A bone health study based on NASA research is underway thanks to San Francisco-based Bone Health Technologies, Inc., the San Francisco VA Health Care System, and the University of California, San Francisco (UCSF). The osteoporosis prevention study regarding non-drug interventions will focus on treating osteopenia in postmenopausal women of diverse racial and ethnic backgrounds.
The research effort is being led by UCSF Professor and Department of Medicine Master Clinician Dr. Dolores M. Shoback, an endocrinologist at the San Francisco VA Health Care System, and Dr. Anne L. Schafer, chief of Endocrinology and Metabolism at the same facility and associate professor of Medicine and Epidemiology & Biostatistics at UCSF.
The team hopes to find improvement in bone density and bone strength at the hip and lumbar spine (with dual energy x-ray absorptiometry and CT scans at one year), as well as an immediate improvement in biochemical markers of bone turnover. The researchers are obtaining urine and serum measurements of bone cell activity before and during use of Bone Health Technologies’ OsteoBoost technology.
The OsteoBoost technology is based on NASA research which, as indicated by the company, has shown that vibration at a precise amplitude and frequency stimulates bones, with OsteoBoost delivering the optimal therapeutic dose directly to the hips and spine.
When OTW inquired as to why osteopenia treatments are lacking, Dr. Shoback explained, “This is because the focus has been on secondary prevention of fractures in patients who have established osteoporosis. That secondary prevention occurs after a patient has sustained a fragility fracture.”
“That fragility fracture marks the woman or man as ‘high-risk,’ and therefore, an important person to target for prescription drug treatments and lifestyle and nutritional interventions to prevent that second or third fracture. Osteopenia is the precursor to osteoporosis, and many patients with osteopenia receive little advice except take calcium and vitamin D.”
“Until a fracture occurs, or the bone mineral density (BMD) by dual energy x-ray absorptiometry reaches -2.5, the patient is not advised to do anything specific. Beyond calcium, vitamin D, and lifestyle interventions that include exercise, we do not have interventions that stimulate bone to rebuild itself or that block the breakdown of bone mass that occurs with menopause.”
“Orthopedic surgeons may not realize that bone loss can be stabilized or improved in animal models and in some interventions in humans with mechanical energy or gentle increased loading to the skeleton,” said Dr. Shoback. “They further may not realize that the majority of fractures that occur will occur in patients who are considered ‘osteopenic’ by BMD measurements, but who have other important clinical risk factors like smoking, frailty, falls, steroid use, and so forth.”
“The majority of fractures occur in patients you would classify by dual energy x-ray absorptiometry testing as ‘osteopenic.’ Perhaps the orthopedic surgeons do not realize that their fracture patients are often classified as ‘osteopenic’ until the fracture occurs, and then, the diagnosis becomes ‘osteoporosis.’"
“The study is being done in two parts. The first is a three-month study that will look at the effects of daily application of gentle vibrational energy to the lower back and hips and assess changes in dual energy x-ray absorptiometry scanning of the BMD at those sites and at the changes in bone turnover markers in response to this three-month intervention.”
“The study then extends for an additional 9 months, continuing the same vibrational energy intervention, to see if spine and hip BMD and estimated bone strength can be improved with a full 12 months of this activity-based, mechanical energy-based intervention. BMD at the 6-month time point will be addressed by dual energy x-ray absorptiometry scanning, and BMD and strength will be addressed at the 12-month time point by dual energy x-ray absorptiometry and quantitative CT scanning.”
“We will also assess patient-reported outcomes. We will do questionnaires on the device itself—ease of use and acceptability—and we will assess for any quality-of-life issues and changes during the study. Participants in the study will also have their calcium and vitamin D intakes assessed and optimized.”
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