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

December 19, 2007 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

A Multicenter, Double Blind, Randomized, Placebo Controlled Study to Assess the Safety and Efficacy of Bazedoxifene in Postmenopausal Asian Women

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100730
      • Beijing, China, 100700
      • Nanjing, China, 210008
      • Shanghai, China, 200040
      • Shanghai, China, 200011
      • Shanghai, China, 100730
      • Tianjin, China, 300052
      • Tianjin, China, 300211
      • Tianjin, China, 200233
  • Korea, Republic of
      • Seoul, Korea, Republic of, 138-736
      • Seoul, Korea, Republic of, 110-744
      • Seoul, Korea, Republic of, 120-752
      • Seoul, Korea, Republic of, 135-710
      • Seoul, Korea, Republic of, 133-792
      • Suwon, Korea, Republic of, 443-721
  • Taiwan
      • Kaohsuing, Taiwan, 833
      • Kaoshsuing, Taiwan, 807
      • Tainan, Taiwan, 704
      • Taipei, Taiwan, 100
      • Tapei, Taiwan, 105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The percent change from baseline in lumbar spine bone mineral density (BMD) after 6 months of treatment

Secondary Outcome Measures

Outcome Measure
Additional BMD evaluation including total hip, femoral neck and trochanter at 6 months
Serum bone markers at 3 and 6 months
Lipid profile at 3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

October 3, 2006

First Submitted That Met QC Criteria

October 3, 2006

First Posted (Estimate)

October 4, 2006

Study Record Updates

Last Update Posted (Estimate)

December 28, 2007

Last Update Submitted That Met QC Criteria

December 19, 2007

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3068A1-303

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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