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Safety and Efficacy Trial With Zoledronic Acid for the Treatment of Paget's Disease of Bone, Including an Extended Observation Period

NCT00103740 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 185

Last updated 2012-06-04

Study results available
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Summary

The primary objective of this core study was to show non-inferiority of zoledronic acid to risedronate, with respect to the proportion of patients who achieved therapeutic response. The extended observation period included participants of the core study who responded to treatment.

Conditions

  • Paget's Disease of Bone

Interventions

DRUG

zoledronic acid

5 mg zoledronic acid in 5 mL of sterile water for infusion

DRUG

placebo to zoledronic acid

5 mL of sterile water for infusion

DRUG

Risedronate

30mg oral tablets overencapsulated to match the placebo capsules

DRUG

Placebo to risedronate

oral capsules

DRUG

Calcium and vitamin D supplements

Calcium and vitamin D supplements were supplied

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-04-30
Primary Completion
2003-12-31
Completion
2011-04-30

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • France
  • Germany
  • New Zealand
  • South Africa
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00103740 on ClinicalTrials.gov