Efficacy and Safety of Single Dose of 5 mg Zoledronic Acid in Chinese Patients With Paget's Disease of Bone (PDB)
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
1 other identifier
interventional
9
1 country
4
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Oct 2008
Typical duration for phase_4
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 15, 2008
CompletedFirst Posted
Study publicly available on registry
October 16, 2008
CompletedStudy Start
First participant enrolled
October 30, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 14, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 14, 2011
CompletedFebruary 23, 2017
February 1, 2017
2.2 years
October 15, 2008
February 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
at the end of 3 months and 6 months
Secondary Outcomes (2)
The percent change from baseline in total Serum Alkaline Phosphatase (SAP).
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).
at the end of 3 months and 6 months
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Confirmed diagnosis of PDB by radiological reports
- Serum Alkaline Phosphatase level (SAP) at least two times the upper limit of the normal (ULN)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Novartis Investigative Site
Beijing, China
Novartis Investigative site
Guangzhou, China
Novartis Investigative site
Nanjing, China
Novartis Investigative site
Shanghai, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2008
First Posted
October 16, 2008
Study Start
October 30, 2008
Primary Completion
January 14, 2011
Study Completion
January 14, 2011
Last Updated
February 23, 2017
Record last verified: 2017-02