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

Osteoporosis Clinical Trial

Official title:

A Multicenter, Double Blind, Randomized, Placebo Controlled Study to Assess the Safety and Efficacy of Bazedoxifene in Postmenopausal Asian Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00384072
• Other study ID #: 3068A1-303
• Status: Completed
• Phase: Phase 3
• First received: October 3, 2006
• Last updated: December 19, 2007
• Start date: May 2006
• Est. completion date: September 2007

Study information

• Verified date: May 2007
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationKorea: Food and Drug AdministrationChina: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Osteoporosis
• Postmenopause

Intervention

Drug:
• bazedoxifene BZA-20

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

China,  Korea, Republic of,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percent change from baseline in lumbar spine bone mineral density (BMD) after 6 months of treatment
Secondary	Additional BMD evaluation including total hip, femoral neck and trochanter at 6 months
Secondary	Serum bone markers at 3 and 6 months
Secondary	Lipid profile at 3 and 6 months