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A Study to Evaluate the Safety and Efficacy of Zoledronic Acid in the Prevention or Delaying of Bone Metastasis in Patients With Stage IIIA and IIIB Non-small Cell Lung Cancer (NSCLC)

NCT00172042 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 437

Last updated 2015-05-04

Study results available
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Summary

30-40% of patients with lung cancer will develop bone metastases during the course of their disease, which can lead to pain, decreased mobility and skeletal complications. This study will investigate the effect of zoledronic acid on preventing or delaying the development of bone metastases and the impact on disease progression/survival in patients with stage IIIA and IIIB Non-small Cell Lung Cancer (NSCLC).

Conditions

  • Non-Small-Cell Lung Cancer

Interventions

DRUG

Zoledronic acid 4 mg

Zoledronic acid 4 mg in 5 mL concentrated solution prepared with 100 mL calcium free infusion solution (0.9 % sodium chloride or 5% glucose solution).

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2010-05-31
Completion
2010-06-30

Countries

  • Belgium
  • China
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • United Kingdom

Study Locations

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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 NCT00172042 on ClinicalTrials.gov