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

Amgen1 site in 1 country384 target enrollmentFebruary 1, 2009

ConditionsCancer Carcinoma Castrate-Resistant Prostate Cancer Prostate Cancer Tumors

InterventionsDenosumab

DrugsDenosumab

Overview

Phase: Phase 3
Intervention: Denosumab
Conditions: Cancer
Sponsor: Amgen
Enrollment: 384
Locations: 1
Primary Endpoint: Overall Survival Through Month 24
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

February 1, 2009

End Date

May 3, 2012

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Amgen

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects must be currently participating in the 20040138 Amgen study
•Subjects must sign the informed consent before any study specific procedures are performed.
•Exclusion Criteria
•Subjects with any prior diagnosis of bone metastasis
•Known hypocalcemia
•Developed sensitivity to mammalian cell derived drug products during the 20040138 study
•Currently receiving any investigational product other than denosumab or having received any investigational product during the 20040138 study
•Any disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with study procedures