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

Recruiting

• Conditions: Atypical Femur Fracture
• Interventions: Device: DXA Se femur scans (previously called IVA femur)

• Registration Number: NCT01747304
• Lead Sponsor: University Health Network, Toronto

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-12-07
• Study First Submitted QC: 2012-12-10
• Study First Posted: 2012-12-11
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-30
• Last Update Posted: 2023-06-01
• Primary Completion: 2024-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 500

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.

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Exclusion Criteria

• There are no exclusions

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AFF group	DXA Se femur scans (previously called IVA femur)	participants in the AFF Cohort study at UHN
Comparator Group	DXA Se femur scans (previously called IVA femur)	Control group from Toronto CaMOS cohort willing to participate.
Screening population	DXA Se femur scans (previously called IVA femur)	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.

Primary Outcome Measures

Name	Time	Method
HD-IVA visualization of incomplete femur fractures	1 day (one time point )	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.

Trial Locations

Locations (1)

University Health Network; 🇨🇦 Toronto, Ontario, Canada