Osteoporosis Treatment in Post-menopausal Women | NCT03006003

Studies
Osteoporosis Treatment in Post-menopausal Women

NCT03006003

Sponsor

Taichung Veterans General Hospital

Status

Unknown status

Last Update Posted

Jan 14, 2019Actual

Enrollment

500Estimated

Phase

Phase 4

Conditions

Depressive Syndrome

Interventions

Raloxifene
Alendronate

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2017Actual

Primary Completion Date

Dec 2021Estimated

Completion Date

Dec 2021Estimated

First Submitted Date

Dec 16, 2016

First Submission Date that Met QC Criteria

Dec 26, 2016

First Posted Date

Dec 30, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 11, 2019

Last Update Posted Date

Jan 14, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Raloxifene group	Experimental	Raloxifene treatment	Drug: Raloxifene
Comparator group	Active Comparator	Alendronate treatment	Drug: Alendronate
Control group	No Intervention	To refuse anti-osteoporosis treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Raloxifene	Drug	Raloxifene tratment more than 4 weeks	Raloxifene group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Brain-derived neurotrophic factor	Serum brain-derived neurotrophic factor (BDNF) Levels	1 year
Vascular cell adhesion molecule-1	Serum vascular cell adhesion molecule-1 (VCAM-1) levels

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Postmenopausal female
Osteoporosis

Exclusion Criteria:

Psychological disorders

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
I-Te Lee, MD, PhD	Contact	+886-4-23741300		itlee@vghtc.gov.tw
I-Te Lee, MD, PhD	Contact			itlee@vghtc.gov.tw

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
outpatient clinic of the Division of Endocrinology and Metabolism in Taichung Veterans General Hospital	Recruiting	Taichung		407	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003866	Depressive Disorder
D010024	Osteoporosis

Ancestor Terms

ID	Term
D019964	Mood Disorders
D001523	Mental Disorders
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020849	Raloxifene Hydrochloride
D019386	Alendronate

Ancestor Terms

ID	Term
D013629	Tamoxifen
D013267	Stilbenes
D001597	Benzylidene Compounds
D001555	Benzene Derivatives

Browse Leaves

Not provided

Browse Branches

Not provided