An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety ofDenosumab (AMG162) in the Treatment of Bone Loss in Subjects UndergoingAndrogen-Deprivation Therapy for Non-metastatic Prostate Cancer

Conditions: medical condition should be Bone Loss in patients undergoing androgen-deprivation therapy (ADT) for non-metastatic prostate cancer
MedDRA version: 9.1Level: LLTClassification code 10065687Term: Bone loss
MedDRA version: 9.1Level: LLTClassification code 10060862Term: Prostate cancer

Registration Number: EUCTR2008-006154-17-NL

Lead Sponsor: Amgen Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 803

Inclusion Criteria

Subjects must be currently participating in the 20040138 study

Subjects must sign the informed consent before any study specific procedures
are performed
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To describe the safety and tolerability of up to 5 years (ie, 3 years under study 20040138 and 2 years under study 20080537) denosumab administration as measured by adverse events, immunogenicity, and safety laboratory parameters in subjects who previously received denosumab.;Secondary Objective: To describe the safety and tolerability of up to 2 years denosumab administration as<br>measured by adverse events, immunogenicity, and safety laboratory parameters in<br>subjects who previously received placebo.;Primary end point(s): The primary endpoints are safety endpoints, including adverse event incidence, serious adverse event incidence, changes in safety laboratory analytes (ie, serum chemistry) and subject incidence of anti-denosumab antibody formation in subjects previously treated with denosumab who receive up to 5 years of denosumab administration.

Secondary Outcome Measures