RecruitingPhase 2NCT04608630

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

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

Sponsor

Australian and New Zealand Intensive Care Research Centre

Enrollment

450 participants

Start Date

Jul 15, 2021

Study Type

INTERVENTIONAL

Conditions

Osteoporosis Critical Illness

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.

Eligibility

Min Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Denosumab 60 MG/ML, a drug called Sodium Chloride 0.9% Injection, and others for people with critical illness and osteoporosis. The study is currently recruiting participants at 22 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDenosumab 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.

DRUGZoledronic 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.

DRUGSodium 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.

DRUGSodium 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