Study Evaluating Bazedoxifene Acetate In Osteoporosis In Postmenopausal Women - Full Text View

Sponsor:	Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:	Wyeth is now a wholly owned subsidiary of Pfizer
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 Other: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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: Bazedoxifene Bazedoxifene Acetate

U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Breast cancer incidence [ Time Frame: 7 years ] [ Designated as safety issue: No ]
Clinical vertebral fractures assessed by X-rays of spine; number of subjects reporting clinical vertebral fractures; will also report Kaplan Meier rate estimate [ Time Frame: 7 years ] [ Designated as safety issue: No ]
Worsening vertebral fractures assessed by X-rays of spine [ Time Frame: 7 years ] [ Designated as safety issue: No ]
Nonvertebral fractures assessed by X-rays of region of interest [ Time Frame: 7 years ] [ Designated as safety issue: No ]
Height changes in mm from baseline to year seven [ Time Frame: 7 years ] [ Designated as safety issue: No ]
Bone mineral density of lumbar spine and hip measured by DXA scans [ Time Frame: 7 years ] [ Designated as safety issue: No ]
Serum bone markers blood samples: osteocalcin - marker of bone formation and C-telopeptide (CTX) -marker of bone resorption [ Time Frame: 7 years ] [ Designated as safety issue: No ]
Lipid parameters [ Time Frame: 7 years ] [ Designated as safety issue: No ]

Enrollment:	7618
Study Start Date:	October 2001
Study Completion Date:	September 2010
Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: A	Drug: Bazedoxifene Acetate BZA 20mg, daily, oral
Placebo Comparator: B	Other: Placebo Placebo, daily, oral

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
Osteoporotic subjects without vertebral fracture who meet BMD criteria, or Osteoporotic subjects with vertebral fracture

Exclusion Criteria:

Diseases that may affect bone metabolism
Vasomotor symptoms requiring treatment
Known history or suspected cancer of the breast
Active or past history of venous thromboembolic events

Contacts and Locations

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

Show 230 Study Locations

Sponsors and Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided by Wyeth is now a wholly owned subsidiary of Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Christiansen C, Chesnut CH 3rd, Adachi JD, Brown JP, Fernandes CE, Kung AW, Palacios S, Levine AB, Chines AA, Constantine GD. Safety of bazedoxifene in a randomized, double-blind, placebo- and active-controlled phase 3 study of postmenopausal women with osteoporosis. BMC Musculoskelet Disord. 2010 Jun 22;11:130.

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier:	NCT00205777 History of Changes
Other Study ID Numbers:	3068A1-301, B1781001
Study First Received:	September 16, 2005
Last Updated:	May 4, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Osteoporosis
Postmenopause

Additional relevant MeSH terms:

Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on February 12, 2012