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ICU survivors at risk of brittle bones: new trial tests One-Time fix

NCT ID NCT04608630

Disease control Sponsor: Australian and New Zealand Intensive Care Research Centre Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a single dose of either zoledronic acid or denosumab can prevent bone loss in older adults who have been in the intensive care unit (ICU). The trial will include 450 women aged 50+ and men aged 70+ who spent at least 2 days in the ICU. Participants will receive one of the two bone-strengthening drugs or a placebo, and their bone density will be measured over one year.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 450 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2021

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Critical Illness osteoporosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Critical illness Osteoporosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    20 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Alfred Health

    COMPLETED

    Melbourne, Victoria, 3004, Australia

  • Auckland City Hospital

    RECRUITING

    Auckland, 1023, New Zealand

  • Austin Health

    COMPLETED

    Melbourne, Victoria, 3084, Australia

  • Barwon Health, University Hospital Geelong

    RECRUITING

    Geelong, Victoria, 3220, Australia

  • Blacktown Hospital

    RECRUITING

    Sydney, New South Wales, 2148, Australia

  • Eastern Health - Box Hill Hospital

    RECRUITING

    Melbourne, Victoria, 3128, Australia

  • Fiona Stanley Hospital

    RECRUITING

    Perth, Western Australia, 6150, Australia

  • Gold Coast University Hospital

    RECRUITING

    Southport, Queensland, 4215, Australia

  • Prince of Wales Hospital

    RECRUITING

    Sydney, New South Wales, 2031, Australia

  • Royal Adelaide Hospital

    RECRUITING

    Adelaide, South Australia, 5000, Australia

  • Royal Melbourne Hospital

    RECRUITING

    Melbourne, Victoria, 3052, Australia

  • Royal Prince Alfred Hospital

    RECRUITING

    Sydney, New South Wales, Australia

  • St John of God Hospital Murdoch

    RECRUITING

    Perth, Western Australia, 6150, Australia

  • St John of God Hospital Subiaco

    RECRUITING

    Perth, Western Australia, 6008, Australia

  • St Vincent's Health Sydney

    RECRUITING

    Sydney, New South Wales, 2010, Australia

  • St Vincents Hospital Melbourne

    RECRUITING

    Melbourne, Victoria, 3065, Australia

  • Sunshine Coast University Hospital

    RECRUITING

    Birtinya, Queensland, 4575, Australia

  • The Wesley Hospital

    RECRUITING

    Brisbane, Queensland, 4066, Australia

  • Wellington Regional Hospital

    RECRUITING

    Wellington, 6021, New Zealand

  • Western Health - Footscray Hospital

    RECRUITING

    Melbourne, Victoria, 3011, Australia

  • Western Health - Sunshine Hospital

    RECRUITING

    Melbourne, Victoria, 3021, Australia

  • Wollongong Hospital, Illawarra Shoalhaven Health

    RECRUITING

    Wollongong, New South Wales, 2525, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.