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

NCT04608630 · tracked via the Priya Life Science Australia tracker

Sponsor

Australian and New Zealand Intensive Care Research Centre

Phase

Phase 2

Started

2021-07-15

Last updated

2026-03-04

Condition(s) studied

Critical IllnessOsteoporosis

Investigational drug(s) / intervention(s)

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

Denosumab 60 MG/ML: Patients allocated to the Denosumab arm will receive Denosumab 60mg in 1ml, administered via subcutaneous injection on Study Days 1 and 180.

Zoledronic Acid 5Mg/Bag 100Ml Inj: 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.

Sodium Chloride 0.9% or 5% Dextrose Intravenous: 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.

Sodium Chloride 0.9% Injection: 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

Study 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

Sex

ALL

Min age

50 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Annualised change in femoral neck bone mineral density for the year after Intensive Care discharge — 12 months
Change in femoral neck bone mineral density T-score between baseline and 12 months

Trial sites (22)

Facility	City	Region	Status
St Vincent's Health Sydney	Sydney	New South Wales	Recruiting
Prince of Wales Hospital	Sydney	New South Wales	Recruiting
Blacktown Hospital	Sydney	New South Wales	Recruiting
Royal Prince Alfred Hospital	Sydney	New South Wales	Recruiting
Wollongong Hospital, Illawarra Shoalhaven Health	Wollongong	New South Wales	Recruiting
Sunshine Coast University Hospital	Birtinya	Queensland	Recruiting
The Wesley Hospital	Brisbane	Queensland	Recruiting
Gold Coast University Hospital	Southport	Queensland	Recruiting
Royal Adelaide Hospital	Adelaide	South Australia	Recruiting
Barwon Health, University Hospital Geelong	Geelong	Victoria	Recruiting
Alfred Health	Melbourne	Victoria	Completed
Western Health - Footscray Hospital	Melbourne	Victoria	Recruiting
Western Health - Sunshine Hospital	Melbourne	Victoria	Recruiting
Royal Melbourne Hospital	Melbourne	Victoria	Recruiting
St Vincents Hospital Melbourne	Melbourne	Victoria	Recruiting
Austin Health	Melbourne	Victoria	Completed
Eastern Health - Box Hill Hospital	Melbourne	Victoria	Recruiting
St John of God Hospital Subiaco	Perth	Western Australia	Recruiting
Fiona Stanley Hospital	Perth	Western Australia	Recruiting
St John of God Hospital Murdoch	Perth	Western Australia	Recruiting
Auckland City Hospital	Auckland	New Zealand	Recruiting
Wellington Regional Hospital	Wellington	New Zealand	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04608630 on ClinicalTrials.gov ↗ ← All trials in Australia