Atypical Fracture Cohort Study

Atypical Femur Fracture Clinical Trial

Official title:

Atypical Femur Fracture Ontario Cohort Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01747291
• Other study ID #: 09-0532
• Status: Recruiting
• Start date: June 2009
• Est. completion date: December 2026

Study information

• Verified date: May 2023
• Source: University Health Network, Toronto
• Contact: Judite Scher, MSc
• Phone: 416-340-4841
• Email: jscher[@]uhnresearch.ca
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atypical Femur Fracture
• Atypical Subtrochanteric Fracture
• Femoral Fractures
• Fractures, Bone
• Hip Fractures
• Osteoporosis
• Osteoporosis With AFf

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario
Canada	St Michael's Hospital	Toronto	Ontario
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Examine how AFFs affect quality of life, functional recovery and health outcomes.	This exploratory study will examine how AFFs affect quality of life, functional recovery and health outcomes over time.	baseline and every 6-12 months
Primary	Prospectively identify and diagnose atypical fracture patients in Ontario	The objective of this exploratory study is to identify and diagnose AFF patients	baseline
Secondary	Examine risk factors and predictors for AFFs	This exploratory study will examine risk factors and predictors for AFFs	baseline