PRevEnting FracturEs in REnal Disease - 1

Korábbi kezelés

• Current use of an osteoporosis medication including:
  • Denosumab
  • Bisphosphonates
  • Alendronate (Fosavance or Fosamax)
  • Risedronate (Actonel or Actonel DR)
  • Zoledronic acid (Aclasta) or Pamidronate
  • Raloxifene (Evista)
  • Oral or conjugated estrogen
  • Topical, oral or injectable testosterone (Androgel, Testim, Fortesta, Androderm, testosterone enanthate and testosterone cypionate)
  • Teriperatide (Forteo)
  • Romosozumab (Evenity)
  • Calcitonin (Calcimar)
• Major dental surgery planned within the next 6 months (e.g. root canal).

Más betegség

• History of femur fracture attributed to osteoporosis medication use (i.e. midshaft femoral fracture or atypical femoral fracture)
• Known allergy or intolerance to denosumab.

Egyéb

• Expected to recover kidney function, stop hemodialysis, pursue palliative care, or transfer to home or peritoneal dialysis within 12 months (as assessed by a health professional).
• Expected to start IV bisphosphonates (i.e. pamidronate or zoledronic acid).
• Current use of cinacalcet (Sensipar).
• Of childbearing status
• Expected to receive a parathyroidectomy for hyperparathyroidism in the next 12 months

• Treating nephrologist/nurse practitioner in the dialysis unit deems that a prescription for study drug (denosumab) will be safe/reasonable in the potential participant.
• Age ≥40 years
• 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)
• Baseline albumin-corrected serum calcium ≥2.15 mmol/L, PTH ≥15 pmol/L (or 2-9x the upper limit of normal for the local laboratory).
• High risk of fragility fracture defined by: a) ≥15% 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),OR b) a prior history of hip or vertebral fracture (where the later could have been asymptomatic and only observed radiographically), OR c) two or more fragility fractures of the humerus, wrist, and/or pelvis (e.g. 2 humerus fractures, humerus and wrist fracture).43