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