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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00238745
First received: October 12, 2005
Last updated: December 17, 2007
Last verified: December 2007
History of Changes
  Purpose

Dose-response in Japanese patients with postmenopausal osteoporosis.


Condition Intervention Phase
Postmenopausal Osteoporosis
 Drug: Bazedoxifene
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Official Title: Bone Mineral Density Increase and Safety of TSE-424 Compared to Placebo in Osteoporotic Postmenopausal Women

Resource links provided by NLM:

U.S. FDA Resources

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

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

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

Estimated Enrollment: 375
Study Start Date: August 2003
Study Completion Date: March 2007
  Eligibility

Ages Eligible for Study:   up to 85 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Wyeth is now a wholly owned subsidiary of Pfizer

Additional 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
Study First Received: October 12, 2005
Last Updated: December 17, 2007
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

ClinicalTrials.gov processed this record on May 21, 2013