A Study of Ibandronate (Bondronat) in Participants With Malignant Bone Disease

Pain; Bone Neoplasms; Neoplasm Metastasis Clinical Trial

Official title: Randomized, Open Label Study to Assess the Efficacy and Safety of the Intravenous and Oral Ibandronic Acid for Improving the Performance Status of Patients With Malignant Bone Disease Secondary to Solid Tumors and Hematological Malignancies

Status Completed

Clinical Trial Summary

This study will assess the efficacy and safety of ibandronate (Bondronat), administered intravenously (IV) or orally (PO), in participants with malignant bone disease and moderate to severe pain. Participants will be randomized to receive ibandronate either as a 6-mg IV infusion every 3 to 4 weeks or a 50-mg tablet PO daily. Pain response and Karnofsky Performance Index (KPI) will be measured at intervals throughout the study. The anticipated time on study treatment is 4 months and the target sample size is 150 individuals.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

• NCT number: NCT02561039
• Study type: Interventional
• Source: Hoffmann-La Roche
• Status: Completed
• Phase: Phase 3
• Start date: December 2006
• Completion date: March 2008