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

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: 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 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: 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