Fact CheckerSign in

NCT04608630RecruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 4 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
450 (estimated)
First submitted
25 Oct 2020
Start date
15 Jul 2021
Primary completion date
28 Feb 2027
Lead sponsor
Australian and New Zealand Intensive Care Research Centre
Diseases
Osteoporosis
NCT number
NCT04608630

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 450
  • From 15 Jul 2021 to the primary completion date, 28 Feb 2027
  • 22 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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)

Other illness

  • Cancer related metastatic bone disease or multiple myeloma
  • Paget's disease
  • Obvious holes in teeth or broken teeth or dental or gum infection

Lab values

  • International Normalised Ratio \> 3.0 or Platelet count \< 30 10\^9/L

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (22)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Royal Adelaide Hospital
Coordinator of this site? Confirm its status
AdelaideAustraliaRecruiting
Sunshine Coast University Hospital
Coordinator of this site? Confirm its status
BirtinyaAustraliaRecruiting
The Wesley Hospital
Coordinator of this site? Confirm its status
BrisbaneAustraliaRecruiting
Barwon Health - University Hospital Geelong
Coordinator of this site? Confirm its status
GeelongAustraliaRecruiting
Alfred Health
Coordinator of this site? Confirm its status
MelbourneAustraliaCompleted
Austin Health
Coordinator of this site? Confirm its status
MelbourneAustraliaCompleted
Eastern Health - Box Hill Hospital
Coordinator of this site? Confirm its status
MelbourneAustraliaRecruiting
Royal Melbourne Hospital
Coordinator of this site? Confirm its status
MelbourneAustraliaRecruiting
Western Health - Footscray Hospital
Coordinator of this site? Confirm its status
MelbourneAustraliaRecruiting
St Vincents Hospital Melbourne
Coordinator of this site? Confirm its status
MelbourneAustraliaRecruiting
Western Health - Sunshine Hospital
Coordinator of this site? Confirm its status
MelbourneAustraliaRecruiting
St John of God Hospital Murdoch
Coordinator of this site? Confirm its status
PerthAustraliaRecruiting
Fiona Stanley Hospital
Coordinator of this site? Confirm its status
PerthAustraliaRecruiting
St John of God Hospital Subiaco
Coordinator of this site? Confirm its status
PerthAustraliaRecruiting
Gold Coast University Hospital
Coordinator of this site? Confirm its status
SouthportAustraliaRecruiting
Royal Prince Alfred Hospital
Coordinator of this site? Confirm its status
SydneyAustraliaRecruiting
Prince of Wales Hospital
Coordinator of this site? Confirm its status
SydneyAustraliaRecruiting
St. Vincent's Health Sydney
Coordinator of this site? Confirm its status
SydneyAustraliaRecruiting
Blacktown Hospital
Coordinator of this site? Confirm its status
SydneyAustraliaRecruiting
Wollongong Hospital, Illawarra Shoalhaven Health
Coordinator of this site? Confirm its status
WollongongAustraliaRecruiting
Auckland City Hospital
Coordinator of this site? Confirm its status
AucklandNew ZealandRecruiting
Wellington Regional Hospital
Coordinator of this site? Confirm its status
WellingtonNew ZealandRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.