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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 months
Awards & highlights
PREFERRED-1 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.Check my eligibility
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.See study design
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.
PREFERRED-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can get denosumab through my provincial drug benefits.
Select...
I am 40 years old or older.
PREFERRED-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adherence to study intervention
Adherence to usual care
Recruitment rate
Secondary outcome measures
Fragility fracture
Mean change in parathyroid hormone
Mean change in serum calcium
+6 morePREFERRED-1 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.
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Who is running the clinical trial?
ICESUNKNOWN
4 Previous Clinical Trials
529,329 Total Patients Enrolled
Western UniversityOTHER
26 Previous Clinical Trials
128,481 Total Patients Enrolled
Western University, CanadaLead Sponsor
239 Previous Clinical Trials
57,393 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility 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.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 can get denosumab through my provincial drug benefits.I am expected to start IV treatment with drugs like pamidronate or zoledronic acid.My doctor expects my kidney function to improve or change my dialysis method within a year.My kidney doctor or nurse thinks it's safe for me to take the study drug.I am 40 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Usual care
- Group 2: Intervention
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What diseases can be remedied with Intervention?
"Intervention can be utilized for treating skeletally mature individuals with bone-related issues and androgen levels."
Answered by AI
What potential risks should patients consider before opting for Intervention?
"With the conclusion of a Phase 4 trial, Intervention has been approved and our team at Power assigns it an indicative safety score of 3."
Answered by AI
Are there still opportunities for participation in this research study?
"Indications from clinicaltrials.gov suggest that recruitment for this trial is ongoing; it was initiated on June 11th 2022 and most recently updated January 13th 2023."
Answered by AI
Can you elaborate on any similar experiments that have employed Intervention?
"At the present time, there are 43 clinical trials researching Intervention. Of those studies, 12 have advanced to Phase 3. Primarily situated in Nedlands, Western Australia though dispersed across 507 locations worldwide; these experiments aim to understand Intervention's efficacy better."
Answered by AI
What is the aggregate figure of participants in this experiment?
"Affirmative, the particulars on clinicaltrials.gov demonstrate that this trial is still in need of participants. The research was initially posted June 11th 2022 and most recently revised January 13th 2023. 60 individuals are being sought from a single site to participate in the study."
Answered by AI
What impact is this research designed to have on the field?
"This 15-month trial has one primary goal: to measure the rate of patient recruitment. The secondary objectives involve determining participant satisfaction with intervention, e-consent, and the e-platform via a Likert scale (1=not satisfied; 5=very satisfied)."
Answered by AI
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