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
1326
mi
from
Bay Shore, NY
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1306
mi
from
Albany, NY
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1157
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from
Anaheim, CA
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1407
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from
Burien, WA
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1214
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from
Calgary,
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349
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from
Dallas, TX
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East Providence, Rhode Island 02915
1425
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from
East Providence, RI
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715
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from
Fort Wayne, IN
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1306
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from
Garden City, NY
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1135
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from
Greenbelt, MD
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660
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from
Huntsville, AL
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1150
mi
from
Laguna Hills, CA
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1163
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from
Lancaster, PA
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1171
mi
from
Long Beach, CA
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1334
mi
from
Middlebury, CT
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Myrtle Beach, South Carolina 29572
1099
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from
Myrtle Beach, SC
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1353
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from
New Britain, CT
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262
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from
Omaha, NE
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1294
mi
from
Poughkeepsie, NY
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971
mi
from
Salem, VA
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San Bernardino, California 92408
1114
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from
San Bernardino, CA
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1143
mi
from
San Diego, CA
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1181
mi
from
Santa Monica, CA
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574
mi
from
Sartell, MN
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1410
mi
from
Seattle, WA
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1407
mi
from
Tacoma, WA
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?
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from
Trinity, FL
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