The FDA Approves a New Non-drug Device to Treat Low Bone Density


The FDA approved a belt that you wear that sends specific shocks to your spine and hips. It is the first non-drug prescription medical device to treat low bone density, which is a risk factor for osteoporosis. The new device, which has been shown to work in clinical studies, gives women who have gone through menopause an option to take vitamin and mineral supplements.

Because they no longer have estrogen, women who have gone through menopause are more likely to break bones. Loss of estrogen can cause osteopenia, or low bone density because it helps keep bone density up. 40.4% of people around the world have osteopenia, which is a condition that can lead to osteoporosis.

Osteoboost is a new wearing device made by Bone Health Technologies (BHT) that sends shocks to the lower back and hips to help bones grow. The device was recently cleared by the FDA to treat osteopenia. It is the first non-drug prescription medical gadget to get this kind of approval.

When the FDA made its news on January 18, CEO of BHT Laura Yecies said, “Today’s groundbreaking decision represents the first non-drug therapy approved to treat this widespread and serious condition.” “Osteoboost gives us a new treatment option that works with the body’s natural way of making bones grow. It doesn’t cause any serious side effects.” Women’s health hasn’t gotten enough attention for too long. This is a big step forward for older women who haven’t had access to good treatment choices and are looking for a way to keep their bones healthy.

Whole-body vibration therapy (WBVT) is a branch of NASA technology that was created to keep pilots from losing bone density while they worked in zero gravity. It does this by simulating the bones’ mechanical stress during high-impact exercise. Studies have shown that WBVT helps bones grow and can stop older women from losing bone in their hips and lower back. WBVT is usually sent by a rotating platform that stands alone. Instead, Osteoboost sends low-intensity shocks directly to the hips and lower back, which are the most common places for osteoporotic fractures.

The FDA gave its approval based on results from a clinical study that looked at how well Osteoboost worked. These results were released in the Journal of the Endocrine Society. 126 women over 50 with low bone density who had gone through menopause were part of the randomized controlled study. They did Osteoboost treatment five times a week for a year, with the belt either in an active setting or a fake setting.

In the fake setting, the gadget made a sound but didn’t send out a jolt. In the 50–60-year-old age group, there were big differences in the percent change in vertebral bone strength. Those in the sham group lost 3.4% of their vertebral bone strength, while those in the active group lost only 0.5%. People who followed through with Osteoboost treatment three times a week lost 2.84% of their bone strength, while the exercise group only lost 0.48%.

This means that the sham group lost five times more bone strength. The Osteoboost treatment also kept the bone density of the first lumbar vertebra (L1). The active group lost 0.29% of bone mineral density (BMD), while the sham group lost 1.97%, which is 6.8 times more than the active group.

“When women lose estrogen and quickly lose bone mass, it threatens their health and their ability to live an active life,” said Laura Bilek, the study’s lead author. “Changes in lifestyle, like exercise and diet, are good for bones, but the effect is small.” It looks like Osteoboost could help slow down the loss of bone mass and strength, and it could fill in the gaps in treatment.

When BHT asked the FDA to approve Osteoboost before it was named a Breakthrough Device, they used the De Novo classification process, which lets new medical devices be put into a category for marketing. With its approval, it opens up a whole new group of treatments for low bone density that don’t involve drugs. Osteoboost is also important because it is the first medical gadget that was developed and approved to treat osteopenia.

At the moment, the only way to treat osteopenia is to take calcium and vitamin D tablets.

David Karpf, an Adjunct Clinical Professor of Endocrinology, Gerontology, and Metabolism at Stanford University School of Medicine, said, “The field of bone health right now is missing new approaches. There are no new agents in clinical trials for osteoporosis and nothing for women who have osteopenia.” “Because our population is getting older, we need new ways to stop the loss of bone mass and strength that all women go through during or after menopause.”

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