NCT04608630 Bone Loss Prevention With Zoledronic Acid or Denosumab in Critically Ill Adults
| NCT ID | NCT04608630 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Australian and New Zealand Intensive Care Research Centre |
| Condition | Critical Illness |
| Study Type | INTERVENTIONAL |
| Enrollment | 450 participants |
| Start Date | 2021-07-15 |
| Primary Completion | 2027-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 450 participants in total. It began in 2021-07-15 with a primary completion date of 2027-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Neil Orford, A/Prof
STUDY CHAIR
Barwon Health; ANZIC Research Centre
Frequently Asked Questions
Who can join the NCT04608630 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Critical Illness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04608630 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04608630 currently recruiting?
Yes, NCT04608630 is actively recruiting participants. Contact the research team at allison.bone@monash.edu for enrollment information.
Where is the NCT04608630 trial being conducted?
This trial is being conducted at Sydney, Australia, Sydney, Australia, Sydney, Australia, Sydney, Australia and 11 additional locations.
Who is sponsoring the NCT04608630 clinical trial?
NCT04608630 is sponsored by Australian and New Zealand Intensive Care Research Centre. The principal investigator is Neil Orford, A/Prof at Barwon Health; ANZIC Research Centre. The trial plans to enroll 450 participants.