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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00774020

Enrollment

Registered

2008-10-16

Start date

2008-10-30

Completion date

2011-01-14

Last updated

2017-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paget's Disease of Bone

Keywords

Paget's Disease of Bone, Serum Alkaline Phosphatase

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).

Interventions

DRUGZoledronic acid

5mg, i.v. single dose

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

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/

Design outcomes

Primary

Measure	Time frame
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.	at the end of 3 months and 6 months

Secondary

Measure	Time frame
The percent change from baseline in total Serum Alkaline Phosphatase (SAP).	at the end of 3 months and 6 months
The percent change from baseline in serum cross-linked C-telopeptide of type I collagen (CTX).	at the end of 3 months and 6 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026