Denosumab for Broken Bones in Dialysis Patients
(PREFERRED-1 Trial)

Recruiting in Palo Alto (17 mi)

+5 other locations

Overseen byKristin K Clemens, MD, MSc

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Western University, Canada

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?PREFERRED-1 is a pilot study for a large randomized, pragmatic, open-label, comparative-effectiveness trial. The pilot study will enroll at least 60 patients from 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

Eligibility Criteria

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

I am at high risk for breaking bones easily due to conditions like osteoporosis.

Your blood tests show high levels of calcium, PTH, or alkaline phosphatase.

I can get denosumab through my provincial drug benefits.

+2 more

Exclusion Criteria

You are currently taking certain medications for osteoporosis, have certain planned dental surgeries, or have specific allergies or intolerances.

I am currently taking cinacalcet (Sensipar).

I am expected to start IV treatment with drugs like pamidronate or zoledronic acid.

+1 more

Participant Groups

The PREFERRED-1 study tests whether Denosumab can prevent fractures better than usual care in patients with kidney disease on dialysis. At least 60 participants from various centers will either follow a Denosumab care pathway including calcium and vitamin D supplements plus monitoring or receive the standard fracture prevention treatments.

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment3 Interventions

60 mg of denosumab (Prolia) will be administered every 6 months over a 15 - month period. Monitoring of serum calcium and phosphate will occur and bloodwork will be drawn for 7 weeks following each denosumab injection. Correction of vitamin D deficiency (if required), the adjustment of calcium dialysate and the provision of intravenous (IV) or oral (po) calcitriol/calcidiol will be administered as needed following each denosumab injection as described in the Beside Protocol. Once the study monitoring period is over, serum calcium monitoring and management will occur as per routine care in the dialysis centre. All intervention activities will occur during regularly scheduled hemodyalisis sessions.

Group II: Usual careActive Control1 Intervention

Usual care participants will continue to receive the typical standard of care in their dialysis unit which includes their routine dialysis monitoring and bloodwork. They will not receive denosumab, calcium and vitamin prophylaxis. There will be no extra monitoring or bloodwork.

Denosumab is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Prolia for:

Osteoporosis in postmenopausal women
Bone loss associated with hormone ablation therapy for prostate cancer
Bone loss associated with hormone ablation therapy for breast cancer

🇺🇸 Approved in United States as Prolia for:

Treatment of postmenopausal women with osteoporosis at high risk for fracture
Treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer
Treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer

🇨🇦 Approved in Canada as Prolia for:

Treatment of osteoporosis in postmenopausal women at high risk for fracture
Treatment to increase bone mass in men with osteoporosis at high risk for fracture

🇯🇵 Approved in Japan as Prolia for: