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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01747304

Enrollment

285

Registered

2012-12-11

Start date

2012-07-31

Completion date

2026-12-31

Last updated

2025-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atypical Femur Fracture

Keywords

Atypical Femur Fracture, DXA

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.

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

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 100 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
HD-IVA visualization of incomplete femur fractures	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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026