Bone Loss Prevention With Zoledronic Acid or Denosumab in Critically Ill Adults
Bone Loss Prevention With Zoledronic Acid or Denosumab in Critically Ill Adults - A Randomised Controlled Trial
Australian and New Zealand Intensive Care Research Centre
450 participants
Jul 15, 2021
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- 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 Criteria11
- 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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Interventions
Patients allocated to the Denosumab arm will receive Denosumab 60mg in 1ml, administered via subcutaneous injection on Study Days 1 and 180.
Patients allocated to the Zoledronic acid arm will receive Zoledronic acid 5mg in 100ml 0.9% Sodium Chloride or 5% Dextrose, administered via intravenous infusion over at least 15 minutes on Study Day 1.
Patients allocated to the placebo arm and Denosumab arm will receive 0.9% Sodium Chloride or 5% Dextrose 100ml administered via intravenous infusion over at least 15 minutes on Day 1.
Patients allocated to the placebo arm and Zoledronic acid arm will receive 0.9% Sodium Chloride 1ml administered via subcutaneous injection on Days 1 and Day 180
Locations(22)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04608630