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Controlled Study of ONO-5920 in Patients With Involutional Osteoporosis in Japan

Primary Purpose

Involutional Osteoporosis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
ONO-5920
Sponsored by
Ono Pharmaceutical Co. Ltd
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Involutional Osteoporosis focused on measuring ONO-5920, osteoporosis, bisphosphonate

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Patients with fragility fracture according to the diagnostic criterial for the diagnosis of Primary Osteoporosis Patients having radiographically confirmed vertebral (T4-L4) fractures Other inclusion criteria as specified in the study protocol Exclusion Criteria: Patients having secondary osteoporosis or another condition that presents low bone mass Patients having findings on X-ray that affect evaluation of vertebral fracture Patients that have been administered bisphosphonate derivatives Other exclusion criteria as specified in the study protocol

Sites / Locations

    Outcomes

    Primary Outcome Measures

    New fragility vertebral fracture

    Secondary Outcome Measures

    New clinical fracture, biochemical markers of bone turnover, height, mean bone mineral density of the lumbar spoine (L2-4 BMD), lower back pain

    Full Information

    First Posted
    September 13, 2005
    Last Updated
    October 10, 2012
    Sponsor
    Ono Pharmaceutical Co. Ltd
    Collaborators
    Astellas Pharma Inc
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00212667
    Brief Title
    Controlled Study of ONO-5920 in Patients With Involutional Osteoporosis in Japan
    Official Title
    Controlled Study of ONO-5920 in Patients With Involutional Osteoporosis in Japan
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2002 (undefined)
    Primary Completion Date
    September 2006 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ono Pharmaceutical Co. Ltd
    Collaborators
    Astellas Pharma Inc

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the efficacy and safety of ONO-5920 in patients with involutional osteoporosis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Involutional Osteoporosis
    Keywords
    ONO-5920, osteoporosis, bisphosphonate

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    650 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    ONO-5920
    Primary Outcome Measure Information:
    Title
    New fragility vertebral fracture
    Secondary Outcome Measure Information:
    Title
    New clinical fracture, biochemical markers of bone turnover, height, mean bone mineral density of the lumbar spoine (L2-4 BMD), lower back pain

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    55 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with fragility fracture according to the diagnostic criterial for the diagnosis of Primary Osteoporosis Patients having radiographically confirmed vertebral (T4-L4) fractures Other inclusion criteria as specified in the study protocol Exclusion Criteria: Patients having secondary osteoporosis or another condition that presents low bone mass Patients having findings on X-ray that affect evaluation of vertebral fracture Patients that have been administered bisphosphonate derivatives Other exclusion criteria as specified in the study protocol
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Project Leader, Development Planning
    Organizational Affiliation
    Ono Pharmaceutical Co. LtTd.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19101754
    Citation
    Matsumoto T, Hagino H, Shiraki M, Fukunaga M, Nakano T, Takaoka K, Morii H, Ohashi Y, Nakamura T. Effect of daily oral minodronate on vertebral fractures in Japanese postmenopausal women with established osteoporosis: a randomized placebo-controlled double-blind study. Osteoporos Int. 2009 Aug;20(8):1429-37. doi: 10.1007/s00198-008-0816-7. Epub 2008 Dec 20.
    Results Reference
    derived

    Learn more about this trial

    Controlled Study of ONO-5920 in Patients With Involutional Osteoporosis in Japan

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