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A Multicenter, Randomized Placebo Controlled Pilot MicroCT Study to Estimate the Effect of Treatment With Denosumab (AMG 162) and Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density

Primary Purpose

Postmenopausal Osteoporosis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Alendronate
Denosumab
Placebo
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postmenopausal Osteoporosis focused on measuring Post Menopausal, Osteoporosis, MicroCT, Amgen, denosumab, Extreme CT, XCT, Fosamax, Alendronate

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Key Inclusion Criteria: Postmenopausal, ambulatory women between 50 and 70 years old who are generally in good health. Must have low bone mineral density and meet specific eligibility criteria. Key Exclusion Criteria: -Subjects must not currently be receiving any medication that affects bone metabolism or have an underlying condition that affects their ability to take alendronate or receive denosumab.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    Experimental

    Active Comparator

    Arm Label

    3

    1

    2

    Arm Description

    Placebo for denosumab and placebo for alendronate

    denosumab and placebo for alendronate

    Placebo for denosumab and alendronate

    Outcomes

    Primary Outcome Measures

    Cortical Thickness of Radius by XtremeCT Percent Change From Baseline at Month 12
    Cortical Thickness measured by XtremeCT.

    Secondary Outcome Measures

    Cortical Thickness of Tibia by XtremeCT Percent Change From Baseline at Month 12
    Cortical Thickness measured by XtremeCT.

    Full Information

    First Posted
    February 17, 2006
    Last Updated
    July 18, 2014
    Sponsor
    Amgen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00293813
    Brief Title
    A Multicenter, Randomized Placebo Controlled Pilot MicroCT Study to Estimate the Effect of Treatment With Denosumab (AMG 162) and Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density
    Official Title
    A Multicenter, Randomized Placebo Controlled Pilot MicroCT Study to Estimate the Effect of Treatment With Denosumab (AMG 162) and Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2006 (undefined)
    Primary Completion Date
    March 2008 (Actual)
    Study Completion Date
    August 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Amgen

    4. Oversight

    5. Study Description

    Brief Summary
    This study is structured to estimate the effect of denosumab, compared to placebo and alendronate, on several bone parameters.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postmenopausal Osteoporosis
    Keywords
    Post Menopausal, Osteoporosis, MicroCT, Amgen, denosumab, Extreme CT, XCT, Fosamax, Alendronate

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    247 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    3
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo for denosumab and placebo for alendronate
    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    denosumab and placebo for alendronate
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    Placebo for denosumab and alendronate
    Intervention Type
    Drug
    Intervention Name(s)
    Alendronate
    Intervention Description
    Alendronate 70 mg PO QW
    Intervention Type
    Drug
    Intervention Name(s)
    Denosumab
    Intervention Description
    denosumab 60 mg SC q 6 mos
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo for alendronate and placebo for denosumab
    Primary Outcome Measure Information:
    Title
    Cortical Thickness of Radius by XtremeCT Percent Change From Baseline at Month 12
    Description
    Cortical Thickness measured by XtremeCT.
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Cortical Thickness of Tibia by XtremeCT Percent Change From Baseline at Month 12
    Description
    Cortical Thickness measured by XtremeCT.
    Time Frame
    12 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Key Inclusion Criteria: Postmenopausal, ambulatory women between 50 and 70 years old who are generally in good health. Must have low bone mineral density and meet specific eligibility criteria. Key Exclusion Criteria: -Subjects must not currently be receiving any medication that affects bone metabolism or have an underlying condition that affects their ability to take alendronate or receive denosumab.
    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
    20222106
    Citation
    Seeman E, Delmas PD, Hanley DA, Sellmeyer D, Cheung AM, Shane E, Kearns A, Thomas T, Boyd SK, Boutroy S, Bogado C, Majumdar S, Fan M, Libanati C, Zanchetta J. Microarchitectural deterioration of cortical and trabecular bone: differing effects of denosumab and alendronate. J Bone Miner Res. 2010 Aug;25(8):1886-94. doi: 10.1002/jbmr.81.
    Results Reference
    background
    PubMed Identifier
    24275677
    Citation
    Zebaze RM, Libanati C, Austin M, Ghasem-Zadeh A, Hanley DA, Zanchetta JR, Thomas T, Boutroy S, Bogado CE, Bilezikian JP, Seeman E. Differing effects of denosumab and alendronate on cortical and trabecular bone. Bone. 2014 Feb;59:173-9. doi: 10.1016/j.bone.2013.11.016. Epub 2013 Nov 22.
    Results Reference
    background
    PubMed Identifier
    34530172
    Citation
    Hu YJ, Chines A, Shi Y, Seeman E, Guo XE. The effect of denosumab and alendronate on trabecular plate and rod microstructure at the distal tibia and radius: A post-hoc HR-pQCT study. Bone. 2022 Jan;154:116187. doi: 10.1016/j.bone.2021.116187. Epub 2021 Sep 14.
    Results Reference
    derived
    Links:
    URL
    http://www.amgentrials.com
    Description
    AmgenTrials clinical trials website

    Learn more about this trial

    A Multicenter, Randomized Placebo Controlled Pilot MicroCT Study to Estimate the Effect of Treatment With Denosumab (AMG 162) and Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density

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