Bone Health Technologies to Begin OsteoBoost Study

Bone Health Technologies (BHT) is kicking off a one-year long study of its OsteoBoost device in treating osteoporosis in postmenopausal women. The company is undertaking the trial in partnership with the San Francisco Veterans Affairs Health Care System (SFVAHCS), the University of California, San Francisco (UCSF), and Northern California Institute for Research and Education (NCIRE).

BHT intends to enroll 50 patients with diverse racial and ethnic backgrounds who are not currently taking any osteoporosis drugs and have DXA scan bone density T-scores between -1.0 and -2.4. The study will measure improvements in bone density and bone strength at the hip and lumbar spine as measured by DXA and CT scans after one year, as well as an immediate improvement in biochemical markers of bone turnover. There will be urine and serum measurements of bone cell activity, reflecting both bone formation and bone resorption, before and during use of the OsteoBoost technology. Participants in the study will benefit from the most advanced analysis and monitoring of their bone health by some of the leading clinicians in the field.

“We aim to analyze the effect of the OsteoBoost technology on bone health in an in-depth and detailed manner with the highest standard of clinical evidence so that future clinicians can prescribe with confidence,” said Laura Yecies, CEO of Bone Health Technologies.
 
The study is being led by UCSF Professor and Department of Medicine Master Clinician Dr. Dolores M. Shoback, a practicing endocrinologist at the SFVAHCS, and Dr. Anne L. Schafer, chief of Endocrinology and Metabolism at the SFVAHCS and associate professor of Medicine and Epidemiology & Biostatistics at UCSF.
 
The UCSF/SFVAHCS teams will rigorously test the nonpharmacologic intervention, which could be incorporated into the preventive regimens recommended to postmenopausal women. Trial organizers want to ensure testing in women of diverse racial and ethnic backgrounds. Safe and effective treatments for the 52 million patients with osteopenia are desperately needed and it is important that the treatments and recommendations are based on evidence from study cohorts representing the broadest diversity of the American population, according to the company.
 
BHT’s OsteoBoost technology could potentially solvie a critical unmet need. Earlier this year, the company received a Commercialization Readiness Pilot Program Grant from the National Institutes of Health and the firm also has previously received U.S. Food and Drug Administration Breakthrough Device Designation. Moreover, it closed a $2.75 million funding round, was awarded additional patents, and added top industry professionals to its board.
 
The OsteoBoost technology is based on NASA research, which has proved that mechanical stimulation of bones through vibration can improve bone density and may help improve the lives of individuals dealing with different bone diseases. BHT has previously conducted a clinical study that showed that once daily 30-minute treatment with OsteoBoost reduced bone loss activity in study participants and is currently conducting a pivotal trial at the University of Nebraska Medical Center assessing the impact of OsteoBoost on bone density and bone strength after one year of treatment. The trial at the University of Nebraska recently concluded.
 
Bone Health Technologies is a San Francisco-based company that applies science and medical expertise to create better health outcomes for those at risk of developing osteoporosis and the associated bone fractures.