Trial information
A Study to Evaluate Renal Safety of Intravenous Bondronat (ibandronate) in Patients With Metastatic Bone Disease due to Breast Cancer
Status: No longer recruiting
Protocol number: ML19188
Sponsor: Roche SAS
Company division: Pharmaceutical
Official Scientific Title: A randomized, open label study to evaluate the renal safety of Bondronat infusions over 15 minutes or 60 minutes in patients with metastatic bone disease due to breast cancer
Brief summary: This study will evaluate renal function in patients with metastatic bone disease due to breast cancer receiving infusions of Bondronat 6mg iv over either 15 minutes or 60 minutes, every 3 weeks. Efficacy and safety of Bondronat in the 2 groups of patients will also be compared. The anticipated time on study treatment is 6 months and the target sample size is 100-500 individuals. Target sample size is
318.
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. Creatinine clearance 28 days after last infusion
Key secondary outcomes: 1. Renal Safety: Degradation of renal function; renal tolerance up to 6 months. Efficacy: bone pain, bone events, analgesics consumption, Karnofsky index up to 6 months. Safety: AEs.
Inclusion criteria:
- women >=18 years of age;
- breast cancer with >= 1 bone metastasis.
Exclusion criteria:
- bisphosphonate therapy in the 3 weeks before randomization;
- known hypersensitivity to ibandronate or other bisphosphonates
Gender: Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: January, 2006
Trial registration date: 05/04/2006
Date last updated: 12/2/2008
Link to trial result
This trial was conducted at the following locations:
France
- Amboise
- Angers
- Bayonne
- Besancon
- Brest
- Clermont-Ferrand
- Gap
- Hyeres
- Le Chesnay
- Nantes
- Paris
- Rennes
- Rouen
- Saint Brieuc
- Saint Gregoire
- Saint Jean
- Saint-Cloud
- Salouel
- Strasbourg
- Trappes
- Valenciennes
- Vandoeuvre-Les-Nancy
- Villejuif
