Atypical Fracture Cohort Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01747291
Recruitment Status : Recruiting
First Posted : December 11, 2012
Last Update Posted : November 29, 2016
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:
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 or disease
Atypical Femur Fracture Atypical Subtrochanteric Fracture Osteoporosis With AFf

Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Atypical Femur Fracture Ontario Cohort Registry
Study Start Date : June 2009
Estimated Primary Completion Date : December 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Atypical femur fracture cohort

Primary Outcome Measures :
  1. Prospectively identify and diagnose atypical fracture patients in Ontario [ Time Frame: baseline ]
    The objective of this exploratory study is to identify and diagnose AFF patients

Secondary Outcome Measures :
  1. Examine risk factors and predictors for AFFs [ Time Frame: baseline ]
    This exploratory study will examine risk factors and predictors for AFFs

Other Outcome Measures:
  1. Examine how AFFs affect quality of life, functional recovery and health outcomes. [ Time Frame: baseline and every 6-12 months ]
    This exploratory study will examine how AFFs affect quality of life, functional recovery and health outcomes over time.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01747291

Contact: Judite Scher, MSc 416-340-4841

Canada, Ontario
McMaster University Enrolling by invitation
Hamilton, Ontario, Canada
University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact    416-340-4843   
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
Principal Investigator: Angela m Cheung, MD, PhD University Health Network, Toronto

Responsible Party: University Health Network, Toronto Identifier: NCT01747291     History of Changes
Other Study ID Numbers: 09-0532
First Posted: December 11, 2012    Key Record Dates
Last Update Posted: November 29, 2016
Last Verified: November 2016

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