PRevEnting FracturEs in REnal Disease 1 (PREFERRED-1)
Kidney Diseases, Dialysis; Complications, Fragility Fracture
About this trial
This is an interventional other trial for Kidney Diseases focused on measuring Pilot Study, Fracture, denosumab, hemodialysis, registries
Eligibility Criteria
Inclusions:
- Treating nephrologist/nurse practitioner in the hemodialysis centre deems that a prescription for denosumab will be safe/reasonable in the potential participant;
- Age ≥40 years (as the World Health Organization's Fracture Risk Assessment Tool can be used to risk stratify patients 40 years and older);
- Access to long-term provincial drug benefits through the Ontario Drug Benefits Program or Ontario Disability Support Program (to ensure that patients have coverage for denosumab both during the trial, and after its completion);
- Baseline albumin-corrected serum calcium ≥2.15 mmol/L, PTH 15-60 pmol/L, and if available total alkaline phosphatase 80-120U/L;
High risk of fragility fracture defined by any of a), b) or c):
- >20% 10-year risk of major osteoporotic fracture or >3% 10-year risk of hip fracture (using the World Health Organization's Fracture Risk Assessment Tool which is validated in hemodialysis), 41,42
- history of hip or vertebral fracture (where the latter could have been asymptomatic and only observed radiographically),
- two or more fragility fractures of the humerus, wrist, and/or pelvis (e.g., 2 humerus fractures, humerus and wrist fracture).43
Exclusions:
- Patient is expected to recover kidney function, stop hemodialysis, pursue palliative care, receive a transplant, or transfer to home or peritoneal dialysis within 12 months of randomization (as assessed by healthcare staff in the patient's hemodialysis centre);
- Patient expected to start intravenous (IV) bisphosphonates (i.e., pamidronate or zoledronic acid) for cancer within 12 months of randomization;
- Patient expected to receive a parathyroidectomy for hyperparathyroidism within 12 months of randomization;
- Current use of cinacalcet;
Current use of another osteoporosis medication including :
Alendronate Risedronate Zoledronic acid Raloxifene Oral or conjugated estrogen Topical, oral or injectable testosterone Teriparatide Romozosumab Calcitonin;
- 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 12 months (e.g., root canal or dental extraction)
- Known allergy or intolerance to denosumab.
Sites / Locations
- Kingston Health Sciences Centre
- London Health Sciences CentreRecruiting
- The Ottawa Hospital
- St. Michaels Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Intervention
Usual care
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.
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.