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Study Evaluating Bazedoxifene Dose-Response in Japanese Patients With Postmenopausal Osteoporosis.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00238745
Recruitment Status : Completed
First Posted : October 13, 2005
Last Update Posted : December 20, 2007
Sponsor:
Information provided by:

Study Description
Brief Summary:
Dose-response in Japanese patients with postmenopausal osteoporosis.

Condition or disease Intervention/treatment Phase
Postmenopausal Osteoporosis Drug: Bazedoxifene Drug: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 375 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Official Title: Bone Mineral Density Increase and Safety of TSE-424 Compared to Placebo in Osteoporotic Postmenopausal Women
Study Start Date : August 2003
Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Bone mineral density of lumbar spine (L1-L4) at 2 years.

Secondary Outcome Measures :
  1. Bone metabolic makers, bone fracture, bone mineral density of lumbar spine (L2-L4) and lip, lipid parameters, height and adverse events.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 85 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be postmenopausal and diagnosed as osteoporosis based on bone mineral density and/or vertebral fracture.

Exclusion Criteria:

  • Diseases which possibly induce secondary osteoporosis or osteopenia and affect on bone metabolism.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00238745


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
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00238745     History of Changes
Other Study ID Numbers: 3068A1-207
First Posted: October 13, 2005    Key Record Dates
Last Update Posted: December 20, 2007
Last Verified: December 2007

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Postmenopausal Osteoporosis

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