Osteoporosis affects 10 million Americans over the age of 50 and leads to 1.5 million bone fractures per year, primarily in women. For senior citizens who suffer fractures of the hip, 20% will die within one year. Unfortunately, pharmacological treatments for osteoporosis have been met with resistance due to significant adverse side effects. This project aims to develop and test a non-invasive device to prevent bone loss in postmenopausal women by delivering vibrational stimulus to skeletal sites that are at high risk for fractures, particularly the hip and spine. Existing vibration devices require patients to stand on a platform for extended periods of time, which can lead to noncompliance, especially in the home setting. Moreover, when delivered through the feet, vibrations are attenuated significantly by the time they reach the hip and spine. The proposed device offers to more directly stimulate these skeletal sites of interest using accelerometer- based feedback while allowing patients to wear the device during many everyday activities, which is hypothesized to increase compliance. TheraNova will test this hypothesis through an initial feasibility study involving 20 postmenopausal women who will use the device 10 minutes per day for 16 weeks. Before beginning the study, refinements to the device will be made with user input to ensure that it will be comfortable for the study participants. Compliance rates during the 16-week study will be tracked and compared with rates from prior studies that have used vibration platforms. It is expected that the wearable vibration device will have higher rates of compliance than the platform devices. In addition to tracking compliance, this proposal aims to measure changes in levels of bone turnover in the study participants through analysis of urinary collagen cross-linked N-telopeptide (NTx) and bone-specific alkaline phosphatase (ALP), biochemical markers for bone resorption and formation. It is expected that NTx levels will decrease and ALP levels will increase over the course of the 16-week study, which will support the therapeutic feasibility of the wearable vibration device. Furthermore, effectiveness of the device in decreasing NTx and increasing ALP is expected to correlate with levels of compliance. Successful completion of this research will form the basis for a much larger study that will investigate the effect of the wearable vibration device on bone mineral density (BMD) and fracture rates in postmenopausal women.

Public Health Relevance

Osteoporosis results in 1.5 million bone fractures and direct costs of $18 billion in the United States annually. This proposal seeks to prevent bone loss in postmenopausal women, who are disproportionately affected by the disease, through the development of a wearable vibration device to stimulate the skeletal sites where fractures most often occur. This device has the potential to halt or delay the onset of osteoporosis, which will reduce the number of fractures and associated costs while improving patient health.

National Institute of Health (NIH)
National Institute on Aging (NIA)
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
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Special Emphasis Panel (ZRG1-MOSS-S (10))
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Williams, John
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Theranova, LLC
San Francisco
United States
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