A New Device to measure Whole and Tissue Level Bone Strength.

Abstract The majority of patients who fracture have non-osteoporotic bone mineral density. Often, the result of a fracture is devastating and results in substantial morbidity and health care costs. One cause of fragility in these patients is poor bone quality that subsequently contributes to higher risk for fracture. Yet few techniques are available to

accurately assess bone quality in the clinic. Dual energy x-ray absorptiometry (DXA) is the most used clinical surrogate for fracture risk, but DXA does not account for bone quality and thus overestimates bone health. OsteoProbe® Reference Point Indenter enables the measurement of bone quality in human patients and has

been used safely on over 3,000 individuals. The OsteoProbe® quantifies bone material quality as a measure termed bone material strength index (BMSi) at the tibia through the use of a rapid microindentation process. A significant and highly predictive relationship has been demonstrated between tibial BMSi and fracture occurrence

at multiple skeletal sites. BMSi has also been shown to be strongly predictive of bone strength at the femoral neck. As fragility fractures often occur at the hip, wrist, and the spine, this study will investigate the relationship between OsteoProbe measurements at the tibia and bone strength at these clinically relevant skeletal sites on

post-menopausal cadavers. We hypothesize that tibial OsteoProbe® measurements will predict bone strength at the whole bone and tissue levels at the hip, wrist, and spine. At each of these skeletal sites, OsteoProbe measurements, BMD, and whole bone and tissue level mechanical testing will be performed. The proposal aims

to: (1) establish the mechanistic basis by which a clinically relevant surrogate of in vivo bone strength could be accurately measured at the hip, wrist, and spine; (2) transition OsteoProbe into the final commercial configuration optimized for usability in the target commercial environment; and (3) provide for an FDA approval

of OsteoProbe as a clinically useful device aimed at addressing the bone quality diagnostic gap.