Bone Loss Prevention With Zoledronic Acid or Denosumab in Critically Ill Adults (NCT04608630) | Clinical Trial Compass
RecruitingPhase 2
Bone Loss Prevention With Zoledronic Acid or Denosumab in Critically Ill Adults
Australia, New Zealand450 participantsStarted 2021-07-15
Plain-language 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 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.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Annualised change in femoral neck bone mineral density for the year after Intensive Care discharge
Timeframe: 12 months
Trial details
NCT IDNCT04608630
SponsorAustralian and New Zealand Intensive Care Research Centre