Atypical Fracture Cohort Study

NCT ID: NCT01747291

Last Updated: 2023-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Atypical Femur Fracture Atypical Subtrochanteric Fracture Osteoporosis With AFf

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Atypical femur fracture cohort

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Angela m Cheung, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

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McMaster University

Hamilton, Ontario, Canada

Site Status ENROLLING_BY_INVITATION

University Health Network

Toronto, Ontario, Canada

Site Status RECRUITING

St Michael's Hospital

Toronto, Ontario, Canada

Site Status ENROLLING_BY_INVITATION

Countries

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Canada

Central Contacts

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Judite Scher, MSc

Role: CONTACT

416-340-4841

Facility Contacts

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Role: primary

416-340-4843

Other Identifiers

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09-0532

Identifier Type: -

Identifier Source: org_study_id

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