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

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00481169

Purpose

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.

Condition	Intervention	Phase
Osteoporosis	Drug: Bazedoxifene Acetate (TSE-424)	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Osteoporosis

Drug Information available for: Raloxifene hydrochloride Raloxifene Bazedoxifene Bazedoxifene Acetate

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Enrollment:	1742
Study Start Date:	July 2001
Study Completion Date:	September 2004
Primary Completion Date:	July 2004 (Final data collection date for primary outcome measure)

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.

Eligibility

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

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00481169

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Study ID Numbers:	3068A1-300
Study First Received:	May 30, 2007
Last Updated:	August 20, 2009
ClinicalTrials.gov Identifier:	NCT00481169 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Postmenopausal Osteoporosis

Additional relevant MeSH terms:

Estrogen Antagonists
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Osteoporosis
Bone Diseases, Metabolic
Bone Density Conservation Agents

Selective Estrogen Receptor Modulators
Bone Diseases
Pharmacologic Actions
Estrogen Receptor Modulators
Raloxifene
Musculoskeletal Diseases
Osteoporosis, Postmenopausal

ClinicalTrials.gov processed this record on November 22, 2009