Real clinical results.
Real bone benefits.

Learn more about our university-led clinical trial which laid the foundation for FDA clearance of Osteoboost.
Woman wearing her Osteoboost while standing on a pathway in a park

From academic lab to FDA clearance

Validated in a rigorous clinical trial, Osteoboost received FDA clearance in 2024 as the first non-drug therapy for low bone density.
University-led trial Conducted by researchers at the University of Nebraska Medical Center, a top academic medical institution.
Breakthrough Device status Designated a Breakthrough Device by the FDA for providing a more effective treatment for osteopenia.
Gold-standard study design A randomized, double-blinded, sham-controlled study—meeting the highest standard in clinical research.
FDA De Novo clearance Cleared in 2024 as the first non-drug wearable device to treat osteopenia in postmenopausal women.
Woman walking alongside a brick building wearing Osteoboost

How the Osteoboost trial was designed

Study design
The 12-month trial was randomized, double-blinded, and sham-controlled—the highest standard for clinical research.
Number of trial participants
The study enrolled 126 postmenopausal women with low bone density—64 assigned to active treatment and 62 to sham.
Age of trial participants
All participants were postmenopausal. Participants had an average age of 61.4 years, with a range from 52 to 82.
Treatment protocol
Participants were instructed to self-administer Osteoboost for 30 minutes per day, at least 5 times/week.
Diagnostic tools
Bone strength and density were assessed using DXA and CT imaging—both standard, quantitative clinical measurement tools.
Primary endpoint
The main outcome was the percent  change in L1 vertebral bone strength, using CT scans analyzed with biomechanical modeling.
Supplements
Participants received daily calcium and vitamin D supplements to standardize nutrition and isolate the effect of therapy.
Sham control
The control group used an inactive version of the device that emitted sound but delivered no vibration to the user.

The results speak for themselves

Significant reductions in bone loss were observed among participants who adhered to the treatment protocol.

85% reduction in vertebral bone density loss

Participants who used Osteoboost at least 3 times per week saw an 85% reduction in loss of vertebral bone density after 12 months, compared to the placebo group.
Graph showing that participants who used Osteoboost at least 3 times per week saw an 85% reduction in loss of vertebral bone density after 12 months, compared to the placebo group.

83% reduction in vertebral bone strength loss

Participants who used Osteoboost at least 3 times per week saw an 83% reduction in loss of vertebral bone strength after 12 months, compared to the placebo group.
Graph showing that participants who used Osteoboost at least 3 times per week saw an 83% reduction in loss of vertebral bone strength after 12 months, compared to the placebo group.

55% reduction in hip bone density loss

Participants who used Osteoboost at least 3 times per week saw a 55% reduction in loss of hip bone density after 12 months, compared to the placebo group.
Graph showing that participants who used Osteoboost at least 3 times per week saw a 55% reduction in loss of hip bone density after 12 months, compared to the placebo group.

Safe.
Comfortable.
Easy-to-use.

Osteoboost demonstrated an excellent safety profile and high patient adherence.

82% adherance

Easy to follow, with 82% adherence among study completers.

Easy to use regularly

Participants rated it 8/10 for ease of fitting in 5 weekly sessions.

No serious side effects

No device-related serious adverse events were reported in the study.

4.1 sessions per week

The average use was 4.1 sessions per week for study completers.

Scientific advisors and investigators

We’re honored to work with top experts in the areas of bone health and osteoporosis to research and validate Osteoboost’s unique vibration therapy.
Dr. Harold Rosen, MD
Harvard Medical School, Beth Israel Deaconess Medical Center
Professor of Endocrinology at Harvard Medical School, Director Osteoporosis Prevention and Treatment Center at Beth Israel Deaconess Medical Center, leading expert in bone densitometry, biochemical markers of bone turnover and metabolic bone disease.
Dr. David B. Karpf, MD
Stanford University School of Medicine
Professor of Endocrinology at Stanford University School of Medicine, Director Stanford Osteoporosis and Metabolic Bone Disease Clinic, leading researcher on osteoporosis medications (Fosomax trial) and board member of American Bone Health.
Dr. Laura Bilek, PhD, PT
University of Nebraska Medical Center
Associate Dean for Research in the College of Allied Health Professions at the University of Nebraska Medical Center (UNMC). Expert in clinical research for the treatment of low bone mass.
Dr. Tony Keaveny, PhD
University of California Berkeley
Professor of Mechanical Engineering and Bioengineering, UC Berkeley, director of the Berkeley Orthopaedic Biomechanics Lab; Expert in bone mechanics and inventor of VirtuOst.

Ready to get stronger?

Developed by experts, proven in clinical trial, and cleared by the FDA for postmenopausal women with osteopenia.
Woman standing by a waterfront wearing Osteoboost