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 - Full Text View

Sponsor:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00838201

Purpose

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.

Condition	Intervention	Phase
Cancer Carcinoma Castrate-Resistant Prostate Cancer Prostate Cancer Tumors	Drug: Denosumab	Phase III

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety Study
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Denosumab

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:

adverse event incidence, serious adverse event incidence, changes in safety laboratory analytes (ie, serum chemistry) and incidence of anti-denosumab antibody formation in subjects previously treated with denosomuab [ Time Frame: 5 years of treatment on denosumab ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

adverse event incidence, serious adverse event incidence, changes in safety laboratory analytes (ie, serum chemistry) and incidence of anti-denosumab antibody formation in subjects previously treated with denosomuab [ Time Frame: 2 years of treatment on denosumab ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	800
Study Start Date:	February 2009
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Denosumab 60 mg SC of Denosumab will be administered on study day 1, month 6, month 12, and month 18

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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:

Developed sensitivity to mammalian cell derived drug products during the Amgen 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00838201

Contacts

Contact: Amgen Call Center

866-572-6436

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Locations

United States, Alabama
Research Site	Recruiting
Huntsville, Alabama, United States
United States, California
Research Site	Recruiting
Santa Monica, California, United States
Research Site	Recruiting
San Bernardino, California, United States
Research Site	Completed
San Diego, California, United States
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Long Beach, California, United States
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Anaheim, California, United States
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Laguna Hills, California, United States
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San Diego, California, United States
United States, Connecticut
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Middlebury, Connecticut, United States
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New Britain, Connecticut, United States
United States, Florida
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Trinity, Florida, United States
United States, Indiana
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Fort Wayne, Indiana, United States
United States, Maryland
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Greenbelt, Maryland, United States
United States, Minnesota
Research Site	Recruiting
Sartell, Minnesota, United States
United States, Nebraska
Research Site	Recruiting
Omaha, Nebraska, United States
United States, New York
Research Site	Recruiting
Garden City, New York, United States
Research Site	Recruiting
Albany, New York, United States
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Bay Shore, New York, United States
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Poughkeepsie, New York, United States
United States, Pennsylvania
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Lancaster, Pennsylvania, United States
United States, Rhode Island
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Providence, Rhode Island, United States
United States, South Carolina
Research Site	Recruiting
Myrtle Beach, South Carolina, United States
United States, Texas
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Dallas, Texas, United States
United States, Virginia
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Salem, Virginia, United States
United States, Washington
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Burien, Washington, United States
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Tacoma, Washington, United States
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Seattle, Washington, United States
Canada, Alberta
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Calgary, Alberta, Canada
Canada, British Columbia
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Vancouver, British Columbia, Canada
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Victoria, British Columbia, Canada
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Surrey, British Columbia, Canada
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Kelowna, British Columbia, Canada
Canada, Ontario
Research Site	Recruiting
Toronto, Ontario, Canada
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North York, Ontario, Canada
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Burlington, Ontario, Canada
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North Bay, Ontario, Canada
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Kitchener, Ontario, Canada
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Barrie, Ontario, Canada
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Oakville, Ontario, Canada
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Brantford, Ontario, Canada
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Markham, Ontario, Canada
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Kingston, Ontario, Canada
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Sudbury, Ontario, Canada
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Oshawa, Ontario, Canada
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Guelph, Ontario, Canada
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Newmarket, Ontario, Canada
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London, Ontario, Canada
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Scarborough, Ontario, Canada
Canada, Quebec
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Montreal, Quebec, Canada
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Greenfield Park, Quebec, Canada
Czech Republic
Research Site	Recruiting
Olomouc, Czech Republic
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Brno, Czech Republic
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Jindrichuv, Czech Republic
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Praha 6, Czech Republic
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Praha 2, Czech Republic
Finland
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Seinajoki, Finland
Hungary
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Balatonfured, Hungary
Research Site	Recruiting
Budapest, Hungary
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Gyor, Hungary
Netherlands
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Winterswijk, Netherlands
Research Site	Recruiting
Tilburg, Netherlands
Poland
Research Site	Recruiting
Wroclaw, Poland
Research Site	Recruiting
Bialystok, Poland
Research Site	Recruiting
Warszawa, Poland
Research Site	Recruiting
Siedlce, Poland
Research Site	Recruiting
Lublin, Poland

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20080537
Study First Received:	February 5, 2009
Last Updated:	November 19, 2009
ClinicalTrials.gov Identifier:	NCT00838201 History of Changes
Health Authority:	Canada: Health Canada; Mexico: Ministry of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration

Keywords provided by Amgen:

Androgen deprivation therapy for non-metastatic prostate cancer

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Genital Neoplasms, Male
Prostatic Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Genital Diseases, Male
Hormones

Pharmacologic Actions
Carcinoma
Neoplasms
Neoplasms by Site
Prostatic Neoplasms
Neoplasms, Glandular and Epithelial
Androgens

ClinicalTrials.gov processed this record on November 27, 2009