Development and validation of a novel non-invasive device for measuring the mechanical properties of cortical bone

Abstract AEIOU ScientificLLCAEIOUaims to develop and commercialize Ohio Universityandapos sOHIOandapos spatent pending Cortical Bone Mechanics TechnologyCBMTas a non invasive medical device for improving the diagnosis and monitoring of osteoporosis and other bone diseasesOsteoporosis and low bone mass affectmillion Americans andmillion people worldwideIn womenthe resulting fragility fractures cause paindisability and a higher death rate than heart diseasestroke and breast cancer combinedThe associated annual medical expenses will reach $billion in the US andbillion in Europe byWhile osteoporosis is characterized by a decline in bone strength leading to an increased risk of fractureno commercially available medical device measures bone strengthInsteadphysicians decide who to treat to prevent fragility fractures based on bone mineral densityBMDmeasured by dual energy X ray absorptiometryDXAor based on clinical risk factors assessed by FRAXa World Health Organization questionnaireUnfortunatelyrepeated and consistent prospective studies have found that neither of these methods predicts fractures wellBone stiffness accurately predicts bone strengthbut the current method for measuring bone stiffnessQuasistatic Mechanical TestingQMTcan only be performed on excised bonesOHIOandapos s novel CBMT enablesfor the first timenoninvasive measurements of bone stiffness that are indistinguishable from QMT measurementsRAEIOUandapos s long term goal is to develop a commercial medical device based on this technologyHigh demand for a CBMT based medical device has been confirmed through interviews ofpotential customers in theiCorps@Ohio programIn Phase I of this SBIR projectwe will conduct human factors engineering studies in Aimto guide the designfabrication and validation of a CBMT medical device in AimIn Aimwe will conduct a controlled experiment to confirm that CBMT can detect effects of changes in bone protein on bone mechanics that are unique and independent of BMDIn Phase II of this SBIR projectAEIOU and clinical collaborators will conduct studies of patients with age related and secondary osteoporosis and low bone mass to study the effectiveness of CBMT for predicting fragility fractures and for monitoring disease progression and treatmentand to document adverse events associated with the use of CBMT in these populations