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Prevention study for Critical Illness
Official title Bone Loss Prevention With Zoledronic Acid or Denosumab in Critically Ill Adults
ClinicalTrials.gov ID: NCT04608630
What this study is testing
What is Denosumab 60 MG/ML?
Denosumab 60 MG/ML is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for critical illness.
Also referred to as Prolia, Xgeva.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- 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...
- Expected to survive the current hospital admission
You likely can't join if
- 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
See the full eligibility 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...
- Expected to survive the current hospital admission
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Sydney, New South Wales, Australia
- Wollongong, New South Wales, Australia
- Birtinya, Queensland, Australia
- Brisbane, Queensland, Australia
- Southport, Queensland, Australia
- Adelaide, South Australia, Australia
- Geelong, Victoria, Australia
- Melbourne, Victoria, Australia
- Perth, Western Australia, Australia
- Auckland, New Zealand
- Wellington, New Zealand
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sydney, New South Wales, Australia; Wollongong, New South Wales, Australia; Birtinya, Queensland, Australia; Brisbane, Queensland, Australia; Southport, Queensland, Australia; Adelaide, South Australia, Australia and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.