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Completed

NCT Number: NCT00384072

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

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.

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Key information

Conditions

Postmenopause Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis

Age range

45 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Beijing, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bazedoxifene BZA-20

Drug

Primary outcomes

  1. The percent change from baseline in lumbar spine bone mineral density (BMD) after 6 months of treatment

Secondary outcomes

  1. Additional BMD evaluation including total hip, femoral neck and trochanter at 6 months

  2. Serum bone markers at 3 and 6 months

  3. Lipid profile at 3 and 6 months

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Study completion
2007
First posted
Oct 4, 2006
Registry last updated
Dec 28, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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