Study of atypical femur fractures in osteoporosis patients
Atypical Femur Fracture Ontario Cohort Registry
This study is trying to learn more about unusual thigh bone fractures in people with osteoporosis who have been taking a certain medication for a long time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 20 Years to 100 Years |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Locations | 3 sites (Hamilton, Ontario and 2 other locations) |
| Trial ID | NCT01747291 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather detailed clinical data on patients who have experienced atypical femur fractures (AFFs) associated with osteoporosis, particularly those who have been on long-term bisphosphonate therapy. By establishing a network of specialists across southern Ontario, the study seeks to collect meaningful information from a larger cohort of patients to better understand the causes and characteristics of these debilitating fractures. The study will include patients over the age of 20 who meet specific diagnostic criteria for AFFs or similar low-trauma fractures. The findings could provide insights into the relationship between bisphosphonate use and the occurrence of AFFs.
Who should consider this trial
Good fit: Ideal candidates for this study are patients over the age of 20 who have experienced an atypical femur fracture or a similar low-trauma fracture.
Not a fit: Patients with high trauma fractures or those with fractures due to metastatic disease or other metabolic bone diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of atypical femur fractures in osteoporosis patients.
How similar studies have performed: While there have been case reports and small studies on atypical femur fractures, this study aims to provide more comprehensive data, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hamilton, Ontario and 2 other locations
- McMaster University — Hamilton, Ontario, Canada (Enrolling_by_invitation)
- University Health Network — Toronto, Ontario, Canada (Recruiting)
- St Michael's Hospital — Toronto, Ontario, Canada (Enrolling_by_invitation)
Study contacts
- Principal investigator: Angela m Cheung, MD, PhD — University Health Network, Toronto
- Study coordinator: Judite Scher, MSc
- Email: jscher@uhnresearch.ca
- Phone: 416-340-4841
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.