Osteoporosis Treatment in Post-menopausal Women

Depressive Syndrome Clinical Trial

Official title:

The Assessment of Osteoporosis Treatment in Post-menopausal Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03006003
• Other study ID #: CE16256A
• Status: Recruiting
• Phase: Phase 4
• Start date: January 1, 2017
• Est. completion date: December 2021

Study information

• Verified date: January 2018
• Source: Taichung Veterans General Hospital
• Contact: I-Te Lee, MD, PhD
• Phone: +886-4-23741300
• Email: itlee[@]vghtc.gov.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Postmenopausal female

• Osteoporosis

Exclusion Criteria:

• Psychological disorders

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Syndrome
• Osteoporosis

Intervention

Drug:
• Raloxifene
Raloxifene tratment more than 4 weeks
• Alendronate
Alendronic acid 70mg with Colecalciferol 70mcg

Locations

Country	Name	City	State
Taiwan	outpatient clinic of the Division of Endocrinology and Metabolism in Taichung Veterans General Hospital	Taichung
Taiwan	Taichung Veterans General Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Taichung Veterans General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

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