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 |
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.
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
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