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Clinical Trials/NCT01747304
NCT01747304
Active, not recruiting
Not Applicable

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

University Health Network, Toronto1 site in 1 country285 target enrollmentJuly 1, 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Atypical Femur Fracture
Sponsor
University Health Network, Toronto
Enrollment
285
Locations
1
Primary Endpoint
HD-IVA visualization of incomplete femur fractures
Status
Active, not recruiting
Last Updated
8 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2012
End Date
December 1, 2026
Last Updated
8 months ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

HD-IVA visualization of incomplete femur fractures

Time Frame: 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.

Study Sites (1)

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