Osteoporosis Treatment in Post-menopausal Women

Phase 4

• Conditions: Depressive Syndrome
• Interventions: Drug: Raloxifene; Drug: Alendronate

• Registration Number: NCT03006003
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2016-12-16
• Study First Submitted QC: 2016-12-26
• Study First Posted: 2016-12-30
• Study Start: 2017-01-01
• Status Verified: 2018-01
• Last Update Submitted: 2019-01-11
• Last Update Posted: 2019-01-14
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 500

Inclusion Criteria

• Postmenopausal female
• Osteoporosis

Exclusion Criteria

• Psychological disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Raloxifene group	Raloxifene	Raloxifene treatment
Comparator group	Alendronate	Alendronate treatment

Primary Outcome Measures

Name	Time	Method
Brain-derived neurotrophic factor	3 months	Serum brain-derived neurotrophic factor (BDNF) Levels

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan

outpatient clinic of the Division of Endocrinology and Metabolism in Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan