Overview
A Study of Ibandronate (Bondronat) in Participants With Malignant Bone Disease
Status:
Completed
Completed
Trial end date:
2008-03-01
2008-03-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Hoffmann-La RocheTreatments:
Diphosphonates
Ibandronic Acid
Criteria
Inclusion Criteria:- Adults at least 18 years of age
- Malignant bone disease due to multiple myeloma or cancer of the lung, prostate,
gastrointestinal (GI) tract, ovary, or bladder
- Bone pain defined as a Brief Pain Inventory (BPI) most acute pain score greater than
or equal to 4
- Radiologically confirmed bone disease disease
Exclusion Criteria:
- Previous treatment with ibandronate (Bondronat) within previous 2 months
- Severely impaired renal function
- Known brain metastases