drugset / Trial / NCT02561039
A Study of Ibandronate (Bondronat) in Participants With Malignant Bone Disease
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ibandronate | Other / unclassified | 6 mg | Intravenous |
| Subject | Ibandronate | Other / unclassified | 50 mg | Intravenous |