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Safety and Efficacy of AAE581 in Postmenopausal Women With Osteoporosis

Primary Purpose

Osteoporosis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
AAE581
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring osteoporosis/osteopenia, BMD, postmenopausal

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: BMD T Score between -2 to -3.5 50-75 years old Exclusion Criteria: Urolithiasis Bisphosphonates Other protocol-defined inclusion/exclusion criteria may apply.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Lumbar spine BMD and total hip BMD after 1 year treatment
    Safety and tolerability of one year treatment with different doses

    Secondary Outcome Measures

    Effect of the different doses on BMD of lumbar spine, femoral neck, total hip, forearm and total body
    Effect of the different doses on markers for bone formation and bone resorption
    Structural information on cortical and trabecular bone at different anatomic sites after 6 and 12 months of treatment
    Histological information on bone biopsy after 12 months of treatment

    Full Information

    First Posted
    January 3, 2005
    Last Updated
    May 7, 2012
    Sponsor
    Novartis Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00100607
    Brief Title
    Safety and Efficacy of AAE581 in Postmenopausal Women With Osteoporosis
    Official Title
    Safety and Efficacy of AAE581 in Postmenopausal Women With Osteoporosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2004 (undefined)
    Primary Completion Date
    September 2005 (Actual)
    Study Completion Date
    September 2005 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Novartis Pharmaceuticals

    4. Oversight

    5. Study Description

    Brief Summary
    This study will test the safety and efficacy of AAE581 in increasing Lumbar Spine bone mineral density (BMD) at 12 months, by Dexa-scan (DXA) in postmenopausal women with osteoporosis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoporosis
    Keywords
    osteoporosis/osteopenia, BMD, postmenopausal

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    676 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    AAE581
    Primary Outcome Measure Information:
    Title
    Lumbar spine BMD and total hip BMD after 1 year treatment
    Title
    Safety and tolerability of one year treatment with different doses
    Secondary Outcome Measure Information:
    Title
    Effect of the different doses on BMD of lumbar spine, femoral neck, total hip, forearm and total body
    Title
    Effect of the different doses on markers for bone formation and bone resorption
    Title
    Structural information on cortical and trabecular bone at different anatomic sites after 6 and 12 months of treatment
    Title
    Histological information on bone biopsy after 12 months of treatment

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: BMD T Score between -2 to -3.5 50-75 years old Exclusion Criteria: Urolithiasis Bisphosphonates Other protocol-defined inclusion/exclusion criteria may apply.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Novartis Pharmaceuticals
    Organizational Affiliation
    Novartis Pharmaceuticals
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Safety and Efficacy of AAE581 in Postmenopausal Women With Osteoporosis

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