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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by University Health Network, Toronto
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01747304
First received: December 7, 2012
Last updated: November 30, 2015
Last verified: November 2015
  Purpose
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.

Condition Intervention
Atypical Femur Fracture
Device: DXA Se femur scans (previously called IVA femur)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Evaluation of Dual Energy X-ray Absorptiometry Scanners in the Identification of Atypical Femur Fractures - A Validation Study

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • HD-IVA visualization of incomplete femur fractures [ Time Frame: 1 day (one time point ) ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 500
Study Start Date: July 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)
Single Energy Beam (previously called inter-vertebral assessment) by Dual energy x-ray absorptiometry of affected femur
Other Name: SF Femur scans
Comparator Group
Control group from Toronto CaMOS cohort willing to participate.
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
Other Name: SF Femur scans
AFF group
participants in the AFF Cohort study at UHN
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
Other Name: SF Femur scans

  Eligibility

Ages Eligible for Study:   18 Years to 100 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Osteoporosis/Bone Mineral Density Lab out-patients
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01747304

Contacts
Contact: Judite Scher, MSc CCRI 416-340-4841 jscher@uhnresearch.ca

Locations
Canada, Ontario
University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Scher       jscher@uhnresearch.ca   
Principal Investigator: Angela M Cheung, MD, PhD, CCD         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Angela M Cheung, MD, PhD, CCD University Health Network, Toronto
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01747304     History of Changes
Other Study ID Numbers: IVA 12-0352-AE 
Study First Received: December 7, 2012
Last Updated: November 30, 2015
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
Atypical Femur Fracture
DXA

Additional relevant MeSH terms:
Femoral Fractures
Fractures, Bone
Leg Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on February 08, 2016