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Trial registered on ANZCTR


Registration number
ACTRN12624001403527
Ethics application status
Approved
Date submitted
11/11/2024
Date registered
27/11/2024
Date last updated
27/11/2024
Date data sharing statement initially provided
27/11/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A pragmatic, randomised study of treatments to prevent the acute phase response following first zoledronate infusion
Scientific title
A pragmatic, randomised study of dexamethasone and paracetamol regimens to prevent the acute phase response following first zoledronate infusion in women aged 60- 70 years
Secondary ID [1] 313353 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
This is a substudy to an extension study of ACTRN12612000270819.

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis 335711 0
Condition category
Condition code
Musculoskeletal 332277 332277 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1. 4mg daily oral dexamethasone for 3 days, starting immediately pre zoledronate infusion (3 days total)
Arm 2. 4mg daily oral dexamethasone for 2 days, starting immediately pre zoledronate infusion, and then 4mg oral dexamethasone on day 3 only if symptomatic (ie 2-3 days total)
Arm 3. 1g oral paracetamol four times per day for 3 days starting immediately pre-zoledronate infusion. (3 days total)
Adherence to all medications will be checked with a self-reported question on how many tablets were taken
Intervention code [1] 329939 0
Treatment: Drugs
Comparator / control treatment
Arm 4. 1g oral paracetamol up to four times per day for 3 days starting post infusion and only taken if symptomatic. Adherence to all medications will be checked with a self-reported question on how many tablets were taken. Note that there are 4 active treatment arms without a pre-specified "control" group.
Control group
Active

Outcomes
Primary outcome [1] 339849 0
Difference between groups in mean greatest temperature change from baseline
Timepoint [1] 339849 0
Temperature will be assessed at baseline (pre-infusion) and then three times daily for 3 days (day of infusion and 2 days post-infusion).
Secondary outcome [1] 441642 0
Between-group difference in change in mean symptom score from baseline for 4 major symptom clusters (headache, nausea, muscle or joint pain, and fever). This will be assesses as a composite endpoint of the symptom clusters.
Timepoint [1] 441642 0
Symptom questionnaire will be completed at baseline (pre-infusion) and daily for 3 days (day of infusion and 2 days post-infusion) and at 7 days
Secondary outcome [2] 441643 0
Between-group difference in change in mean symptom score from baseline for remaining symptoms listed in the symptom questionnaire (All symptoms in questionnaire are fever, joint pain, joint swelling, muscle aches/ pain, stomach pain, nausea or vomiting, diarrhoea, other gut or bowel symptoms, fatigue, headache, blocked/runny nose, red/painful eye, any other symptom) This will be assessed as a composite outcome.
Timepoint [2] 441643 0
Symptom questionnaire will be completed at baseline (pre-infusion) and daily for 3 days (day of infusion and 2 days post-infusion) and at 7 days.
Secondary outcome [3] 441644 0
Between-group differences in the proportions in each group with an increase in oral temperature following zoledronate (increase of at least 1°C above baseline and final temp > 37.5°C)
Timepoint [3] 441644 0
Temperature will be assessed at baseline (pre-infusion) and then three times daily for 3 days (day of infusion and 2 days post-infusion).
Secondary outcome [4] 441645 0
Between-group differences in proportions in each group with at least one acute phase response-related symptom
Timepoint [4] 441645 0
Symptom questionnaire will be completed at baseline (pre-infusion) and daily for 3 days (day of infusion and 2 days post-infusion) and at 7 days
Secondary outcome [5] 441646 0
Between-group differences in proportions in each group requiring rescue medication
Timepoint [5] 441646 0
Rescue medication questionnaire will be completed daily for 3 days (day of infusion and 2 days post-infusion) and at 7 days.

Eligibility
Key inclusion criteria
Women participating in an extension study of a 10 year study of intermittent zoledronate who received placebo-placebo in the core study (ACTRN12612000270819)
Minimum age
60 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Previous use of zoledronate
2. Contraindications to use of any substudy medication. (eg poorly controlled diabetes, and chronic liver disease, but generally anyone eligible for the extension study will very likely have no contraindications to dexamethasone or paracetamol use)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random numbers with variable block size
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment outside Australia
Country [1] 26720 0
New Zealand
State/province [1] 26720 0

Funding & Sponsors
Funding source category [1] 317799 0
Government body
Name [1] 317799 0
HRC (Health Research Council) of NZ
Country [1] 317799 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 320126 0
None
Name [1] 320126 0
Address [1] 320126 0
Country [1] 320126 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316482 0
Northern A Health and Disability Ethics Committee 
Ethics committee address [1] 316482 0
Ethics committee country [1] 316482 0
New Zealand
Date submitted for ethics approval [1] 316482 0
23/10/2024
Approval date [1] 316482 0
07/11/2024
Ethics approval number [1] 316482 0

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

Contacts
Principal investigator
Name 138034 0
Dr Mark Bolland
Address 138034 0
Dept of Medicine, Private Bag 92024, Auckland 1123, New Zealand
Country 138034 0
New Zealand
Phone 138034 0
+64 9 373 7599 83004
Fax 138034 0
Email 138034 0
m.bolland@auckland.ac.nz
Contact person for public queries
Name 138035 0
Mark Bolland
Address 138035 0
Dept of Medicine, Private Bag 92024, Auckland 1123, New Zealand
Country 138035 0
New Zealand
Phone 138035 0
+64 9 373 7599 83004
Fax 138035 0
Email 138035 0
m.bolland@auckland.ac.nz
Contact person for scientific queries
Name 138036 0
Mark Bolland
Address 138036 0
Dept of Medicine, Private Bag 92024, Auckland 1123, New Zealand
Country 138036 0
New Zealand
Phone 138036 0
+64 9 373 7599 83004
Fax 138036 0
Email 138036 0
m.bolland@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Deidentified data underpinning the study results and publication
When will data be available (start and end dates)?
After 12 months from publication with no end date
Available to whom?
Researchers with approved protocol
Available for what types of analyses?
Any methodological sound analyses
How or where can data be obtained?
Contacting the principal investigator by email m.bolland@auckland.ac.nz with approved protocol


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.