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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00774020
First received: October 15, 2008
Last updated: April 23, 2012
Last verified: April 2012
  Purpose

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

  Eligibility

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
China
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
Investigators
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
Diphosphonates
Zoledronic acid
Bone Density Conservation Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014