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

NCT01747304 | Active Not Recruiting

• 1 other identifier: 12-0352
• Study Type: observational
• Target: 285
• Locations: 1 country
• Sites: 1

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.

Conditions

Atypical Femur Fracture

Keywords

Atypical Femur Fracture; DXA

Outcome Measures

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.

  1 day (one time point )

Study Arms (3)

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

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

Also known as: SF Femur scans

AFF group; Comparator Group; Screening population

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Osteoporosis/Bone Mineral Density Lab out-patients

You may qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Study Officials

• Angela M Cheung, MD, PhD, CCD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2012
• First Posted: December 11, 2012
• Study Start: July 1, 2012
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 19, 2025

Record last verified: 2025-08

Locations

CA (1)