Bone Loss Prevention With Zoledronic Acid or Denosumab in Critically Ill Adults
BoneZone
1 other identifier
interventional
450
2 countries
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2021
Longer than P75 for phase_2
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2020
CompletedFirst Posted
Study publicly available on registry
October 29, 2020
CompletedStudy Start
First participant enrolled
July 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 28, 2027
March 4, 2026
March 1, 2026
5.6 years
October 25, 2020
March 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Annualised change in femoral neck bone mineral density for the year after Intensive Care discharge
Change in femoral neck bone mineral density T-score between baseline and 12 months
12 months
Secondary Outcomes (8)
Annualised change in lumbar spine bone mineral density for the year after Intensive Care discharge
12 months
Clinical fragility fracture
6 and 12 months
Vertebral fracture
12 months
Falls
6 and 12 months
Hospital readmission
12 months
- +3 more secondary outcomes
Study Arms (3)
Denosumab
ACTIVE COMPARATORPatients allocated to the Denosumab arm will receive Denosumab 60mg in 1ml, administered via subcutaneous injection on Study Days 1 and 180.
Zoledronic acid
ACTIVE COMPARATORPatients allocated to the Zoledronic acid arm will receive Zoledronic acid 5mg in 100ml 0.9% Sodium Chloride or 5% Dextrose, administered via intravenous infusion over at least 15 minutes on Study Day 1.
Placebo
PLACEBO COMPARATORPatients allocated to the placebo arm will receive 0.9% Sodium Chloride 1ml administered via subcutaneous injection on Days 1 and Day 180 and 0.9% Sodium Chloride 100ml or 5% Dextrose administered via intravenous infusion over at least 15 minutes on Day 1.
Interventions
Patients allocated to the Denosumab arm will receive Denosumab 60mg in 1ml, administered via subcutaneous injection on Study Days 1 and 180.
Patients allocated to the Zoledronic acid arm will receive Zoledronic acid 5mg in 100ml 0.9% Sodium Chloride or 5% Dextrose, administered via intravenous infusion over at least 15 minutes on Study Day 1.
Patients allocated to the placebo arm and Denosumab arm will receive 0.9% Sodium Chloride or 5% Dextrose 100ml administered via intravenous infusion over at least 15 minutes on Day 1.
Patients allocated to the placebo arm and Zoledronic acid arm will receive 0.9% Sodium Chloride 1ml administered via subcutaneous injection on Days 1 and Day 180
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
St Vincent's Health Sydney
Sydney, New South Wales, 2010, Australia
Prince of Wales Hospital
Sydney, New South Wales, 2031, Australia
Blacktown Hospital
Sydney, New South Wales, 2148, Australia
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia
Wollongong Hospital, Illawarra Shoalhaven Health
Wollongong, New South Wales, 2525, Australia
Sunshine Coast University Hospital
Birtinya, Queensland, 4575, Australia
The Wesley Hospital
Brisbane, Queensland, 4066, Australia
Gold Coast University Hospital
Southport, Queensland, 4215, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Barwon Health, University Hospital Geelong
Geelong, Victoria, 3220, Australia
Alfred Health
Melbourne, Victoria, 3004, Australia
Western Health - Footscray Hospital
Melbourne, Victoria, 3011, Australia
Western Health - Sunshine Hospital
Melbourne, Victoria, 3021, Australia
Royal Melbourne Hospital
Melbourne, Victoria, 3052, Australia
St Vincents Hospital Melbourne
Melbourne, Victoria, 3065, Australia
Austin Health
Melbourne, Victoria, 3084, Australia
Eastern Health - Box Hill Hospital
Melbourne, Victoria, 3128, Australia
St John of God Hospital Subiaco
Perth, Western Australia, 6008, Australia
Fiona Stanley Hospital
Perth, Western Australia, 6150, Australia
St John of God Hospital Murdoch
Perth, Western Australia, 6150, Australia
Auckland City Hospital
Auckland, 1023, New Zealand
Wellington Regional Hospital
Wellington, 6021, New Zealand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Neil Orford, A/Prof
Barwon Health; ANZIC Research Centre
- STUDY CHAIR
Priya Nair, A/Prof
St Vincent's Health Sydney
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2020
First Posted
October 29, 2020
Study Start
July 15, 2021
Primary Completion (Estimated)
February 28, 2027
Study Completion (Estimated)
February 28, 2027
Last Updated
March 4, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- As per the ANZIC Research Centre Data Sharing Policy
- Access Criteria
- As per the ANZIC Research Centre Data Sharing Policy
At the conclusion of the study, the study management committee will consider requests from researchers who provide a methodologically sound scientific proposal as per the Data Sharing Policy set out in the ANZIC Research Centre Terms of Reference.