drugset / Trial / NCT02561039

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

NCT02561039

Phase 3 Completed 97 enrolled Hoffmann-La Roche
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2006-12
Primary completion
2008-03
Completion
2008-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Ibandronate Other / unclassified 6 mg Intravenous
Subject Ibandronate Other / unclassified 50 mg Intravenous