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 - Tabular View

Tracking Information

First Received Date ^ICMJE

February 5, 2009

Last Updated Date

November 19, 2009

Start Date ^ICMJE

February 2009

Estimated Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

adverse event incidence, serious adverse event incidence, changes in safety laboratory analytes (ie, serum chemistry) and incidence of anti-denosumab antibody formation in subjects previously treated with denosomuab [ Time Frame: 5 years of treatment on denosumab ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00838201 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

adverse event incidence, serious adverse event incidence, changes in safety laboratory analytes (ie, serum chemistry) and incidence of anti-denosumab antibody formation in subjects previously treated with denosomuab [ Time Frame: 2 years of treatment on denosumab ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label, Single Group Assignment, Safety Study

Condition ^ICMJE

Cancer
Carcinoma
Castrate-Resistant Prostate Cancer
Prostate Cancer
Tumors

Intervention ^ICMJE

Drug: Denosumab

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

800

Estimated Completion Date

September 2012

Estimated Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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:

Developed sensitivity to mammalian cell derived drug products during the Amgen 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

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Amgen Call Center

866-572-6436

Location Countries ^ICMJE

United States, Canada, Czech Republic, Finland, Hungary, Netherlands, Poland

Administrative Information

NCT ID ^ICMJE

NCT00838201

Responsible Party

Global Development Leader, Amgen Inc.

Study ID Numbers ^ICMJE

20080537

Study Sponsor ^ICMJE

Amgen

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Amgen

Information Provided By

Amgen

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP