A randomized study investigating whether taking a steroid medication (dexamethasone) for three days reduces the risk of an acute phase response reaction
A randomized controlled trial to assess the effect of a three day course of dexamethasone on the incidence of the acute phase response following treatment with zoledronic acid
Bone & Joint Research Group, University of Auckland
60 participants
May 24, 2021
Interventional
Conditions
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..
Eligibility
Inclusion Criteria2
- Females or males aged greater than or equal to 20 years
- Prescribed zoledronic acid for the first time
Exclusion Criteria7
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
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.
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12621000415808