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Monoclonal Antibodies

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

Phase 4

Waitlist Available

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

No Placebo-Only Group

Drug Has Already Been Approved

Pivotal Trial

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 months

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.

0 / 5Eligibility criteria met