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Active Not RecruitingNCT01747304

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

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

Status
Active Not Recruiting
Phase
Study type
Observational
Enrollment
285 (actual)
Sponsor
University Health Network, Toronto · Academic / Other
Sex
Female
Age
18 Years – 100 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEDXA Se femur scans (previously called IVA femur)Single Energy Beam (previously called inter-vertebral assessment) by Dual energy x-ray absorptiometry of affected femur

Timeline

Start date
2012-07-01
Primary completion
2026-12-01
Completion
2026-12-01
First posted
2012-12-11
Last updated
2025-08-19

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT01747304. Inclusion in this directory is not an endorsement.