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
135
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from 43215
Fort Wayne, IN
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513
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from 43215
Albany, NY
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1962
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Anaheim, CA
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517
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from 43215
Bay Shore, NY
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2007
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from 43215
Burien, WA
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1670
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from 43215
Calgary,
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910
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from 43215
Dallas, TX
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East Providence, Rhode Island 02915
621
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from 43215
East Providence, RI
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496
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from 43215
Garden City, NY
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334
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from 43215
Greenbelt, MD
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410
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from 43215
Huntsville, AL
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1956
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from 43215
Laguna Hills, CA
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353
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from 43215
Lancaster, PA
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1975
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from 43215
Long Beach, CA
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528
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from 43215
Middlebury, CT
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Myrtle Beach, South Carolina 29572
487
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from 43215
Myrtle Beach, SC
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547
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from 43215
New Britain, CT
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682
mi
from 43215
Omaha, NE
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490
mi
from 43215
Poughkeepsie, NY
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243
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from 43215
Salem, VA
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San Bernardino, California 92408
1919
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from 43215
San Bernardino, CA
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1951
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from 43215
San Diego, CA
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1985
mi
from 43215
Santa Monica, CA
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687
mi
from 43215
Sartell, MN
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2005
mi
from 43215
Seattle, WA
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2012
mi
from 43215
Tacoma, WA
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?
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from 43215
Trinity, FL
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