drugset / Trial / NCT04608630

Bone Loss Prevention With Zoledronic Acid or Denosumab in Critically Ill Adults

NCT04608630

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2021-07-15
Primary completion
2027-02-28
Completion
2027-02-28

Drugs

EvaluationDrugModalityDoseRoute
Comparator Denosumab Monoclonal antibody 60 mg Subcutaneous
Comparator Zoledronic acid Other / unclassified 5 mg Intravenous

Indications