drugset / Trial / NCT04608630
Bone Loss Prevention With Zoledronic Acid or Denosumab in Critically Ill Adults
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Denosumab | Monoclonal antibody | 60 mg | Subcutaneous |
| Comparator | Zoledronic acid | Other / unclassified | 5 mg | Intravenous |