The Effects of Seasonal Changes in Osteoporosis Treatment | NCT02977949

Studies
The Effects of Seasonal Changes in Osteoporosis Treatment

NCT02977949

Sponsor

Toshihiko Kono

Status

Unknown status

Last Update Posted

Nov 30, 2016Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Selective Estrogen Receptor Modulator (SERM)

Interventions

Raloxifene

Countries

Japan

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

Nov 2016

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 2012

Primary Completion Date

Jul 2018Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

Nov 23, 2016

First Submission Date that Met QC Criteria

Nov 26, 2016

First Posted Date

Nov 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

Nov 26, 2016

Last Update Posted Date

Nov 30, 2016Estimated

Description Module

Brief Summary

There are few reports concerning to the seasonal variation of osteoporosis treatment. In this study, we plan to compare clinical efficacy and safety by seasons.

Detailed Description

Vitamin D insufficiency is common in many countries. Vitamin D insufficiency is associated with osteoporosis and the responses to osteoporosis treatment. 25-hydroxyvitamin D (25OHD) is considered to be the best estimate of body stores of vitamin D and the seasonal variation of 25OHD is well known. But there are few reports concerning to the seasonal variation of osteoporosis treatment. In this study, we plan to compare clinical efficacy and safety by seasons in patients treated by raloxifene.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

24 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Name	Type	Description	Arm Group Labels	Other Names
Raloxifene	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effects of raloxifene on bone mineral density in postmenopausal osteoporosis.		Up to 36 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Postmenopausal women

Exclusion Criteria:

Patients who could not use SERM

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Osteoporosis patients using raloxifene more for two years.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rui Niimi, MD	Contact	(81)-59-365-0023		furikakefuri@hotmail.co.jp

Overall Officials

Name	Affiliation	Role
Rui Niimi, MD	Tomidahama Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tomidahama Hospital	Recruiting	Yokkaichi	Mie-ken	510-8008	Japan

Intervention Browse Module

MeSH Terms

ID	Term
D020849	Raloxifene Hydrochloride

Ancestor Terms

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

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Browse Branches

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