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PRevEnting FracturEs in REnal Disease - 1

Study acronym: PREFERRED-1
StatusActive, Not Recruiting
PhasePhase 4
Started
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.

Record History

See every version on ClinicalTrials.gov ↗

  1. Secondary endpoints: 9 to 8
    • Study description expanded, about 15 words
    • Study title expanded, about 1 word
    v9
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 6 of 6 sites
    v8
  3. Study sites: 4 to 6
    • Eligibility criteria shortened, about 7 words
    • Study description expanded, about 9 words
    v7
  4. Study sites: 1 to 4
    • Study description expanded, about 67 words
    • Study title shortened, about 1 word
    v6
  5. Eligibility criteria shortened, about 21 wordsv5
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  1. Eligibility criteria shortened, about 45 wordsv4
  2. Trial status: Not Yet Recruiting to Recruitingv3 Show 6 more changesShow less
    • Primary and study completion dates: Dec 2023 to Dec 2025
    • Study sites: 0 to 1
    • Start date changed from estimate of May 2022 to Jun 11, 2022
    • Interventions: Calcium and vitamin D prophylaxis (Other), Denosumab 60 mg/ml [Prolia] (Drug), Monitoring of post-injection calcium and phosphate… to Calcium and vitamin D prophylaxis (Other), Denosumab 60 mg/ml (Drug), Monitoring of post-injection calcium and phosphate (Diagnostic Test)
    • Eligibility criteria expanded, about 55 words
    • Study description expanded, about 372 words
  3. Primary completion date: Apr 2023 to Dec 2023v2 Show 5 more changesShow less
    • Start date: Jan 2022 to May 2022
    • Study completion date: Sep 2023 to Dec 2023
    • Interventions: Calcium and vitamin D prophylaxis (Other), Denosumab 60 mg/ml [Prolia] (Drug), Monitoring of calcium and phosphate (Diagnostic Test) to Calcium and vitamin D prophylaxis (Other), Denosumab 60 mg/ml [Prolia] (Drug), Monitoring of post-injection calcium and phosphate…
    • Eligibility criteria expanded, about 118 words
    • Secondary endpoints: details revised at 5 of 9 entries
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
(from sponsor)		 Kidney Diseases, Dialysis; Complications, Fragility Fracture, Chronic Kidney Disease-Mineral and Bone Disorder
Related terms Chronic Kidney Disease-Mineral and Bone Disorder, Fractures, Bone, Kidney Diseases
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov