Phase 2 study for people with Osteoporosis

Recruiting Phase 2

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Recruiting

Phase Phase 2

Sponsor Australian and New Zealand Intensive Care Research Centre

Registry number NCT04608630

Started 15 July 2021 Today 16 October 2026 Estimated completion 28 February 2027

Where this trial is running

Trial sites and the status recorded for each
Site	City	State or country	Status at this site
St Vincent's Health Sydney	Sydney	NSW	Recruiting
Prince of Wales Hospital	Sydney	NSW	Recruiting
Blacktown Hospital	Sydney	NSW	Recruiting
Royal Prince Alfred Hospital	Sydney	NSW	Recruiting
Wollongong Hospital, Illawarra Shoalhaven Health	Wollongong	NSW	Recruiting
Sunshine Coast University Hospital	Birtinya	QLD	Recruiting
The Wesley Hospital	Brisbane	QLD	Recruiting
Gold Coast University Hospital	Southport	QLD	Recruiting
Royal Adelaide Hospital	Adelaide	SA	Recruiting
Barwon Health, University Hospital Geelong	Geelong	VIC	Recruiting
Alfred Health	Melbourne	VIC	Completed
Western Health - Footscray Hospital	Melbourne	VIC	Recruiting
Western Health - Sunshine Hospital	Melbourne	VIC	Recruiting
Royal Melbourne Hospital	Melbourne	VIC	Recruiting
St Vincents Hospital Melbourne	Melbourne	VIC	Recruiting
Austin Health	Melbourne	VIC	Completed
Eastern Health - Box Hill Hospital	Melbourne	VIC	Recruiting
St John of God Hospital Subiaco	Perth	WA	Recruiting
Fiona Stanley Hospital	Perth	WA	Recruiting
St John of God Hospital Murdoch	Perth	WA	Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 50 Years and over

Sex Anyone, regardless of sex

Healthy volunteers Not accepted

Enrolment target 450

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

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

Dates on the record

Started 15 July 2021

Estimated completion 28 February 2027

Registry last updated 4 March 2026

Checked by Voxsanity 11 October 2026

Results, publications and the official record

No results are posted on the official record yet.
No publications are listed on the official record yet.
Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.

Sources and dates

ClinicalTrials.gov – the record this page reformats
ClinicalTrials.gov processing date: 4 March 2026.
This page last checked by Voxsanity: 11 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.

Voxsanity

Clinical trials recruiting in Australia, from the public registries · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial, which may be relevant to my care:

Trial: NCT04608630

Sponsor: Australian and New Zealand Intensive Care Research Centre

Phase: Phase 2

Status: Recruiting

Condition: Osteoporosis

More information: https://clinicaltrials.gov/study/NCT04608630

Eligibility criteria, as the registry published them

Reproduced exactly, unedited. Written for researchers rather than for patients.

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

A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a registered health practitioner to access unapproved therapeutic goods for individual patients.

Not medical advice. Voxsanity reformats information published by public registries. It does not give medical advice and is not a substitute for talking to your doctor.