Trial information
A Study of Bondronat (Ibandronate) as Treatment for Metastatic Bone Pain in Patients With Different Tumor Types
Status: Completed
Protocol number: ML18108
Sponsor: F Hoffman-La Roche Ltd
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of oral Bondronat, intravenous Bondronat, or intravenous zoledronic on pain response in patients with different tumor types
Brief summary: This study will compare the efficacy, safety and effect on quality of life of Bondronat, administered by the oral and intravenous routes, and that of zoledronic acid administered intravenously, in patients with metastatic bone pain. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Target sample size is 210.
Study phase: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Parallel; Safety/Efficacy study
Condition: Pain; Bone Neoplasms; Neoplasm Metastasis
Intervention type: Drug
Intervention name: ibandronate[Bondronat]
Primary outcome: 1. Change in bone pain and analgesic consumption from baseline at week 12
Key secondary outcomes: 1. Treatment of bone pain with radiotherapy at week 12. Safety and tolerability; renal safety. WHO performance status
Inclusion criteria:
- adult patients >=18 years of age;
- neoplastic disease, ie, breast cancer, hormone-refractory prostate cancer, lung cancer, and any other solid malignancy;
- bone metastases;
- pain corresponding with area of bone metastases;
- no change in systemic cancer treatment for >=6 weeks before screening;
- use of at least a weak opioid for pain;
- adequate kidney function.
Exclusion criteria:
- central nervous system or meningeal metastases;
- radiation therapy to bone sites 4 weeks before screening;
- no change in systemic cancer treatment for >=6 weeks before screening;
- receipt of a bisphosphonate within 3 weeks of the screening period.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 12/09/2005
Date last updated: 8/29/2008
Link to trial result
This trial was conducted at the following locations:
Italy
- Sassari
- Torrette di Ancona
