Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2025-12-27 @ 10:04 PM
Study NCT ID:
NCT05096195
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-31
First Post:
2021-09-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PRevEnting FracturEs in REnal Disease - 1
Sponsor:
Western University, Canada
Organization:
Study Overview
Official Title:
Denosumab for the Prevention of Fragility Fractures in Hemodialysis: a Pilot Study for an Innovative, Randomized-controlled Trial, Embedded in Routine Care
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREFERRED-1
Brief Summary:
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.
Primary outcomes include recruitment feasibility and treatment adherence. Secondary outcomes include safety and participant satisfaction with our protocol and processes.
Detailed Description:
Despite a fragility fracture risk that is \>5-fold higher than those without chronic kidney disease (CKD), there is a lack of evidence on how to prevent fracture in patients on hemodialysis. Medications known to prevent fragility fracture in other populations, are either contraindicated in dialysis, or associated with severe side effects.
Denosumab (Prolia) is one of the only Health Canada approved medications for fragility fracture prevention across the CKD stages. While small clinical trials inclusive of hemodialysis patients have noted that denosumab improves bone mineral density and reduces bone turnover, whether this treatment effectively and safely prevents fragility fracture in this population still remains unclear.
Instead of conducting an expensive traditional RCT where results might fail to apply to the "real-world", the study will embed a trial of denosumab into routine care. The intervention will be delivered by healthcare staff. Participants will be closely followed at the dialysis unit where the participant has dialysis treatments. Baseline characteristics and outcomes will be captured using routine care data including administrative health data.
The overarching aim of the PREFERRED Program is to determine whether a denosumab care pathway vs. usual care (i.e., non-use of denosumab) alters the risk of fragility fracture in patients receiving in-centre hemodialysis. PREFERRED-1 is a pilot study that will inform the feasibility of conducting a large-scale, efficiently run, randomized-controlled trial in Canada to test whether denosumab reduces the risk of fragility fracture in patients receiving hemodialysis. The goal is to understand if individual level recruitment is feasible and timely, and if the intervention is acceptable to patients.
The objectives of PREFERRED-1 are to:
1. Examine whether streamlined methods of enrollment can facilitate recruitment across multiple centres in a timely way;
2. Demonstrate good adherence with the trial protocol and examine whether well-received by participants;
3. Ensure that participants are adherent with treatment assignment (i.e., intervention group to denosumab, minimal cross-over to denosumab in usual group);
4. Confirm there are no 'signals' of unmanageable harm (i.e. hypocalcemia) that would prevent testing of our intervention on a larger scale.
PREFERRED-1 will be deemed a success if:
* The study can randomly allocate at least 60 patients from at least 6 hemodialysis centres within 6-months of the trial being activated at each centre.
* Demonstrate that patients randomly allocated to denosumab receive over 90% of the scheduled injections at 0, 6 and 12 months
* Patients randomly allocated to no denosumab (i.e. usual care) do not receive a prescription for denosumab.
This "high-risk" innovative pragmatically approached trial focused on better treatments for fracture prevention in those with kidney disease will
1. inform transformational change in the care of real-world patients;
2. produce essential knowledge to safely prevent fracture in patients with kidney disease, and the associated costs to the healthcare system;
3. foster the conduct of collaborative, multidisciplinary care for those with complex kidney disease.
Denosumab (Prolia) is one of the only Health Canada approved medications for fragility fracture prevention across the CKD stages. While small clinical trials inclusive of hemodialysis patients have noted that denosumab improves bone mineral density and reduces bone turnover, whether this treatment effectively and safely prevents fragility fracture in this population still remains unclear.
Instead of conducting an expensive traditional RCT where results might fail to apply to the "real-world", the study will embed a trial of denosumab into routine care. The intervention will be delivered by healthcare staff. Participants will be closely followed at the dialysis unit where the participant has dialysis treatments. Baseline characteristics and outcomes will be captured using routine care data including administrative health data.
The overarching aim of the PREFERRED Program is to determine whether a denosumab care pathway vs. usual care (i.e., non-use of denosumab) alters the risk of fragility fracture in patients receiving in-centre hemodialysis. PREFERRED-1 is a pilot study that will inform the feasibility of conducting a large-scale, efficiently run, randomized-controlled trial in Canada to test whether denosumab reduces the risk of fragility fracture in patients receiving hemodialysis. The goal is to understand if individual level recruitment is feasible and timely, and if the intervention is acceptable to patients.
The objectives of PREFERRED-1 are to:
1. Examine whether streamlined methods of enrollment can facilitate recruitment across multiple centres in a timely way;
2. Demonstrate good adherence with the trial protocol and examine whether well-received by participants;
3. Ensure that participants are adherent with treatment assignment (i.e., intervention group to denosumab, minimal cross-over to denosumab in usual group);
4. Confirm there are no 'signals' of unmanageable harm (i.e. hypocalcemia) that would prevent testing of our intervention on a larger scale.
PREFERRED-1 will be deemed a success if:
* The study can randomly allocate at least 60 patients from at least 6 hemodialysis centres within 6-months of the trial being activated at each centre.
* Demonstrate that patients randomly allocated to denosumab receive over 90% of the scheduled injections at 0, 6 and 12 months
* Patients randomly allocated to no denosumab (i.e. usual care) do not receive a prescription for denosumab.
This "high-risk" innovative pragmatically approached trial focused on better treatments for fracture prevention in those with kidney disease will
1. inform transformational change in the care of real-world patients;
2. produce essential knowledge to safely prevent fracture in patients with kidney disease, and the associated costs to the healthcare system;
3. foster the conduct of collaborative, multidisciplinary care for those with complex kidney disease.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: