PRevEnting FracturEs in REnal Disease - 1

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.

Timeline

Start

2022-06-11

Primary completion

2025-12

Completion

2025-12

Publications

• Clemens KK, Cowan A, Dixon S, Naylor K, Weir MA, Thain J, Khan T, Silver S, Molnar AO, Sultan N, Holden RM, Hiremath S, Wald R, Kitchlu A, Arnold J, Field B, Garg AX. PRevEnting FracturEs in REnal Disease-1 (PREFERRED-1): protocol for a pilot study of a pragmatic, randomised controlled trial of denosumab for the prevention of fragility fractures in haemodialysis. BMJ Open. 2025 Sep 10;15(9):e097195. doi: 10.1136/bmjopen-2024-097195.

Drugs

Indications