ANZICS CTG Endorsed Study

Bone Zone

Bone Loss Prevention with Zoledronic Acid or Denosumab in Critically Ill Women – A Randomised Controlled Trial

Study Description

Intensive care patients face health issues that extend beyond their critical illness. A specific area where critical illness may adversely affect the well-being of survivors is increased bone turnover during critical illness, and accelerated bone loss in subsequent years. Critical illness bone loss begins in the first days of critical illness, occurs in both men and women, and is greatest in post-menopausal women.

Bone antiresorptive therapies are effective at reducing bone loss and decreasing fracture risk in non-critically ill populations. There is currently insufficient high-quality evidence to support routine, early use of antiresorptive medications in critically ill adults. The Bone Zone trial is a phase III multi-centre randomised placebo-controlled trial of 450 women aged 50-years or greater and men aged 70 years or greater requiring ICU for greater than 2 calendar days, to determine the efficacy of denosumab or zoledronic acid on prevention of BMD loss in the year after critical illness.

Management Committee

A/Prof Neil Orford, A/Prof Priya Nair, Prof Jacqueline Center, Prof Carol Hodgson, Prof Mark Kotowicz, Prof Bala Venkatesh, Ms Allison Bone, Prof Rinaldo Bellomo, Dr Edward Litton, Dr Paul Young, Ms Claire Reynolds, Mr Tony Trapani, Jemma Trickey

Administering Institution

ANZIC -RC, Monash University

Sample Size

450 patients

Funding 

Medical Research Future Fund – Rare Cancers, Rare Diseases and Unmet Need

Reference

CTG2021-05, NCT04608630

Contact

Alison Bone (email)