Atypical Fracture Cohort Study

NCT01747291 | Recruiting

• 1 other identifier: 09-0532
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 3

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.

Conditions

Atypical Femur Fracture; Atypical Subtrochanteric Fracture; Osteoporosis With AFf

Outcome Measures

Primary Outcomes (1)

• Prospectively identify and diagnose atypical fracture patients in Ontario

  The objective of this exploratory study is to identify and diagnose AFF patients

  baseline

Secondary Outcomes (1)

• Examine risk factors and predictors for AFFs

  baseline

Other Outcomes (1)

• Examine how AFFs affect quality of life, functional recovery and health outcomes.

  baseline and every 6-12 months

Study Arms (1)

Atypical femur fracture cohort

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (3)

McMaster University

Hamilton, Ontario, Canada

ENROLLING BY INVITATION

University Health Network

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

St Michael's Hospital

Toronto, Ontario, Canada

ENROLLING BY INVITATION

Study Officials

• Angela m Cheung, MD, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Judite Scher, MSc

CONTACT

416-340-4841; jscher@uhnresearch.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2012
• First Posted: December 11, 2012
• Study Start: June 1, 2009
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 23, 2023

Record last verified: 2023-05

Locations

CA (3)