Wednesday, January 15, 2025 1/15/2025

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

Award Number: R01AR075964
ORGANIZATION: NATIONAL INSTITUTE OF ARTHRITIS & MUSCULOSKELETAL & SKIN DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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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 with short life expectancy. Successful completion of this project will address a critical gap in our ability to individualize evaluation and management of these patients.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $639,383 )
2024	2024	BETH ISRAEL DEACONESS MEDICAL CENTER, INC.	330 BROOKLINE AVE	BOSTON	MA	02215	SUFFOLK	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	5	3/29/2024	NON-COMPETING CONTINUATION	$593,241
2024	2024	BETH ISRAEL DEACONESS MEDICAL CENTER, INC.	330 BROOKLINE AVE	BOSTON	MA	02215	SUFFOLK	USA	Arthritis, Musculoskeletal and Skin Diseases Research	001	5	6/7/2024	NON-COMPETING CONTINUATION	$46,142
														Subtotal = $639,383

Issue Date FY: 2023 ( Subtotal = $681,073 )
2023	2023	BETH ISRAEL DEACONESS MEDICAL CENTER, INC	330 BROOKLINE AVE	BOSTON	MA	02215	SUFFOLK	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	4	3/24/2023	NON-COMPETING CONTINUATION	$681,073
														Subtotal = $681,073

Issue Date FY: 2022 ( Subtotal = $1,028,816 )
2022	2022	BETH ISRAEL DEACONESS MEDICAL CENTER, INC	330 BROOKLINE AVE	BOSTON	MA	02215	SUFFOLK	USA	Arthritis, Musculoskeletal and Skin Diseases Research	001	3	9/12/2022	SUPPLEMENT FOR EXPANSION	$352,266
2022	2022	BETH ISRAEL DEACONESS MEDICAL CENTER, INC	330 BROOKLINE AVE	BOSTON	MA	02215	SUFFOLK	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	3	6/29/2022	NON-COMPETING CONTINUATION	$676,550
														Subtotal = $1,028,816

Issue Date FY: 2021 ( Subtotal = $131,892 )
2021	2021	BETH ISRAEL DEACONESS MEDICAL CENTER, INC	330 BROOKLINE AVE	BOSTON	MA	02215	SUFFOLK	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	2	4/12/2021	NON-COMPETING CONTINUATION	$131,892
														Subtotal = $131,892

Issue Date FY: 2020 ( Subtotal = $1,246,210 )
2020	2020	BETH ISRAEL DEACONESS MEDICAL CENTER, INC	330 BROOKLINE AVE	BOSTON	MA	02215	SUFFOLK	USA	Arthritis, Musculoskeletal and Skin Diseases Research	001	1	8/12/2020	NEW	$534,723
2020	2020	BETH ISRAEL DEACONESS MEDICAL CENTER, INC	330 BROOKLINE AVE	BOSTON	MA	02215	SUFFOLK	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	1	3/15/2020	NEW	$182,666
2020	2020	BETH ISRAEL DEACONESS MEDICAL CENTER, INC	330 BROOKLINE AVE	BOSTON	MA	02215	SUFFOLK	USA	Arthritis, Musculoskeletal and Skin Diseases Research	002	1	9/25/2020	NEW	$528,821
														Subtotal = $1,246,210

Grand Total All Awards = $3,727,374

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

Award Number: R01AR075964

ORGANIZATION: NATIONAL INSTITUTE OF ARTHRITIS & MUSCULOSKELETAL & SKIN DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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