Trial information
A Study of Bondronat (Ibandronate) in Elderly Patients With Bone Metastases.
Status: Terminated
Protocol number: ML18107
Sponsor: F. Hoffmann-La Roche Ltd
Company division: Pharmaceutical
Official Scientific Title: A randomized, open label study to evaluate the effect of oral and intravenous Bondronat on pain response in elderly patients with bone metastases from different tumor types
Brief summary: This study will assess the efficacy and safety of Bondronat in the treatment of bone metastases in elderly patients with different metastatic tumor types. Patients will be randomized to receive Bondronat in one of two regimens; group A will receive a loading dose of 6mg iv Bondronat on days 1, 2 and 3 and 6mg iv every 3-4 weeks until week 24, and group B will receive a loading dose of 6mg iv Bondronat on days 1, 2 and 3, then 50mg/day po after 3-4 weeks until week 24. Pain response will be measured throughout the study. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals. Target sample size is
100.
Study phase: II
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% decrease in mean pain score over a 7 day period, with <=15% increase in mean analgesic consumption).
Key secondary outcomes: 1. Efficacy: Pain response, as determined by Average Pain scale; time to pain response; duration of pain response; analgesic consumption. Safety: AEs, lab parameters, renal safety.
Inclusion criteria:
- elderly patients, >=70 years of age;
- neoplastic disease (breast cancer, hormone-refractory prostate cancer, lung cancer and all other solid tumors);
- presence of documented bone metastases;
- bone pain corresponding to areas of bone metastases;
- use of at least a weak opioid.
Exclusion criteria:
- patients with an impending pathological fracture;
- known symptomatic CNS or meningeal metastases;
- patients who have received a bisphosphonate within 3 weeks of the start of screening.
Gender: Males or Females
Age limits: Min: 70 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 08/16/2006
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
Italy
