Trial information
A Study of Intravenous Bondronat (Ibandronate) in Patients With Breast Cancer and Bone Metastasis
Status: Completed
Protocol number: ML17632
Sponsor: Roche Pharma (Switzerland) AG
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of the renal safety of intravenous Bondronat in patients with metastatic bone disease from breast cancer
Brief summary: This study will evaluate the renal safety of intravenous Bondronat in patients with metastatic bone disease resulting from breast cancer. Kidney function and bone pain will be assessed during the study. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Target sample size is 130.
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. Renal safety
Key secondary outcomes: 1. Bone pain, analgesic requirement, WHO performance status, creatinine clearance, markers of tubular and glomerular damage, safety and tolerability
Inclusion criteria:
- women >=18 years of age;
- breast cancer with >=1 bone metastasis;
- good renal function;
- if bisphosphonate therapy is ongoing, last dose must be >=3 weeks before start of study medication.
Exclusion criteria:
- high-dose chemotherapy within past 6 months;
- known hypersensitivity to ibandronate or other bisphosphonates;
- radiation therapy within previous 5 weeks;
- abdominal metastases with renal involvement.
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:
Austria
- Bludesch
- Graz
- Innsbruck
- Klagenfurt
- Salzburg
- Wien
Germany
Switzerland
- Allschwil
- Baden
- Chur
- Genolier
- Locarno
- St Gallen
