None listed
Conditions
Brief summary
This is a two-year, double-blind, randomized, placebo-controlled trial of zoledronate for erosive gout. The study will include 100 participants with tophaceous gout; 50 randomly assigned to annual administration of iv zoledronate 5mg, and 50 assigned to annual administration of placebo (0.9%NaCl). Participants will undergo clinical assessment, laboratory testing and radiographic assessment of bone erosion (by CT and plain radiography) at baseline, and after 1 and 2 years. Zoledronate (5mg) or placebo (0.9% NaCl) will be administered intravenously over 15 minutes during the baseline and year 1 visits. The study duration is 2 years. The primary endpoint will be the change from baseline in total CT erosion score, in the zoledronate group compared to the control group.
Interventions
Annual administration of intravenous (iv)zoledronate 5mg over 15 minutes for two years
Sponsors
University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
A diagnosis of gout, as described by Wallace. At least one tophus, confirmed by a rheumatologist On stable therapy for gout (no change in the last 3 months) Age over 18 years Able to provide informed consent
Exclusion criteria
Prolonged treatment with potent bisphosphonates in the last two years Impaired renal function (creatinine clearance <30 ml/minute) Serum calcium < 2.1mmol/L Serum 25(OH)D < 15ng/ml Allergy to bisphosphonate Pregnancy or breastfeeding Unstable systemic medical condition
Outcome results
None listed