PRevEnting FracturEs in Renal Disease - 1

• Status: Not yet recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

Summary

PREFERRED-1 is a pilot study for a large randomized, pragmatic, open-label, comparative-effectiveness trial. The pilot will enroll at least 60 patients across 6 different hemodialysis centres in Ontario, Canada. Patients on outpatient maintenance hemodialysis at high risk of fragility fracture will be randomized 1:1 to denosumab vs. no-denosumab (i.e. usual care).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Western University, Canada
• Collaborators: Academic Medical Organization of Southwestern Ontario; ICES; The Kidney Foundation of Canada; Western University
• Treatments: Calcium; Calcium, Dietary; Denosumab; Vitamin D

Criteria

Inclusion Criteria:

1. Treating nephrologist/nurse practitioner in the dialysis unit approves patient(s) enrollment.

2. Age ≥40 years

3. Access to provincial drug benefits (i.e. Ontario Drug Benefits Program, Ontario Disability Support Program)

4. Baseline albumin-corrected serum calcium ≥2.15 mmol/L, parathyroid hormone (PTH) 15-60 pmol/L, alkaline phosphatase (ALP) 80-120U/L.

5. High risk of fragility fracture defined by fracture history or World Health Organization's Fracture Risk Assessment Tool

Exclusion Criteria:

1. Expected to recover kidney function, stop hemodialysis and pursue palliative care, start IV bisphosphonates (i.e. pamidronate or zoledronic acid) for cancer, receive a kidney transplant, or transfer to home or peritoneal dialysis within 12 months of randomization (as assessed by a health professional).

2. Use of cinacalcet (Sensipar) within the last 3 months.

3. Use another osteoporosis medication including:

Alendronate (Fosavance or Fosamax) Risedronate (Actonel or Actonel DR) Raloxifene (Evista) Oral or conjugated estrogen Topical, oral or injectable testosterone (Androgel, Testim, Fortesta, Androderm, testosterone enanthate and testosterone cypionate Teriparatide (Forteo) Romosozumab (Evenity) Calcitonin (Calcimar)

4. History of femur fracture attributed to osteoporosis medication use (i.e midshaft femoral fracture or atypical femoral fracture)

5. Major dental surgery planned within the next 12 months (e.g. root canal).

6. Known allergy or intolerance to denosumab.