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

Randomized, Open Label Study to Assess the Efficacy and Safety of the Intravenous and Oral Ibandronic Acid for Improving the Performance Status of Patients With Malignant Bone Disease Secondary to Solid Tumors and Hematological Malignancies

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.

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