NCT04608630RecruitingPhase 2
Bone Loss Prevention With Zoledronic Acid or Denosumab in Critically Ill Adults
Bone Loss Prevention With Zoledronic Acid or Denosumab in Critically Ill Adults - A Randomised Controlled Trial
Source: ClinicalTrials.gov · Last updated 4 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 450 (estimated)
- First submitted
- 25 Oct 2020
- Start date
- 15 Jul 2021
- Primary completion date
- 28 Feb 2027
- Lead sponsor
- Australian and New Zealand Intensive Care Research Centre
- Diseases
- Osteoporosis
- NCT number
- NCT04608630
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 450
- From 15 Jul 2021 to the primary completion date, 28 Feb 2027
- 22 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current estimated Glomerular Filtration Rate \<30ml/min or receiving renal replacement therapy
- 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)
Other illness
- Cancer related metastatic bone disease or multiple myeloma
- Paget's disease
- Obvious holes in teeth or broken teeth or dental or gum infection
Lab values
- International Normalised Ratio \> 3.0 or Platelet count \< 30 10\^9/L
Other
- Pregnancy
- Known contraindication to denosumab or zoledronic acid
- Known untreated hypoparathyroidism
- 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
Who the study is looking for
- 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
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (22)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Adelaide Hospital Coordinator of this site? Confirm its status | Adelaide | Australia | Recruiting |
| Sunshine Coast University Hospital Coordinator of this site? Confirm its status | Birtinya | Australia | Recruiting |
| The Wesley Hospital Coordinator of this site? Confirm its status | Brisbane | Australia | Recruiting |
| Barwon Health - University Hospital Geelong Coordinator of this site? Confirm its status | Geelong | Australia | Recruiting |
| Alfred Health Coordinator of this site? Confirm its status | Melbourne | Australia | Completed |
| Austin Health Coordinator of this site? Confirm its status | Melbourne | Australia | Completed |
| Eastern Health - Box Hill Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| Royal Melbourne Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| Western Health - Footscray Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| St Vincents Hospital Melbourne Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| Western Health - Sunshine Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| St John of God Hospital Murdoch Coordinator of this site? Confirm its status | Perth | Australia | Recruiting |
| Fiona Stanley Hospital Coordinator of this site? Confirm its status | Perth | Australia | Recruiting |
| St John of God Hospital Subiaco Coordinator of this site? Confirm its status | Perth | Australia | Recruiting |
| Gold Coast University Hospital Coordinator of this site? Confirm its status | Southport | Australia | Recruiting |
| Royal Prince Alfred Hospital Coordinator of this site? Confirm its status | Sydney | Australia | Recruiting |
| Prince of Wales Hospital Coordinator of this site? Confirm its status | Sydney | Australia | Recruiting |
| St. Vincent's Health Sydney Coordinator of this site? Confirm its status | Sydney | Australia | Recruiting |
| Blacktown Hospital Coordinator of this site? Confirm its status | Sydney | Australia | Recruiting |
| Wollongong Hospital, Illawarra Shoalhaven Health Coordinator of this site? Confirm its status | Wollongong | Australia | Recruiting |
| Auckland City Hospital Coordinator of this site? Confirm its status | Auckland | New Zealand | Recruiting |
| Wellington Regional Hospital Coordinator of this site? Confirm its status | Wellington | New Zealand | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.