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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00774020 |
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).
Condition | Intervention | Phase |
---|---|---|
Paget's Disease of Bone |
Drug: Zoledronic acid |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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 (PDB) in China |
Estimated Enrollment: | 20 |
Study Start Date: | October 2008 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Zoledronic acid
5mg, i.v. single dose
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Ages Eligible for Study: | 30 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Contact: Novartis Pharmaceuticals | +41 61 324 1111 |
China | |
Novartis Investigative Site | |
Beijing, China | |
Novartis Investigative site | |
Shanghai, China | |
Novartis Investigative site | |
Nanjing, China | |
Novartis Investigative site | |
Guangzhou, China |
Principal Investigator: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CZOL446K2419 |
Study First Received: | October 15, 2008 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00774020 |
Health Authority: | China: State Food and Drug Administration |
Paget's Disease of Bone Serum Alkaline Phosphatase |
Diphosphonates Zoledronic acid Musculoskeletal Diseases Osteitis Deformans |
Osteitis Bone Diseases Pagets disease |
Physiological Effects of Drugs Bone Density Conservation Agents Pharmacologic Actions |