Atypical Fracture Cohort Study

Recruiting

• Conditions: Atypical Femur Fracture; Osteoporosis With AFf; Atypical Subtrochanteric Fracture

• Registration Number: NCT01747291
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2012-12-07
• Study First Submitted QC: 2012-12-07
• Study First Posted: 2012-12-11
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-19
• Last Update Posted: 2023-05-23
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prospectively identify and diagnose atypical fracture patients in Ontario	baseline	The objective of this exploratory study is to identify and diagnose AFF patients

Secondary Outcome Measures

Name	Time	Method
Examine risk factors and predictors for AFFs	baseline	This exploratory study will examine risk factors and predictors for AFFs

Trial Locations

Locations (3)

St Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

McMaster University; 🇨🇦 Hamilton, Ontario, Canada

University Health Network; 🇨🇦 Toronto, Ontario, Canada