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Osteoporosis Treatment in Post-menopausal Women

Sponsor
Taichung Veterans General Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03006003
Collaborator
(none)
500
Enrollment
2
Locations
3
Arms
59
Anticipated Duration (Months)
250
Patients Per Site
4.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study will be conducted to assess the depressive symptoms and related markers in the postmenopausal female after anti-osteoporosis treatment.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

Fracture is one of the important complications in female. Osteoporosis should be treated in postmenopausal female due to high risk of fracture. Recently, there have been many classes of medications developed for preventing bone loss. Raloxifene, an oral form of anti-osteoporosis medication, has been reported to improved central nervous disorders. Therefore, this study is designed to assess the depressive symptoms and related markers in the postmenopausal female after anti-osteoporosis treatment.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Assessment of Osteoporosis Treatment in Post-menopausal Women
Actual Study Start Date :
Jan 1, 2017
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Raloxifene group

Raloxifene treatment

Drug: Raloxifene
Raloxifene tratment more than 4 weeks
Other Names:
  • Evista

    		•
    Active Comparator: Comparator group

    Alendronate treatment

    Drug: Alendronate
    Alendronic acid 70mg with Colecalciferol 70mcg
    Other Names:
  • FOSAMAX PLUS

    		•
    No Intervention: Control group

    To refuse anti-osteoporosis treatment

    Outcome Measures

    Primary Outcome Measures

    1. Brain-derived neurotrophic factor [3 months]

      Serum brain-derived neurotrophic factor (BDNF) Levels

    Secondary Outcome Measures

    1. Brain-derived neurotrophic factor [1 year]

      Serum brain-derived neurotrophic factor (BDNF) Levels

    2. Vascular cell adhesion molecule-1 [3 months]

      Serum vascular cell adhesion molecule-1 (VCAM-1) levels

    3. Orexin-A [3 months]

      Serum Orexin-A levels

    4. Body components [3 months]

      Fat tissue ratio

    5. Zung self-rating depression scale [3 months]

      Questionnaire for depressive symptoms

    6. 5-Item Geriatric Depression Scale [3 months]

      Questionnaire for Cognitive assessment

    7. The Mini Mental State Examination (MMSE) [3 months]

      Questionnaire for Cognitive assessment

    8. The Barthel index [3 months]

      Questionnaire for Cognitive assessment

    9. Instrumental Activities of Daily Living (IADL) [3 months]

      Questionnaire for Cognitive assessment

    10. ankle-brachial index [3 months]

      Peripheral artery disease assessment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Postmenopausal female

    • Osteoporosis

    Exclusion Criteria:
    • Psychological disorders

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 outpatient clinic of the Division of Endocrinology and Metabolism in Taichung Veterans General Hospital Taichung Taiwan 407
    2 Taichung Veterans General Hospital Taichung Taiwan 407

    Sponsors and Collaborators

    • Taichung Veterans General Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Taichung Veterans General Hospital
    ClinicalTrials.gov Identifier:
    NCT03006003
    Other Study ID Numbers:
    • CE16256A
    First Posted:
    Dec 30, 2016
    Last Update Posted:
    Jan 14, 2019
    Last Verified:
    Jan 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Taichung Veterans General Hospital
    Osteoporosis
    Raloxifene
    Central nervous disorders
    Additional relevant MeSH terms:
    Osteoporosis
    Depressive Disorder
    Alendronate
    Raloxifene Hydrochloride

    Study Results

    No Results Posted as of Jan 14, 2019