NCT04608630View on ClinicalTrials.gov

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

PHASE2RecruitingINTERVENTIONAL
Enrollment

450

Participants

Timeline

Start Date

July 15, 2021

Primary Completion Date

February 28, 2027

Study Completion Date

February 28, 2027

Conditions
Critical IllnessOsteoporosis
Interventions
DRUG

Denosumab 60 MG/ML

Patients allocated to the Denosumab arm will receive Denosumab 60mg in 1ml, administered via subcutaneous injection on Study Days 1 and 180.

DRUG

Zoledronic Acid 5Mg/Bag 100Ml Inj

Patients allocated to the Zoledronic acid arm will receive Zoledronic acid 5mg in 100ml 0.9% Sodium Chloride or 5% Dextrose, administered via intravenous infusion over at least 15 minutes on Study Day 1.

DRUG

Sodium Chloride 0.9% or 5% Dextrose Intravenous

Patients allocated to the placebo arm and Denosumab arm will receive 0.9% Sodium Chloride or 5% Dextrose 100ml administered via intravenous infusion over at least 15 minutes on Day 1.

DRUG

Sodium Chloride 0.9% Injection

Patients allocated to the placebo arm and Zoledronic acid arm will receive 0.9% Sodium Chloride 1ml administered via subcutaneous injection on Days 1 and Day 180

Trial Locations (23)

1023

RECRUITING

Auckland City Hospital, Auckland

2010

RECRUITING

St Vincent's Health Sydney, Sydney

2031

RECRUITING

Prince of Wales Hospital, Sydney

2148

RECRUITING

Blacktown Hospital, Sydney

2305

RECRUITING

John Hunter Hospital, Newcastle

2525

RECRUITING

Wollongong Hospital, Illawarra Shoalhaven Health, Wollongong

3004

COMPLETED

Alfred Health, Melbourne

3011

RECRUITING

Western Health - Footscray Hospital, Melbourne

3021

RECRUITING

Western Health - Sunshine Hospital, Melbourne

3052

RECRUITING

Royal Melbourne Hospital, Melbourne

3065

RECRUITING

St Vincents Hospital Melbourne, Melbourne

3084

COMPLETED

Austin Health, Melbourne

3128

RECRUITING

Eastern Health - Box Hill Hospital, Melbourne

3220

RECRUITING

Barwon Health, University Hospital Geelong, Geelong

4066

RECRUITING

The Wesley Hospital, Brisbane

4215

RECRUITING

Gold Coast University Hospital, Southport

4575

RECRUITING

Sunshine Coast University Hospital, Birtinya

5000

RECRUITING

Royal Adelaide Hospital, Adelaide

6008

RECRUITING

St John of God Hospital Subiaco, Perth

6021

RECRUITING

Wellington Regional Hospital, Wellington

6150

RECRUITING

Fiona Stanley Hospital, Perth

RECRUITING

St John of God Hospital Murdoch, Perth

Unknown

RECRUITING

Royal Prince Alfred Hospital, Sydney

All Listed Sponsors
lead

Australian and New Zealand Intensive Care Research Centre

OTHER