Using DXA scans to identify incomplete atypical femur fractures
Evaluation of Dual Energy X-ray Absorptiometry Scanners in the Identification of Atypical Femur Fractures - A Validation Study
University Health Network, Toronto · NCT01747304
This study is testing if a special type of bone scan can help find early signs of unusual thigh bone fractures in people at risk for them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | Female |
| Sponsor | University Health Network, Toronto (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT01747304 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the use of DXA scanners, which are typically employed to assess bone mineral density in osteoporosis patients, to identify incomplete atypical femur fractures (AFFs). The study utilizes a specific scan mode called SE Femur scans to screen patients at risk for these fractures. By examining patients with known incomplete AFFs and those at risk, the study aims to determine the effectiveness of this low radiation screening method. The goal is to provide a reliable and sensitive approach for detecting these debilitating fractures during routine bone density assessments.
Who should consider this trial
Good fit: Ideal candidates include patients with known incomplete atypical femur fractures and those at risk attending the osteoporosis clinic at UHN.
Not a fit: Patients who do not have a history of atypical femur fractures or are not at risk for such fractures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection of atypical femur fractures, potentially reducing complications and enhancing patient outcomes.
How similar studies have performed: While the use of DXA scans for bone density assessment is well-established, the application of SE Femur scans for identifying atypical fractures is a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Known AFF group 1. A subject must have experienced an incomplete atypical low trauma fracture of the femoral shaft; 2. Is a patient at the UHN osteoporosis clinic. Comparison Group 1. Must be scheduled for a bone mineral density scan at UHN 2. Have been on any bisphosphonate for 5 years or longer, and; 3. Have unexplained symptoms of leg, hip, thigh, or knee pain. Exclusion Criteria: * There are no exclusions
Where this trial is running
Toronto, Ontario
- University Health Network — Toronto, Ontario, Canada (RECRUITING)
Study contacts
- Principal investigator: Angela M Cheung, MD, PhD, CCD — University Health Network, Toronto
- Study coordinator: Judite Scher, MSc CCRI
- Email: jscher@uhnresearch.ca
- Phone: 416-340-4841
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Atypical Femur Fracture, DXA