At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 6 enrolled
Drug / intervention
Zoledronic Aciddrug
Likely dose
Zoledronic Acid 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open Label, Reclast®/Aclasta®, Re-treatment of Relapsed Patients With Paget's Disease of Bone Who Participated in the CZOL446K2304 and CZOL446K2305 Core Registration Studies
In Brief
A Phase 4 clinical trial evaluating Zoledronic Acid for Paget's Disease of the Bone. Completed, enrolled 6 participants across 11 sites in 6 countries.
Detailed Summary
The purpose of this study was to demonstrate that participants with Paget's disease of the bone who had responded to zoledronic acid treatment as participants in the core registration studies CZOL446K2304 and CZOL446K2305 and later experienced a relapse can be successfully treated with a 5 milligram (mg) infusion of zoledronic acid.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPaget's Disease of the Bone
CountriesBelgium, Canada, New Zealand, South Africa, Spain, United Kingdom
Collaborators--
Timeline
Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 2008
Enrollment StartOct 2008
Primary CompletionMar 2011
TodayJul 2026
First PostedAug 22, 2008
Enrollment StartOct 21, 2008
Primary CompletionMar 14, 2011
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 17.9 years ago
Interventions
Zoledronic Aciddrug
Zoledronic acid 5 mg intravenous infusion once