AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Amgen.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00089674
First received: August 9, 2004
Last updated: December 3, 2009
Last verified: December 2009
  Purpose

This study will evaluate AMG 162 in the treatment of bone loss in subjects undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer.


Condition Intervention Phase
Prostate Cancer
Drug: AMG 162
Drug: Placebo
Phase 3

Study Type: 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
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • The primary endpoint is the percentage change from baseline in lumbar spine BMD to month 24. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent change of femoral neck BMD, and total hip BMD from baseline to month 24 [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Percent change of lumbar spine BMD, femoral neck BMD and total hip BMD from baseline to month 36 [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Subject incidence of any fracture and subject incidence of new vertebral fracture over the 36-month evaluation period [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Time to first clinical fracture over the 36-month evaluation period [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Subject incidence of any fracture during the 24-month evaluation period [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Adverse event incidence by system organ class and preferred term [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Laboratory values (including changes in chemistry, hematology, and immunological laboratory parameters) [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Changes in vital signs, weight and height at each visit [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Subject incidence of anti-AMG 162 antibodies [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • AMG 162 serum levels at day 1, and months 1, 3, 6, 12, 15, 18, 24, 30 and 36 (PK) [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]

Enrollment: 1468
Study Start Date: August 2004
Estimated Study Completion Date: May 2010
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AMG 162 Drug: AMG 162
60 mg (1.0mL) administered subcutaneously at Day 1, Months 6, 12, 18, 24, 30
Placebo Comparator: Placebo Drug: Placebo
60 mg (1.0mL) administered subcutaneously at Day 1, Months 6, 12, 18, 24, 30

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Other criteria also apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00089674

  Show 138 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00089674     History of Changes
Other Study ID Numbers: 20040138, HALT
Study First Received: August 9, 2004
Last Updated: December 3, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Prostate Cancer
Bone Loss with Prostate Cancer
Treatment of bone loss in patients undergoing androgen deprivation therapy (ADT) for non-metastatic prostate cancer (PC).

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014