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



Status:Completed
Conditions:Prostate Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:10/20/2018
Start Date:February 1, 2009
End Date:May 3, 2012

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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.


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
We found this trial at
27
sites
Myrtle Beach, South Carolina 29572
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Myrtle Beach, SC
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Albany, NY
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Anaheim, CA
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Bay Shore, NY
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Burien, WA
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Calgary,
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Dallas, TX
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East Providence, Rhode Island 02915
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East Providence, RI
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Fort Wayne, IN
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Garden City, NY
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Greenbelt, MD
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Huntsville, AL
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Laguna Hills, CA
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Lancaster, PA
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Long Beach, CA
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Middlebury, CT
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New Britain, CT
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Omaha, NE
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Poughkeepsie, NY
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Salem, VA
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San Bernardino, California 92408
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San Bernardino, CA
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San Diego, CA
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Santa Monica, CA
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Sartell, MN
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Seattle, WA
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Tacoma, WA
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Trinity, FL
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