Study Complete
Sponsor ID
20080537

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

Sponsor ID
20080537
Clinicaltrials.gov ID
NCT00838201
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

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.

Additional Study Details

Phase
Phase 3
Product
denosumab
Type
Interventional
Masking
None (Open Label)
Enrollment
384
Additional Study Details

Protocol Summary

Primary Outcome Measures

Safety endpoints in subjects previously treated with denosumab who receive up to 5 years of denosumab administration.

Timeframe: 24 months

Secondary Outcome Measures

Safety endpoints in subjects previously treated with placebo who receive up to 2 years of denosumab administration.

Timeframe: 24 months

Study Documents

Study Synopsis
Available Language(s): English

Locations

Location
Status
Contact Us
Location
Research Site
Santa Monica, CA, United States, 90404
Status
Recruiting
Location
Research Site
Anaheim, CA, United States, 92801
Status
Recruiting
Location
Research Site
San Bernardino, CA, United States, 92404
Status
Recruiting
Location
Research Site
Dallas, TX, United States, 75231
Status
Completed
Location
Research Site
Omaha, NE, United States, 68114
Status
Recruiting
Location
Research Site
Middlebury, CT, United States, 06762
Status
Recruiting
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