Atypical Fracture Cohort Study

Atypical Femur Fracture Ontario Cohort Registry

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01747291

Enrollment

300

Registered

2012-12-11

Start date

2009-06-01

Completion date

2028-12-01

Last updated

2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atypical Femur Fracture, Atypical Subtrochanteric Fracture, Osteoporosis With AFf

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 100 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Examine risk factors and predictors for AFFs	baseline	This exploratory study will examine risk factors and predictors for AFFs

Countries

Canada

Contacts

CONTACTJudite Scher, MSc

jscher@uhnresearch.ca416-340-4841

PRINCIPAL_INVESTIGATORAngela m Cheung, MD, PhD

University Health Network, Toronto

Outcome results