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Efficacy and Safety of Single Dose of 5 mg Zoledronic Acid in Chinese Patients With Paget's Disease of Bone (PDB)

Primary Purpose

Paget's Disease of Bone

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Zoledronic acid
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paget's Disease of Bone focused on measuring Paget's Disease of Bone, Serum Alkaline Phosphatase

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Confirmed diagnosis of PDB by radiological reports
  • Serum Alkaline Phosphatase level (SAP) at least two times the upper limit of the normal (ULN)

Exclusion Criteria:

  • 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.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative site
  • Novartis Investigative site
  • Novartis Investigative site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The percent change from baseline in total Serum Alkaline Phosphatase (SAP).
The percent change from baseline in serum cross-linked C-telopeptide of type I collagen (CTX).

Full Information

First Posted
October 15, 2008
Last Updated
February 21, 2017
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00774020
Brief Title
Efficacy and Safety of Single Dose of 5 mg Zoledronic Acid in Chinese Patients With Paget's Disease of Bone (PDB)
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
October 30, 2008 (Actual)
Primary Completion Date
January 14, 2011 (Actual)
Study Completion Date
January 14, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paget's Disease of Bone
Keywords
Paget's Disease of Bone, Serum Alkaline Phosphatase

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Zoledronic acid
Intervention Description
5mg, i.v. single dose
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
The percent change from baseline in total Serum Alkaline Phosphatase (SAP).
Time Frame
at the end of 3 months and 6 months
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed diagnosis of PDB by radiological reports Serum Alkaline Phosphatase level (SAP) at least two times the upper limit of the normal (ULN) Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Novartis Investigative Site
City
Beijing
Country
China
Facility Name
Novartis Investigative site
City
Guangzhou
Country
China
Facility Name
Novartis Investigative site
City
Nanjing
Country
China
Facility Name
Novartis Investigative site
City
Shanghai
Country
China

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of Single Dose of 5 mg Zoledronic Acid in Chinese Patients With Paget's Disease of Bone (PDB)

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