Clinical Trials Directory

Trials / Completed

CompletedNCT00838201

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

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

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
384 (actual)
Sponsor
Amgen · Industry
Sex
Male
Age
18 Years
Healthy volunteers
Not accepted

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 adverse events, immunogenicity, and safety laboratory parameters in subjects who previously received denosumab for non-metastatic prostate cancer.

Conditions

Interventions

TypeNameDescription
DRUGDenosumab60 mg SC of Denosumab will be administered on study day 1, month 6, month 12, and month 18

Timeline

Start date
2009-02-01
Primary completion
2012-05-03
Completion
2012-05-03
First posted
2009-02-06
Last updated
2018-10-18
Results posted
2013-09-24

Locations

74 sites across 6 countries: United States, Canada, Finland, Hungary, Mexico, Poland

Source: ClinicalTrials.gov record NCT00838201. Inclusion in this directory is not an endorsement.