Comparison Between Raloxifene and Bazedoxifene

NCT ID: NCT01973738

Last Updated: 2016-10-19

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

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2018-12-31

Brief Summary

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Although there are two kinds of selective estrogen receptor modulator (SERM) :raloxifene (RLX) and bazedoxifene (BZA), the difference is still unclear. In this study, we plan to compare clinical efficacy and safety between RLX and BZA.

Detailed Description

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Selective estrogen receptor modulator (SERM) is an important option for postmenopausal osteoporosis. There are two SERM approved in Japan for the treatment of postmenopausal osteoporosis in women at increased risk of fracture. One is raloxifene (RLX), and the other is bazedoxifene (BZA). There are few reports concerning to the clinical efficacy and safety data. In this study, we plan to compare clinical efficacy and safety between RLX and BZA.

The main objective of this study is to reveal the effects of RLX and BZA on bone mineral density, bone turnover markers, and bone quality markers.

Conditions

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Selective Estrogen Receptor Modulator

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

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

Locations

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Tomidahama Hospital

Yokkaichi, Mie-ken, Japan

Site Status RECRUITING

Countries

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Japan

Facility Contacts

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Rui Niimi, MD, PhD

Role: primary

(81)-59-365-0023

Other Identifiers

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IRB TH 05

Identifier Type: -

Identifier Source: org_study_id

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