CompletedPhase 2Phase 3ACTRN12608000463370

A randomized double blind placebo controlled trial of zoledronate in the treatment of bone erosions in gout

Zoledronate for prevention of erosive gout


Sponsor

University of Auckland

Enrollment

100 participants

Start Date

Dec 16, 2008

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 90 Yearss

Plain Language Summary

Simplified for easier understanding

This trial tests whether zoledronate (a bone-strengthening infusion) can help repair bone damage caused by gout. It is for adults aged 18-90 who have gout with at least one tophus (a deposit of uric acid crystals) confirmed by a rheumatologist. Participants will receive either zoledronate or a placebo infusion and be monitored for improvements in bone erosions.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Annual administration of intravenous (iv)zoledronate 5mg over 15 minutes for two years

Annual administration of intravenous (iv)zoledronate 5mg over 15 minutes for two years


Locations(1)

New Zealand

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