Trial information
A Study to Assess the Efficacy of Oral Bondronat (Ibandronate) in Patients With Metastatic Bone Disease Due to Breast Cancer
Status: Completed
Protocol number: MO16777
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of the effect of Bondronat compared with zoledronic acid on bone turnover, bone resorption, and bone formation in patients with metastatic bone disease from breast cancer
Brief summary: This study will evaluate the efficacy of orally administered Bondronat and that of zoledronic acid administered intravenously (iv) in patients with metastatic bone disease due to breast cancer. The study will assess effects of the drugs on bone turnover. The anticipated time of study treatment is 3-6 months, and the target sample size is 100-500 individuals.
Target sample size is
250.
Study phase: IV
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. Biochemical markers of bone turnover: bone resorption, bone formation, and other measurements
Key secondary outcomes: 1. Efficacy: Bone pain and analgesic consumption, WHO performance status, treatment of bone pain with radiotherapy.
Safety: Renal safety, adverse events, and laboratory values.
Pharmacodynamics: Biochemical markers of bone turnover
Inclusion criteria:
- female patients >=18 years of age;
- histologically confirmed breast cancer;
- >=1 radiologically confirmed bone lesion (<=6 months before screening);
- stable anticancer therapy for >=1 month before beginning study medication.
Exclusion criteria:
- previous treatment with bisphosphonate or gallium nitrate within the last 4 months;
- history of brain metastases;
- administration of any investigational drug within 30 days preceding the first dose of study drug;
- pregnant or breast-feeding females;
- patients who have received recent bone surgery or radiotherapy to bone, or who have bone radiotherapy scheduled within 2 weeks of beginning study medication;
- patients who have received previous radionuclide therapy (within 4 months of beginning study medication);
- high-dose chemotherapy within 6 months of beginning study medication;
- patients with untreated esophagitis or gastric ulcers.
Gender: Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 04/05/2005
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
Australia
Belgium
Germany
- Ahlen
- Bonn
- Stuttgart
- Trier
Netherlands
Russian Federation
- Kazan
- Moscow
- St Petersburg
Switzerland
United Kingdom
- Edinburgh
- Manchester
- Newcastle upon Tyne
- Sheffield
