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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
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.
Age
18 - No limit years
Sex
MALE
Healthy Volunteers
No
Research Site
Huntsville, Alabama, United States
Research Site
Anaheim, California, United States
Research Site
Laguna Hills, California, United States
Research Site
Long Beach, California, United States
Research Site
San Bernardino, California, United States
Research Site
San Diego, California, United States
Research Site
San Diego, California, United States
Research Site
Santa Monica, California, United States
Research Site
Middlebury, Connecticut, United States
Research Site
New Britain, Connecticut, United States
Start Date
February 1, 2009
Primary Completion Date
May 3, 2012
Completion Date
May 3, 2012
Last Updated
October 18, 2018
384
ACTUAL participants
Denosumab
DRUG
Lead Sponsor
Amgen
NCT06696768
NCT06498635
Data Source & Attribution
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