Clinical Trial

PRevEnting FracturEs in REnal Disease - 1

Study acronym: PREFERRED-1
Active, Not Recruiting Phase 4
View on ClinicalTrials.gov →
Record status
This record was last updated May 31, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
Summary
PREFERRED-1 is a pilot study designed to determine the feasibility of a large randomized, pragmatic, open-label, comparative-effectiveness trial of denosumab for the prevention of fragility fractures in people receiving hemodialysis. The pilot study will enroll at least 60 patients from across at least 6 different hemodialysis centres in Ontario, Canada. Patients on outpatient maintenance hemodialysis at high risk of fragility fracture, will be randomized 1:1 to a denosumab care pathway vs. usual care. Primary outcomes include recruitment feasibility and treatment adherence. Secondary outcomes include safety and participant satisfaction with our protocol and processes.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2021-10-14; most recent amendment 2025-05-26.
Status change: Recruiting → Active, Not Recruiting 2024-09-09
Status change: Not Yet Recruiting → Recruiting 2023-01-13
Trial Details
NCT Number NCT05096195
Lead Sponsor Western University, Canada
Collaborators: ICES, Academic Medical Organization of Southwestern Ontario, Western University, The Kidney Foundation of Canada
Conditions Kidney Diseases, Dialysis; Complications, Fragility Fracture, Chronic Kidney Disease-Mineral and Bone Disorder
Enrollment 60 participants
Start Date 2022-06-11
Primary Completion 2025-12 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2025-05-31