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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04608630




Registration number
NCT04608630
Ethics application status
Date submitted
25/10/2020
Date registered
29/10/2020

Titles & IDs
Public title
Bone Loss Prevention With Zoledronic Acid or Denosumab in Critically Ill Adults
Scientific title
Bone Loss Prevention With Zoledronic Acid or Denosumab in Critically Ill Adults - A Randomised Controlled Trial
Secondary ID [1] 0 0
ANZIC-RC/NO001
Universal Trial Number (UTN)
Trial acronym
BoneZone
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical Illness 0 0
Osteoporosis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Denosumab 60 MG/ML
Treatment: Drugs - Zoledronic Acid 5Mg/Bag 100Ml Inj
Treatment: Drugs - Sodium Chloride 0.9% Intravenous
Treatment: Drugs - Sodium Chloride 0.9% Injection

Active comparator: Denosumab - Patients allocated to the Denosumab arm will receive Denosumab 60mg in 1ml, administered via subcutaneous injection on Study Days 1 and 180.

Active comparator: Zoledronic acid - Patients allocated to the Zoledronic acid arm will receive Zoledronic acid 5mg in 100ml 0.9% Sodium Chloride, administered via intravenous infusion over at least 15 minutes on Study Day 1.

Placebo comparator: Placebo - Patients 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 administered via intravenous infusion over at least 15 minutes on Day 1.


Treatment: Drugs: Denosumab 60 MG/ML
Patients allocated to the Denosumab arm will receive Denosumab 60mg in 1ml, administered via subcutaneous injection on Study Days 1 and 180.

Treatment: Drugs: Zoledronic Acid 5Mg/Bag 100Ml Inj
Patients allocated to the Zoledronic acid arm will receive Zoledronic acid 5mg in 100ml 0.9% Sodium Chloride, administered via intravenous infusion over at least 15 minutes on Study Day 1.

Treatment: Drugs: Sodium Chloride 0.9% Intravenous
Patients allocated to the placebo arm and Denosumab arm will receive 0.9% Sodium Chloride 100ml administered via intravenous infusion over at least 15 minutes on Day 1.

Treatment: Drugs: Sodium Chloride 0.9% Injection
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Annualised change in femoral neck bone mineral density for the year after Intensive Care discharge
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Annualised change in lumbar spine bone mineral density for the year after Intensive Care discharge
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
Clinical fragility fracture
Timepoint [2] 0 0
6 and 12 months
Secondary outcome [3] 0 0
Vertebral fracture
Timepoint [3] 0 0
12 months
Secondary outcome [4] 0 0
Falls
Timepoint [4] 0 0
6 and 12 months
Secondary outcome [5] 0 0
Hospital readmission
Timepoint [5] 0 0
12 months
Secondary outcome [6] 0 0
Mortality
Timepoint [6] 0 0
12 months
Secondary outcome [7] 0 0
Change in quality of life
Timepoint [7] 0 0
0, 6 and 12 months.
Secondary outcome [8] 0 0
Bone turnover outcomes (nested sub-study)
Timepoint [8] 0 0
0, Day 7, Day 28, 6 and 12 months

Eligibility
Key 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
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/07/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/02/2027
Actual
Sample size
Target
450
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
John Hunter Hospital - Newcastle
Recruitment hospital [2] 0 0
St Vincent's Health Sydney - Sydney
Recruitment hospital [3] 0 0
Prince of Wales Hospital - Sydney
Recruitment hospital [4] 0 0
Blacktown Hospital - Sydney
Recruitment hospital [5] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment hospital [6] 0 0
Wollongong Hospital, Illawarra Shoalhaven Health - Wollongong
Recruitment hospital [7] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [8] 0 0
The Wesley Hospital - Brisbane
Recruitment hospital [9] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [10] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [11] 0 0
Launceston General Hospital - Launceston
Recruitment hospital [12] 0 0
Barwon Health, University Hospital Geelong - Geelong
Recruitment hospital [13] 0 0
Alfred Health - Melbourne
Recruitment hospital [14] 0 0
Western Health - Footscray Hospital - Melbourne
Recruitment hospital [15] 0 0
Western Health - Sunshine Hospital - Melbourne
Recruitment hospital [16] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [17] 0 0
St Vincents Hospital Melbourne - Melbourne
Recruitment hospital [18] 0 0
Austin Health - Melbourne
Recruitment hospital [19] 0 0
Eastern Health - Box Hill Hospital - Melbourne
Recruitment hospital [20] 0 0
St John of God Hospital Subiaco - Perth
Recruitment hospital [21] 0 0
Fiona Stanley Hospital - Perth
Recruitment hospital [22] 0 0
St John of God Hospital Murdoch - Perth
Recruitment postcode(s) [1] 0 0
2305 - Newcastle
Recruitment postcode(s) [2] 0 0
2010 - Sydney
Recruitment postcode(s) [3] 0 0
2031 - Sydney
Recruitment postcode(s) [4] 0 0
2148 - Sydney
Recruitment postcode(s) [5] 0 0
- Sydney
Recruitment postcode(s) [6] 0 0
2525 - Wollongong
Recruitment postcode(s) [7] 0 0
4575 - Birtinya
Recruitment postcode(s) [8] 0 0
4066 - Brisbane
Recruitment postcode(s) [9] 0 0
4215 - Southport
Recruitment postcode(s) [10] 0 0
5000 - Adelaide
Recruitment postcode(s) [11] 0 0
7250 - Launceston
Recruitment postcode(s) [12] 0 0
3220 - Geelong
Recruitment postcode(s) [13] 0 0
3004 - Melbourne
Recruitment postcode(s) [14] 0 0
3011 - Melbourne
Recruitment postcode(s) [15] 0 0
3021 - Melbourne
Recruitment postcode(s) [16] 0 0
3052 - Melbourne
Recruitment postcode(s) [17] 0 0
3065 - Melbourne
Recruitment postcode(s) [18] 0 0
3084 - Melbourne
Recruitment postcode(s) [19] 0 0
3128 - Melbourne
Recruitment postcode(s) [20] 0 0
6008 - Perth
Recruitment postcode(s) [21] 0 0
6150 - Perth
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Other
Name
Australian and New Zealand Intensive Care Research Centre
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Neil Orford, A/Prof
Address 0 0
Barwon Health; ANZIC Research Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Allison Bone
Address 0 0
Country 0 0
Phone 0 0
+61 3 9903 0343
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF)
When will data be available (start and end dates)?
As per the ANZIC Research Centre Data Sharing Policy
Available to whom?
As per the ANZIC Research Centre Data Sharing Policy
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.monash.edu/__data/assets/pdf_file/0005/1098428/2017-10-05-ANZIC-RC-Terms-of-Ref.pdf


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04608630