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An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women With Low Bone Mineral Density

Primary Purpose

Low Bone Mineral Density

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

About this trial

This is an interventional treatment trial for Low Bone Mineral Density focused on measuring bone loss, osteoporosis

Eligibility Criteria

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

Inclusion Criteria: Subject must be ambulatory Subject must have atteneded the 20010223 end-of-study visit and have completed all tests and procedures during the end-of-study visit signed informed consent must be obtained before any study-specific procedures Exclusion Criteria: Experienced severe and/or serious adverse event which were thought to be related to denosumab administration during the 20010223 study. Developed grade 3 or 4 laboratory abnormalities based on Common Terminology Criteria for Adverse Events v3.0 during the 20010223 study which did not normalized upon follow up or did not have diagnosis or treatment. Newly diagnosed conditions such as hyper/hypo thyroidism, rheumatoid arthritis, other bone diseases, renal disease. Using therapies while participating in the 20010223 study such as oral bisphosphonates, calcitonin, oral strontium, SERMS, systemic glucocortiocosteriods.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    AMG 162

    Arm Description

    AMG 162; 60 mg/mL of Denosumab given to all subjects at Screening/Day 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36 and Month 42

    Outcomes

    Primary Outcome Measures

    Lumbar Spine Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8
    Total Hip Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8
    Distal 1/3 Radius Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8

    Secondary Outcome Measures

    Bone-Specific Alkaline Phosphatase Percent Change From Parent Study 20010223 Baseline to Year 8
    Serum C-Telopeptide Percent Change From Parent Study 20010223 Baseline to Year 8

    Full Information

    First Posted
    May 10, 2006
    Last Updated
    July 3, 2017
    Sponsor
    Amgen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00325468
    Brief Title
    An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women With Low Bone Mineral Density
    Official Title
    An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women With Low Bone Mineral Density
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    May 1, 2006 (Actual)
    Primary Completion Date
    March 28, 2011 (Actual)
    Study Completion Date
    August 2, 2012 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women with Low Bone Mineral Density

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Low Bone Mineral Density
    Keywords
    bone loss, osteoporosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    200 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    AMG 162
    Arm Type
    Experimental
    Arm Description
    AMG 162; 60 mg/mL of Denosumab given to all subjects at Screening/Day 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36 and Month 42
    Intervention Type
    Drug
    Intervention Name(s)
    AMG 162
    Intervention Description
    AMG 162; 60 mg/mL of Denosumab given to all subjects at Screening/Day 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36 and Month 42
    Primary Outcome Measure Information:
    Title
    Lumbar Spine Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8
    Time Frame
    8 years
    Title
    Total Hip Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8
    Time Frame
    8 years
    Title
    Distal 1/3 Radius Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8
    Time Frame
    8 years
    Secondary Outcome Measure Information:
    Title
    Bone-Specific Alkaline Phosphatase Percent Change From Parent Study 20010223 Baseline to Year 8
    Time Frame
    8 years
    Title
    Serum C-Telopeptide Percent Change From Parent Study 20010223 Baseline to Year 8
    Time Frame
    8 years

    10. Eligibility

    Sex
    Female
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subject must be ambulatory Subject must have atteneded the 20010223 end-of-study visit and have completed all tests and procedures during the end-of-study visit signed informed consent must be obtained before any study-specific procedures Exclusion Criteria: Experienced severe and/or serious adverse event which were thought to be related to denosumab administration during the 20010223 study. Developed grade 3 or 4 laboratory abnormalities based on Common Terminology Criteria for Adverse Events v3.0 during the 20010223 study which did not normalized upon follow up or did not have diagnosis or treatment. Newly diagnosed conditions such as hyper/hypo thyroidism, rheumatoid arthritis, other bone diseases, renal disease. Using therapies while participating in the 20010223 study such as oral bisphosphonates, calcitonin, oral strontium, SERMS, systemic glucocortiocosteriods.
    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
    21159841
    Citation
    Miller PD, Wagman RB, Peacock M, Lewiecki EM, Bolognese MA, Weinstein RL, Ding B, San Martin J, McClung MR. Effect of denosumab on bone mineral density and biochemical markers of bone turnover: six-year results of a phase 2 clinical trial. J Clin Endocrinol Metab. 2011 Feb;96(2):394-402. doi: 10.1210/jc.2010-1805. Epub 2010 Dec 15.
    Results Reference
    derived
    Links:
    URL
    http://www.amgentrials.com
    Description
    AmgenTrials clinical trials website

    Learn more about this trial

    An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women With Low Bone Mineral Density

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