Study Complete
Sponsor ID
20040113
Denosumab (AMG 162) in Bisphosphonate Naive Metastatic Breast Cancer
Study Details
This study is to evaluate various doses and schedules for denosumab administration and characterize the safety profile in this indication.
Protocol Summary
Primary Outcome Measures
Percent Change From Baseline to Week 13 in uNTx/Cr
Timeframe: Baseline and week 13
Secondary Outcome Measures
Percent Change From Baseline to Week 25 in uNTx
Timeframe: Baseline and week 25
Achieving 65% or More Reduction in uNTx From Baseline at Week 13
Timeframe: Baseline and week 13
Achieving 65% or More Reduction in uNTX From Baseline at Week 25
Timeframe: Baseline and week 25
Time to 65% or More Reduction in uNTX From Baseline
Timeframe: Baseline and week 57
Percent Change From Baseline to Week 13 in Serum CTX
Timeframe: Baseline and week 13
Percent Change From Baseline to Week 25 in Serum CTX
Timeframe: Baseline and week 25
Percent Change From Baseline to Week 13 in P1NP
Timeframe: Baseline and week 13
Percent Change From Baseline to Week 25 in P1NP
Timeframe: Baseline and week 25
Percent Change From Baseline to Week 13 in TRAP5b
Timeframe: Baseline and week 13
Percent Change From Baseline to Week 25 in TRAP5b
Timeframe: Baseline and week 25
Percent Change From Baseline to Week 13 in BSAP
Timeframe: Baseline and week 13
Percent Change From Baseline to Week 25 in BSAP
Timeframe: Baseline and week 25
Percent Change From Baseline to Week 13 in Osteocalcin
Timeframe: Baseline and week 13
Percent Change From Baseline to Week 25 in Osteocalcin
Timeframe: Baseline and week 25
Time to First Skeletal Related Event
Timeframe: Day 1 and week 25
Skeletal Related Event
Timeframe: Day 1 and week 25
Occurrence of Hypercalcemia
Timeframe: Day 1 and week 57
Study Documents
Study Synopsis
Available Language(s): English
Locations
No locations found.