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

Paget's Disease of Bone Clinical Trial

Official title:
Randomized, Double-Blind, Safety and Efficacy Trial With Intravenous Zoledronic Acid for the Treatment of Paget's Disease of Bone Using Risedronate as a Comparator, Including an Extended Observation Period

Status Completed

Clinical Trial Summary

The primary objective of this core study was to show non-inferiority of zoledronic acid to risedronate, with respect to the proportion of patients who achieved therapeutic response. The extended observation period included participants of the core study who responded to treatment.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00103740
Study type	Interventional
Source	Novartis
Contact
Status	Completed
Phase	Phase 3
Start date	April 2002
Completion date	April 2011

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See also
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Completed	`NCT00774020` - Efficacy and Safety of Single Dose of 5 mg Zoledronic Acid in Chinese Patients With Paget's Disease of Bone (PDB)	Phase 4
Completed	`NCT00480662` - A Research Study to Test the Effectiveness of MK0217 in Patients With Paget's Bone Disease (0217-206)(COMPLETED)	Phase 3
Completed	`NCT00051636` - Safety and Efficacy Trial With Zoledronic Acid for the Treatment of Paget's Disease of Bone, Including an Extended Observation Period	Phase 3
Completed	`NCT00306046` - 18F-Fluoride Positron Emission Tomography (PET) in Paget's Disease of Bone	N/A
Active, not recruiting	`NCT02802384` - Pathophysiology of Paget's Disease of Bone