Spots Global Cancer Trial Database for A Study of Ibandronate (Bondronat) in Participants With Malignant Bone Disease
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Trial Identification
Brief Title: A Study of Ibandronate (Bondronat) in Participants With Malignant Bone Disease
Official Title: 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
Study ID: NCT02561039
Interventions
Study Description
Brief 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
, Bourgas, , Bulgaria
, Haskovo, , Bulgaria
, Pleven, , Bulgaria
, Plovdiv, , Bulgaria
, Sofia, , Bulgaria
, Sofia, , Bulgaria
, Varna, , Bulgaria
, Varna, , Bulgaria
, Vratza, , Bulgaria
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_CHAIR
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