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

October 17, 2018 updated by: Amgen

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

384

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2V 1P9
        • Research Site
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 2H4
        • Research Site
      • Surrey, British Columbia, Canada, V3V 1N1
        • Research Site
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Research Site
      • Victoria, British Columbia, Canada, V8T 5G1
        • Research Site
      • Victoria, British Columbia, Canada, V8V 3N1
        • Research Site
    • Ontario
      • Barrie, Ontario, Canada, L4M 7G1
        • Research Site
      • Brantford, Ontario, Canada, N3R 4N3
        • Research Site
      • Burlington, Ontario, Canada, L7N 3V2
        • Research Site
      • Burlington, Ontario, Canada, L7S 1V2
        • Research Site
      • Guelph, Ontario, Canada, N1H 5J1
        • Research Site
      • Kingston, Ontario, Canada, K7L 3J7
        • Research Site
      • Kitchener, Ontario, Canada, N2N 2B9
        • Research Site
      • London, Ontario, Canada, N6A 4G5
        • Research Site
      • Markham, Ontario, Canada, L6B 1A1
        • Research Site
      • Newmarket, Ontario, Canada, L3X 1W1
        • Research Site
      • North Bay, Ontario, Canada, P1B 7K8
        • Research Site
      • North York, Ontario, Canada, M2J 1V1
        • Research Site
      • Oakville, Ontario, Canada, L6H 3P1
        • Research Site
      • Oshawa, Ontario, Canada, L1H 7K4
        • Research Site
      • Scarborough, Ontario, Canada, M1P 2T7
        • Research Site
      • Sudbury, Ontario, Canada, P3E 4T3
        • Research Site
      • Toronto, Ontario, Canada, M4N 3M5
        • Research Site
      • Toronto, Ontario, Canada, M2J 1V1
        • Research Site
      • Toronto, Ontario, Canada, M6A 3B5
        • Research Site
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H3
        • Research Site
      • Montreal, Quebec, Canada, H3G 1A4
        • Research Site
  • Finland
      • Seinajoki, Finland, 60220
        • Research Site
      • Tampere, Finland, 33520
        • Research Site
  • Hungary
      • Balatonfured, Hungary, 8230
        • Research Site
      • Budapest, Hungary, 1204
        • Research Site
      • Budapest, Hungary, 1036
        • Research Site
      • Gyor, Hungary, 9023
        • Research Site
      • Nyiregyhaza, Hungary, 4400
        • Research Site
  • Mexico
      • Toluca, Mexico, 50120
        • Research Site
      • Veracruz, Mexico, 91700
        • Research Site
    • Distrito F
      • Mexico City, Distrito F, Mexico, 07760
        • Research Site
      • Mexico City, Distrito F, Mexico, 14140
        • Research Site
  • Poland
      • Bialystok, Poland, 15-276
        • Research Site
      • Bydgoszcz, Poland, 85-171
        • Research Site
      • Lublin, Poland, 20-718
        • Research Site
      • Lublin, Poland, 20-954
        • Research Site
      • Opole, Poland, 45-086
        • Research Site
      • Siedlce, Poland, 08-110
        • Research Site
      • Warszawa, Poland, 02-781
        • Research Site
      • Warszawa, Poland, 00-416
        • Research Site
      • Wroclaw, Poland, 50-088
        • Research Site
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Research Site
    • California
      • Anaheim, California, United States, 92801
        • Research Site
      • Laguna Hills, California, United States, 92653
        • Research Site
      • Long Beach, California, United States, 90813
        • Research Site
      • San Bernardino, California, United States, 92404
        • Research Site
      • San Diego, California, United States, 92120
        • Research Site
      • San Diego, California, United States, 92103
        • Research Site
      • Santa Monica, California, United States, 90404
        • Research Site
    • Connecticut
      • Middlebury, Connecticut, United States, 06762
        • Research Site
      • New Britain, Connecticut, United States, 06052
        • Research Site
    • Florida
      • Trinity, Florida, United States, 34655
        • Research Site
    • Indiana
      • Fort Wayne, Indiana, United States, 46825
        • Research Site
    • Maryland
      • Greenbelt, Maryland, United States, 20770
        • Research Site
    • Minnesota
      • Sartell, Minnesota, United States, 56377
        • Research Site
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Research Site
    • New York
      • Albany, New York, United States, 12208
        • Research Site
      • Bay Shore, New York, United States, 11706
        • Research Site
      • Garden City, New York, United States, 11530
        • Research Site
      • Poughkeepsie, New York, United States, 12601
        • Research Site
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17604
        • Research Site
    • Rhode Island
      • East Providence, Rhode Island, United States, 02914
        • Research Site
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Research Site
    • Texas
      • Dallas, Texas, United States, 75231
        • Research Site
    • Virginia
      • Salem, Virginia, United States, 24153
        • Research Site
    • Washington
      • Burien, Washington, United States, 98166
        • Research Site
      • Seattle, Washington, United States, 98104
        • Research Site
      • Tacoma, Washington, United States, 98405
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Drug: Denosumab
60 mg SC of Denosumab will be administered on study day 1, month 6, month 12, and month 18

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival Through Month 24
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2009

Primary Completion (Actual)

May 3, 2012

Study Completion (Actual)

May 3, 2012

Study Registration Dates

First Submitted

February 5, 2009

First Submitted That Met QC Criteria

February 5, 2009

First Posted (Estimate)

February 6, 2009

Study Record Updates

Last Update Posted (Actual)

October 18, 2018

Last Update Submitted That Met QC Criteria

October 17, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20080537

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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