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A Study to Assess the Efficacy of Intravenous/Oral Bondronat (Ibandronate) in Patients With Metastatic Bone Disease Experiencing Moderate to Severe Pain

NCT00099177 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2017-08-16

No results posted yet for this study

Summary

This 2 arm study will compare the efficacy of a regimen of intravenous (iv) and oral Bondronat with that of zoledronic acid in patients with malignant bone disease experiencing moderate to severe pain. Patients will be randomized to receive either Bondronat (6mg iv on days 1, 2 and 3 followed by Bondronat 5Omg po daily from day 22 to week 24) or zoledronic acid (4mg iv on day 1, and then every 3-4 weeks). The anticipated time of study treatment is 6-12 months, and the target sample size is 100-500 individuals.

Conditions

  • Pain
  • Bone Neoplasm
  • Neoplasm Metastasis

Interventions

DRUG

ibandronate [Bondronat]

6mg iv on days 1-3, and 50mg po from day 22 to week 24

DRUG

zoledronic acid

4mg iv on day 1, and every 3-4 weeks

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2007-12-31
Completion
2007-12-31

Countries

  • United States
  • Argentina
  • Australia
  • Chile
  • Germany
  • Greece
  • Guatemala
  • Hungary
  • Italy
  • Mexico
  • Panama
  • Poland
  • Puerto Rico
  • Russia
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
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 NCT00099177 on ClinicalTrials.gov