Extension Study to Evaluate Long Term Safety of Denosumab in Subjects Undergoing ADT for Non-Metastatic Prostate Cancer
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.
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
- 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
- Jan 31, 2009
- Primary completion
- May 2, 2012
- Completion
- May 2, 2012
- Last update posted
- Oct 17, 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.
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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 17, 2018 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00838201 live on ClinicalTrials.gov.