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Clinical Trials/NCT01747291
NCT01747291
Recruiting
Not Applicable

Atypical Femur Fracture Ontario Cohort Registry

University Health Network, Toronto3 sites in 1 country300 target enrollmentJune 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Atypical Femur Fracture
Sponsor
University Health Network, Toronto
Enrollment
300
Locations
3
Primary Endpoint
Prospectively identify and diagnose atypical fracture patients in Ontario
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2009
End Date
December 2026
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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.

Outcomes

Primary Outcomes

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 Outcomes

  • Examine risk factors and predictors for AFFs(baseline)

Study Sites (3)

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