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

Atypical Femur Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01747304
• Other study ID #: 12-0352
• Status: Recruiting
• Start date: July 2012
• Est. completion date: December 2025

Study information

• Verified date: May 2023
• Source: University Health Network, Toronto
• Contact: Judite Scher, MSc CCRI
• Phone: 416-340-4841
• Email: jscher[@]uhnresearch.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Atypical Femur Fracture
• Femoral Fractures
• Fractures, Bone

Intervention

Device:
• 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

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 )