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

University Health Network, Toronto

Status: Enrolling

Conditions: Atypical Femur Fracture

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

Study type: Observational

Funder types: Other

Identifiers

NCT01747304

12-0352

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: Female

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

500 participants in 3 patient groups

Screening population

Description:

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.

Treatment:

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

Comparator Group

Description:

Control group from Toronto CaMOS cohort willing to participate.

Treatment:

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

AFF group

Description:

participants in the AFF Cohort study at UHN

Treatment:

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