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Osteoporosis Treatment in Post-menopausal Women

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ClinicalTrials.gov Identifier: NCT03006003
Recruitment Status : Not yet recruiting
First Posted : December 30, 2016
Last Update Posted : December 30, 2016
Sponsor:
Information provided by (Responsible Party):
Taichung Veterans General Hospital

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
Depressive Syndrome Drug: Raloxifene Drug: Alendronate 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 Type : Interventional  (Clinical Trial)
Estimated 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
Study Start Date : December 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Arm Intervention/treatment
Experimental: Raloxifene group
Raloxifene treatment
Drug: Raloxifene
Raloxifene tratment more than 4 weeks
Other Name: Evista

Active Comparator: Comparator group
Alendronate treatment
Drug: Alendronate
Alendronic acid 70mg with Colecalciferol 70mcg
Other Name: FOSAMAX PLUS

No Intervention: Control group
To refuse anti-osteoporosis treatment



Primary Outcome Measures :
  1. Brain-derived neurotrophic factor [ Time Frame: 3 months ]
    Serum brain-derived neurotrophic factor (BDNF) Levels


Secondary Outcome Measures :
  1. Brain-derived neurotrophic factor [ Time Frame: 1 year ]
    Serum brain-derived neurotrophic factor (BDNF) Levels

  2. Vascular cell adhesion molecule-1 [ Time Frame: 3 months ]
    Serum vascular cell adhesion molecule-1 (VCAM-1) levels

  3. Orexin-A [ Time Frame: 3 months ]
    Serum Orexin-A levels

  4. Body components [ Time Frame: 3 months ]
    Fat tissue ratio

  5. Zung self-rating depression scale [ Time Frame: 3 months ]
    Questionnaire for depressive symptoms

  6. 5-Item Geriatric Depression Scale [ Time Frame: 3 months ]
    Questionnaire for Cognitive assessment

  7. The Mini Mental State Examination (MMSE) [ Time Frame: 3 months ]
    Questionnaire for Cognitive assessment

  8. The Barthel index [ Time Frame: 3 months ]
    Questionnaire for Cognitive assessment

  9. Instrumental Activities of Daily Living (IADL) [ Time Frame: 3 months ]
    Questionnaire for Cognitive assessment

  10. ankle-brachial index [ Time Frame: 3 months ]
    Peripheral artery disease assessment



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Postmenopausal female
  • Osteoporosis

Exclusion Criteria:

  • Psychological disorders

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03006003


Contacts
Contact: I-Te Lee, MD, PhD +886-4-23741300 itlee@vghtc.gov.tw
Contact: I-Te Lee, MD, PhD itlee@vghtc.gov.tw

Locations
Taiwan
outpatient clinic of the Division of Endocrinology and Metabolism in Taichung Veterans General Hospital
Taichung, Taiwan, 407
Sponsors and Collaborators
Taichung Veterans General Hospital

Responsible Party: Taichung Veterans General Hospital
ClinicalTrials.gov Identifier: NCT03006003     History of Changes
Other Study ID Numbers: CE16256A
First Posted: December 30, 2016    Key Record Dates
Last Update Posted: December 30, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not available

Keywords provided by Taichung Veterans General Hospital:
Osteoporosis
Raloxifene
Central nervous disorders

Additional relevant MeSH terms:
Osteoporosis
Depressive Disorder
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Mood Disorders
Mental Disorders
Alendronate
Raloxifene Hydrochloride
Bone Density Conservation Agents
Physiological Effects of Drugs
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators