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Bone Loss Prevention With Zoledronic Acid or Denosumab in Critically Ill Adults

Study acronym: BoneZone
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Study sites: 23 to 22v12
  2. Study sites: 24 to 23v11
  3. Interventions: Denosumab 60 MG/ML (Drug), Sodium Chloride 0.9% Injection (Drug), Sodium Chloride 0.9% Intravenous (Drug), Zoledronic Acid 5Mg/Bag 100Ml… to Denosumab 60 MG/ML (Drug), Sodium Chloride 0.9% Injection (Drug), Sodium Chloride 0.9% or 5% Dextrose Intravenous (Drug), Zoledronic Acid…
    • Secondary endpoints: details revised at 1 of 8 entries
    • Site details revised at 1 of 24 sites
    v10
  4. Primary completion date: Dec 2023 to Feb 28, 2027
    • Study sites: 23 to 24
    • Study completion date: May 2025 to Feb 28, 2027
    v9
  5. Study sites: 17 to 23v8
Show 6 earlier versionsHide 6 earlier versions
  1. Study sites: 12 to 17
    • Eligibility criteria expanded, about 14 words
    • Study description expanded, about 97 words
    • Study title revised
    v7
  2. Study sites: 9 to 12
    • Eligibility criteria expanded, about 4 words
    v6
  3. Study sites: 8 to 9v5
  4. Study sites: 3 to 8v4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 2021 to Jul 15, 2021
    • Site details revised at 3 of 3 sites
    v3
  6. Primary endpoint revised
    • Eligibility criteria expanded, about 23 words
    • Secondary endpoints revised (8)
    • Study description expanded, about 11 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The Bone Zone trial is a prospective, multi-centre, double-blind, phase II, randomised controlled trial evaluating the effect of denosumab or zoledronic acid compared to placebo on change in bone mineral density over one year in women aged 50 years or older and men aged 70 years or older requiring admission to intensive care for greater than 24 hours. 450 women aged 50 years or older and men aged 70 years or older, admitted to intensive care for greater than 24 hours will be recruited into the study from participating study centres.
Trial Details
NCT Number NCT04608630
Lead Sponsor Australian and New Zealand Intensive Care Research Centre
Conditions
(from sponsor)		 Critical Illness, Osteoporosis
Related terms Critical Illness, Osteoporosis
Enrollment 450 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov