NCT04110795

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
29mo left

Started Jun 2018

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Jun 2018Dec 2028

Study Start

First participant enrolled

June 25, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 1, 2019

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

May 11, 2026

Status Verified

May 1, 2026

Enrollment Period

9.5 years

First QC Date

September 25, 2019

Last Update Submit

May 6, 2026

Conditions

Atypical Femur Fracture

Outcome Measures

Primary Outcomes (3)

  • Associations between AFF and clinical Risk Factor

    Associations between AFFs and clinical risk factors

    baseline

  • Associations between AFF and common genetic variants

    Associations of common genetic variants among patients with AFFs

    baseline

  • 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

Study Arms (2)

Cases

Atypical Femur fracture cases

Other: No Intervention

Control

matched to AFF cases by race, age, length of ART use

Other: No Intervention

Interventions

No InterventionOTHER

No Intervention

CasesControl

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community based population in Ontario and British Columbia Canada

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Adachi Medical Centre

Hamilton, Ontario, L8N 1Y2, Canada

Location

Bone Research & Education Centre

Oakville, Ontario, L6M 1M1, Canada

Location

University Health Network, TGH

Toronto, Ontario, M5G 2C4, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood samples serum samples fingernail samples

Study Officials

  • Angela M Cheung, MD PhD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2019

First Posted

October 1, 2019

Study Start

June 25, 2018

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

May 11, 2026

Record last verified: 2026-05

Locations

CA(3)