Clinical trial NCT01747291: Atypical Fracture Cohort Study
Official title: Atypical Femur Fracture Ontario Cohort Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atypical Femur Fracture
Atypical Subtrochanteric Fracture
Osteoporosis With AFf
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2012-12-11
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Prospectively identify and diagnose atypical fracture patients in Ontario
timeFrame: baseline
Secondary outcomes:
measure: Examine risk factors and predictors for AFFs
timeFrame: baseline
Other outcomes:
measure: Examine how AFFs affect quality of life, functional recovery and health outcomes.
timeFrame: baseline and every 6-12 months
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
city: Toronto
country: Canada
facility: St Michael's Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Angela m Cheung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: