Study Evaluating the Safety and Efficacy of Bazedoxifene in Postmenopausal Asian Women - Full Text View

Purpose

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.

Condition	Intervention	Phase
Postmenopause Osteoporosis	Drug: bazedoxifene BZA-20	Phase III

MedlinePlus related topics:

Minerals Osteoporosis

Drug Information available for:

Bazedoxifene

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by Wyeth:

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

Estimated Enrollment:	500
Study Start Date:	May 2006
Study Completion Date:	September 2007

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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):
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:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00384072

Locations


China

	Beijing, China, 100730

	Beijing, China, 100700

	Nanjing, China, 210008

	Shanghai, China, 100730

	Tianjin, China, 200233

	Tianjin, China, 300052

	Tianjin, China, 300211

	Shanghai, China, 200011

	Shanghai, China, 200040

Korea, Republic of

	Seoul, Korea, Republic of, 120-752

	Seoul, Korea, Republic of, 133-792

	Suwon, Korea, Republic of, 443-721

	Seoul, Korea, Republic of, 138-736

	Seoul, Korea, Republic of, 135-710

	Seoul, Korea, Republic of, 110-744

Taiwan

	Tapei, Taiwan, 105

	Taipei, Taiwan, 100

	Kaohsuing, Taiwan, 833

	Tainan, Taiwan, 704

	Kaoshsuing, Taiwan, 807

Sponsors and Collaborators

Wyeth

Investigators


Study Director:	Medical Monitor	Wyeth

Principal Investigator:	Trial Manager	For China, medinfo@wyeth.com

Principal Investigator:	Trial Manager	For Taiwan, medinfo@wyeth.com

More Information

Study ID Numbers:	3068A1-303
First Received:	October 3, 2006
Last Updated:	December 19, 2007
ClinicalTrials.gov Identifier:	NCT00384072
Health Authority:	United States: Food and Drug Administration; Korea: Food and Drug Administration; China: State Food and Drug Administration

Keywords provided by Wyeth:

postmenopausal

women

SERM

osteoporosis

Study placed in the following topic categories:

Musculoskeletal Diseases

Osteoporosis

Bone Diseases, Metabolic

Bone Diseases

ClinicalTrials.gov processed this record on October 29, 2008

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00384072