Trial information
PREFERENCE study - A Study of Oral and Intravenous Bondronat (Ibandronate) in Patients With Breast Cancer and Bone Metastasis
Status: Completed
Protocol number: ML17633
Sponsor: Roche Pharma (Schweiz) AG
Company division: Pharmaceutical
Official Scientific Title: A multidose, randomized, crossover study to evaluate patient preference for oral vs intravenous Bondronat in patients with metastatic bone disease from breast cancer
Brief summary: A study of patient preference between oral and intravenous Bondronat in patients with metastatic bone disease resulting from breast cancer. All patients in the study will undergo a period of treatment with one formulation, then switch to the other formulation for a second period of treatment. Patients will be asked to identify their preferred treatment regimen, and will be evaluated for bone pain and quality of life. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Target sample size is 100.
Study phase: IV
Study type: Interventional; Treatment; Randomized; Open Label; Active; Crossover; Safety/Efficacy study
Condition: Pain; Bone Neoplasms; Neoplasm Metastasis
Intervention type: Drug
Intervention name: ibandronate[Bondronat]
Primary outcome: 1. Questionnaire to evaluate the preferred drug formulation
Key secondary outcomes: 1. Brief Pain Inventory and EORTC QLQ-C30 questionnaire for measurement of quality of life. Safety: adverse events and laboratory tests
Inclusion criteria:
- women >=18 years of age;
- breast cancer with >=1 bone metastasis;
- if bisphosphonate therapy is ongoing, last dose must be >=3 weeks before start of study medication.
Exclusion criteria:
- severe kidney disease;
- known hypersensitivity to ibandronate or other bisphosphonates;
- radiation therapy during last 5 weeks.
Gender: Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 08/26/2005
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
Switzerland
- Aarau
- Baden
- Basel
- Bruderholz
- Chur
- Geneve
- Liestal
- Locarno
- Thun
- Zürich
