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

May 30, 2023 updated by: University Health Network, Toronto

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Recruiting
        • University Health Network
        • Contact:
        • Principal Investigator:
          • Angela M Cheung, MD, PhD, CCD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Osteoporosis/Bone Mineral Density Lab out-patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Screening population
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)
Single Energy Beam (previously called inter-vertebral assessment) by Dual energy x-ray absorptiometry of affected femur
Other Names:
  • SF Femur scans
Comparator Group
Control group from Toronto CaMOS cohort willing to participate.
Device: DXA Se femur scans (previously called IVA femur)
Single Energy Beam (previously called inter-vertebral assessment) by Dual energy x-ray absorptiometry of affected femur
Other Names:
  • SF Femur scans
AFF group
participants in the AFF Cohort study at UHN
Device: DXA Se femur scans (previously called IVA femur)
Single Energy Beam (previously called inter-vertebral assessment) by Dual energy x-ray absorptiometry of affected femur
Other Names:
  • SF Femur scans

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day (one time point )

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Angela M Cheung, MD, PhD, CCD, University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

December 7, 2012

First Submitted That Met QC Criteria

December 10, 2012

First Posted (Estimated)

December 11, 2012

Study Record Updates

Last Update Posted (Actual)

June 1, 2023

Last Update Submitted That Met QC Criteria

May 30, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-0352

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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