Extension Study to Evaluate Long Term Safety of Denosumab in Subjects Undergoing ADT for Non-Metastatic Prostate Cancer
NCT ID: NCT00838201
Last Updated: 2018-10-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
384 participants
INTERVENTIONAL
2009-02-01
2012-05-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm 1
Denosumab
60 mg SC of Denosumab will be administered on study day 1, month 6, month 12, and month 18
Interventions
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Denosumab
60 mg SC of Denosumab will be administered on study day 1, month 6, month 12, and month 18
Eligibility Criteria
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Inclusion Criteria
* Subjects must sign the informed consent before any study specific procedures are performed.
Exclusion Criteria
* 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
18 Years
MALE
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Huntsville, Alabama, United States
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Anaheim, California, United States
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Laguna Hills, California, United States
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Long Beach, California, United States
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San Bernardino, California, United States
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San Diego, California, United States
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San Diego, California, United States
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Santa Monica, California, United States
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Middlebury, Connecticut, United States
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New Britain, Connecticut, United States
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Trinity, Florida, United States
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Fort Wayne, Indiana, United States
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Greenbelt, Maryland, United States
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Sartell, Minnesota, United States
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Omaha, Nebraska, United States
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Albany, New York, United States
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Bay Shore, New York, United States
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Garden City, New York, United States
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Poughkeepsie, New York, United States
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Lancaster, Pennsylvania, United States
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East Providence, Rhode Island, United States
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Myrtle Beach, South Carolina, United States
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Dallas, Texas, United States
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Salem, Virginia, United States
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Burien, Washington, United States
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Seattle, Washington, United States
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Tacoma, Washington, United States
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Calgary, Alberta, Canada
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Kelowna, British Columbia, Canada
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Surrey, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Victoria, British Columbia, Canada
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Victoria, British Columbia, Canada
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Barrie, Ontario, Canada
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Brantford, Ontario, Canada
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Burlington, Ontario, Canada
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Burlington, Ontario, Canada
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Greater Sudbury, Ontario, Canada
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Guelph, Ontario, Canada
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Kingston, Ontario, Canada
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Kitchener, Ontario, Canada
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London, Ontario, Canada
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Markham, Ontario, Canada
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Newmarket, Ontario, Canada
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North Bay, Ontario, Canada
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North York, Ontario, Canada
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Oakville, Ontario, Canada
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Oshawa, Ontario, Canada
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Scarborough Village, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Greenfield Park, Quebec, Canada
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Montreal, Quebec, Canada
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Seinäjoki, , Finland
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Tampere, , Finland
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Balatonfüred, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Győr, , Hungary
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Nyíregyháza, , Hungary
Research Site
Mexico City, Distrito F, Mexico
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Mexico City, Distrito F, Mexico
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Toluca, , Mexico
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Veracruz, , Mexico
Research Site
Bialystok, , Poland
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Bydgoszcz, , Poland
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Lublin, , Poland
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Lublin, , Poland
Research Site
Opole, , Poland
Research Site
Siedlce, , Poland
Research Site
Warsaw, , Poland
Research Site
Warsaw, , Poland
Research Site
Wroclaw, , Poland
Countries
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20080537
Identifier Type: -
Identifier Source: org_study_id
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