Back to resultsStudy Evaluating the Safety and Efficacy of Bazedoxifene in Postmenopausal Asian Women
Primary Purpose
Postmenopause, Osteoporosis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
bazedoxifene BZA-20
Sponsored by
About this trial
This is an interventional prevention trial for Postmenopause focused on measuring postmenopausal, women, SERM, osteoporosis
Eligibility Criteria
Inclusion Criteria:
- Generally healthy Asian women 45 years of age or older who are at least 1 year postmenopausal
Subjects must qualify for one of the following categories (a or b):
- Greater than 1 year but less than 5 years postmenopausal with at least one of the ospeoporosis risk factors
- 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:
- One (1) or more osteoporotic vertebral fractures (T4 - L4)
- BMD T-score at the lumbar spine or femoral neck less than -2.5
- Past history or active nontraumatic venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis
Sites / Locations
Outcomes
Primary Outcome Measures
The percent change from baseline in lumbar spine bone mineral density (BMD) after 6 months of treatment
Secondary Outcome Measures
Additional BMD evaluation including total hip, femoral neck and trochanter at 6 months
Serum bone markers at 3 and 6 months
Lipid profile at 3 and 6 months
Full Information
NCT ID
NCT00384072
First Posted
October 3, 2006
Last Updated
December 19, 2007
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00384072
Brief Title
Study Evaluating the Safety and Efficacy of Bazedoxifene in Postmenopausal Asian Women
Official Title
A Multicenter, Double Blind, Randomized, Placebo Controlled Study to Assess the Safety and Efficacy of Bazedoxifene in Postmenopausal Asian Women
Study Type
Interventional
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopause, Osteoporosis
Keywords
postmenopausal, women, SERM, osteoporosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
bazedoxifene BZA-20
Primary Outcome Measure Information:
Title
The percent change from baseline in lumbar spine bone mineral density (BMD) after 6 months of treatment
Secondary Outcome Measure Information:
Title
Additional BMD evaluation including total hip, femoral neck and trochanter at 6 months
Title
Serum bone markers at 3 and 6 months
Title
Lipid profile at 3 and 6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Generally healthy Asian women 45 years of age or older who are at least 1 year postmenopausal
Subjects must qualify for one of the following categories (a or b):
Greater than 1 year but less than 5 years postmenopausal with at least one of the ospeoporosis risk factors
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:
One (1) or more osteoporotic vertebral fractures (T4 - L4)
BMD T-score at the lumbar spine or femoral neck less than -2.5
Past history or active nontraumatic venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Trial Manager
Organizational Affiliation
For China, medinfo@wyeth.com
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Trial Manager
Organizational Affiliation
For Taiwan, medinfo@wyeth.com
Official's Role
Principal Investigator
Facility Information:
City
Beijing
ZIP/Postal Code
100700
Country
China
City
Beijing
ZIP/Postal Code
100730
Country
China
City
Nanjing
ZIP/Postal Code
210008
Country
China
City
Shanghai
ZIP/Postal Code
100730
Country
China
City
Shanghai
ZIP/Postal Code
200011
Country
China
City
Shanghai
ZIP/Postal Code
200040
Country
China
City
Tianjin
ZIP/Postal Code
200233
Country
China
City
Tianjin
ZIP/Postal Code
300052
Country
China
City
Tianjin
ZIP/Postal Code
300211
Country
China
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
133-792
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
City
Suwon
ZIP/Postal Code
443-721
Country
Korea, Republic of
City
Kaohsuing
ZIP/Postal Code
833
Country
Taiwan
City
Kaoshsuing
ZIP/Postal Code
807
Country
Taiwan
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
City
Tapei
ZIP/Postal Code
105
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Study Evaluating the Safety and Efficacy of Bazedoxifene in Postmenopausal Asian Women
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