Osteoporosis Treatment in Post-menopausal Women

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

Detailed Description
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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.

Official Title
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The Assessment of Osteoporosis Treatment in Post-menopausal Women

Conditions
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Depressive Syndrome

Intervention / Treatment
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* Drug: Raloxifene
* Drug: Alendronate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Postmenopausal female Osteoporosis Exclusion Criteria: Psychological disorders

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Raloxifene group<br>Raloxifene treatment | Drug: Raloxifene<br>* Raloxifene tratment more than 4 weeks<br>* Other names: Evista;|
| Active Comparator: Comparator group<br>Alendronate treatment | Drug: Alendronate<br>* Alendronic acid 70mg with Colecalciferol 70mcg<br>* Other names: FOSAMAX PLUS;|
| No Intervention: Control group<br>To refuse anti-osteoporosis treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain-derived neurotrophic factor | Serum brain-derived neurotrophic factor (BDNF) Levels | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain-derived neurotrophic factor | Serum brain-derived neurotrophic factor (BDNF) Levels | 1 year | 
| Vascular cell adhesion molecule-1 | Serum vascular cell adhesion molecule-1 (VCAM-1) levels | 3 months | 
| Orexin-A | Serum Orexin-A levels | 3 months | 
| Body components | Fat tissue ratio | 3 months | 
| Zung self-rating depression scale | Questionnaire for depressive symptoms | 3 months | 
| 5-Item Geriatric Depression Scale | Questionnaire for Cognitive assessment | 3 months | 
| The Mini Mental State Examination (MMSE) | Questionnaire for Cognitive assessment | 3 months | 
| The Barthel index | Questionnaire for Cognitive assessment | 3 months | 
| Instrumental Activities of Daily Living (IADL) | Questionnaire for Cognitive assessment | 3 months | 
| ankle-brachial index | Peripheral artery disease assessment | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoporosis, Raloxifene, Central nervous disorders