A Study to Assess the Short Term Efficacy of Intravenous Ibandronate (Bondronat) in Participants With Metastatic Bone Pain Due to Breast Cancer

Pain; Bone Neoplasms; Neoplasm Metastasis Clinical Trial

Official title: Open-Label Study to Establish the Short Term Efficacy of Intravenous Loading-Doses of Bondronat 6 mg in Patients With Breast Cancer and Skeletal Metastases Experiencing Moderate to Severe Pain, Within 7 Days After Initiation of Treatment

Status Completed

Clinical Trial Summary

This study will assess the short term efficacy of ibandronate (6 mg intravenous [IV]) in participants with breast cancer and malignant bone disease, with moderate to severe pain. All participants will receive an IV infusion of ibandronate on Days 1, 2, and 3, and pain response will be measured on Days 1-7. The anticipated time on study treatment is 3 days, and the target sample size is 182 individuals.

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bone Neoplasms
• Neoplasm Metastasis
• Pain; Bone Neoplasms; Neoplasm Metastasis

• NCT number: NCT02553707
• Study type: Interventional
• Source: Hoffmann-La Roche
• Status: Completed
• Phase: Phase 4
• Start date: July 2006
• Completion date: December 2008