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

RECRUITING

NCT04608630

PHASE2

Sponsor: Australian and New Zealand Intensive Care Research Centre

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.

Official title: Bone Loss Prevention With Zoledronic Acid or Denosumab in Critically Ill Adults - A Randomised Controlled Trial

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

450

Start Date

2021-07-15

Completion Date

2027-02-28

Last Updated

2026-03-04

Healthy Volunteers

No

Conditions

Critical Illness Osteoporosis

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

Locations (22)

St Vincent's Health Sydney

Sydney, New South Wales, Australia

Prince of Wales Hospital

Sydney, New South Wales, Australia

Blacktown Hospital

Sydney, New South Wales, Australia

Royal Prince Alfred Hospital

Sydney, New South Wales, Australia

Wollongong Hospital, Illawarra Shoalhaven Health

Wollongong, New South Wales, Australia

Sunshine Coast University Hospital

Birtinya, Queensland, Australia

The Wesley Hospital

Brisbane, Queensland, Australia

Gold Coast University Hospital

Southport, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Barwon Health, University Hospital Geelong

Geelong, Victoria, Australia

Alfred Health