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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

Bone Loss Prevention With Zoledronic Acid or Denosumab in Critically Ill Adults (NCT04608630) is a Phase 2 interventional studying Critical Illness and Osteoporosis, sponsored by Australian and New Zealand Intensive Care Research Centre. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Critical Illness and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 450 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Denosumab 60 MG/ML

Patients allocated to the Denosumab arm will receive Denosumab 60mg in 1ml, administered via subcutaneous injection on Study Days 1 and 180.

DRUG

Zoledronic Acid 5Mg/Bag 100Ml Inj

Patients allocated to the Zoledronic acid arm will receive Zoledronic acid 5mg in 100ml 0.9% Sodium Chloride or 5% Dextrose, administered via intravenous infusion over at least 15 minutes on Study Day 1.

DRUG

Sodium Chloride 0.9% or 5% Dextrose Intravenous

Patients allocated to the placebo arm and Denosumab arm will receive 0.9% Sodium Chloride or 5% Dextrose 100ml administered via intravenous infusion over at least 15 minutes on Day 1.

DRUG

Sodium Chloride 0.9% Injection

Patients allocated to the placebo arm and Zoledronic acid arm will receive 0.9% Sodium Chloride 1ml administered via subcutaneous injection on Days 1 and Day 180

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

St Vincent's Health Sydney
Sydney, New South Wales, Australia
Prince of Wales Hospital
Sydney, New South Wales, Australia
Blacktown Hospital
Sydney, New South Wales, Australia
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia
Wollongong Hospital, Illawarra Shoalhaven Health
Wollongong, New South Wales, Australia
Sunshine Coast University Hospital
Birtinya, Queensland, Australia
The Wesley Hospital
Brisbane, Queensland, Australia
Gold Coast University Hospital
Southport, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Barwon Health, University Hospital Geelong
Geelong, Victoria, Australia
Alfred Health
Melbourne, Victoria, Australia
Western Health - Footscray Hospital
Melbourne, Victoria, Australia
Western Health - Sunshine Hospital
Melbourne, Victoria, Australia
Royal Melbourne Hospital
Melbourne, Victoria, Australia
St Vincents Hospital Melbourne
Melbourne, Victoria, Australia
Austin Health
Melbourne, Victoria, Australia
Eastern Health - Box Hill Hospital
Melbourne, Victoria, Australia
St John of God Hospital Subiaco
Perth, Western Australia, Australia
Fiona Stanley Hospital
Perth, Western Australia, Australia
St John of God Hospital Murdoch
Perth, Western Australia, Australia

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT04608630), the sponsor (Australian and New Zealand Intensive Care Research Centre), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT04608630 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT04608630?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT04608630?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT04608630. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT04608630. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.