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A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate 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
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer

Inclusion Criteria


Other criteria also apply

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

The primary endpoint is the percentage change from baseline in lumbar spine BMD to month 24.

Outcome Time Frame:

24 months

Safety Issue:

No

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Food and Drug Administration

Study ID:

20040138

NCT ID:

NCT00089674

Start Date:

August 2004

Completion Date:

May 2010

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Bone Loss with Prostate Cancer
  • Treatment of bone loss in patients undergoing androgen deprivation therapy (ADT) for non-metastatic prostate cancer (PC).
  • Prostatic Neoplasms

Name

Location

Research SiteAlabaster, Alabama  
Research SiteAnchorage, Alaska  
Research SiteMesa, Arizona  
Research SiteAnaheim, California  
Research SiteBoulder, Colorado  
Research SiteDanbury, Connecticut  
Research SiteBoca Raton, Florida  
Research SiteArlington Heights, Illinois  
Research SiteBloomington, Indiana  
Research SiteHays, Kansas  
Research SiteBaltimore, Maryland  
Research SiteBeverly, Massachusetts  
Research SiteAlexandria, Minnesota  
Research SiteGrand Island, Nebraska  
Research SiteBelleville, New Jersey  
Research SiteAlbany, New York  
Research SiteAsheville, North Carolina  
Research SiteBend, Oregon  
Research SiteAllentown, Pennsylvania  
Research SitePawtucket, Rhode Island  
Research SiteCharleston, South Carolina  
Research SiteChattanooga, Tennessee  
Research SiteAbilene, Texas  
Research SiteIvins, Utah  
Research SiteAbington, Virginia  
Research SiteAuburn, Washington  
Research SiteCheyenne, Wyoming