Bone Loss Prevention With Zoledronic Acid or Denosumab in Critically Ill Adults
Recruiting · NCT04608630 · Interventional (participants receive a specific treatment) · Lead sponsor: Australian and New Zealand Intensive Care Research Centre
View the official record on ClinicalTrials.gov →Interventions studied
Denosumab 60 MG/MLSodium Chloride 0.9% InjectionSodium Chloride 0.9% or 5% Dextrose IntravenousZoledronic Acid 5Mg/Bag 100Ml Inj
What this trial is about
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.
Who can take part
Age range
50 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
22 locations listed.
- Auckland City Hospital - Auckland, New Zealand
- Wellington Regional Hospital - Wellington, New Zealand
- St Vincent's Health Sydney - Sydney, New South Wales, Australia
- Prince of Wales Hospital - Sydney, New South Wales, Australia
- Blacktown Hospital - Sydney, New South Wales, Australia
- Royal Prince Alfred Hospital - Sydney, New South Wales, Australia
- Wollongong Hospital, Illawarra Shoalhaven Health - Wollongong, New South Wales, Australia
- Sunshine Coast University Hospital - Birtinya, Queensland, Australia
- The Wesley Hospital - Brisbane, Queensland, Australia
- Gold Coast University Hospital - Southport, Queensland, Australia
- Royal Adelaide Hospital - Adelaide, South Australia, Australia
- Barwon Health, University Hospital Geelong - Geelong, Victoria, Australia
- Alfred Health - Melbourne, Victoria, Australia
- Western Health - Footscray Hospital - Melbourne, Victoria, Australia
- Western Health - Sunshine Hospital - Melbourne, Victoria, Australia
- Royal Melbourne Hospital - Melbourne, Victoria, Australia
- St Vincents Hospital Melbourne - Melbourne, Victoria, Australia
- Austin Health - Melbourne, Victoria, Australia
- Eastern Health - Box Hill Hospital - Melbourne, Victoria, Australia
- St John of God Hospital Subiaco - Perth, Western Australia, Australia
- Fiona Stanley Hospital - Perth, Western Australia, Australia
- St John of God Hospital Murdoch - Perth, Western Australia, Australia