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

RecruitingPhase 2Ages 50 Years - anyAllAustralian and New Zealand Intensive Care Researc…
NCT04608630 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Female age ≥ 50 years or male age ≥ 70 years * Has been in the Intensive Care Unit for 2 or more calendar days and is not expected to be discharged from the Intensive Care Unit on the second day * Has required Intensive Care Unit level support (i.e. intravenous vasoactive drugs, or invasive mechanical ventilation, or non-invasive ventilation or high flow nasal oxygen at Fraction inspired Oxygen ≥0.4 and/or gas flows ≥40L/m) for a minimum cumulative duration of 6 hours * Expected to survive the current hospital admission Exclusion Criteria: * Cancer related metastatic bone disease or multiple myeloma * Paget's disease * Pregnancy * Current estimated Glomerular Filtration Rate \<30ml/min or receiving renal replacement therapy * Known contraindication to denosumab or zoledronic acid * Obvious holes in teeth or broken teeth or dental or gum infection * Known untreated hypoparathyroidism * Current treatment with anti-fracture agent (bisphosphonate, strontium or teriparatide within previous 2 years, or menopausal hormone therapy or romosozumab within previous 12-months or denosumab within previous 6 months) * Current fragility fracture of hip, spine, femur or forearm * Exceeds weight limit for BMD scan at site or unable to undertake Bone Mineral Density for any reason * International Normalised Ratio \> 3.0 or Platelet count \< 30 10\^9/L
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What it tests

  • Denosumab 60 MG/ML
  • Zoledronic Acid 5Mg/Bag 100Ml Inj
  • Sodium Chloride 0.9% or 5% Dextrose Intravenous
  • Sodium Chloride 0.9% Injection
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Where

22 sites
St Vincent's Health Sydney
Sydney, Australia
Prince of Wales Hospital
Sydney, Australia
Blacktown Hospital
Sydney, Australia
Royal Prince Alfred Hospital
Sydney, Australia
Wollongong Hospital, Illawarra Shoalhaven Health
Wollongong, Australia
Sunshine Coast University Hospital
Birtinya, Australia
The Wesley Hospital
Brisbane, Australia
Gold Coast University Hospital
Southport, Australia

…and 14 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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