Biomechanics of Metastatic Defects in Bone
The Purpose of This Study is to Monitor Fracture Risk Associated With Bone Tumors in Cancer Patients
1 other identifier
observational
245
2 countries
8
Brief Summary
The purpose of this study is to monitor fracture risk associated with bone tumors in cancer patients. Previous studies from our lab have suggested that it is possible to compute the mechanical strength of bones with tumors using computed tomography (CT) scans, which are like three-dimensional X-ray pictures of the affected bones. The next step in determining the usefulness of this type of strength analysis is to see if we can accurately predict who is at risk for bone fracture and which patients are at high risk of fractures. This non-invasive analysis may help physicians determine the best treatment to reduce the risk of an impending bone fracture in the future.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2009
Longer than P75 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 31, 2014
CompletedFirst Posted
Study publicly available on registry
April 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedMay 9, 2024
May 1, 2024
17 years
March 31, 2014
May 7, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Fracture Risk Assessment in Patients with Skeletal Metastasis
Based on past studies, metastatic lesion in cancer bone alters both the material and geometric properties of the bone while rigidity, the structural property, integrates both two properties in bone. For a cancerous bone, the axial (EA), bending (EI), and torsional (GJ) rigidity determine the capacity of the bone to resist axial, bending and twisting loads respectively. Because the weakest segment of the bone dictates the load capacity of the entire bone, we have developed algorithms to calculate the minimal rigidity of a bone with an osteolytic lesion using serial, trans-axial, computed tomography (CT) images through the affected bone to measure both the bone tissue mineral density and cross-sectional geometry. If the ratio of EA, EI or GI in compare with the normal bone's EA, EI, or GI was 65% or less, pathological fracture will be predicted. This non-invasive analysis may help physicians determine the best treatment to reduce the risk of an impending bone fracture in the future.
0-4 Months
Secondary Outcomes (1)
Fracture Risk Assessment in Patients with Skeletal Metastasis (Following-up with Changes)
4-12 Months
Eligibility Criteria
When a patient presents to the orthopaedic oncologist with lower appendicular skeletal skeletal metastasis, as per standard clinical practice biplanar radiographs and CT scans of the involved bone(s) plus the contralateral limb will be obtained. Informed consent will be obtained for CT scan with the contralateral limb (Both limbs are in the gantry and are imaged together-this is not an additional step, as this is how patients are scanned for general care of lesions in the lower limbs) to provide a patient specific internal control and calcium hydroxyapatite phantom for standardizing bone density estimates. Post-processing of the image data will be conducted by the Orthopaedic Biomechanics Lab at BIDMC to calculate fracture risk associated with the bone lesion.
You may qualify if:
- Patient with metastatic cancer bone lesions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Alvin and Lois Lapidus Cancer Center, Sinai Hospital of Baltimore, Inc
Baltimore, Maryland, 21215, United States
Department of Orthopaedic Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School
Boston, Massachusetts, United States
Department of Orthopaedic Surgery, University of Minnesota Medical Center
Minneapolis, Minnesota, United States
Department of Orthopedic Surgery, Upstate Medical University
Syracuse, New York, 13057, United States
Department of Orthopaedic Surgery, Rhode Island Hospital
Providence, Rhode Island, 02905, United States
Section of Orthopaedic Oncology, University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States
Edwards Comprehensive Cancer Center, Marshall University
Huntington, West Virginia, United States
Department of Orthopaedic Surgery, McGill University Health Centre
Montreal, Quebec, Canada
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ara Nazarian, PhD
anazaria@bidmc.harvard.edu
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Orthopedic Surgery
Study Record Dates
First Submitted
March 31, 2014
First Posted
April 10, 2014
Study Start
January 1, 2009
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
May 9, 2024
Record last verified: 2024-05