Extension Study to Evaluate Long Term Safety of Denosumab in Subjects Undergoing ADT for Non-Metastatic Prostate Cancer
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
1 other identifier
interventional
384
6 countries
74
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 cancer
Started Feb 2009
74 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 5, 2009
CompletedFirst Posted
Study publicly available on registry
February 6, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 3, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 3, 2012
CompletedResults Posted
Study results publicly available
September 24, 2013
CompletedOctober 18, 2018
September 1, 2018
3.3 years
February 5, 2009
July 23, 2013
October 17, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival Through Month 24
24 months
Study Arms (1)
Arm 1
EXPERIMENTALInterventions
60 mg SC of Denosumab will be administered on study day 1, month 6, month 12, and month 18
Eligibility Criteria
You may qualify if:
- Subjects must be currently participating in the 20040138 Amgen study
- Subjects must sign the informed consent before any study specific procedures are performed.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (74)
Research Site
Huntsville, Alabama, 35801, United States
Research Site
Anaheim, California, 92801, United States
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Laguna Hills, California, 92653, United States
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Long Beach, California, 90813, United States
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San Bernardino, California, 92404, United States
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San Diego, California, 92103, United States
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San Diego, California, 92120, United States
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Santa Monica, California, 90404, United States
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Middlebury, Connecticut, 06762, United States
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New Britain, Connecticut, 06052, United States
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Trinity, Florida, 34655, United States
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Fort Wayne, Indiana, 46825, United States
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Greenbelt, Maryland, 20770, United States
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Sartell, Minnesota, 56377, United States
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Omaha, Nebraska, 68114, United States
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Albany, New York, 12208, United States
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Bay Shore, New York, 11706, United States
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Garden City, New York, 11530, United States
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Poughkeepsie, New York, 12601, United States
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Lancaster, Pennsylvania, 17604, United States
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East Providence, Rhode Island, 02914, United States
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Myrtle Beach, South Carolina, 29572, United States
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Dallas, Texas, 75231, United States
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Salem, Virginia, 24153, United States
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Burien, Washington, 98166, United States
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Seattle, Washington, 98104, United States
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Tacoma, Washington, 98405, United States
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Calgary, Alberta, T2V 1P9, Canada
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Kelowna, British Columbia, V1Y 2H4, Canada
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Surrey, British Columbia, V3V 1N1, Canada
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Vancouver, British Columbia, V5Z 1M9, Canada
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Victoria, British Columbia, V8T 5G1, Canada
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Victoria, British Columbia, V8V 3N1, Canada
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Barrie, Ontario, L4M 7G1, Canada
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Brantford, Ontario, N3R 4N3, Canada
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Burlington, Ontario, L7N 3V2, Canada
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Burlington, Ontario, L7S 1V2, Canada
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Greater Sudbury, Ontario, P3E 4T3, Canada
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Guelph, Ontario, N1H 5J1, Canada
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Kingston, Ontario, K7L 3J7, Canada
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Kitchener, Ontario, N2N 2B9, Canada
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London, Ontario, N6A 4G5, Canada
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Markham, Ontario, L6B 1A1, Canada
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Newmarket, Ontario, L3X 1W1, Canada
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North Bay, Ontario, P1B 7K8, Canada
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North York, Ontario, M2J 1V1, Canada
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Oakville, Ontario, L6H 3P1, Canada
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Oshawa, Ontario, L1H 7K4, Canada
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Scarborough Village, Ontario, M1P 2T7, Canada
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Toronto, Ontario, M2J 1V1, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M6A 3B5, Canada
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Greenfield Park, Quebec, J4V 2H3, Canada
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Montreal, Quebec, H3G 1A4, Canada
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Seinäjoki, 60220, Finland
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Tampere, 33520, Finland
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Balatonfüred, 8230, Hungary
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Budapest, 1036, Hungary
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Budapest, 1204, Hungary
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Győr, 9023, Hungary
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Nyíregyháza, 4400, Hungary
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Mexico City, Distrito F, 07760, Mexico
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Mexico City, Distrito F, 14140, Mexico
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Toluca, 50120, Mexico
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Veracruz, 91700, Mexico
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Bialystok, 15-276, Poland
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Bydgoszcz, 85-171, Poland
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Lublin, 20-718, Poland
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Lublin, 20-954, Poland
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Opole, 45-086, Poland
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Siedlce, 08-110, Poland
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Warsaw, 00-416, Poland
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Warsaw, 02-781, Poland
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Wroclaw, 50-088, Poland
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2009
First Posted
February 6, 2009
Study Start
February 1, 2009
Primary Completion
May 3, 2012
Study Completion
May 3, 2012
Last Updated
October 18, 2018
Results First Posted
September 24, 2013
Record last verified: 2018-09