Personalizing Osteoporosis Care: Clinical & Genetic Risk Factors for AFFs

Atypical Femur Fracture Clinical Trial

Official title:

Personalizing Osteoporosis Care: Clinical & Genetic Risk Factors for Atypical Femur Fractures

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04110795
• Other study ID #: 18-6171
• Status: Active, not recruiting
• Start date: June 25, 2018
• Est. completion date: December 31, 2027

Study information

• Verified date: May 2023
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1200
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Atypical Femur Fracture
• Femoral Fractures
• Osteoporosis

Intervention

Other:
• No Intervention
No Intervention

Locations

Country	Name	City	State
Canada	Adachi Medical Centre	Hamilton	Ontario
Canada	Bone Research & Education Centre	Oakville	Ontario
Canada	University Health Network, TGH	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Associations between AFF and clinical Risk Factor	Associations between AFFs and clinical risk factors	baseline
Primary	Associations between AFF and common genetic variants	Associations of common genetic variants among patients with AFFs	baseline
Primary	Validation of top genetic variants	To validate the top few genetic variants identified in the above case-control study in a separate cohort of 100 cases and 100 controls.	baseline