Atypical Fracture Cohort Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Atypical Femur Fracture, Atypical Subtrochanteric Fracture, Osteoporosis With AFf. Basic parameters: 20 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Atypical Femur Fracture Ontario Cohort Registry
Overview
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.
Primary outcome measures
- Prospectively identify and diagnose atypical fracture patients in Ontario [Time frame: baseline]
Secondary outcome measures (1)
- Examine risk factors and predictors for AFFs [Time frame: baseline]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Canada · 3 centers
- McMaster University — Hamilton
- University Health Network — Toronto
- St Michael's Hospital — Toronto
Identifiers
NCT: NCT01747291 · 09-0532