Michael Barbella, Managing Editor03.29.23
Bone Health Technologies (BHT) is touting encouraging topline results of its Osteoboost Vibration Belt trial.
Using Osteoboost more than three times per week in each of four quarters significantly reduced the loss of vertebral bone strength, and no device-related serious adverse events were reported, according to the study results. The trial used CT scan analysis to measure the change in vertebral bone strength after one year of treatment and showed a decrease in the rate of decline of multiple subcomponents of bone strength, including vertebral bone density and cortical bone strength, with all endpoint measures improving.
BHT conducted the trial in partnership with Laura Bilek, Ph.D., associate dean of Research in the College of Allied Health Professions at the University of Nebraska Medical Center (UNMC) and an expert in clinical research for low bone mass treatment. The randomized, double-blinded sham-controlled trial enrolled 126 patients.
“There is a clear public health need and patient desire for a non-pharmacological intervention for bone strength. Osteoboost is the first non-drug intervention to demonstrate clinical CT evidence of improved vertebral bone strength,” BHT CEO Laura Yecies said.
The study also found high compliance for the treatment, as those who completed the trial used the device an average of four times per week—an excellent result for a home-use device. As a belt, wearing the device for 30-minute treatment sessions is easy to incorporate into daily activities. The study demonstrated a clear dose response with larger strength gains associated with more frequent use.
These results demonstrate a major step forward in osteopenia treatment and potential osteoporosis prevention, BHT bigwigs said. There are currently no approved prescription treatments for most of the 53 million patients with osteopenia. Many of these patients will progress to osteoporosis, yet pharmaceutical treatments for osteoporosis have a very low adoption rate. This trial gives hope that device technology such as Osteoboost may allow those suffering from bone-density-related problems to receive a non-drug treatment with no serious adverse side effects.
BHT’s Osteoboost technology is based on NASA research, which has proven that mechanical stimulation of bones through vibration can improve bone density. The company has received three grants from the National Institutes of Health and has also received U.S. Food and Drug Administration (FDA) Breakthrough Device Designation. BHT has raised $4.75 million in capital from investors in women’s health and is supported by investigators, board members, and advisors expert in women’s health, osteoporosis, and orthopedics, including Karen Drexler, Drs. Nancy Lynch, Dolores Shoback, Anne Schafer, and Bilek.
Osteoboost is limited by federal law to investigational use.
Bone Health Technologies applies science and medical expertise to create better health outcomes for women and men at risk of developing osteoporosis and associated bone fractures.
Using Osteoboost more than three times per week in each of four quarters significantly reduced the loss of vertebral bone strength, and no device-related serious adverse events were reported, according to the study results. The trial used CT scan analysis to measure the change in vertebral bone strength after one year of treatment and showed a decrease in the rate of decline of multiple subcomponents of bone strength, including vertebral bone density and cortical bone strength, with all endpoint measures improving.
BHT conducted the trial in partnership with Laura Bilek, Ph.D., associate dean of Research in the College of Allied Health Professions at the University of Nebraska Medical Center (UNMC) and an expert in clinical research for low bone mass treatment. The randomized, double-blinded sham-controlled trial enrolled 126 patients.
“There is a clear public health need and patient desire for a non-pharmacological intervention for bone strength. Osteoboost is the first non-drug intervention to demonstrate clinical CT evidence of improved vertebral bone strength,” BHT CEO Laura Yecies said.
The study also found high compliance for the treatment, as those who completed the trial used the device an average of four times per week—an excellent result for a home-use device. As a belt, wearing the device for 30-minute treatment sessions is easy to incorporate into daily activities. The study demonstrated a clear dose response with larger strength gains associated with more frequent use.
These results demonstrate a major step forward in osteopenia treatment and potential osteoporosis prevention, BHT bigwigs said. There are currently no approved prescription treatments for most of the 53 million patients with osteopenia. Many of these patients will progress to osteoporosis, yet pharmaceutical treatments for osteoporosis have a very low adoption rate. This trial gives hope that device technology such as Osteoboost may allow those suffering from bone-density-related problems to receive a non-drug treatment with no serious adverse side effects.
BHT’s Osteoboost technology is based on NASA research, which has proven that mechanical stimulation of bones through vibration can improve bone density. The company has received three grants from the National Institutes of Health and has also received U.S. Food and Drug Administration (FDA) Breakthrough Device Designation. BHT has raised $4.75 million in capital from investors in women’s health and is supported by investigators, board members, and advisors expert in women’s health, osteoporosis, and orthopedics, including Karen Drexler, Drs. Nancy Lynch, Dolores Shoback, Anne Schafer, and Bilek.
Osteoboost is limited by federal law to investigational use.
Bone Health Technologies applies science and medical expertise to create better health outcomes for women and men at risk of developing osteoporosis and associated bone fractures.