Study Evaluating Bazedoxifene Acetate in Osteoporosis - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00205777

Purpose

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

Condition	Intervention	Phase
Osteoporosis	Drug: Bazedoxifene Acetate Drug: Raloxifene Other: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Fracture Incidence Reduction and Safety of TSE-424 (Bazedoxifene Acetate) Compared to Placebo and Raloxifene in Osteoporotic Postmenopausal Women

Resource links provided by NLM:

MedlinePlus related topics: Fractures 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:

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 ]

Secondary Outcome Measures:

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

Estimated Enrollment:	7609
Study Start Date:	October 2001
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator	Drug: Bazedoxifene Acetate BZA 20mg BZA 40mg
B: Active Comparator	Drug: Bazedoxifene Acetate BZA 20mg BZA 40mg
C: Active Comparator	Drug: Raloxifene 60mg
D: Placebo Comparator	Other: Placebo Placebo

Eligibility

Ages Eligible for Study:	55 Years to 80 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00205777

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3068A1-301
Study First Received:	September 16, 2005
Last Updated:	May 6, 2008
ClinicalTrials.gov Identifier:	NCT00205777 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Osteoporosis
Postmenopause

Study placed in the following topic categories:

Estrogen Antagonists
Estrogens
Hormone Antagonists
Fractures, Bone
Hormones, Hormone Substitutes, and Hormone Antagonists
Osteoporosis
Bone Diseases, Metabolic

Bone Density Conservation Agents
Selective Estrogen Receptor Modulators
Bone Diseases
Hormones
Estrogen Receptor Modulators
Raloxifene
Musculoskeletal Diseases

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

ClinicalTrials.gov processed this record on July 02, 2009