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The Effects of Seasonal Changes in Osteoporosis Treatment

NCT ID: NCT02977949

Last Updated: 2016-11-30

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

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Selective Estrogen Receptor Modulator (SERM)

Keywords

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SERM Season Variation Vitamin D

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Raloxifene

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Postmenopausal women

Exclusion Criteria

* Patients who could not use SERM
Minimum Eligible Age

45 Years

Maximum Eligible Age

100 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Toshihiko Kono

OTHER

Sponsor Role lead

Responsible Party

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Toshihiko Kono

Head of Hospital

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Rui Niimi, MD

Role: STUDY_DIRECTOR

Tomidahama Hospital

Locations

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Tomidahama Hospital

Yokkaichi, Mie-ken, Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Rui Niimi, MD

Role: CONTACT

Phone: (81)-59-365-0023

Email: [email protected]

Facility Contacts

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Rui Niimi, MD, PhD

Role: primary

Other Identifiers

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TH 05-2

Identifier Type: -

Identifier Source: org_study_id