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NCT Number: NCT01747291

Atypical Fracture Cohort Study

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.

Recruiting

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Key information

Age range

20 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

McMaster University, Hamilton, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  1. Examine risk factors and predictors for AFFs

    Time frame: baseline

    This exploratory study will examine risk factors and predictors for AFFs

Other outcomes

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

    Time frame: baseline and every 6-12 months

    This exploratory study will examine how AFFs affect quality of life, functional recovery and health outcomes over time.

Study contacts

Contact information is provided by the study sponsor or research team.

Judite Scher, MSc

CONTACT

[email protected]

416-340-4841

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

Atypical Femur Fracture Ontario Cohort Registry

Important dates

Study start
2009
Primary completion
2027
Study completion
2028
First posted
Dec 11, 2012
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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