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

August 9, 2004
December 3, 2009
August 2004
June 2008   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00089674 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer
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

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Prostate Cancer
  • Drug: AMG 162
    60 mg (1.0mL) administered subcutaneously at Day 1, Months 6, 12, 18, 24, 30
  • Drug: Placebo
    60 mg (1.0mL) administered subcutaneously at Day 1, Months 6, 12, 18, 24, 30
  • Experimental: AMG 162
    Intervention: Drug: AMG 162
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1468
May 2010
June 2008   (final data collection date for primary outcome measure)

Other criteria also apply

Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Czech Republic,   Finland,   Hungary,   Mexico,   Netherlands,   Poland,   Switzerland
 
NCT00089674
20040138, HALT
Not Provided
Global Development Leader, Amgen Inc.
Amgen
Not Provided
Study Director: MD Amgen
Amgen
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP