BONE-ZONE Trial
Bone Loss prevention with Zoledronic Acid or Denosumab in Critically Ill Adults – A Randomised Controlled Trial
A Phase II Multicentre Randomised Controlled Trial
Aim: Our primary objective is to compare the effect of subcutaneous denosumab or intravenous zoledronic acid 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.
Rationale: 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. One year after critical illness, 80% of women aged 50 years or greater are classified as osteoporotic or osteopaenic, compared to 71% of the approximately 3.7 million Australian women aged 50 years or greater. This population is most likely to suffer the major consequence of accelerated bone loss, fragility fracture, and the associated morbidity, loss of quality of life, and economic cost.
In the BONE-ZONE Trial we will compare the efficacy of denosumab or zoledronic acid compared to placebo on the effect of bone mineral density loss in the year after critical illness.
Study Progress: Participant recruitment commenced in August 2021. A target of 450 women aged 50 years or greater and men aged 70 years or greater will be enrolled at sites in Australia and New Zealand.
Trial Registration: ClinicalTrials.gov NCT04608630
