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NCT Number: NCT01747304

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Atypical Femur Fracture

Age range

18 year–100 year

Sex eligibility

Female

Study type

Observational

Primary location

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DXA Se femur scans (previously called IVA femur)

Device

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

Other names: SF Femur scans

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2026
Study completion
2026
First posted
Dec 11, 2012
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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