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Osteoporosis Treatment in Post-menopausal Women

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ClinicalTrials.gov Identifier: NCT03006003
Recruitment Status : Recruiting
First Posted : December 30, 2016
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
Taichung Veterans General Hospital

Tracking Information
First Submitted Date  ICMJE December 16, 2016
First Posted Date  ICMJE December 30, 2016
Last Update Posted Date January 14, 2019
Actual Study Start Date  ICMJE January 1, 2017
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 26, 2016)
Brain-derived neurotrophic factor [ Time Frame: 3 months ]
Serum brain-derived neurotrophic factor (BDNF) Levels
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03006003 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 26, 2016)
  • Brain-derived neurotrophic factor [ Time Frame: 1 year ]
    Serum brain-derived neurotrophic factor (BDNF) Levels
  • Vascular cell adhesion molecule-1 [ Time Frame: 3 months ]
    Serum vascular cell adhesion molecule-1 (VCAM-1) levels
  • Orexin-A [ Time Frame: 3 months ]
    Serum Orexin-A levels
  • Body components [ Time Frame: 3 months ]
    Fat tissue ratio
  • Zung self-rating depression scale [ Time Frame: 3 months ]
    Questionnaire for depressive symptoms
  • 5-Item Geriatric Depression Scale [ Time Frame: 3 months ]
    Questionnaire for Cognitive assessment
  • The Mini Mental State Examination (MMSE) [ Time Frame: 3 months ]
    Questionnaire for Cognitive assessment
  • The Barthel index [ Time Frame: 3 months ]
    Questionnaire for Cognitive assessment
  • Instrumental Activities of Daily Living (IADL) [ Time Frame: 3 months ]
    Questionnaire for Cognitive assessment
  • ankle-brachial index [ Time Frame: 3 months ]
    Peripheral artery disease assessment
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Osteoporosis Treatment in Post-menopausal Women
Official Title  ICMJE The Assessment of Osteoporosis Treatment in Post-menopausal Women
Brief Summary The study will be conducted to assess the depressive symptoms and related markers in the postmenopausal female after anti-osteoporosis treatment.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Depressive Syndrome
Intervention  ICMJE
  • Drug: Raloxifene
    Raloxifene tratment more than 4 weeks
    Other Name: Evista
  • Drug: Alendronate
    Alendronic acid 70mg with Colecalciferol 70mcg
    Other Name: FOSAMAX PLUS
Study Arms  ICMJE
  • Experimental: Raloxifene group
    Raloxifene treatment
    Intervention: Drug: Raloxifene
  • Active Comparator: Comparator group
    Alendronate treatment
    Intervention: Drug: Alendronate
  • No Intervention: Control group
    To refuse anti-osteoporosis treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 26, 2016)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Postmenopausal female
  • Osteoporosis

Exclusion Criteria:

  • Psychological disorders
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: I-Te Lee, MD, PhD +886-4-23741300 itlee@vghtc.gov.tw
Contact: I-Te Lee, MD, PhD itlee@vghtc.gov.tw
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03006003
Other Study ID Numbers  ICMJE CE16256A
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Not available
Responsible Party Taichung Veterans General Hospital
Study Sponsor  ICMJE Taichung Veterans General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Taichung Veterans General Hospital
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP