Who is eligible for clinical trial NCT05096195?

Participants must meet the protocol's inclusion criteria for Kidney Diseases. The stated age range is 40 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT05096195 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-05-26

PRevEnting FracturEs in REnal Disease - 1 (NCT05096195)

Denosumab for the Prevention of Fragility Fractures in Hemodialysis: a Pilot Study for an Innovative, Randomized-controlled Trial, Embedded in Routine Care

🔵 Active, Not Recruiting Phase4 💊 Investigational Drug / Biologic Sponsor: Western University, Canada

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (21 items).

Location: Kingston Health Sciences Centre — Kingston, Ontario

Age range: 40 Years

🧪 Interventions in This Study

Denosumab 60 mg/ml (DRUG)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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

Usually NOT eligible if any of the following apply:

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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (6 Sites)

Kingston Health Sciences Centre — Kingston, Ontario
London Health Sciences Centre — London, Ontario
The Ottawa Hospital — Ottawa, Ontario
Huron Perth Healthcare Alliance - Stratford General Hospital — Stratford, Ontario
St. Michaels Hospital — Toronto, Ontario
Woodstock Hospital — Woodstock, Ontario

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

Check the checklist above to see if you may qualify.
Review the official NIH record below to find the coordinating site.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗