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Active, not recruitingNCT01747304Updated Aug 19, 2025

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

An observational study in Atypical Femur Fracture, sponsored by University Health Network, Toronto. Active, not recruiting at 1 site in Canada. Open to female participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-19.

Sponsored by University Health Network, Toronto · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
285
Ages
18 Years to 100 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Atypical Femur Fracture

Keywords

  • Atypical Femur Fracture
  • DXA
03

In context

Lead sponsor

University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Osteoporosis/Bone Mineral Density Lab out-patients

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

Exclusion Criteria:

  • There are no exclusions
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
285 participants (actual)
Patient registry
No

Groups and cohorts

  • 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)

  • Comparator Group

    Control group from Toronto CaMOS cohort willing to participate.

    Device: DXA Se femur scans (previously called IVA femur)

  • AFF group

    participants in the AFF Cohort study at UHN

    Device: DXA Se femur scans (previously called IVA femur)

Interventions

  • 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

    Also known as: SF Femur scans

06

What researchers measure

Primary outcomes

  1. HD-IVA visualization of incomplete femur fractures

    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.

    Time frame: 1 day (one time point )

07

Study locations

1 site
  • University Health Network
    Toronto, Ontario M5G 2C4, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01747304
Lead sponsor
University Health Network, Toronto
Responsible party
Sponsor
First posted
Dec 11, 2012
Start date
Jul 2012
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Aug 19, 2025

Study contacts

Angela M Cheung, MD, PhD, CCD
principal investigator · University Health Network, Toronto

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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