Denosumab for Broken Bones in Dialysis Patients
(PREFERRED-1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
If you are currently taking certain osteoporosis medications, including denosumab, bisphosphonates, or others listed in the trial's exclusion criteria, you will need to stop taking them to participate in this trial. The protocol does not specify a washout period, but you should discuss this with the trial team.
Is denosumab safe for dialysis patients?
How is the drug denosumab unique for treating broken bones in dialysis patients?
Denosumab is unique because it is a monoclonal antibody (a type of protein made in the lab) that targets RANKL, which is involved in bone breakdown, and it is administered as an injection every six months. Unlike other treatments, it has shown effectiveness in increasing bone mineral density in dialysis patients, but it also carries a risk of severe hypocalcemia (low calcium levels in the blood), requiring careful monitoring and supplementation with calcium and vitamin D.12367
Who Is on the Research Team?
Kristin K Clemens, MD, MSc
Principal Investigator
St. Joseph's Health Care London
Are You a Good Fit for This Trial?
This trial is for adults over 40 on outpatient maintenance hemodialysis with chronic kidney disease at high risk of bone fractures. They must have certain blood calcium, PTH, and ALP levels and be eligible for denosumab through Ontario's drug programs. Exclusions include current use of specific osteoporosis medications or treatments, planned major dental surgery, known allergy to denosumab, or expected changes in dialysis treatment within a year.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 60 mg of denosumab every 6 months over a 15-month period, with monitoring of serum calcium and phosphate, and administration of vitamin D and calcium as needed.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including monitoring of serum calcium and parathyroid hormone levels.
What Are the Treatments Tested in This Trial?
Interventions
- Denosumab
Denosumab is already approved in European Union, United States, Canada, Japan for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Western University, Canada
Lead Sponsor
ICES
Collaborator
Western University
Collaborator
ICES
Industry Sponsor
Academic Medical Organization of Southwestern Ontario
Collaborator
The Kidney Foundation of Canada
Collaborator