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

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
First received: October 15, 2008
Last updated: April 23, 2012
Last verified: April 2012

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 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Novartis:

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. [ Time Frame: at the end of 3 months and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The percent change from baseline in total Serum Alkaline Phosphatase (SAP). [ Time Frame: at the end of 3 months and 6 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: October 2008
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Zoledronic acid
5mg, i.v. single dose


Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00774020

Novartis Investigative Site
Beijing, China
Novartis Investigative site
Guangzhou, China
Novartis Investigative site
Nanjing, China
Novartis Investigative site
Shanghai, China
Sponsors and Collaborators
Novartis Pharmaceuticals
Principal Investigator: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00774020     History of Changes
Other Study ID Numbers: CZOL446K2419
Study First Received: October 15, 2008
Last Updated: April 23, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Novartis:
Paget's Disease of Bone
Serum Alkaline Phosphatase

Additional relevant MeSH terms:
Bone Diseases
Osteitis Deformans
Musculoskeletal Diseases
Zoledronic acid
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014