Clinical Trial: Efficacy and Safety of Single Dose of 5 mg Zoledronic Acid in Chinese Patients With Paget's Disease of Bone (PDB)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A 6 Months, Open-Label Phase IV Study to Confirm the Safety and Efficacy of Single Intravenous Dose of 5 mg Zoledronic Acid for the Patients of Paget's Disease of Bone (PD
Brief Summary: The purpose of this study is to document the efficacy and safety profiles of single intravenous dose of 5 mg zoledronic acid for the Chinese patients of Paget's Disease of Bone (PDB).
Detailed Summary:
Sponsor: Novartis Pharmaceuticals
Current Primary Outcome: The proportion of patients who achieve therapeutic response (a reduction of at least 75% from baseline in total Serum Alkaline Phosphatase (SAP) excess or normalization of SAP. [ Time Frame: at the end of 3 months and 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- The percent change from baseline in total Serum Alkaline Phosphatase (SAP). [ Time Frame: at the end of 3 months and 6 months ]
- The percent change from baseline in serum cross-linked C-telopeptide of type I collagen (CTX). [ Time Frame: at the end of 3 months and 6 months ]
Original Secondary Outcome: Same as current
Information By: Novartis
Dates:
Date Received: October 15, 2008
Date Started: October 30, 2008
Date Completion:
Last Updated: February 21, 2017
Last Verified: February 2017
