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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00384072
First received: October 3, 2006
Last updated: December 19, 2007
Last verified: May 2007
  Purpose

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.


Condition Intervention Phase
Postmenopause
Osteoporosis
Drug: bazedoxifene BZA-20
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: A Multicenter, Double Blind, Randomized, Placebo Controlled Study to Assess the Safety and Efficacy of Bazedoxifene in Postmenopausal Asian Women

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 500
Study Start Date: May 2006
Study Completion Date: September 2007
  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00384072

Locations
China
Beijing, China, 100730
Beijing, China, 100700
Nanjing, China, 210008
Shanghai, China, 200040
Shanghai, China, 200011
Shanghai, China, 100730
Tianjin, China, 300211
Tianjin, China, 200233
Tianjin, China, 300052
Korea, Republic of
Seoul, Korea, Republic of, 120-752
Seoul, Korea, Republic of, 133-792
Seoul, Korea, Republic of, 138-736
Seoul, Korea, Republic of, 135-710
Seoul, Korea, Republic of, 110-744
Suwon, Korea, Republic of, 443-721
Taiwan
Kaohsuing, Taiwan, 833
Kaoshsuing, Taiwan, 807
Tainan, Taiwan, 704
Taipei, Taiwan, 100
Tapei, Taiwan, 105
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For China, medinfo@wyeth.com
Principal Investigator: Trial Manager For Taiwan, medinfo@wyeth.com
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00384072     History of Changes
Other Study ID Numbers: 3068A1-303
Study First Received: October 3, 2006
Last Updated: December 19, 2007
Health Authority: United States: Food and Drug Administration
Korea: Food and Drug Administration
China: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
postmenopausal
women
SERM
osteoporosis

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Bazedoxifene
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 18, 2014