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

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 Site	Alabaster, Alabama
Research Site	Anchorage, Alaska
Research Site	Mesa, Arizona
Research Site	Anaheim, California
Research Site	Boulder, Colorado
Research Site	Danbury, Connecticut
Research Site	Boca Raton, Florida
Research Site	Arlington Heights, Illinois
Research Site	Bloomington, Indiana
Research Site	Hays, Kansas
Research Site	Baltimore, Maryland
Research Site	Beverly, Massachusetts
Research Site	Alexandria, Minnesota
Research Site	Grand Island, Nebraska
Research Site	Belleville, New Jersey
Research Site	Albany, New York
Research Site	Asheville, North Carolina
Research Site	Bend, Oregon
Research Site	Allentown, Pennsylvania
Research Site	Pawtucket, Rhode Island
Research Site	Charleston, South Carolina
Research Site	Chattanooga, Tennessee
Research Site	Abilene, Texas
Research Site	Ivins, Utah
Research Site	Abington, Virginia
Research Site	Auburn, Washington
Research Site	Cheyenne, Wyoming