Document text
Principal Investigator: Peter Burks
Organization: ACTIVE LIFE SCIENTIFIC, INC.
Fiscal Year: 2024
Award: $1,716,342
Funding agency: National Institute on Aging
Abstract
Most 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 7,000 individuals. The OsteoProbe® quantifies bone material quality as a measure
termed bone material strength index (BMSi). Measurements are made in a routine exam on the midshaft of the
tibia by a safe and rapid microindentation process. A significant and predictive relationship has been
demonstrated between tibial BMSi and fracture occurrence at multiple skeletal sites in published studies and in
our Phase II study. Since fragility fractures occur most often at the hip, wrist, and the spine, this renewal will
allow us to confirm the predictive relationship between OsteoProbe measurements at the tibia and bone strength
at these clinically relevant skeletal sites on male cadavers. As in our original Phase II, we hypothesize that tibial
OsteoProbe® measurements will predict bone strength at the whole bone and tissue levels at the hip, wrist, and
spine for both males and females. At each of these skeletal sites, OsteoProbe measurements, BMD, and whole
bone and tissue level mechanical testing will be performed. The renewal proposal aims to: (1) establish and
confirm the mechanistic basis by which a clinically relevant surrogate of in vivo bone strength could be accurately
measured at the hip, wrist, and spine for males; (2) develop OsteoProbe into a more manufacturable device that
can be produced and supported in volume; and (3) provide pivotal data for an FDA 510(k) approval of a new,
commercially attractive, and reimbursable marketing claim for OsteoProbe.
Terms: <Address><Adopted><Area><Body Tissues><Bone Density><Bone Mineral Density><Bone Tissue><Budgets><Cadaver><Clinic><Clinical><Code><Coding System><Communication><Coxa><DEXA><DXA><Data><Data Analyses><Data Analysis><Death Rate><Decision Making><Development><Devices><Diagnosis><Diagnostic><Diagnostic Device><Diagnostic Equipment><Dual-Energy X-Ray Absorptiometry><Dual-Energy Xray Absorptiometry><Environment><Face><Female><Femur><Fracture><Funding><Future><General Population><General Public><Grant><Health Care Costs><Health Costs><Healthcare><Healthcare Costs><Hip><Hip region structure><Human><Individual><Intention><Investments><Label><Marketing><Measurement><Measures><Mechanics><Medical><Medical Device><Modern Man><Modernization><Morbidity><Morbidity - disease rate><Osteopenia><Osteopenias><Osteoporosis><Pathway interactions><Patients><Phase><Physicians><Population><Privatization><Procedures><Process><Production><Productivity><Public Health><Publishing><Race><Races><Radial><Radius><Regulation><Research><Risk><SBIR><Secure><Site><Small Business Innovation Research><Small Business Innovation Research Grant><Spinal Column><Spine><Statistical Data Analyses><Statistical Data Analysis><Statistical Data Interpretation><Techniques><Testing><Time><Tissues><Vertebral column><Woman><Women's study><Work><Wrist><age associated><age correlated><age dependent><age linked><age related><age specific><aged group><aged groups><aged individual><aged individuals><aged people><aged person><aged persons><aged population><aged populations><aging population><backbone><bone><bone fracture><bone fragility><bone health><bone quality><bone strength><cadaveric><cadavers><clinical decision-making><clinical predictors><clinical relevance><clinical significance><clinically relevant><clinically significant><commercialization><cost><data interpretation><demographics><design><designing><developmental><faces><facial><female study><fracture risk><fragile bone><fragility fracture><handheld mobile device><health care><high risk><improved><in vivo><indexing><male><manufacturability><manufacture><mechanic><mechanical><men><mobile computing><mobile device><mobile platform><mobile technology><mortality><mortality rate><mortality ratio><new technology><novel><novel technologies><pathway><phase 2 study><phase II study><population aging><racial><racial background><racial diversity><racial origin><racially diverse><sex><skeletal><statistical analysis><study among females><study among women><study in females><study in women><study on females><study on women><study within women><tibia><tool><usability>