Study Evaluating the Safety and Efficacy of Bazedoxifene in Postmenopausal Asian Women

NCT ID: NCT00384072

Last Updated: 2007-12-28

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-09-30

Brief Summary

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The purpose of this study is to evaluate the effect of 20 mg of bazedoxifene in comparison to placebo on bone mineral density after 6 months of therapy in a population of postmenopausal Asian women.

Detailed Description

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Conditions

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Postmenopause Osteoporosis

Keywords

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postmenopausal women SERM osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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bazedoxifene BZA-20

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Generally healthy Asian women 45 years of age or older who are at least 1 year postmenopausal
2. Subjects must qualify for one of the following categories (a or b):

1. Greater than 1 year but less than 5 years postmenopausal with at least one of the ospeoporosis risk factors
2. Equal or greater than 5 years postmenopausal with BMD T-score at lumbar spine or femoral neck between -1 and -2.5 (values of -1 and -2.5 are acceptable) with at least one osteoporosis risk factor

Exclusion Criteria

1. One (1) or more osteoporotic vertebral fractures (T4 - L4)
2. BMD T-score at the lumbar spine or femoral neck less than -2.5
3. Past history or active nontraumatic venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis
Minimum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For China, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Taiwan, [email protected]

Locations

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Beijing, , China

Site Status

Beijing, , China

Site Status

Nanjing, , China

Site Status

Shanghai, , China

Site Status

Shanghai, , China

Site Status

Shanghai, , China

Site Status

Tianjin, , China

Site Status

Tianjin, , China

Site Status

Tianjin, , China

Site Status

Seoul, , South Korea

Site Status

Seoul, , South Korea

Site Status

Seoul, , South Korea

Site Status

Seoul, , South Korea

Site Status

Seoul, , South Korea

Site Status

Suwon, , South Korea

Site Status

Kaohsuing, , Taiwan

Site Status

Kaoshsuing, , Taiwan

Site Status

Tainan City, , Taiwan

Site Status

Taipei, , Taiwan

Site Status

Tapei, , Taiwan

Site Status

Countries

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China South Korea Taiwan

Other Identifiers

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3068A1-303

Identifier Type: -

Identifier Source: org_study_id