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

> **NIH NIH R44** · ACTIVE LIFE SCIENTIFIC, INC. · 2022 · $50,000

## Abstract

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.

## Key facts

- **NIH application ID:** 10656708
- **Project number:** 3R44AG071034-02S1
- **Recipient organization:** ACTIVE LIFE SCIENTIFIC, INC.
- **Principal Investigator:** Peter Burks
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $50,000
- **Award type:** 3
- **Project period:** 2021-01-01 → 2023-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10656708

## Citation

> US National Institutes of Health, RePORTER application 10656708, A New Device to measure Whole and Tissue Level Bone Strength. (3R44AG071034-02S1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10656708. Licensed CC0.

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