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
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Female
Pain; Bone Neoplasms; Neoplasm Metastasis
Female
Pain; Bone Neoplasms; Neoplasm Metastasis
Trial Information
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
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.
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 and analgesic consumption
Outcome Time Frame:
Days 1, 7 and 14
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Turkey: Ministry of Health
Study ID:
ML20684
NCT ID:
NCT00502736
Start Date:
January 2008
Completion Date:
March 2009
Related Keywords:
- Pain; Bone Neoplasms; Neoplasm Metastasis
- Bone Neoplasms
- Breast Neoplasms
- Neoplasms
- Neoplasm Metastasis
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