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A Study of MK0217A and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227)

Primary Purpose

Osteoporosis, Vitamin D Deficiency

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0217A, alendronate sodium (+) cholecalciferol / Duration of Treatment: 24 weeks
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Men or postmenopausal women who are osteoporotic Exclusion Criteria: Vitamin D deficiency Other disease of bone or mineral metabolism Digestive disease causing malabsorption Other medical conditions that are not adequately treated

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Safety and tolerability; primary parameter assessed is the proportion of patients who develop hypercalcuria

    Secondary Outcome Measures

    Full Information

    First Posted
    September 21, 2004
    Last Updated
    November 7, 2014
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00092079
    Brief Title
    A Study of MK0217A and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227)
    Official Title
    A 15-Week, Double-Blind, Randomized, Active-Controlled, Multi-Center Study With 24-Week Extension to Evaluate the Safety, Tolerability, Efficacy of Alendronate 70 mg Plus Vitamin D3 2800 IU Combination Tablet in Men and Postmenopausal Women With Osteoporosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2004 (undefined)
    Primary Completion Date
    November 2004 (Actual)
    Study Completion Date
    November 2004 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to test the safety, tolerability, and effectiveness of an investigational drug and dietary supplement to reduce the risk of vitamin D insufficiency and deficiency during treatment of osteoporosis in men and postmenopausal women.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    652 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    MK0217A, alendronate sodium (+) cholecalciferol / Duration of Treatment: 24 weeks
    Primary Outcome Measure Information:
    Title
    Safety and tolerability; primary parameter assessed is the proportion of patients who develop hypercalcuria

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Men or postmenopausal women who are osteoporotic Exclusion Criteria: Vitamin D deficiency Other disease of bone or mineral metabolism Digestive disease causing malabsorption Other medical conditions that are not adequately treated
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitior
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16968578
    Citation
    Recker R, Lips P, Felsenberg D, Lippuner K, Benhamou L, Hawkins F, Delmas PD, Rosen C, Emkey R, Salzmann G, He W, Santora AC. Alendronate with and without cholecalciferol for osteoporosis: results of a 15-week randomized controlled trial. Curr Med Res Opin. 2006 Sep;22(9):1745-55. doi: 10.1185/030079906x120913.
    Results Reference
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    PubMed Identifier
    19185560
    Citation
    Binkley N, Ringe JD, Reed JI, Ljunggren O, Holick MF, Minne HW, Liu M, Lamotta A, West JA, Santora AC. Alendronate/vitamin D3 70 mg/2800 IU with and without additional 2800 IU vitamin D3 for osteoporosis: results from the 24-week extension of a 15-week randomized, controlled trial. Bone. 2009 Apr;44(4):639-47. doi: 10.1016/j.bone.2008.05.002. Epub 2008 May 15.
    Results Reference
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    Learn more about this trial

    A Study of MK0217A and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227)

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