Preventing bone loss in critically ill adults using medications
Bone Loss Prevention With Zoledronic Acid or Denosumab in Critically Ill Adults - A Randomised Controlled Trial
PHASE2 · Australian and New Zealand Intensive Care Research Centre · NCT04608630
This study is testing if two medications can help prevent bone loss in critically ill adults over 50 who have been in the ICU for more than a day.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 450 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Australian and New Zealand Intensive Care Research Centre (other) |
| Drugs / interventions | denosumab, romosozumab |
| Locations | 22 sites (Sydney, New South Wales and 21 other locations) |
| Trial ID | NCT04608630 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of denosumab and zoledronic acid in preventing bone loss in critically ill adults aged 50 and older for women and 70 and older for men, who have been in the Intensive Care Unit (ICU) for more than 24 hours. Participants will be randomly assigned to receive either one of the medications or a placebo, and their bone mineral density will be measured over the course of one year. The study aims to address the significant bone loss that occurs during and after critical illness, which can lead to increased fracture risk. By understanding the impact of these treatments, the trial seeks to improve long-term outcomes for ICU survivors.
Who should consider this trial
Good fit: Ideal candidates are women aged 50 years or older and men aged 70 years or older who have been in the ICU for more than 24 hours and require intensive care support.
Not a fit: Patients with cancer-related metastatic bone disease, severe renal impairment, or those currently receiving anti-fracture treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the risk of osteoporosis and fractures in critically ill patients.
How similar studies have performed: Previous studies have indicated that interventions like denosumab and zoledronic acid can be effective in preventing bone loss, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Sydney, New South Wales and 21 other locations
- St Vincent's Health Sydney — Sydney, New South Wales, Australia (RECRUITING)
- Prince of Wales Hospital — Sydney, New South Wales, Australia (RECRUITING)
- Blacktown Hospital — Sydney, New South Wales, Australia (RECRUITING)
- Royal Prince Alfred Hospital — Sydney, New South Wales, Australia (RECRUITING)
- Wollongong Hospital, Illawarra Shoalhaven Health — Wollongong, New South Wales, Australia (RECRUITING)
- Sunshine Coast University Hospital — Birtinya, Queensland, Australia (RECRUITING)
- The Wesley Hospital — Brisbane, Queensland, Australia (RECRUITING)
- Gold Coast University Hospital — Southport, Queensland, Australia (RECRUITING)
- Royal Adelaide Hospital — Adelaide, South Australia, Australia (RECRUITING)
- Barwon Health, University Hospital Geelong — Geelong, Victoria, Australia (RECRUITING)
- Alfred Health — Melbourne, Victoria, Australia (COMPLETED)
- Western Health - Footscray Hospital — Melbourne, Victoria, Australia (RECRUITING)
- Western Health - Sunshine Hospital — Melbourne, Victoria, Australia (RECRUITING)
- Royal Melbourne Hospital — Melbourne, Victoria, Australia (RECRUITING)
- St Vincents Hospital Melbourne — Melbourne, Victoria, Australia (RECRUITING)
- Austin Health — Melbourne, Victoria, Australia (COMPLETED)
- Eastern Health - Box Hill Hospital — Melbourne, Victoria, Australia (RECRUITING)
- St John of God Hospital Subiaco — Perth, Western Australia, Australia (RECRUITING)
- Fiona Stanley Hospital — Perth, Western Australia, Australia (RECRUITING)
- St John of God Hospital Murdoch — Perth, Western Australia, Australia (RECRUITING)
- Auckland City Hospital — Auckland, New Zealand (RECRUITING)
- Wellington Regional Hospital — Wellington, New Zealand (RECRUITING)
Study contacts
- Study coordinator: Allison Bone
- Email: allison.bone@monash.edu
- Phone: +61 3 9903 0343
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Critical Illness, Osteoporosis, Intensive Care Unit, Bone densitometry, Zoledronic acid, Denosumab