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Monoclonal Antibodies

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

Phase 4
Recruiting
Led By Kristin K Clemens, MD, MSc
Research Sponsored by Western University, Canada
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Access to denosumab through provincial drug benefits (i.e. evidence of receiving outpatient prescription medications through the Ontario Drug Benefits Program, Ontario Disability Support Program)
Age ≥40 years
Must not have
Current use of an osteoporosis medication including: Denosumab, Bisphosphonates, Alendronate (Fosavance or Fosamax), Risedronate (Actonel or Actonel DR), Zoledronic acid (Aclasta) or Pamidronate, Raloxifene (Evista), Oral or conjugated estrogen, Topical, oral or injectable testosterone (Androgel, Testim, Fortesta, Androderm, testosterone enanthate and testosterone cypionate), Teriperatide (Forteo), Romosozumab (Evenity), Calcitonin (Calcimar), Of childbearing status, History of femur fracture attributed to osteoporosis medication use (i.e. midshaft femoral fracture or atypical femoral fracture), Major dental surgery planned within the next 6 months (e.g. root canal), Known allergy or intolerance to denosumab, Expected to receive a parathyroidectomy for hyperparathyroidism in the next 12 months
Current use of cinacalcet (Sensipar)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 months
Awards & highlights

Summary

This trialwill compare the effectiveness of denosumab vs. usual care in reducing fractures in patients on hemodialysis in Ontario, Canada.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Denosumab may cause low calcium levels in the blood, infections, skin issues like eczema or rashes, joint pain, muscle pain, nausea. It might also lead to more serious effects such as unusual thigh bone fractures or jawbone problems especially after dental procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can get denosumab through my provincial drug benefits.
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I am 40 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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You are currently taking certain medications for osteoporosis, have certain planned dental surgeries, or have specific allergies or intolerances.
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I am currently taking cinacalcet (Sensipar).
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I am expected to start IV treatment with drugs like pamidronate or zoledronic acid.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adherence to study intervention
Adherence to usual care
Recruitment rate
Secondary study objectives
Fragility fracture
Mean change in parathyroid hormone
Mean change in serum calcium
+6 more

Trial Design

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.

Find a Location

Who is running the clinical trial?

ICESUNKNOWN
4 Previous Clinical Trials
529,329 Total Patients Enrolled
Western UniversityOTHER
29 Previous Clinical Trials
128,671 Total Patients Enrolled
Western University, CanadaLead Sponsor
248 Previous Clinical Trials
53,316 Total Patients Enrolled

Media Library

Denosumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05096195 — Phase 4
Fragility Fractures Research Study Groups: Usual care, Intervention
Fragility Fractures Clinical Trial 2023: Denosumab Highlights & Side Effects. Trial Name: NCT05096195 — Phase 4
Denosumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05096195 — Phase 4
~20 spots leftby Dec 2025
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