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Trial record 1 of 1 for:    20040135
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AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT00089661
Recruitment Status : Completed
First Posted : August 11, 2004
Results First Posted : January 26, 2010
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date  ICMJE August 9, 2004
First Posted Date  ICMJE August 11, 2004
Results First Submitted Date  ICMJE December 22, 2009
Results First Posted Date  ICMJE January 26, 2010
Last Update Posted Date October 17, 2018
Actual Study Start Date  ICMJE October 1, 2004
Actual Primary Completion Date May 11, 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2010)
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 [ Time Frame: 12 months ]
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2010)
  • Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 6 [ Time Frame: 6 months ]
    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
  • Total Hip Bone Mineral Density Percent Change From Baseline at Month 12 [ Time Frame: 12 months ]
    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
  • Total Hip Bone Mineral Density Percent Change From Baseline at Month 6 [ Time Frame: 6 months ]
    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
  • Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12 [ Time Frame: 12 months ]
    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
  • Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 6 [ Time Frame: 6 months ]
    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer
Brief Summary The purpose of this trial is to evaluate AMG 162 in the treatment of bone loss in subjects undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Cancer
  • Low Bone Mineral Density
  • Osteopenia
Intervention  ICMJE
  • Drug: Placebo
    60 mg (1.0 mL) administered subcutaneously every six months, beginning on Study Day 1, for a total treatment period of 24 months
  • Drug: AMG 162 / Denosumab
    60 mg (1.0 mL) administered subcutaneously every six months, beginning on Study Day 1, for a total treatment period of 24 months
Study Arms  ICMJE
  • Experimental: AMG 162 / Denosumab
    Intervention: Drug: AMG 162 / Denosumab
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 7, 2008)
252
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 27, 2009
Actual Primary Completion Date May 11, 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • Histologically or cytologically confirmed adenocarcinoma of the breast
  • Subjects with early stage disease who are estrogen receptor positive and who have completed their treatment pathway (surgery, chemo-therapy, radiation, and/or hormone therapy) and are currently on or will initiate aromatase inhibitor therapy, and are expected to stay on aromatase inhibitor therapy for the duration of the 24-month study
  • All treatment pathway must be completed ≥ 4 weeks prior to study entry, and all acute toxic effect of any above therapy must be resolved to ≤ Grade 1 by National Cancer Institution (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
  • Female > 18 years of age
  • ECOG Performance status 0 and 1
  • Lumbar spine, total hip or femoral neck BMD equivalent to a t-score classification of -1.0 to -2.5
  • Subject is willing and able to provide signed consent before any study-specific procedure

Other criteria also apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Canada,   United States
 
Administrative Information
NCT Number  ICMJE NCT00089661
Other Study ID Numbers  ICMJE 20040135
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date September 2018

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