Bone Loss Prevention With Zoledronic Acid or Denosumab in Critically Ill Adults (BoneZone)
Critical Illness, Osteoporosis
About this trial
This is an interventional treatment trial for Critical Illness focused on measuring Intensive Care Unit, Osteoporosis, Bone densitometry, Zoledronic acid, Denosumab
Eligibility Criteria
Inclusion Criteria:
- Female
- Age ≥ 50 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, teriparatide within previous 2 years, or menopausal hormone therapy within previous 12-months or denosumab within previous 6 months)
- Current fragility fracture of hip, spine, femur or forearm
- Weight >120 kg or unable to undertake Bone Mineral Density for any reason
- International Normalised Ratio > 3.0 or Platelet count < 30 10^9/L
Sites / Locations
- John Hunter Hospital
- St Vincent's Health SydneyRecruiting
- Royal North Shore HospitalRecruiting
- Blacktown Hospital
- Royal Prince Alfred HospitalRecruiting
- Wollongong Hospital, Illawarra Shoalhaven HealthRecruiting
- Sunshine Coast University Hospital
- The Wesley HospitalRecruiting
- Gold Coast University HospitalRecruiting
- Royal Adelaide HospitalRecruiting
- Launceston General HospitalRecruiting
- Barwon Health, University Hospital GeelongRecruiting
- Alfred HealthRecruiting
- Western Health - Footscray HospitalRecruiting
- Western Health - Sunshine HospitalRecruiting
- Royal Melbourne HospitalRecruiting
- St Vincents Hospital MelbourneRecruiting
- Austin HealthRecruiting
- Eastern Health - Box Hill HospitalRecruiting
- St John of God Hospital SubiacoRecruiting
- Fiona Stanley HospitalRecruiting
- St John of God Hospital MurdochRecruiting
- Auckland City HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Placebo Comparator
Denosumab
Zoledronic acid
Placebo
Patients allocated to the Denosumab arm will receive Denosumab 60mg in 1ml, administered via subcutaneous injection on Study Days 1 and 180.
Patients allocated to the Zoledronic acid arm will receive Zoledronic acid 5mg in 100ml 0.9% Sodium Chloride, administered via intravenous infusion over at least 15 minutes on Study Day 1.
Patients allocated to the placebo arm will receive 0.9% Sodium Chloride 1ml administered via subcutaneous injection on Days 1 and Day 180 and 0.9% Sodium Chloride 100ml administered via intravenous infusion over at least 15 minutes on Day 1.