Phase 2 Osteoporosis Trial, Recruiting NCT04608630 Sponsor: Australian and New Zealand Intensive Care Research Centre Condition: Osteoporosis
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Phase 2 Osteoporosis Trial, Recruiting

NCT04608630
Recruiting Phase 2 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Women aged 50 or older, or men aged 70 or older
  • People who have been in the Intensive Care Unit (ICU) for at least 2 full days and are not expected to leave the ICU on that second day
  • People who have needed a significant level of ICU support — such as breathing machines, oxygen therapy at high levels, or medications to support blood pressure — for at least 6 hours in total
  • People who are expected to survive their current hospital stay

Who may not be able to join:

  • People who have cancer that has spread to the bones, or who have a blood cancer called multiple myeloma
  • People who have a bone condition called Paget's disease
  • People who are pregnant
  • People whose kidneys are not working well enough (based on a specific blood test result), or who are already receiving dialysis or a similar kidney treatment
  • People who are known to have a reason they cannot take either of the study medications (denosumab or zoledronic acid)
  • People who have obvious holes in their teeth, broken teeth, or a current dental or gum infection
  • People with a known, untreated condition where the parathyroid glands do not work properly (confirm with trial site)
  • People currently being treated with certain bone-strengthening medications — including bisphosphonates, strontium, or teriparatide within the past 2 years, or hormone therapy or romosozumab within the past 12 months, or denosumab within the past 6 months
  • People who currently have a fragility fracture (a break caused by weakened bones) of the hip, spine, thigh bone, or forearm
  • People whose body weight exceeds the limit for the bone density scanning equipment at the trial site, or who are unable to have a bone density scan for any reason
  • People with certain abnormal blood test results related to blood clotting or platelet levels

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 22 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Neil Orford, A/Prof, Barwon Health; ANZIC Research Centre

Phone: +61 3 9903 0343

Australian sites

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

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Australian and New Zealand Intensive Care Research Centre
Registry
ClinicalTrials.gov
Start date
15 July 2021
Est. completion
28 February 2027

Where this trial is recruiting

🇦🇺 Australia 🇳🇿 New Zealand

20 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Annualised change in femoral neck bone mineral density for the year after Intensive Care discharge

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov