Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2025-12-24 @ 2:06 PM
NCT ID:
NCT05096195
Eligibility Criteria:
Inclusion criteria:
* 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
Exclusion criteria:
* 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).
* 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)
* Of childbearing status
* 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 6 months (e.g. root canal).
* Known allergy or intolerance to denosumab.
* Expected to receive a parathyroidectomy for hyperparathyroidism in the next 12 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT05096195
Study Brief:
Protocol Section:
NCT05096195