Recruiting

Observational Study

Sponsor:

University Health Network, Toronto

Code:

NCT01747291

Conditions

Atypical Femur Fracture

Atypical Subtrochanteric Fracture

Osteoporosis With AFf

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT01747291

Start date

Jun, 2009

Status verified date

May, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

Atypical femur fracture cohort

Primary outcome measure

  • Prospectively identify and diagnose atypical fracture patients in Ontario [ Time Frame: baseline ]

Central Contacts and Locations

Central contacts

Locations

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contacts

Principal Investigator:

Angela M Cheung, MD PhD

More Information

Sponsor

University Health Network, Toronto

Last update posted

May 11, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-05-11.