Osteoporosis Treatment in Post-menopausal Women

January 11, 2019 updated by: Taichung Veterans General Hospital

The Assessment of Osteoporosis Treatment in Post-menopausal Women

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

Study Overview

Status

Unknown

Conditions

Intervention / 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 Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Taichung, Taiwan, 407
        • Recruiting
        • Taichung Veterans General Hospital
        • Contact:
          • I-Te Lee, MD, PhD
      • Taichung, Taiwan, 407
        • Recruiting
        • outpatient clinic of the Division of Endocrinology and Metabolism in Taichung Veterans General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Postmenopausal female
  • Osteoporosis

Exclusion Criteria:

  • Psychological disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Raloxifene group
Raloxifene treatment
Drug: Raloxifene
Raloxifene tratment more than 4 weeks
Other Names:
  • Evista
ACTIVE_COMPARATOR: Comparator group
Alendronate treatment
Drug: Alendronate
Alendronic acid 70mg with Colecalciferol 70mcg
Other Names:
  • FOSAMAX PLUS
NO_INTERVENTION: Control group
To refuse anti-osteoporosis treatment

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taichung Veterans General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2017

Primary Completion (ANTICIPATED)

December 1, 2021

Study Completion (ANTICIPATED)

December 1, 2021

Study Registration Dates

First Submitted

December 16, 2016

First Submitted That Met QC Criteria

December 26, 2016

First Posted (ESTIMATE)

December 30, 2016

Study Record Updates

Last Update Posted (ACTUAL)

January 14, 2019

Last Update Submitted That Met QC Criteria

January 11, 2019

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE16256A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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