Bone Loss Prevention With Zoledronic Acid or Denosumab in Critically Ill Adults
Trial Parameters
Brief Summary
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
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 teripar