Not Yet RecruitingPhase 4ACTRN12624001403527

A pragmatic, randomised study of treatments to prevent the acute phase response following first zoledronate infusion

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

Sponsor

University of Auckland

Enrollment

180 participants

Start Date

Dec 1, 2024

Study Type

Interventional

Conditions

Osteoporosis

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.

Eligibility

Sex: FemalesMin Age: 60 Yearss

Inclusion Criteria1

Women participating in an extension study of a 10 year study of intermittent zoledronate who received placebo-placebo in the core study (ACTRN12612000270819)

Exclusion Criteria2

Previous use of zoledronate
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)

Interested in this trial?

Get notified about updates and connect with the research team.

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 infus

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