Bone Loss Prevention With Zoledronic Acid or Denosumab in Critically Ill Adults
Recruiting
Phase 2
Interventional Study
Critical Illness
Osteoporosis
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 50 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 450 (estimated)
- Sponsor
- Australian and New Zealand Intensive Care Research Centre · Other
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About This Trial
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…
Trial Locations
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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 drug…
Contacts