Clinical Trial: Re-treatment of Patients With Paget's Disease Using Zoledronic Acid
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: An Open Label, Reclast®/Aclasta®, Re-treatment of Relapsed Patients With Paget's Disease of Bone Who Participated in the CZOL446K2304 and CZOL446K2305 Core Regis
Brief Summary: The purpose of this study is to demonstrate that patients 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 5mg infusion of zoledronic acid.
Detailed Summary: Uncontrolled study
Sponsor: Novartis Pharmaceuticals
Current Primary Outcome: Normalization of total serum alkaline phosphatase within 6 months after a single 5 mg re-treatment dose of zoledronic acid [ Time Frame: 6 months ]
Original Primary Outcome: Normalization of total serum alkaline phosphates within 6 months after a single 5 mg re-treatment dose
Current Secondary Outcome:
- Collect information pertaining to relapse diagnosis to define retreatment guidelines for Paget's disease [ Time Frame: 6 months ]
- Changes in SAP levels relative to baseline [ Time Frame: 3 & 6 months ]
- Collect adverse events profile for re-treated patients [ Time Frame: 6 months ]
Original Secondary Outcome:
- Collect information pertaining to relapse diagnosis to define guidelines for Paget's disease
- Changes in SAP levels at 3 and 6 months post re-treatment
- Collect adverse events profile for re-treated patients
Information By: Novartis
Dates:
Date Received: August 21, 2008
Date Started: October 2008
Date Completion:
Last Updated: November 15, 2016
Last Verified: April 2013
