Trial Information
An Open Label Study to Assess the Effect of Intravenous Loading Doses of Bondronat on Metastatic Bone Pain in Patients With Breast Cancer and Skeletal Metastases.
Inclusion Criteria:
- adult patients, >=18 years of age;
- breast cancer;
- bone metastases;
- mean worst pain score >=4 during 3 day baseline period;
- stable dose of analgesics over a 3 day baseline period;
- adequate renal function.
Exclusion Criteria:
- bisphosphonate treatment within 3 weeks of study enrollment;
- a change in antineoplastic treatment within 6 weeks of study enrollment;
- bone radiation within 2 weeks of study enrollment;
- active infection.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Pain response (20% decrease in mean pain score compared to baseline, and <=50% increase in mean analgesic consumption
Outcome Time Frame:
Days 5 - 7
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Greece: E.O.F. (National drug organization)
Study ID:
ML20247
NCT ID:
NCT00478270
Start Date:
Completion Date:
January 2008
Related Keywords:
- Pain;
- Bone Neoplasms;
- Neoplasm Metastasis
- Bone Neoplasms
- Breast Neoplasms
- Neoplasms
- Neoplasm Metastasis