Osteoporosis Treatment in Post-menopausal Women

NCT ID: NCT03006003

Last Updated: 2019-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2021-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Depressive Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Raloxifene group

Raloxifene treatment

Group Type EXPERIMENTAL

Raloxifene

Intervention Type DRUG

Raloxifene tratment more than 4 weeks

Comparator group

Alendronate treatment

Group Type ACTIVE_COMPARATOR

Alendronate

Intervention Type DRUG

Alendronic acid 70mg with Colecalciferol 70mcg

Control group

To refuse anti-osteoporosis treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Raloxifene

Raloxifene tratment more than 4 weeks

Intervention Type DRUG

Alendronate

Alendronic acid 70mg with Colecalciferol 70mcg

Intervention Type DRUG

Other Intervention Names

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Evista FOSAMAX PLUS

Eligibility Criteria

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Inclusion Criteria

* Postmenopausal female
* Osteoporosis

Exclusion Criteria

* Psychological disorders
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Taichung Veterans General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Taichung, , Taiwan

Site Status RECRUITING

Taichung Veterans General Hospital

Taichung, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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I-Te Lee, MD, PhD

Role: CONTACT

+886-4-23741300

I-Te Lee, MD, PhD

Role: CONTACT

Facility Contacts

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I Te Lee, MD

Role: primary

886-4-23741340

I-Te Lee, MD, PhD

Role: primary

Other Identifiers

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CE16256A

Identifier Type: -

Identifier Source: org_study_id

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