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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-30

Study Completion Date

2011-01-14

Brief Summary

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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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Detailed Description

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Conditions

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Paget's Disease of Bone

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Zoledronic acid

Intervention Type DRUG

5mg, i.v. single dose

Interventions

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Zoledronic acid

5mg, i.v. single dose

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No