Testing Two Bone-Protecting Drugs in Critically Ill Older Adults
Tests denosumab or zoledronic acid against placebo to protect bone in intensive care patients.
Plain-language title generated from the registry record
Registry title: Bone Loss Prevention With Zoledronic Acid or Denosumab in Critically Ill Adults
Key facts
- Where
- Adelaide, Birtinya, Brisbane, Geelong, Melbourne, Perth, Southport, Sydney, and Wollongong, AustraliaSee the 20 sites
- Phase
- Phase 2
Where in Australia
- Royal Adelaide HospitalAdelaide, AustraliaTaking people
- Sunshine Coast University HospitalBirtinya, AustraliaTaking people
- The Wesley HospitalBrisbane, AustraliaTaking people
- Barwon Health - University Hospital GeelongGeelong, AustraliaTaking people
- Eastern Health - Box Hill HospitalMelbourne, AustraliaTaking people
- Royal Melbourne HospitalMelbourne, AustraliaTaking people
- St Vincents Hospital MelbourneMelbourne, AustraliaTaking people
- Western Health - Footscray HospitalMelbourne, AustraliaTaking people
- Western Health - Sunshine HospitalMelbourne, AustraliaTaking people
- Alfred HealthMelbourne, AustraliaNo longer taking part
- Austin HealthMelbourne, AustraliaNo longer taking part
- Fiona Stanley HospitalPerth, AustraliaTaking people
- St John of God Hospital MurdochPerth, AustraliaTaking people
- St John of God Hospital SubiacoPerth, AustraliaTaking people
- Gold Coast University HospitalSouthport, AustraliaTaking people
- Blacktown HospitalSydney, AustraliaTaking people
- Prince of Wales HospitalSydney, AustraliaTaking people
- Royal Prince Alfred HospitalSydney, AustraliaTaking people
- St. Vincent's Health SydneySydney, AustraliaTaking people
- Wollongong Hospital, Illawarra Shoalhaven HealthWollongong, AustraliaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Australian and New Zealand Intensive Care Research Centre
- Trial code
- NCT04608630
- Record updated
- 4 March 2026
- Original description
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.Read full original descriptionShow less
Bone Loss Prevention With Zoledronic Acid or Denosumab in Critically Ill Adults - A Randomised Controlled Trial
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.
Inclusion: 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: Current estimated Glomerular Filtration Rate <30ml/min or receiving renal replacement therapy; 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); Cancer related metastatic bone disease or multiple myeloma; Paget's disease; Obvious holes in teeth or broken teeth or dental or gum infection; International Normalised Ratio > 3.0 or Platelet count < 30 10\^9/L; Pregnancy; Known contraindication to denosumab or zoledronic acid; Known untreated hypoparathyroidism; 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.