# CTRA Software Solution for Fracture Risk Assessment of Axial Skeleton

> **NIH NIH R44** · BIOSENSICS, LLC · 2020 · $1,490,863

## Abstract

PROJECT SUMMARY/ABSTRACT
 Elderly patients with cancer have a higher risk of bony metastases than middle-aged patients (four times
higher in men and three times higher in women). Approximately 50% of these cases of bony metastases involve
the spine. Cancer patients are living longer as a result of new and aggressive treatments, but at sites of skeletal
metastasis fractures occur in 17%-35% of affected bones after minimal trauma. Fractures due to metastatic
disease in the spine vary from stable fractures with minimal pain and impairment to unstable fractures causing
pain, major functional impairment, and neurologic deficits. Moreover, axial, skeletal metastases and the resultant
fractures increase the risk for spinal instability, spinal cord compression, and neurological compromise. These
complications have a devastating effect on quality of life, and, therefore prediction and prevention of fractures
due to metastatic disease in the spine is critical. Clinicians currently make subjective assessments regarding a
patient's fracture risk and response to treatment, which are now recognized to be inaccurate. To address this
shortcoming, we have developed a methodology called Computed Tomography-based Rigidity Analysis (CTRA)
for assessment of bone fracture risk. This method uses computed tomography (CT) images of the bone to
calculate its structural rigidity, as a mechanical assay representing changes in bone tissue material and geometry
induced by different factors such as age, trauma, or the neoplastic process. CTRA has been shown to provide
estimates of bone load capacity and predict pathologic fractures in 20 ex-vivo, pre-clinical, and clinical studies.
 BioSensics is currently working on the development and commercialization of CTRA software for
appendicular skeleton. This effort includes software design, as well as development of reimbursement strategies
for CTRA, which is critical for large scale clinical usage of the technology and successful commercialization. In
this Direct Phase II SBIR application, BioSensics, in collaboration with Beth Israel Deaconess Medical Center
and Mayo Clinic, proposes to significantly expand the commercialization potential of CTRA by expanding its
application to the axial skeleton. The aims of this project are to 1) Develop an age-, race- and gender-based
normative structural rigidity database for the axial skeleton, 2) Develop fracture threshold values for CTRA
analysis, 3) Develop auto-segmentation and material properties assignment algorithms, and 4) Develop and
validate the CTRA software solution for axial skeleton. Software development will follow design controls in
accordance with 21 CFR 820.30 and include life cycle processes required for the safe maintenance of the CTRA
software based on International Standard IEC 62304 for medical device software.

## Key facts

- **NIH application ID:** 10013115
- **Project number:** 5R44AG065014-02
- **Recipient organization:** BIOSENSICS, LLC
- **Principal Investigator:** ARA NAZARIAN
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,490,863
- **Award type:** 5
- **Project period:** 2019-09-15 → 2022-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10013115

## Citation

> US National Institutes of Health, RePORTER application 10013115, CTRA Software Solution for Fracture Risk Assessment of Axial Skeleton (5R44AG065014-02). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10013115. Licensed CC0.

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