Bone Loss Prevention With Zoledronic Acid or Denosumab in Critically Ill Adults
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age50+
SponsorAustralian and New Zealand Intensive Care Research Centre
About this 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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Cancer related metastatic bone disease or multiple myeloma
Paget's disease
Pregnancy
Current estimated Glomerular Filtration Rate <30ml/min or receiving renal replacement therapy
Trial design
Treatments tested in this trial
- Denosumab 60 MG/ML
- Zoledronic Acid 5Mg/Bag 100Ml Inj
- Sodium Chloride 0.9% or 5% Dextrose Intravenous
- Sodium Chloride 0.9% Injection
Treatment groups
450 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov