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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
384

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 3, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 3, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 6, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 18, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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