NCT05096195Active, not recruitingPhase 4
PRevEnting FracturEs in REnal Disease - 1
Denosumab for the Prevention of Fragility Fractures in Hemodialysis: a Pilot Study for an Innovative, Randomized-controlled Trial, Embedded in Routine Care
Source: ClinicalTrials.gov · Last updated 31 May 2025
Brief summary (registry, in English)
PREFERRED-1 is a pilot study designed to determine the feasibility of a large randomized, pragmatic, open-label, comparative-effectiveness trial of denosumab for the prevention of fragility fractures in people receiving hemodialysis. The pilot study will enroll at least 60 patients from across at least 6 different hemodialysis centres in Ontario, Canada. Patients on outpatient maintenance hemodialysis at high risk of fragility fracture, will be randomized 1:1 to a denosumab care pathway vs. usual care. Primary outcomes include recruitment feasibility and treatment adherence. Secondary outcomes include safety and participant satisfaction with our protocol and processes.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 21 Sept 2021
- Start date
- 11 Jun 2022
- Primary completion date
- Dec 2025
- Lead sponsor
- Western University, Canada
- Diseases
- Chronic kidney disease
- NCT number
- NCT05096195
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 60
- From 11 Jun 2022 to the primary completion date, Dec 2025
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other illness
- History of femur fracture attributed to osteoporosis medication use (i.e. midshaft femoral fracture or atypical femoral fracture)
- Known allergy or intolerance to denosumab.
Other
- 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
Who the study is looking for
- 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
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kingston Health Sciences Centre Coordinator of this site? Confirm its status | Kingston | Canada | Unknown status |
| London Health Sciences Centre Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| The Ottawa Hospital Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| Huron Perth Healthcare Alliance - Stratford General Hospital Coordinator of this site? Confirm its status | Stratford | Canada | Unknown status |
| St. Michaels Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Woodstock Hospital Coordinator of this site? Confirm its status | Woodstock | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.