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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT00838201

Public ClinicalTrials.gov record NCT00838201. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 29, 2026, 10:50 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00838201
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Amgen
Industry
Enrollment
384 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
Male
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 1, 2009 (Actual)
Primary completion
May 3, 2012 (Actual)
Completion
May 3, 2012 (Actual)
Last update posted
Oct 18, 2018

2009 – 2012

United States locations

U.S. sites
27
U.S. states
15
U.S. cities
26
Facility City State ZIP Site status
Research Site Huntsville Alabama 35801 —
Research Site Anaheim California 92801 —
Research Site Laguna Hills California 92653 —
Research Site Long Beach California 90813 —
Research Site San Bernardino California 92404 —
Research Site San Diego California 92103 —
Research Site San Diego California 92120 —
Research Site Santa Monica California 90404 —
Research Site Middlebury Connecticut 06762 —
Research Site New Britain Connecticut 06052 —
Research Site Trinity Florida 34655 —
Research Site Fort Wayne Indiana 46825 —
Research Site Greenbelt Maryland 20770 —
Research Site Sartell Minnesota 56377 —
Research Site Omaha Nebraska 68114 —
Research Site Albany New York 12208 —
Research Site Bay Shore New York 11706 —
Research Site Garden City New York 11530 —
Research Site Poughkeepsie New York 12601 —
Research Site Lancaster Pennsylvania 17604 —
Research Site East Providence Rhode Island 02914 —
Research Site Myrtle Beach South Carolina 29572 —
Research Site Dallas Texas 75231 —
Research Site Salem Virginia 24153 —
Research Site Burien Washington 98166 —
Research Site Seattle Washington 98104 —
Research Site Tacoma Washington 98405 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 47 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00838201, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 18, 2018 · Synced Oct 29, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00838201 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →