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NCT00238745 Clinical Trial

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

Postmenopausal Osteoporosis Clinical Trial

Official title:
Bone Mineral Density Increase and Safety of TSE-424 Compared to Placebo in Osteoporotic Postmenopausal Women

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00238745
Other study ID # 3068A1-207
Secondary ID
Status Completed
Phase Phase 2
First received October 12, 2005
Last updated December 17, 2007
Start date August 2003
Est. completion date March 2007

Study information
Verified date December 2007
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority Japan: Pharmaceuticals and Medical Devices Agency
Study type Interventional

Clinical Trial Summary

Dose-response in Japanese patients with postmenopausal osteoporosis.

Recruitment information / eligibility
Status Completed
Enrollment 375
Est. completion date March 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group N/A to 85 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

Intervention

Drug:
• Bazedoxifene

• Placebo

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Outcome
Type Measure Description Time frame Safety issue
Primary Bone mineral density of lumbar spine (L1-L4) at 2 years.
Secondary Bone metabolic makers, bone fracture, bone mineral density of lumbar spine (L2-L4) and lip, lipid parameters, height and adverse events.
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