SBIR-STTR Award

Direct to Phase II

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. Public Health Relevance Statement Narrative Patients who suffer a fracture but have non-osteoporotic BMD present a unique challenge to physicians since they have no way of identifying these patients before a fracture occurs. A new device for measuring living bone tissue quality, OsteoProbe, was developed as a result of private investment, research and development and its measurement, Bone Material Strength Index (BMSi) is predictive of skeletal fragility in fracture-susceptible populations. This study will 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; transition OsteoProbe into the final commercial configuration optimized for usability in the target commercial environment; and provide for an FDA approval of OsteoProbe as a clinically useful device aimed at addressing the bone quality diagnostic gap.

Project Terms:
Accreditation ; Adoption ; Behavior ; Biocompatible Materials ; Biomaterials ; biological material ; Biophysics ; biophysical foundation ; biophysical principles ; biophysical sciences ; bone ; Bone Density ; Bone Mineral Density ; Bone Diseases ; bone disorder ; Metabolic Bone Diseases ; bone metabolism disorder ; metabolic bone disease ; metabolic bone disorder ; Cadaver ; Clinical Research ; Clinical Study ; Disease ; Disorder ; Environment ; Foundations ; Fracture ; bone fracture ; Glues ; Hip region structure ; Coxa ; Hip ; Hospitals ; Human ; Modern Man ; Incidence ; indexing ; instrumentation ; Investments ; Life Style ; Lifestyle ; Metabolism ; Intermediary Metabolism ; Metabolic Processes ; Methods ; Minerals ; Morbidity - disease rate ; Morbidity ; Neck ; Pain ; Painful ; Patients ; Peer Review ; Physicians ; Play ; Privatization ; Professional Organizations ; professional association ; professional membership ; professional society ; Proteins ; Publications ; Scientific Publication ; Publishing ; radius bone structure ; Radial Bone ; Radius Bone ; Research ; research and development ; Development and Research ; R & D ; R&D ; Risk ; Role ; social role ; Societies ; medical specialties ; Specialty ; Vertebral column ; Spinal Column ; Spine ; backbone ; Technology ; Testing ; tibia ; Tissues ; Body Tissues ; United States ; United States Food and Drug Administration ; Food and Drug Administration ; USFDA ; Woman ; Work ; Wrist ; Measures ; Health Care Costs ; Health Costs ; Healthcare Costs ; base ; Label ; sensor ; improved ; Procedures ; Distal ; Site ; Clinical ; Phase ; Series ; Postmenopause ; Post-Menopause ; Post-menopausal Period ; Postmenopausal Period ; post-menopausal ; postmenopausal ; Individual ; European ; Measurement ; Endocrinologist ; Diagnostic ; Nature ; mechanical ; Mechanics ; Bone Tissue ; Investigation ; Clinic ; Sensory ; Techniques ; System ; Location ; skeletal ; Vertebrae ; Vertebral ; spine bone structure ; Medical center ; American ; bone loss ; sterile ; Sterility ; Structure ; Devices ; Radiation ; Modeling ; handheld device ; handheld equipment ; portability ; vulnerable group ; Vulnerable Populations ; Address ; DEXA ; DXA ; Dual-Energy Xray Absorptiometry ; Dual-Energy X-Ray Absorptiometry ; Data ; International ; Predictive Value ; Regulatory Pathway ; Resolution ; in vivo ; Validation ; Monitor ; Process ; Authorization documentation ; Authorization ; Permission ; Development ; developmental ; nano ; bone health ; bone quality ; bone strength ; Population ; clinically relevant ; clinical relevance ; graphical user interface ; Graphical interface ; graphic user interface ; software user interface ; usability ; high risk ; Radiation exposure ; fragility fracture ; fracture risk ; mechanical properties ;