Study Evaluating Bazedoxifene Acetate in Osteoporosis - Tabular View

Tracking Information

First Received Date ^ICMJE

September 16, 2005

Last Updated Date

May 6, 2008

Start Date ^ICMJE

October 2001

Estimated Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Incidence reduction of new vertebral fractures. [ Time Frame: 7 years ] [ Designated as safety issue: No ]
To compare the safety profile fo bazedoxifene acetate to placebo. [ Time Frame: 7 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Incidence reduction of new vertebral fractures.
To compare the safety profile fo bazedoxifene acetate to placebo.

Change History

Complete list of historical versions of study NCT00205777 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Breast cancer incidence; Clinical vertebral fractures; Worsening vertebral fractures; Nonvertebral fractures; Height changes [ Time Frame: 7 years ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Breast cancer incidence; Clinical vertebral fractures; Worsening vertebral fractures; Nonvertebral fractures; Height changes

Descriptive Information

Brief Title ^ICMJE

Study Evaluating Bazedoxifene Acetate in Osteoporosis

Official Title ^ICMJE

Fracture Incidence Reduction and Safety of TSE-424 (Bazedoxifene Acetate) Compared to Placebo and Raloxifene in Osteoporotic Postmenopausal Women

Brief Summary

The purpose of this study is to determine whether bazedoxifene acetate is safe and effective in the treatment of osteoporosis in postmenopausal women

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Osteoporosis

Intervention ^ICMJE

Drug: Bazedoxifene Acetate
Drug: Raloxifene
Other: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

7609

Estimated Completion Date

September 2010

Estimated Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Must be at least 2 years postmenopausal

Exclusion Criteria:

Diseases that may affect bone metabolism
Vasomotor symptoms requiring treatment
Known history or suspected cancer of the breast

Gender

Female

Ages

55 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00205777

Responsible Party

Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth

Study ID Numbers ^ICMJE

3068A1-301

Study Sponsor ^ICMJE

Wyeth

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Wyeth

Information Provided By

Wyeth

Verification Date

May 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP