None listed
Conditions
Brief summary
A randomised controlled trial designed to determine which of 4 treatments is best to prevent the acute phase response following first zoledronate infusion. We are assessing which of 4 strategies (dexamethasone daily for 3 days, dexamethasone daily for 2 days, regular paracetamol for 3 days, or paracetamol only as required) is the most effective clinical treatment for preventing symptoms following zoledronate infusion. All strategies have been used in clinical practice previously and have been shown in clinical trials to be better than no treatment.
Interventions
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 w
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
Sponsors
University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Healthy volunteers
No
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)
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)
Outcome results
None listed