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Personalizing Osteoporosis Care: Clinical & Genetic Risk Factors for AFFs

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ClinicalTrials.gov Identifier: NCT04110795
Recruitment Status : Recruiting
First Posted : October 1, 2019
Last Update Posted : September 30, 2020
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:
The overall objective of this project is to identify clinical and genetic risk factors for Atypical Femur Fractures (AFFs) in Anti-resorptive therapy (ART) users by conducting a case control study of 330 cases of AFFs and 660 controls without AFFs matched for age, sex, race and duration of ART.

Condition or disease Intervention/treatment
Atypical Femur Fracture Other: No Intervention

Detailed Description:
Antiresorptive therapy (ART) drugs are effective osteoporosis treatment and help decrease osteoporosis-related fractures. However, their long-term use has been associated with rare but serious atypical femur fractures (AFFs). Fear of these side effects has caused a substantial decline in the use of these effective drugs and rising fracture rates. The investigators propose to compare 330 cases of people with AFFs to 660 matched controls to explore similarities and differences in (1) clinical findings, such as type of ART and length of use, prior fracture, bone density, femur geometry, etc., and (2) genetic variants, and then (3) to validate the top few genetic variants to see if they are indeed present in an additional group of 100 AFF patients and not present in 100 control subjects. This study will determine clinical and genetic risk factors for these debilitating atypical fractures such that at-risk patients in the future can be treated differently to avoid them.

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Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Personalizing Osteoporosis Care: Clinical & Genetic Risk Factors for Atypical Femur Fractures
Actual Study Start Date : June 25, 2018
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Cases
Atypical Femur fracture cases
Other: No Intervention
No Intervention

Control
matched to AFF cases by race, age, length of ART use
Other: No Intervention
No Intervention




Primary Outcome Measures :
  1. Associations between AFF and clinical Risk Factor [ Time Frame: baseline ]
    Associations between AFFs and clinical risk factors

  2. Associations between AFF and common genetic variants [ Time Frame: baseline ]
    Associations of common genetic variants among patients with AFFs

  3. Validation of top genetic variants [ Time Frame: baseline ]
    To validate the top few genetic variants identified in the above case-control study in a separate cohort of 100 cases and 100 controls.


Biospecimen Retention:   Samples With DNA
whole blood samples serum samples fingernail samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Community based population in Ontario and British Columbia Canada
Criteria

Inclusion Criteria:

  • Cases: Have experienced a confirmed, documented Atypical femur fracture
  • Controls: currently on anti-resorptive therapy, matches AFF case by age, race and length of ART use

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04110795


Contacts
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Contact: Judy Scher, MSc 416-340-4841 Judy.Scher@uhnresearch.ca

Locations
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Canada, Ontario
Adachi Medical Centre Recruiting
Hamilton, Ontario, Canada, L8N 1Y2
Contact: Shannon Reitsma    905-529-0612      
Principal Investigator: JD Adachi, MD         
Bone Research & Education Centre Recruiting
Oakville, Ontario, Canada, L6M 1M1
Contact: Hajar Abu Alrob    905-844-5677    hajarabualrob@boneresearch.ca   
Principal Investigator: Aliya Khan, Md         
University Health Network, TGH Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Sameh Melk    416-340-4800 ext 5703    Sam.melk@uhnresearch.ca   
Principal Investigator: Angela MW Cheung, MD PhD         
Sub-Investigator: Lianne E Tile, MD, ME         
Sponsors and Collaborators
University Health Network, Toronto
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Angela M Cheung, MD PhD University Health Network, Toronto
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT04110795    
Other Study ID Numbers: AFF Control Study 18-6171
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: September 30, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoporosis
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Leg Injuries