Osteoporosis Treatment in Post-menopausal Women

NCT03006003 — Phase 4, Unknown, 500 participants, Taichung Veterans General Hospital

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The Assessment of Osteoporosis Treatment in Post-menopausal Women

Registry	NCT03006003
Status	Unknown
Phase	Phase 4
Study type	Interventional; non randomized, parallel, masking: none, treatment
Enrollment	500 (Estimated)
Sponsor	Taichung Veterans General Hospital (Other)
Conditions	Depressive Syndrome
Interventions	Raloxifene, Alendronate (Drug)
Dates	start 2017-01-01, primary completion 2021-12-01 (estimated), completion 2021-12-01 (estimated), first posted 2016-12-30, last updated 2019-01-14
Locations	2 sites in Taiwan

-Summary

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

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Raloxifene group	Experimental	Drug: Raloxifene	Raloxifene treatment
Comparator group	Active comparator	Drug: Alendronate	Alendronate treatment
Control group	No intervention		To refuse anti-osteoporosis treatment

Raloxifene (Drug), also known as Evista: Raloxifene tratment more than 4 weeks
Alendronate (Drug), also known as FOSAMAX PLUS: Alendronic acid 70mg with Colecalciferol 70mcg

+Outcome measures

Primary outcomes

Brain-derived neurotrophic factor [3 months]: Serum brain-derived neurotrophic factor (BDNF) Levels

Secondary outcomes

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

+Eligibility

Sex: Female, ages: 20 Years to any

Inclusion Criteria:

* Postmenopausal female
* Osteoporosis

Exclusion Criteria:

* Psychological disorders

+Locations (2)

Facility	City	Country	Status
outpatient clinic of the Division of Endocrinology and Metabolism in Taichung Veterans General Hospital	Taichung	Taiwan	Recruiting
Taichung Veterans General Hospital	Taichung	Taiwan	Recruiting