Status:
COMPLETED
Extension Study to Evaluate Long Term Safety of Denosumab in Subjects Undergoing ADT for Non-Metastatic Prostate Cancer
Lead Sponsor:
Amgen
Conditions:
Cancer
Carcinoma
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
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 adv...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 3 2012
Estimated Enrollment :
384 Patients enrolled
Trial Details
Trial ID
NCT00838201
Start Date
February 1 2009
End Date
May 3 2012
Last Update
October 18 2018
Active Locations (74)
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1
Research Site
Huntsville, Alabama, United States, 35801
2
Research Site
Anaheim, California, United States, 92801
3
Research Site
Laguna Hills, California, United States, 92653
4
Research Site
Long Beach, California, United States, 90813