Atypical Fracture Cohort Study (AFF Cohort)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by University Health Network, Toronto
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01747291
First received: December 7, 2012
Last updated: July 5, 2013
Last verified: July 2013
  Purpose

Osteoporosis is a disease characterized by increased bone fragility and deteriorating bone micro-architecture. The main consequence of osteoporosis is low-trauma fractures, most often of the hip, spine and wrist. Recently, another type of low-trauma fracture, atypical femur fractures (AFFs), have received much attention. Little is known of the cause of these debilitating fractures; however, they have been associated with long term bisphosphonate use. What we currently know about AFFs is based on case reports or small case series, or studies using administrative databases or secondary analyses of bisphosphonate trials. While these reports provide some preliminary information on the relationship between long term bisphosphonate exposure and AFFs, detailed clinical data are absent. As we have established a network of specialists across southern Ontario our group is in a position to collect meaningful information on a larger group of patients who have experienced these debilitating fractures into a centralized AFF registry.


Condition
Atypical Femur Fracture
Atypical Subtrochanteric Fracture
Osteoporosis With AFf

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Atypical Femur Fracture Ontario Cohort Registry

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Prospectively identify and diagnose atypical fracture patients in Ontario [ Time Frame: baseline ] [ Designated as safety issue: No ]
    The objective of this exploratory study is to identify and diagnose AFF patients


Secondary Outcome Measures:
  • Examine risk factors and predictors for AFFs [ Time Frame: baseline ] [ Designated as safety issue: No ]
    This exploratory study will examine risk factors and predictors for AFFs


Other Outcome Measures:
  • Examine how AFFs affect quality of life, functional recovery and health outcomes. [ Time Frame: baseline and every 6-12 months ] [ Designated as safety issue: No ]
    This exploratory study will examine how AFFs affect quality of life, functional recovery and health outcomes over time.


Estimated Enrollment: 300
Study Start Date: June 2009
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Atypical femur fracture cohort

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

primary or tertiary care clinic patients who have experienced an atypical fracture at any point in the past will be eligible for this observational study. Low trauma fractures are defined as fractures sustained with minimal force, such as a fall from standing height.

Criteria

Inclusion Criteria:

  • Patients over the age of 20;
  • Patients who have experienced an incomplete AFF that satisfies the diagnostic criteria as set forth by the American Society of Bone and mineral Research (ASBMR) International Task Force on AFFs or a low (or no) trauma fracture that mimics the features described above at other sites.

Exclusion Criteria:

  • Peri-prosthetic fractures;
  • High trauma fractures;
  • Pathological fractures secondary to metastases or metabolic bone diseases other than osteoporosis.
  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: NCT01747291

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

Locations
Canada, Ontario
McMaster University Enrolling by invitation
Hamilton, Ontario, Canada
University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact    416-340-4843    Osteoporosis@uhn.ca   
Principal Investigator: Angela M Cheung, MD PhD         
Sub-Investigator: Lianne E Tile, MD Med         
Sub-Investigator: Rowena Ridout, MD         
Sub-Investigator: Savannah Cardew, MD         
Sub-Investigator: Robert Bleakney, MD         
Sub-Investigator: Christian Veillette, MD         
Sub-Investigator: Moira Kapral, MD         
St Michael's Hospital Enrolling by invitation
Toronto, Ontario, Canada
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Angela m Cheung, MD, PhD University Health Network, Toronto
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01747291     History of Changes
Other Study ID Numbers: 09-0532
Study First Received: December 7, 2012
Last Updated: July 5, 2013
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Fractures, Bone
Osteoporosis
Femoral Fractures
Hip Fractures
Wounds and Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Leg Injuries
Hip Injuries

ClinicalTrials.gov processed this record on September 30, 2014