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The Change of Bone Markers After Low Dose Alendronate in Postmenopausal Women With Bone Loss

Primary Purpose

Osteoporosis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Alendronate
Sponsored by
Eulji University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring osteoporosis, alendronate, bone marker

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • postmenopausal women (the ages between 50-65 year) with lumbar spine BMD at least 2.0 SD below the peak young adult mean

Exclusion Criteria:

  • severe osteoporosis
  • current medication of osteoposis
  • metabolic bone disease
  • cancer, stroke etc.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Placebo Comparator

    Arm Label

    Alendronate, Placebo

    Arm Description

    All subjects were given 600 mg of calcium and 400 IU of vitamin D supplements. The subjects were randomized to receive weekly alendronate 20 mg (n = 31) or placebo (n = 32).

    Outcomes

    Primary Outcome Measures

    Changes of bone turnover markers
    to determine the short-term efficacy of once-weekly low-dose alendronate, via bone turnover markers and OPG, in the prevention of bone loss in early postmenopausal Korean women with moderate bone loss.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 12, 2007
    Last Updated
    August 2, 2014
    Sponsor
    Eulji University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00460057
    Brief Title
    The Change of Bone Markers After Low Dose Alendronate in Postmenopausal Women With Bone Loss
    Official Title
    The Change of Bone Markers After Low Dose Alendronate in Postmenopausal Women
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2006 (undefined)
    Primary Completion Date
    December 2006 (Actual)
    Study Completion Date
    February 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Eulji University Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    High bone turnover with the bone resorption exceeding bone formation is a major mechanism of postmenopausal osteoporosis. Therefore, inhibition of bone resorption is a rational approach for the prevention. The Objective of the current study was to determine the short-term efficacy of once-weekly low dose alendronate in the prevention of bone loss in early postmenopausal Korean women with moderate bone loss via bone turnover markers. This study was a 12-week, randomized, double-blind clinical trial compared the effects of placebo with alendronate 20 mg once weekly. All subjects received supplemental calcium 600 mg and vitamin D 400 IU daily. Fifty two postmenopausal women (the ages between 50-65 year) with lumbar spine BMD at least 2.0 SD below the peak young adult mean were recruited at Eulji University Hospital, Daejeon, Korea. BMD was measured by DXA at baseline and serum alkaline phosphatase, osteocalcin and C-terminal telopeptide of type I collagen was measured at baseline and 12 weeks after treatment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoporosis
    Keywords
    osteoporosis, alendronate, bone marker

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantInvestigator
    Allocation
    N/A
    Enrollment
    63 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Alendronate, Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    All subjects were given 600 mg of calcium and 400 IU of vitamin D supplements. The subjects were randomized to receive weekly alendronate 20 mg (n = 31) or placebo (n = 32).
    Intervention Type
    Drug
    Intervention Name(s)
    Alendronate
    Other Intervention Name(s)
    Bisphosphonate
    Intervention Description
    Take two tablets (alendronate 10 mg) once weekly with a full glass of plain water in the morning after an overnight fast and to refrain from lying down or taking any other beverage or food for at least 1 h thereafter
    Primary Outcome Measure Information:
    Title
    Changes of bone turnover markers
    Description
    to determine the short-term efficacy of once-weekly low-dose alendronate, via bone turnover markers and OPG, in the prevention of bone loss in early postmenopausal Korean women with moderate bone loss.
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: postmenopausal women (the ages between 50-65 year) with lumbar spine BMD at least 2.0 SD below the peak young adult mean Exclusion Criteria: severe osteoporosis current medication of osteoposis metabolic bone disease cancer, stroke etc.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hee-Jeong Choi, MD, PhD
    Organizational Affiliation
    Department of Family medicine, Eulji University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    The Change of Bone Markers After Low Dose Alendronate in Postmenopausal Women With Bone Loss

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