# Predicting Fracture Risk in Patients Treated with Radiotherapy for Spinal Metastatic Disease

> **NIH NIH R01** · BETH ISRAEL DEACONESS MEDICAL CENTER · 2021 · $131,892

## Abstract

Project Summary/Abstract
We seek to validate a quantitative method to predict the risk of pathologic vertebral fracture (PVF) in cancer
patients treated with radiotherapy for metastatic spine disease before the onset of these complications.
Vertebral bone is the most frequent site of skeletal metastasis. Radiation therapy aims to palliate pain and
reduce the risk of PVF. However, PVF are a common complication afflicting up to 39% of patients within 6
months after-radiotherapy. Clinical guidelines for estimating fracture risk remain subjective and suffer from low
specificity and sensitivity. Improved prediction of PVF risk would facilitate selection of whether, how, and when
to intervene prior to the occurrence of PVF. Such individualized prediction is not available in clinical practice.
 As part of our previous NIH grant, we have developed a computed tomography (CT) based structural
analysis (CT-SAP) to successfully predict the failure of human spines with lytic defects. Based on these
accomplishments, the objectives of this observational prospective study are threefold: 1) To test the
performance of CT-SAP (providing a snapshot of bone structure and calcium content) and bone turnover
markers (providing an indication of disease trajectory) for predicting the baseline risk of vertebral fractures in
a cohort of patients treated with radiotherapy for spinal bone metastases. For this purpose, we will acquire the
standard clinical CT and serum sample at the patient's radiotherapy planning. From the CT, we will derive
individualized estimates of vertebral strength (CT-SAP) and vertebral loading to compute the loading /
strength ratio for both treated and untreated vertebrae, and measure the value for markers for bone
resorption and formation from the serum sample. We will test the independent association of the vertebral
loading / strength ratio and marker value with the observed vertebral fractures within 6 months after treatment.
This novel data will provide information on the effect of radiation and metastatic disease on the baseline and
short term risk of vertebral fracture in this patient cohort. 2) To establish the performance of the spinal
instability neoplastic score (SINS) for predicting the patient's risk of vertebral fracture within 6 months after
treatment and test whether adding the load / strength ratio (CT-SAP) and bone turnover risk models,
independently and combined, improves the model's performance. This will establish a new paradigm for
individualized prediction of baseline risk for fracture in this patient cohort. 3) To test the established model
performance for predicting the evolving risk of PVF within a 3 month interval by acquiring and analyzing the
CT scans and serum samples collected at 3, 6, and 9 months after treatment as part of standard clinical care.
This time period provides clinically meaningful guidelines for assessing the impact of a low vs. high risk of PVF
to the health and quality of life of this infirm population ...

## Key facts

- **NIH application ID:** 10128304
- **Project number:** 5R01AR075964-02
- **Recipient organization:** BETH ISRAEL DEACONESS MEDICAL CENTER
- **Principal Investigator:** RON N ALKALAY
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $131,892
- **Award type:** 5
- **Project period:** 2020-04-01 → 2025-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10128304

## Citation

> US National Institutes of Health, RePORTER application 10128304, Predicting Fracture Risk in Patients Treated with Radiotherapy for Spinal Metastatic Disease (5R01AR075964-02). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10128304. Licensed CC0.

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