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

NCT ID: NCT01747304

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 285 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2026-12-31

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

DXA Se femur scans (previously called IVA femur)

Intervention Type: DEVICE

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

Comparator Group

Control group from Toronto CaMOS cohort willing to participate.

DXA Se femur scans (previously called IVA femur)

Intervention Type: DEVICE

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

AFF group

participants in the AFF Cohort study at UHN

DXA Se femur scans (previously called IVA femur)

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

SF Femur scans

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Angela M Cheung, MD, PhD, CCD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

University Health Network

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

12-0352

Identifier Type: -

Identifier Source: org_study_id