| Trial ID: | L0990 |
| Source ID: | NCT05096195
|
| Associated Drug: |
Denosumab 60 Mg/Ml
|
| Title: |
PRevEnting FracturEs in REnal Disease 1
|
| Acronym: |
PREFERRED-1
|
| Status: |
ACTIVE_NOT_RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Kidney Diseases|Dialysis; Complications|Fragility Fracture|Chronic Kidney Disease-Mineral and Bone Disorder
|
| Interventions: |
DRUG: Denosumab 60 mg/ml|OTHER: Calcium and vitamin D prophylaxis|DIAGNOSTIC_TEST: Monitoring of post-injection calcium and phosphate
|
| Outcome Measures: |
Primary: Recruitment rate, Number or N (%) participants recruited within 4 months of trial initiation at each centre, 4 months|Adherence to study intervention, N(%) participants randomized to the intervention receive \>90% of their scheduled denosumab injections, 15 months|Adherence to usual care, N(%) participants randomized to usual care who do not receive a prescription for denosumab, 15 months | Secondary: Treatment-related hypocalcemia as assessed by CTCAE v4.0, N(%) with Grade 2: albumin-adjusted serum calcium \< 2.00 to 1.75 mmol/L; Grade 3 albumin-adjusted serum calcium \< 1.75 to 1.5 mmol/L; Grade 4: albumin-adjusted serum calcium \< 1.5 mmol/L at 1, 2, 3 and 4 weeks following denosumab injection., 4 weeks following denosumab injection|Mean change in serum calcium, Mean (standard deviation), change in corrected serum calcium between baseline and last followup, 4 weeks following denosumab injection|Median change in serum calcium, Median (interquartile range, IQR), change in corrected serum calcium between baseline and last followup, 4 weeks following denosumab injection|Mean change in parathyroid hormone, Mean (standard deviation) change in parathyroid hormone between baseline and last followup, 4 weeks following denosumab injection|Median change in parathyroid hormone, Median (IQR) change in parathyroid hormone between baseline and last followup, 4 weeks following denosumab injection|Fragility fracture, N (%) with hospital encounter for fragility fracture of the hip, vertebrae, humerus, wrist, or pelvis at 15 months, 15 months|Participant satisfaction with E-Platform, Mean (SD) Likert scale score (1=not satisfied, 5=very satisfied), 15 months|Participant satisfaction with E-Consent, Mean (SD) Likert scale score (1=not satisfied, 5=very satisfied), 15 months|Participant satisfaction with intervention, Mean (SD) Likert scale score in those randomized to intervention (1=not satisfied, 5=very satisfied), 15 months
|
| Sponsor/Collaborators: |
Sponsor: Western University, Canada | Collaborators: ICES|Academic Medical Organization of Southwestern Ontario|Western University|The Kidney Foundation of Canada
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
60
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
|
| Start Date: |
2022-06-11
|
| Completion Date: |
2025-12
|
| Results First Posted: |
|
| Last Update Posted: |
2024-09-19
|
| Locations: |
Kingston Health Sciences Centre, Kingston, Ontario, K7L 2V7, Canada|London Health Sciences Centre, London, Ontario, Canada|The Ottawa Hospital, Ottawa, Ontario, K1Y 4E9, Canada|Huron Perth Healthcare Alliance - Stratford General Hospital, Stratford, Ontario, N5A 2Y6, Canada|St. Michaels Hospital, Toronto, Ontario, M5B 1W8, Canada|Woodstock Hospital, Woodstock, Ontario, N4V 0A4, Canada
|
| URL: |
https://clinicaltrials.gov/show/NCT05096195
|
