None listed
Conditions
Brief summary
This study will aim to determine whether giving a steroid tablet (dexamethasone) for three days after a zoledronic acid infusion will reduce the risk of a side effect known as the acute phase response, which can cause fever, nausea, muscle pains and headache, compared to giving an inactive (placebo) tablet. It is possible that a three-day course of a commonly used steroid, dexamethasone, could reduce the number of patients experiencing this reaction..
Interventions
Participants will be randomized to receive either 3 days of dexamethasone tablets or 3 days of placebo tablets. The group randomized to receive the intervention will receive dexamethasone 4 mg orally administered 1-4 hours prior to the zoledronate infusion and then once daily in the morning for two further days. The method of administration will be an oral tablet.
Sponsors
Bone & Joint Research Group, University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-Females or males aged greater than or equal to 20 years -Prescribed zoledronic acid for the first time
Exclusion criteria
-Prior treatment with zoledronic acid -History of fever, infection, or influenza-like illness within the past week -Diabetes mellitus -Uncontrolled hypertension (blood pressure over 160/90) -Treatment with glucocorticoids within the past week -History of adverse reaction to glucocorticoids in the past -Major systemic illness, including malignancy
Outcome results
None listed