Prostate Cancer Clinical Trial
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
Verified date | September 2018 |
Source | Amgen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 384 |
Est. completion date | May 3, 2012 |
Est. primary completion date | May 3, 2012 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Research Site | Barrie | Ontario |
Canada | Research Site | Brantford | Ontario |
Canada | Research Site | Burlington | Ontario |
Canada | Research Site | Burlington | Ontario |
Canada | Research Site | Calgary | Alberta |
Canada | Research Site | Greenfield Park | Quebec |
Canada | Research Site | Guelph | Ontario |
Canada | Research Site | Kelowna | British Columbia |
Canada | Research Site | Kingston | Ontario |
Canada | Research Site | Kitchener | Ontario |
Canada | Research Site | London | Ontario |
Canada | Research Site | Markham | Ontario |
Canada | Research Site | Montreal | Quebec |
Canada | Research Site | Newmarket | Ontario |
Canada | Research Site | North Bay | Ontario |
Canada | Research Site | North York | Ontario |
Canada | Research Site | Oakville | Ontario |
Canada | Research Site | Oshawa | Ontario |
Canada | Research Site | Scarborough | Ontario |
Canada | Research Site | Sudbury | Ontario |
Canada | Research Site | Surrey | British Columbia |
Canada | Research Site | Toronto | Ontario |
Canada | Research Site | Toronto | Ontario |
Canada | Research Site | Toronto | Ontario |
Canada | Research Site | Vancouver | British Columbia |
Canada | Research Site | Victoria | British Columbia |
Canada | Research Site | Victoria | British Columbia |
Finland | Research Site | Seinajoki | |
Finland | Research Site | Tampere | |
Hungary | Research Site | Balatonfured | |
Hungary | Research Site | Budapest | |
Hungary | Research Site | Budapest | |
Hungary | Research Site | Gyor | |
Hungary | Research Site | Nyiregyhaza | |
Mexico | Research Site | Mexico City | Distrito F |
Mexico | Research Site | Mexico City | Distrito F |
Mexico | Research Site | Toluca | |
Mexico | Research Site | Veracruz | |
Poland | Research Site | Bialystok | |
Poland | Research Site | Bydgoszcz | |
Poland | Research Site | Lublin | |
Poland | Research Site | Lublin | |
Poland | Research Site | Opole | |
Poland | Research Site | Siedlce | |
Poland | Research Site | Warszawa | |
Poland | Research Site | Warszawa | |
Poland | Research Site | Wroclaw | |
United States | Research Site | Albany | New York |
United States | Research Site | Anaheim | California |
United States | Research Site | Bay Shore | New York |
United States | Research Site | Burien | Washington |
United States | Research Site | Dallas | Texas |
United States | Research Site | East Providence | Rhode Island |
United States | Research Site | Fort Wayne | Indiana |
United States | Research Site | Garden City | New York |
United States | Research Site | Greenbelt | Maryland |
United States | Research Site | Huntsville | Alabama |
United States | Research Site | Laguna Hills | California |
United States | Research Site | Lancaster | Pennsylvania |
United States | Research Site | Long Beach | California |
United States | Research Site | Middlebury | Connecticut |
United States | Research Site | Myrtle Beach | South Carolina |
United States | Research Site | New Britain | Connecticut |
United States | Research Site | Omaha | Nebraska |
United States | Research Site | Poughkeepsie | New York |
United States | Research Site | Salem | Virginia |
United States | Research Site | San Bernardino | California |
United States | Research Site | San Diego | California |
United States | Research Site | San Diego | California |
United States | Research Site | Santa Monica | California |
United States | Research Site | Sartell | Minnesota |
United States | Research Site | Seattle | Washington |
United States | Research Site | Tacoma | Washington |
United States | Research Site | Trinity | Florida |
Lead Sponsor | Collaborator |
---|---|
Amgen |
United States, Canada, Finland, Hungary, Mexico, Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Survival Through Month 24 | 24 months |
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