Study Evaluating TSE-424/Placebo/Raloxifene in Preventing Osteoporosis in Postmenopausal Women - Tabular View

Tracking Information

First Received Date ^ICMJE

May 30, 2007

Last Updated Date

August 20, 2009

Start Date ^ICMJE

July 2001

Primary Completion Date

July 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The percent change from baseline in lumbar spine bone mineral density (BMD) after 24 months. [ Time Frame: 24 months ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00481169 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Additional BMD evaluation including total hip, femoral neck and trochanter at months 6, 12, 18 and 24. Serum bone markers at months 3, 6, 9, 12, 18 and 24. Lipid panel at months 3, 6, 12, 18 and 24. [ Time Frame: Up to 24 months ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Study Evaluating TSE-424/Placebo/Raloxifene in Preventing Osteoporosis in Postmenopausal Women

Official Title ^ICMJE

A Multicenter, Double Blind, Randomized, Placebo and Raloxifene Controlled Study to Assess Safety and Efficacy of TSE-424 (Bazedoxifene Acetate) in the Prevention of Postmenopausal Osteoporosis

Brief Summary

The purpose of this study is to determine whether TSE-424 (bazedoxifene acetate), an investigational drug, is safe and effective in the prevention of osteoporosis in postmenopausal women.

Detailed Description

Primary objective: To evaluate the safety and efficacy of 3 doses of TSE-424 (bazedoxifene acetate), an investigational drug, in comparison with those of placebo and raloxifene in preventing osteoporosis in postmenopausal women.

Secondary objective: To evaluate the effect of TSE-424 (bazedoxifene acetate), an investigational drug, in comparison with that of placebo and raloxifene on endometrium, metabolic parameters, vasomotor symptoms, adverse events, and quality of life. Samples will be collected for population pharmacokinetic (PK) analysis.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Osteoporosis

Intervention ^ICMJE

Drug: Bazedoxifene Acetate (TSE-424)

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

Completed

Enrollment ^ICMJE

1742

Completion Date

September 2004

Primary Completion Date

July 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Generally healthy 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): a) Greater than 1 year but less than 5 years postmenopausal with at least one of the osteoporosis risk factors. b) Greater than 5 years postmenopausal with BMD T-score at lumbar spine or femoral neck between -1 and -2.5 (inclusive) with at least one osteoporosis risk factor.

Exclusion Criteria:

One (1) or more osteoporotic vertebral fractures (T4-L4).
Diseases that may affect bone metabolism.
Past history or active nontraumatic venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis.

Gender

Female

Ages

45 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00481169

Responsible Party

Study ID Numbers ^ICMJE

3068A1-300

Study Sponsor ^ICMJE

Wyeth

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Wyeth

Information Provided By

Wyeth

Verification Date

August 2009

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