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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


Phase 3
18 Years
N/A
Not Enrolling
Male
Cancer, Carcinoma, Castrate-Resistant Prostate Cancer, Prostate Cancer, Tumors

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety endpoints in subjects previously treated with denosumab who receive up to 5 years of denosumab administration.

Outcome Description:

Adverse events incidences, serious adverse event incidence, changes in safety laboratory analytes and subject incidence of anti-denosumab antibody formation.

Outcome Time Frame:

24 months

Safety Issue:

Yes

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

Canada: Health Canada

Study ID:

20080537

NCT ID:

NCT00838201

Start Date:

February 2009

Completion Date:

July 2012

Related Keywords:

  • Cancer
  • Carcinoma
  • Castrate-Resistant Prostate Cancer
  • Prostate Cancer
  • Tumors
  • Androgen deprivation therapy for non-metastatic prostate cancer
  • Carcinoma
  • Prostatic Neoplasms

Name

Location
Research Site Alabaster, Alabama  
Research Site Anaheim, California  
Research Site Danbury, Connecticut  
Research Site Boca Raton, Florida  
Research Site Bloomington, Indiana  
Research Site Baltimore, Maryland  
Research Site Alexandria, Minnesota  
Research Site Grand Island, Nebraska  
Research Site Albany, New York  
Research Site Allentown, Pennsylvania  
Research Site Pawtucket, Rhode Island  
Research Site Charleston, South Carolina  
Research Site Abilene, Texas  
Research Site Abington, Virginia  
Research Site Auburn, Washington