Extension Study to Evaluate Long Term Safety of Denosumab in Subjects Undergoing ADT for Non-Metastatic Prostate Cancer
The purpose of this study is to describe the safety and tolerability of up to 5 years (ie, 3 years under the 20040138 Amgen study and 2 years on this study) denosumab administration as measured by adverse events, immunogenicity, and safety laboratory parameters in subjects who previously received denosumab for non-metastatic prostate cancer.
Castrate-Resistant Prostate Cancer
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of Denosumab (AMG 162) in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-Metastatic Prostate Cancer|
- Safety endpoints in subjects previously treated with denosumab who receive up to 5 years of denosumab administration. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]Adverse events incidences, serious adverse event incidence, changes in safety laboratory analytes and subject incidence of anti-denosumab antibody formation.
- Safety endpoints in subjects previously treated with placebo who receive up to 2 years of denosumab administration. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]Adverse event incidence, serious adverse event incidence, changes in safety laboratory analytes, and subject incidence of anti-denosumab antibody formation.
|Study Start Date:||February 2009|
|Study Completion Date:||July 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
|Experimental: Arm 1||
60 mg SC of Denosumab will be administered on study day 1, month 6, month 12, and month 18
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