drugset / Trial / NCT02716792

A Study to Evaluate Renal Safety of Intravenous Ibandronate (Bondronat) in Participants With Metastatic Bone Disease Due to Breast Cancer

NCT02716792

Phase 3 Completed 334 enrolled Hoffmann-La Roche
RandomizedParallel-groupOpen-labelTreatment

Summary

This study will evaluate renal function in participants with metastatic bone disease due to breast cancer receiving intravenous (IV) infusions of ibandronate (Bondronat) 6 milligrams (mg), over either 15 minutes or 60 minutes, every 3 weeks. Efficacy and safety of ibandronate in the 2 groups of participants will also be compared. The anticipated time on study treatment is 7 months, and the target sample size is 318 individuals.

Timeline

Start
2006-01
Primary completion
2008-06
Completion
2008-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Ibandronate Other / unclassified 6 mg Intravenous