Evaluation of IVA (SE Femur Scans) to Identify Incomplete AFFs

Study Overview
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Brief Summary
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DXA scanners are routinely used to assess bone mineral density (BMD) and fracture risk in osteoporosis patients. They provide detailed bone imaging in a low radiation setting. Hologic manufactures scanners that are able to perform high definition instant vertebral fracture assessment (HD-IVA) used to screen at-risk patients for asymptomatic spine fractures instantly and reliably at the same time they are having their yearly BMD. We wish to investigate whether this same proven technology (HD-IVA scan mode) used on femurs (the scan mode is now called SE Femur scans) can be used to screen for atypical fractures of the femur in patients at risk for these debilitating fractures. In this proof of concept study, we propose to examine whether DXA scanners can provide a sensitive low radiation screening method to identify incomplete AFFs in patients with known incomplete AFFs and in patients at risk.

Official Title
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Evaluation of Dual Energy X-ray Absorptiometry Scanners in the Identification of Atypical Femur Fractures - A Validation Study

Conditions
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Atypical Femur Fracture

Intervention / Treatment
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* Device: DXA Se femur scans (previously called IVA femur)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Known AFF group A subject must have experienced an incomplete atypical low trauma fracture of the femoral shaft; Is a patient at the UHN osteoporosis clinic. Comparison Group Must be scheduled for a bone mineral density scan at UHN Have been on any bisphosphonate for 5 years or longer, and; Have unexplained symptoms of leg, hip, thigh, or knee pain. Exclusion Criteria: There are no exclusions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Screening population<br>Healthy post-menopausal women attending bone mineral density screening clinic with leg/hip/groin pain/discomfort/weakness an has been on anti-resorptive therapy for at least 5 years. | Device: DXA Se femur scans (previously called IVA femur)<br>* Single Energy Beam (previously called inter-vertebral assessment) by Dual energy x-ray absorptiometry of affected femur<br>* Other names: SF Femur scans;|
| Comparator Group<br>Control group from Toronto CaMOS cohort willing to participate. | Device: DXA Se femur scans (previously called IVA femur)<br>* Single Energy Beam (previously called inter-vertebral assessment) by Dual energy x-ray absorptiometry of affected femur<br>* Other names: SF Femur scans;|
| AFF group<br>participants in the AFF Cohort study at UHN | Device: DXA Se femur scans (previously called IVA femur)<br>* Single Energy Beam (previously called inter-vertebral assessment) by Dual energy x-ray absorptiometry of affected femur<br>* Other names: SF Femur scans;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HD-IVA visualization of incomplete femur fractures | Hologic DXA scanner using the high-definition IVA (HD-IVA) mode on femur bones will be able to visualize incomplete femur fractures at least 90% of the time in patients with known incomplete AFF. | 1 day (one time point ) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atypical Femur Fracture, DXA