News Digital, amid what he called an “increasing epidemic” of overuse injuries in kids.

It is important that athletes incorporate rest days and stretching in their workout regimen, physicians said. (iStock)

Recovery from this type of injury typically requires rest, said Barsi, which is a difficult message to deliver to a young teen who feels pressure to perform and maintain a spot on a sports team.

“I always emphasize the long-term picture,” Barsi said. “A brief period of rest in the short term is probably better for them.”

He added, “If injuries progress, it can cause long-term harm — then instead of missing a few weeks, they might be missing an entire season.”

“I tell parents and kids that if you’re playing one sport for more hours of a week than your age, you’re doing too much of that sport.”

It’s important that athletes incorporate rest days and stretching in their workout regimen, physicians said.

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“So often, these kids are really tight at baseline, which is probably a combination of not stretching, going through a little bit of a growth spurt and just getting tight naturally,” Barsi said. “When you’re tight, you get predisposed to these injuries, so stretching can actually prevent them.”

He also said athletes should listen to their bodies.

“Pain is their body’s way of telling them to take it easy,” he said. “The old saying ‘no pain, no gain’ doesn’t necessarily hold true.”

An intense volume of training could affect a young athlete’s sense of well-being and quality of life, the new report noted. (iStock)

Dr. Joel Brenner, M.D., one of the authors of the published report, noted in the release, “Sports are such a powerful and fun motivator to keep youth physically and mentally active, but some youth may feel pressure from parents, coaches and others to measure success only by performance.” 

Practices like mindfulness and time away from sports could help prevent burnout and injuries, he suggested.

Hopkins said avoiding burnout and overtraining starts at home.

“I tell parents and kids that if you’re playing one sport for more hours of a week than your age, you’re doing too much of that sport.”

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Both experts recommended incorporating weight training to help strengthen muscles. 

The young athletes should also work with an experienced trainer, said Hopkins, who can monitor the athlete’s form to avoid injuries. 

The athletes should “avoid ego lifting” and gradually build up weight resistance, noted Barsi.

If an athlete displays signs of overtraining or burnout, it’s best to change the contributing factors and consult with a mental health professional if needed, the AAP advised. (iStock)

For clinicians working with families, the AAP report included specific recommendations to help encourage healthy participation in athletics. 

Some suggestions include having the athlete undergo a pre-participation exam by their pediatrician, promoting skill development and avoiding overtraining and overscheduling. 

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Other means of preventing burnout and injury include encouraging athletic autonomy; fostering positive experiences with coaches, parents and peers; and keeping workouts interesting and fun by incorporating age-appropriate games and training.

If an athlete displays signs of overtraining or burnout, it’s best to change the contributing factors and consult with a mental health professional if needed, the AAP advised.

Fox News Digital reached out to the AAP for additional comment.

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