Status:
COMPLETED
Efficacy and Safety of Single Dose of 5 mg Zoledronic Acid in Chinese Patients With Paget's Disease of Bone (PDB)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Paget's Disease of Bone
Eligibility:
All Genders
30+ years
Phase:
PHASE4
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).
Eligibility Criteria
Inclusion
- Confirmed diagnosis of PDB by radiological reports
- Serum Alkaline Phosphatase level (SAP) at least two times the upper limit of the normal (ULN)
Exclusion
- History of hypersensitivity to the active substance or to any of the excipients or to any bisphosphonates;
- History of malignancy of any organ system
- Severe liver or bladder disease;
- Calculated creatinine clearance \< 35 mL/min at baseline;
- Hypocalcaemia;
- Patients with pre-existing dental diseases or who predict to have dental surgeries during the study;
- Evidence of vitamin D deficiency.
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
October 30 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 14 2011
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00774020
Start Date
October 30 2008
End Date
January 14 2011
Last Update
February 23 2017
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Investigative Site
Beijing, China
2
Novartis Investigative site
Guangzhou, China
3
Novartis Investigative site
Nanjing, China
4
Novartis Investigative site
Shanghai, China