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Completed

NCT Number: NCT00774020

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

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).

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Key information

Conditions

Paget's Disease of Bone Bone Diseases Musculoskeletal Diseases Osteitis Deformans

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site, Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Zoledronic acid

Drug

5mg, i.v. single dose

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.

    Time frame: at the end of 3 months and 6 months

Secondary outcomes

  1. The percent change from baseline in total Serum Alkaline Phosphatase (SAP).

    Time frame: at the end of 3 months and 6 months

  2. 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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Oct 16, 2008
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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