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PRevEnting FracturEs in REnal Disease - 1

NCT05096195 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-05-31

No results posted yet for this study

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.

Conditions

  • Kidney Diseases
  • Dialysis; Complications
  • Fragility Fracture
  • Chronic Kidney Disease-Mineral and Bone Disorder

Interventions

DRUG

Denosumab 60 mg/ml

Details described in intervention arm/group description section.

OTHER

Calcium and vitamin D prophylaxis

Details described in intervention arm/group description section.

DIAGNOSTIC_TEST

Monitoring of post-injection calcium and phosphate

Details described in intervention arm/group description section.

Sponsors & Collaborators

  • ICES

    collaborator INDUSTRY

  • Academic Medical Organization of Southwestern Ontario

    collaborator OTHER

  • Western University

    collaborator OTHER

  • The Kidney Foundation of Canada

    collaborator OTHER

  • Western University, Canada

    lead OTHER

Principal Investigators

  • Kristin K Clemens, MD, MSc · St. Joseph's Health Care London

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-11
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05096195 on ClinicalTrials.gov