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Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis

Primary Purpose

Postmenopausal Osteoporosis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
AMG 162
Placebo
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postmenopausal Osteoporosis focused on measuring Osteoporosis, Postmenopausal

Eligibility Criteria

undefined - 90 Years (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Eligibility Criteria - Postmenopausal women with Osteopenia (lumbar spine bone mineral density T-score between 1.0 and -2.5)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    AMG 162

    Placebo

    Arm Description

    60 mg/mL denosumab given day 1, month 6, month 12 and month 18

    Placebo given day 1, month 6, month 12 and month 18

    Outcomes

    Primary Outcome Measures

    Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24
    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.

    Secondary Outcome Measures

    Total Hip Bone Mineral Density Percent Change From Baseline at Month 24
    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
    Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24
    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
    Trochanter Bone Mineral Density Percent Change From Baseline at Month 24
    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
    Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 24
    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
    Total Body (Without Head) Bone Mineral Density Percent Change From Baseline at Month 24
    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
    Distal Radius Trabecular Volumetric Bone Mineral Density Percent Change From Baseline at Month 24
    Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).
    Distal Radius Cortical Volumetric Bone Mineral Density Percent Change From Baseline at Month 24
    Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).
    Distal Radius Total Volumetric Bone Mineral Density Percent Change From Baseline at Month 24
    Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).

    Full Information

    First Posted
    September 17, 2004
    Last Updated
    December 22, 2010
    Sponsor
    Amgen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00091793
    Brief Title
    Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis
    Official Title
    A Randomized, Double-Blind Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2004 (undefined)
    Primary Completion Date
    February 2009 (Actual)
    Study Completion Date
    March 2009 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Amgen

    4. Oversight

    5. Study Description

    Brief Summary
    This study will determine whether treatment with AMG 162 can prevent lumbar spine bone loss in both early and late postmenopausal women with osteopenia, and to further test the safety and tolerability of AMG 162 in this population.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postmenopausal Osteoporosis
    Keywords
    Osteoporosis, Postmenopausal

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    332 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    AMG 162
    Arm Type
    Experimental
    Arm Description
    60 mg/mL denosumab given day 1, month 6, month 12 and month 18
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo given day 1, month 6, month 12 and month 18
    Intervention Type
    Drug
    Intervention Name(s)
    AMG 162
    Intervention Description
    60 mg/mL denosumab given day 1, month 6, month 12 and month 18
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo given at day 1, month 6, month 12 and month 18
    Primary Outcome Measure Information:
    Title
    Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24
    Description
    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
    Time Frame
    24 Months
    Secondary Outcome Measure Information:
    Title
    Total Hip Bone Mineral Density Percent Change From Baseline at Month 24
    Description
    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
    Time Frame
    24 Months
    Title
    Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24
    Description
    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
    Time Frame
    24 Months
    Title
    Trochanter Bone Mineral Density Percent Change From Baseline at Month 24
    Description
    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
    Time Frame
    24 months
    Title
    Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 24
    Description
    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
    Time Frame
    24 months
    Title
    Total Body (Without Head) Bone Mineral Density Percent Change From Baseline at Month 24
    Description
    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
    Time Frame
    24 months
    Title
    Distal Radius Trabecular Volumetric Bone Mineral Density Percent Change From Baseline at Month 24
    Description
    Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).
    Time Frame
    24 months
    Title
    Distal Radius Cortical Volumetric Bone Mineral Density Percent Change From Baseline at Month 24
    Description
    Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).
    Time Frame
    24 months
    Title
    Distal Radius Total Volumetric Bone Mineral Density Percent Change From Baseline at Month 24
    Description
    Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).
    Time Frame
    24 months

    10. Eligibility

    Sex
    Female
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Eligibility Criteria - Postmenopausal women with Osteopenia (lumbar spine bone mineral density T-score between 1.0 and -2.5)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    MD
    Organizational Affiliation
    Amgen
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18381571
    Citation
    Bone HG, Bolognese MA, Yuen CK, Kendler DL, Wang H, Liu Y, San Martin J. Effects of denosumab on bone mineral density and bone turnover in postmenopausal women. J Clin Endocrinol Metab. 2008 Jun;93(6):2149-57. doi: 10.1210/jc.2007-2814. Epub 2008 Apr 1.
    Results Reference
    result
    PubMed Identifier
    19345291
    Citation
    Engelke K, Libanati C, Liu Y, Wang H, Austin M, Fuerst T, Stampa B, Timm W, Genant HK. Quantitative computed tomography (QCT) of the forearm using general purpose spiral whole-body CT scanners: accuracy, precision and comparison with dual-energy X-ray absorptiometry (DXA). Bone. 2009 Jul;45(1):110-8. doi: 10.1016/j.bone.2009.03.669. Epub 2009 Apr 2.
    Results Reference
    result
    PubMed Identifier
    21289258
    Citation
    Bone HG, Bolognese MA, Yuen CK, Kendler DL, Miller PD, Yang YC, Grazette L, San Martin J, Gallagher JC. Effects of denosumab treatment and discontinuation on bone mineral density and bone turnover markers in postmenopausal women with low bone mass. J Clin Endocrinol Metab. 2011 Apr;96(4):972-80. doi: 10.1210/jc.2010-1502. Epub 2011 Feb 2.
    Results Reference
    derived
    Links:
    URL
    http://www.amgentrials.com
    Description
    AmgenTrials clinical trials website
    URL
    http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf
    Description
    Notice regarding posted summaries of trial results

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    Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis

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