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

Phase 2

Completed

• Conditions: Postmenopausal Osteoporosis

• Registration Number: NCT00238745
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

Dose-response in Japanese patients with postmenopausal osteoporosis.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-08
• Study First Submitted: 2005-10-12
• Study First Submitted QC: 2005-10-12
• Study First Posted: 2005-10-13
• Study Completion: 2007-03
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-17
• Last Update Posted: 2007-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 375

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Bone mineral density of lumbar spine (L1-L4) at 2 years.

Secondary Outcome Measures

Name	Time	Method
Bone metabolic makers, bone fracture, bone mineral density of lumbar spine (L2-L4) and lip, lipid parameters, height and adverse events.