Effect of Zoledronic Acid or Denosumab on Bone Loss in Critically Ill Adults – A Randomised Controlled Trial
- Conditions
- Critical illnessOsteoporosisMusculoskeletal - Osteoporosis
- Registration Number
- ACTRN12621000085875
- Lead Sponsor
- Monash University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 450
Female aged 50 years or older or male aged 70 years or older
Has been in ICU for 2 or more calendar days and is not expected to be discharged from ICU on the second day
Has required ICU level support (i.e. intravenous vasoactive drugs, or invasive mechanical ventilation, or non-invasive ventilation or high flow nasal oxygen at FiO2>0.4 and/or gas flows >40L/m) for a minimum cumulative duration of 6-hours
Expected to survive the current hospital admission
Cancer related metastatic bone disease or multiple myeloma
Paget's disease
Pregnancy
Current eGFR <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 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
Weight >120 kg or unable to undertake BMD for any reason
INR>3 or Platelet count <30,000.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method