Trial information
A Study of Loading Doses of Intravenous Bondronat (Ibandronate) in Patients With Breast Cancer and Malignant Bone Disease.
Status: Recruiting
Protocol number: ML20684
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open label study to assess the effect of intravenous loading doses of Bondronat on bone pain in patients with breast cancer and skeletal metastases
Brief summary: This single arm study will assess the efficacy and safety of loading doses of intravenous Bondronat in patients with breast cancer and malignant bone disease experiencing moderate to severe bone pain. Patients will receive an intravenous infusion of 6mg Bondronat on days 1, 2 and 3. The anticipated time on study treatment is 3 months, and the target sample size is <100 individuals. Target sample size is
24.
Study phase: II
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. Pain and analgesic consumption Time frame: Days 1, 7 and 14
Key secondary outcomes: 1. AEs and laboratory parameters Time frame: Days 1, 4 and 7
2. Serum creatinine Time frame: Days 1, 4 and 7
3. Karnofsky index Time frame: Day 7
Inclusion criteria:
- female patients, >=18 years of age;
- breast cancer;
- bone metastases;
- moderate to severe pain;
- adequate renal function.
Exclusion criteria:
- bisphosphonate treatment within 3 weeks of study enrollment.
Gender: Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: October, 2007
Trial registration date: 07/19/2007
Date last updated: 11/21/2008
Link to trial result
This trial is being conducted at the following locations:
Turkey
