drugset / Trial / NCT00051636

Safety and Efficacy Trial With Zoledronic Acid for the Treatment of Paget's Disease of Bone, Including an Extended Observation Period

NCT00051636

Phase 3 Completed 172 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The core study looked at the effect of Zoledronic Acid given once as an intravenous (i.v.) infusion compared to 60 days of oral Risedronate in patients with Paget's disease of bone. The effect was demonstrated in the reduction of serum alkaline phosphatase (SAP). The extended observation period included participants of the core study who responded to treatment.

Timeline

Start
2001-01
Primary completion
2004-03
Completion
2011-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Risedronate Small molecule 30 mg Oral
Subject Zoledronic acid Other / unclassified 5 mg Intravenous

Indications