CompletedPhase 4ACTRN12615000794505

A randomized controlled trial to assess the effect of dexamethasone on the incidence of the acute phase response following treatment with zoledronic acid

In persons receiving treatment with zoledronic acid for fracture prevention or Paget's disease, does the administration of oral dexamethasone, compared to placebo, reduce the incidence of acute phase response?

Sponsor

Bone & Joint Research Group, University of Auckland

Enrollment

40 participants

Start Date

Sep 17, 2015

Study Type

Interventional

Conditions

Paget's disease Metabolic bone disease Osteoporosis

Summary

The aim of this study is to determine whether the daily temperature profile of patients receiving a zoledronic acid infusion is improved by the administration of oral dexamethasone at the time of infusion, compared to placebo. The study will also assess whether there is a decreased incidence and/or severity of symptoms of acute phase response (APR) with oral dexamethasone compared to placebo. This is a prospective randomized-controlled trial of 40 individuals undergoing treatment with zoledronic acid for fracture prevention or Paget’s disease. Individuals meeting inclusion criteria will be randomly and equally allocated to receive either dexamethasone 4mg orally or a placebo tablet at the time of zoledronic acid infusion. Incidence and severity of the acute phase response, determined via assessment of symptoms and temperature, will be compared between groups. At baseline, each participant will undergo oral temperature measurement and will complete a questionnaire relating to symptoms of APR. Daily assessments will continue for 3 days following the intervention. .Fifteen days after the intervention, participants will receive another phone call to inquire about ongoing symptoms.

Eligibility

Sex: Both males and femalesMin Age: 20 Yearss

Inclusion Criteria2

Females or males aged 20 or older.
Prescribed zoledronic acid for the first time for fracture prevention or Paget's disease.

Exclusion Criteria6

Prior treatment with zoledronic acid.
History of fever, infection, or influenza-like illness within the past week.
Diabetes mellitus or uncontrolled hypertension (BP >160/90)
Treatment with glucocorticoids within the past week.
History of adverse reaction to glucocorticoids.
Major systemic illness, including malignancy.

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Interventions

A single dose of dexamethasone 4mg will be given as an oral tablet at the same time that the zoledronic acid infusion is started. Zoledronic acid is conventionally given as a dose of 5mg intraveno

A single dose of dexamethasone 4mg will be given as an oral tablet at the same time that the zoledronic acid infusion is started. Zoledronic acid is conventionally given as a dose of 5mg intravenously over 15 minutes. However, it may also be given as a dose of 2.5mg over 30-45 minutes in patients with mild renal impairment. The decision regarding dose and duration of zoledronic acid infusion will be made by the treating physician prior to study enrollment. To facilitate data collection, participants will receive telephone calls from a study investigator one day, four days, and fifteen days following this intervention.