Trial information
A Study of Bondronat (Ibandronate) in Patients With Malignant Bone Disease.
Status: Completed
Protocol number: ML20713
Sponsor: Roche Bulgaria EOOD
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of the effect of intravenous and oral Bondronat on the performance status of patients with malignant bone disease secondary to solid tumors and hematological malignancies
Brief summary: This study will assess the efficacy and safety of Bondronat, administered intravenously or orally, in patients with malignant bone disease and moderate to severe pain. Patients will be randomized to receive Bondronat either as a 6mg iv infusion every 3-4 weeks, or a 50mg tablet daily. Pain response and Karnofsky Performance Status will be measured at intervals throughout the study. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals. Target sample size is
200.
Study phase: III
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Pain; Bone Neoplasms; Neoplasm Metastasis
Intervention type: Drug
Intervention name: ibandronate[Bondronat]
Primary outcome: 1. Pain response (>25% reduction in worst pain score of BPI, <15% increase in analgesic score); change in KPI.
Key secondary outcomes: 1. Efficacy: time to onset of decrease in worst pain score; interference scales of the BPI; analgesic consumption. Safety: AEs, laboratory parameters, renal toxicity.
Inclusion criteria:
- adult patients >= 18 years of age;
- malignant bone disease due to cancer of the lung, prostate, GI tract, ovary, bladder or multiple myeloma;
- bone pain defined as worst pain score on BPI of >=4;
- radiologically confirmed bone disease.
Exclusion criteria:
- previous treatment with Bondronat within last 2 months;
- severely impaired renal function;
- known brain metastases.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 11/16/2006
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
Bulgaria
- Bourgas
- Haskovo
- Pleven
- Sofia
- Varna
- Vratza
