A Randomized Active-controlled Study of AMG 162 in Breast Cancer Subjects With Bone Metastasis Who Have Not Previously Been Treated With Bisphosphonate Therapy.
18 Years
N/A
Female
Breast Cancer, Metastases, Bone Metastases in Subjects With Advanced Breast Cancer
Trial Information
A Randomized Active-controlled Study of AMG 162 in Breast Cancer Subjects With Bone Metastasis Who Have Not Previously Been Treated With Bisphosphonate Therapy.
Inclusion Criteria:
- Confirmation of breast cancer - At least one bone metastasisType of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Outcome Measure:
Percent Change From Baseline to Week 13 in uNTx/Cr
Outcome Description:
Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Percent change from baseline to week 13 calculated using ((week 13 value - baseline value) / baseline value ) x 100.
Outcome Time Frame:
Baseline and week 13
Safety Issue:
No
Principal Investigator
MD
Investigator Role:
Study Director
Investigator Affiliation:
Amgen
Authority:
Australia: Human Research Ethics Committee
Study ID:
20040113
NCT ID:
NCT00091832
Start Date:
September 2004
Completion Date:
October 2006
Related Keywords:
- Breast Cancer
- Metastases
- Bone Metastases in Subjects With Advanced Breast Cancer
- Breast Cancer
- Cancer
- Breast Neoplasms
- Neoplasm Metastasis
- Neoplasms, Second Primary
- Bone Neoplasms
- Bone Marrow Diseases
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