Trial information
A Study of Intravenous Bondronat (Ibandronate) in Patients With Bone Metastases due to Prostatic Cancer.
Status: Recruiting
Protocol number: ML19981
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open-label study of the effect of Bondronat on bone pain in patients with prostate cancer and bone metastases experiencing moderate to severe pain
Brief summary: This study will evaluate the efficacy of intravenous Bondronat in reducing pain and the use of analgesics in patients experiencing moderate to severe pain from bone metastases from prostate cancer. Patients will receive an intravenous infusion of 6mg Bondronat on days 1, 2 and 3, followed by a 6mg i.v. infusion every 4 weeks for 24 weeks. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals. Target sample size is 30.
Study phase: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Pain; Bone Neoplasms; Neoplasm Metastasis
Intervention type: Drug
Intervention name: ibandronate[Bondronat]
Primary outcome: 1. Pain response at week 13 (>=25% reduction in the worst pain score of the BPI questionnaire, with <=25% increase in analgesic consumption, compared to baseline).
Key secondary outcomes: 1. Efficacy: Pain response at week 25; mean pain response on days 5, 6 and 7; analgesic score; time to pain progression; interference of pain with physical and social functioning. Safety: AEs, laboratory parameters, serum creatinine.
Inclusion criteria:
- male patients, >=18 years of age;
- prostate cancer with documented bone metastases;
- moderate to severe bone pain.
Exclusion criteria:
- previous treatment with bisphosphonates or radionuclides;
- bone surgery within 5 weeks prior to study start;
- impaired renal function.
Gender: Males
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: March, 2006
Trial registration date: 09/18/2006
Date last updated: 8/19/2008
Link to trial result
This trial is being conducted at the following locations:
Macedonia, The Former Yugoslav Republic of
- Ohrid
- Prilep
- Skopje
- Tetovo
