drugset / Trial / NCT00838201

Extension Study to Evaluate Long Term Safety of Denosumab in Subjects Undergoing ADT for Non-Metastatic Prostate Cancer

NCT00838201

Phase 3 Completed 384 enrolled Amgen
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2009-02-01
Primary completion
2012-05-03
Completion
2012-05-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Denosumab Monoclonal antibody 60 mg Subcutaneous