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

• Status: Recruiting
• Trial end date: 2025-05-01
• Target enrollment: 0
• Participant gender: Female

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 requiring admission to intensive care for greater than 24 hours.

450 women aged 50 years or older, admitted to intensive care for greater than 24 hours will be recruited into the study from participating study centres.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Australian and New Zealand Intensive Care Research Centre
• Treatments: Denosumab; Zoledronic Acid

Criteria

Inclusion Criteria:

• Female

• Age ≥ 50 years

• Has been in the Intensive Care Unit for 2 or more calendar days and is not expected to be discharged from the Intensive Care Unit today

• Has required Intensive Care Unit level support (i.e. intravenous vasoactive drugs, or invasive mechanical ventilation, or non-invasive ventilation or high flow nasal oxygen at Fraction inspired Oxygen ≥0.4 and/or gas flows ≥40L/m) for a minimum cumulative duration of 6 hours

• Expected to survive the current hospital admission

Exclusion Criteria:

• Active malignancy

• Metabolic bone disease

• Pregnancy

• Current estimated Glomerular Filtration Rate <30ml/min or receiving renal replacement therapy

• Known contraindication to denosumab or zoledronic acid

• Increased risk of osteonecrosis (poor dentition or oral hygiene, dental infection)

• Known hypoparathyroidism

• Current treatment with anti-fracture agent (bisphosphonate, strontium, teriparatide within previous 2 years, or menopausal hormone therapy within previous 12-months or denosumab within previous 6 months)

• Current indication for anti-fracture therapy (known Bone Mineral Density T-score <-2.5 and/or known fragility fracture)

• Weight >120 kg or unable to undertake Bone Mineral Density for any reason

• International Normalised Ratio > 3.0 or Platelet count < 30 10^9/L