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

Launched by AUSTRALIAN AND NEW ZEALAND INTENSIVE CARE RESEARCH CENTRE · Oct 25, 2020

Keywords

ClinConnect Summary

The Bone Zone trial is studying how two medications, denosumab and zoledronic acid, can help prevent bone loss in critically ill adults. This trial is specifically looking at women aged 50 and older and men aged 70 and older who have been in the Intensive Care Unit (ICU) for more than 24 hours. The goal is to see if these treatments can improve bone health over the course of one year compared to a placebo, which is a treatment that looks like the real medication but has no active ingredients.

To participate in this trial, individuals must meet certain criteria, such as being a woman aged 50 or older or a man aged 70 or older, and having required significant medical support while in the ICU. Participants can expect to receive either one of the medications or a placebo and will be monitored for changes in their bone health. It's important to note that people with specific medical conditions, like certain types of cancer or severe kidney problems, are not eligible to join. This trial is currently recruiting participants from various medical centers, and it aims to help improve care for patients at risk of bone loss during critical illness.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Female age ≥ 50 years or male age ≥ 70 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 on the second day
• • 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:
• • Cancer related metastatic bone disease or multiple myeloma
• • Paget's disease
• • Pregnancy
• • Current estimated Glomerular Filtration Rate \<30ml/min or receiving renal replacement therapy
• • Known contraindication to denosumab or zoledronic acid
• • Obvious holes in teeth or broken teeth or dental or gum infection
• • Known untreated hypoparathyroidism
• • Current treatment with anti-fracture agent (bisphosphonate, strontium or teriparatide within previous 2 years, or menopausal hormone therapy or romosozumab within previous 12-months or denosumab within previous 6 months)
• • Current fragility fracture of hip, spine, femur or forearm
• • Exceeds weight limit for BMD scan at site or unable to undertake Bone Mineral Density for any reason
• • International Normalised Ratio \> 3.0 or Platelet count \< 30 10\^9/L