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A New Active Vitamin D, ED-71 for Osteoporosis

Primary Purpose

Osteoporosis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
ED-71
Alfacalcidol
ED-71 placebo
Alfacalcidol placebo
Sponsored by
Chugai Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis

Eligibility Criteria

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

Inclusion Criteria: Osteoporotic patients who meet any of the following condition: with at least one fragility fracture, above 70 year-old with bone mineral density below 70% young adult mean, with bone mineral density below 60% young adult mean Women three years or more after menopause or men Exclusion Criteria: Current disorders such as primary hyperparathyroidism, Cushing's syndrome,gonadal insufficiency, poorly controlled diabetes mellitus or other causes of secondary osteoporosis A history or suspicion of active urolithiasis at any time Use of bisphosphonates in the past 12 months Use of medications known to affect bone in the past 2 months Abnormal serum calcium, urinary calcium, serum creatinine or liver function tests

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    1

    2

    Arm Description

    Outcomes

    Primary Outcome Measures

    Incidences of vertebral fracture

    Secondary Outcome Measures

    Changes of Lumbar Spine and total hip bone mineral density

    Full Information

    First Posted
    September 2, 2005
    Last Updated
    August 6, 2013
    Sponsor
    Chugai Pharmaceutical
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00144456
    Brief Title
    A New Active Vitamin D, ED-71 for Osteoporosis
    Official Title
    A Prospective, Randomized, Double-blind Study to Compare the Effect of ED-71 With That of Alfacalcidol on Fracture Incidence in Osteoporotic Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2004 (undefined)
    Primary Completion Date
    September 2008 (Actual)
    Study Completion Date
    October 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Chugai Pharmaceutical

    4. Oversight

    5. Study Description

    Brief Summary
    A prospective, randomized, double-blind study to compare the effect of ED-71 with that of alfacalcidol on fracture incidence

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    1056 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Title
    2
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    ED-71
    Intervention Description
    0.75μg/day(p.o.)for 144 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Alfacalcidol
    Intervention Description
    1.0μg/day(p.o.)for 144 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    ED-71 placebo
    Intervention Description
    0 μg/day(p.o.)for 144 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Alfacalcidol placebo
    Intervention Description
    0 μg/day(p.o.)for 144 weeks
    Primary Outcome Measure Information:
    Title
    Incidences of vertebral fracture
    Time Frame
    throughout study
    Secondary Outcome Measure Information:
    Title
    Changes of Lumbar Spine and total hip bone mineral density
    Time Frame
    throughout study

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Osteoporotic patients who meet any of the following condition: with at least one fragility fracture, above 70 year-old with bone mineral density below 70% young adult mean, with bone mineral density below 60% young adult mean Women three years or more after menopause or men Exclusion Criteria: Current disorders such as primary hyperparathyroidism, Cushing's syndrome,gonadal insufficiency, poorly controlled diabetes mellitus or other causes of secondary osteoporosis A history or suspicion of active urolithiasis at any time Use of bisphosphonates in the past 12 months Use of medications known to affect bone in the past 2 months Abnormal serum calcium, urinary calcium, serum creatinine or liver function tests
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Toshio Matsumoto, MD
    Organizational Affiliation
    Department of Medicine and Bioregulatory Sciences, Universitof Tokushima Graduate School of Health Bioscience
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22794117
    Citation
    Shiraki M, Saito H, Matsumoto T. Eldecalcitol normalizes bone turnover markers regardless of their pre-treatment levels. Curr Med Res Opin. 2012 Sep;28(9):1547-52. doi: 10.1185/03007995.2012.712506. Epub 2012 Aug 23.
    Results Reference
    derived
    PubMed Identifier
    21784190
    Citation
    Matsumoto T, Ito M, Hayashi Y, Hirota T, Tanigawara Y, Sone T, Fukunaga M, Shiraki M, Nakamura T. A new active vitamin D3 analog, eldecalcitol, prevents the risk of osteoporotic fractures--a randomized, active comparator, double-blind study. Bone. 2011 Oct;49(4):605-12. doi: 10.1016/j.bone.2011.07.011. Epub 2011 Jul 19.
    Results Reference
    derived

    Learn more about this trial

    A New Active Vitamin D, ED-71 for Osteoporosis

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