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Osteoporosis Treatment in Post-menopausal Women

Primary Purpose

Depressive Syndrome

Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Raloxifene
Alendronate
Sponsored by
Taichung Veterans General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Syndrome focused on measuring Osteoporosis, Raloxifene, Central nervous disorders

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Postmenopausal female
  • Osteoporosis

Exclusion Criteria:

  • Psychological disorders

Sites / Locations

  • outpatient clinic of the Division of Endocrinology and Metabolism in Taichung Veterans General HospitalRecruiting
  • Taichung Veterans General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Raloxifene group

Comparator group

Control group

Arm Description

Raloxifene treatment

Alendronate treatment

To refuse anti-osteoporosis treatment

Outcomes

Primary Outcome Measures

Brain-derived neurotrophic factor
Serum brain-derived neurotrophic factor (BDNF) Levels

Secondary Outcome Measures

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

Full Information

First Posted
December 16, 2016
Last Updated
January 11, 2019
Sponsor
Taichung Veterans General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03006003
Brief Title
Osteoporosis Treatment in Post-menopausal Women
Official Title
The Assessment of Osteoporosis Treatment in Post-menopausal Women
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taichung Veterans General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Syndrome
Keywords
Osteoporosis, Raloxifene, Central nervous disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Raloxifene group
Arm Type
Experimental
Arm Description
Raloxifene treatment
Arm Title
Comparator group
Arm Type
Active Comparator
Arm Description
Alendronate treatment
Arm Title
Control group
Arm Type
No Intervention
Arm Description
To refuse anti-osteoporosis treatment
Intervention Type
Drug
Intervention Name(s)
Raloxifene
Other Intervention Name(s)
Evista
Intervention Description
Raloxifene tratment more than 4 weeks
Intervention Type
Drug
Intervention Name(s)
Alendronate
Other Intervention Name(s)
FOSAMAX PLUS
Intervention Description
Alendronic acid 70mg with Colecalciferol 70mcg
Primary Outcome Measure Information:
Title
Brain-derived neurotrophic factor
Description
Serum brain-derived neurotrophic factor (BDNF) Levels
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Brain-derived neurotrophic factor
Description
Serum brain-derived neurotrophic factor (BDNF) Levels
Time Frame
1 year
Title
Vascular cell adhesion molecule-1
Description
Serum vascular cell adhesion molecule-1 (VCAM-1) levels
Time Frame
3 months
Title
Orexin-A
Description
Serum Orexin-A levels
Time Frame
3 months
Title
Body components
Description
Fat tissue ratio
Time Frame
3 months
Title
Zung self-rating depression scale
Description
Questionnaire for depressive symptoms
Time Frame
3 months
Title
5-Item Geriatric Depression Scale
Description
Questionnaire for Cognitive assessment
Time Frame
3 months
Title
The Mini Mental State Examination (MMSE)
Description
Questionnaire for Cognitive assessment
Time Frame
3 months
Title
The Barthel index
Description
Questionnaire for Cognitive assessment
Time Frame
3 months
Title
Instrumental Activities of Daily Living (IADL)
Description
Questionnaire for Cognitive assessment
Time Frame
3 months
Title
ankle-brachial index
Description
Peripheral artery disease assessment
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Postmenopausal female Osteoporosis Exclusion Criteria: Psychological disorders
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
I-Te Lee, MD, PhD
Phone
+886-4-23741300
Email
itlee@vghtc.gov.tw
First Name & Middle Initial & Last Name or Official Title & Degree
I-Te Lee, MD, PhD
Email
itlee@vghtc.gov.tw
Facility Information:
Facility Name
outpatient clinic of the Division of Endocrinology and Metabolism in Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
I Te Lee, MD
Phone
886-4-23741340
Email
itlee@vghtc.gov.tw
First Name & Middle Initial & Last Name & Degree
I Te Lee, MD
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
I-Te Lee, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Osteoporosis Treatment in Post-menopausal Women

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