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NCT Number: NCT04110795

Personalizing Osteoporosis Care: Clinical & Genetic Risk Factors for AFFs

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Atypical Femur Fracture

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Adachi Medical Centre, Hamilton, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

No intervention

Other

No Intervention

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2027
Study completion
2028
First posted
Oct 1, 2019
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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