Actively Recruiting
Bone Loss Prevention With Zoledronic Acid or Denosumab in Critically Ill Adults
Led by Australian and New Zealand Intensive Care Research Centre · Updated on 2026-03-04
450
Participants Needed
22
Research Sites
293 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Bone Loss Prevention With Zoledronic Acid or Denosumab in Critically Ill Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female age 50 years or older or male age 70 years or older
- Intensive Care Unit admission for 2 or more calendar days and not expected to be discharged from ICU on the second day
- Required ICU level support (intravenous vasoactive drugs, invasive or non-invasive ventilation, or high flow nasal oxygen with specified oxygen or flow levels) for at least 6 hours
- Expected to survive the current hospital admission
You will not qualify if you...
- Cancer-related metastatic bone disease or multiple myeloma
- Paget's disease
- Pregnancy
- Estimated Glomerular Filtration Rate less than 30 ml/min or receiving renal replacement therapy
- Known contraindication to denosumab or zoledronic acid
- Obvious holes in teeth, broken teeth, or dental/gum infection
- Known untreated hypoparathyroidism
- Current treatment with anti-fracture agents within specified recent timeframes
- Current fragility fracture of hip, spine, femur, or forearm
- Exceeds weight limit for bone mineral density scan or unable to undergo BMD scan
- International Normalised Ratio greater than 3.0 or platelet count less than 30 x 10^9/L
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 22 locations
1
St Vincent's Health Sydney
Sydney, New South Wales, Australia, 2010
Actively Recruiting
2
Prince of Wales Hospital
Sydney, New South Wales, Australia, 2031
Actively Recruiting
3
Blacktown Hospital
Sydney, New South Wales, Australia, 2148
Actively Recruiting
4
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia
Actively Recruiting
5
Wollongong Hospital, Illawarra Shoalhaven Health
Wollongong, New South Wales, Australia, 2525
Actively Recruiting
6
Sunshine Coast University Hospital
Birtinya, Queensland, Australia, 4575
Actively Recruiting
7
The Wesley Hospital
Brisbane, Queensland, Australia, 4066
Actively Recruiting
8
Gold Coast University Hospital
Southport, Queensland, Australia, 4215
Actively Recruiting
9
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Actively Recruiting
10
Barwon Health, University Hospital Geelong
Geelong, Victoria, Australia, 3220
Actively Recruiting
11
Alfred Health
Melbourne, Victoria, Australia, 3004
Completed
12
Western Health - Footscray Hospital
Melbourne, Victoria, Australia, 3011
Actively Recruiting
13
Western Health - Sunshine Hospital
Melbourne, Victoria, Australia, 3021
Actively Recruiting
14
Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3052
Actively Recruiting
15
St Vincents Hospital Melbourne
Melbourne, Victoria, Australia, 3065
Actively Recruiting
16
Austin Health
Melbourne, Victoria, Australia, 3084
Completed
17
Eastern Health - Box Hill Hospital
Melbourne, Victoria, Australia, 3128
Actively Recruiting
18
St John of God Hospital Subiaco
Perth, Western Australia, Australia, 6008
Actively Recruiting
19
Fiona Stanley Hospital
Perth, Western Australia, Australia, 6150
Actively Recruiting
20
St John of God Hospital Murdoch
Perth, Western Australia, Australia, 6150
Actively Recruiting
21
Auckland City Hospital
Auckland, New Zealand, 1023
Actively Recruiting
22
Wellington Regional Hospital
Wellington, New Zealand, 6021
Actively Recruiting
Research Team
A
Allison Bone
CONTACT
T
Tony Trapani
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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