Trial information
A Study of Bondronat (Ibandronate) in Patients With Metastatic Bone Disease.
Status: Completed
Protocol number: ML20034
Sponsor: Grupo Roche Syntex de Mexico
Company division: Pharmaceutical
Official Scientific Title: An open-label study to evaluate the effect of a loading dose followed by a maintenance dose of Bondronat on pain relief in patients with bone pain secondary to metastatic bone disease.
Brief summary: This study will assess the efficacy and safety of a loading dose followed by a maintenance dose of Bondronat in patients with malignant bone disease and moderate to severe bone pain. Patients will receive Bondronat as a 6mg iv infusion on 3 consecutive days followed by Bondronat 50mg po daily.Each patient willhave a follow-up of 6 months after receiving the first dose of Bondronat. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is
150.
Study phase: III
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. Proportion of patients with >=25% pain relief after loading dose.
Key secondary outcomes: 1. Efficacy: Magnitude and duration of pain during maintenance phase; improvement in QoL, measured by SF-36. Safety: Adverse events, laboratory parameters.
Inclusion criteria:
- adult patients, >=18 years of age;
- confirmed cancer with >=1 bone or mixed bone lesion;
- inadequately controlled bone pain associated with metastatic bone disease;
- stable chemotherapy, immunochemotherapy and hormone therapy during previous 30 days;
- ECOG I-III.
Exclusion criteria:
- treatment with bisphosphonates or gallium nitrate during previous 3 weeks;
- known hypersensitivity to other bisphosphonates;
- bone surgery or bone radiotherapy during previous 30 days;
- gastritis, esophagitis or untreated gastric ulcer;
- change in antitumoral therapy planned in next 30 days following study entry;
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 09/18/2006
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
Mexico
