Clinical trial NCT00205777: Study Evaluating Bazedoxifene Acetate In Osteoporosis In Postmenopausal Women
Official title: Fracture Incidence Reduction And Safety Of TSE-424 (Bazedoxifene Acetate) Compared To Placebo And Raloxifene In Osteoporotic Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoporosis
Keywords: Osteoporosis
Postmenopause
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 7609
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Percentage of Participants With New Vertebral Fractures Through Month 36
timeFrame: Baseline through Month 36
measure: Percentage of Participants With New Vertebral Fractures Through Month 60
timeFrame: Baseline through Month 60
measure: Percentage of Participants With New Vertebral Fractures Through Month 84
timeFrame: Baseline through Month 84
Secondary outcomes:
measure: Incidence of Breast Cancer Through Month 36
timeFrame: Baseline through Month 36
measure: Incidence of Breast Cancer Through Month 60
timeFrame: Baseline through Month 60
measure: Incidence of Breast Cancer Through Month 84
timeFrame: Baseline through Month 84
measure: Percentage of Participants With New Clinical Vertebral Fractures Through Month 36
timeFrame: Baseline through Month 36
measure: Percentage of Participants With New Clinical Vertebral Fractures Through Month 60
timeFrame: Baseline through Month 60
measure: Percentage of Participants With New Clinical Vertebral Fractures Through Month 84
timeFrame: Baseline through Month 84
measure: Number of Participants With Worsening Vertebral Fractures Through Month 36
timeFrame: Baseline through Month 36
measure: Number of Participants With Worsening Vertebral Fractures Through Month 60
timeFrame: Baseline through Month 60
measure: Number of Participants With Worsening Vertebral Fractures Through Month 84
timeFrame: Baseline through Month 84
measure: Percentage of Participants With Non-vertebral Fractures Through Month 36
timeFrame: Baseline through Month 36
measure: Percentage of Participants With Non-vertebral Fractures Through Month 60
timeFrame: Baseline through Month 60
measure: Percentage of Participants With Non-vertebral Fractures Through Month 84
timeFrame: Baseline through Month 84
measure: Change From Baseline in Height at Month 36
timeFrame: Baseline, Month 36
measure: Change From Baseline in Height at Month 60
timeFrame: Baseline, Month 60
measure: Change From Baseline in Height at Month 84
timeFrame: Baseline, Month 84
measure: Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36
timeFrame: Baseline, Months 6, 12, 18, 24, 36
measure: Percent Change From Baseline in Bone Mineral Density (BMD) at Months 48, 60
timeFrame: Baseline, Month 48, 60
measure: Percent Change From Baseline in Bone Mineral Density (BMD) at Months 72 and 84
timeFrame: Baseline, Month 72, 84
measure: Percent Change From Baseline in Osteocalcin at Month 3, 6 and 12
timeFrame: Baseline, Months 3, 6, 12
measure: Percent Change From Baseline in Osteocalcin at Months 36 and 60
timeFrame: Baseline, Months 36, 60
measure: Percent Change From Baseline in Osteocalcin at Months 72 and 84
timeFrame: Baseline, Months 72, 84
measure: Percent Change From Baseline in C-telopeptide (CTx) at Month 3, 6 and 12
timeFrame: Baseline, Months 3, 6, 12
measure: Percent Change From Baseline in C-telopeptide (CTx) at Months 36 and 60
timeFrame: Baseline, Months 36, 60
measure: Percent Change From Baseline in C-telopeptide (CTx) at Months 72 and 84
timeFrame: Baseline, Months 72, 84
measure: Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36
timeFrame: Baseline, Months 6, 12, 24, 36
measure: Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP
timeFrame: Month 36
measure: Bone Histomorphometric Indices at Month 60: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP
timeFrame: Month 60
measure: Bone Histomorphometric Indices at Month 36: WTh, OTh, TbTh, TbSp and CTh
timeFrame: Month 36
measure: Bone Histomorphometric Indices at Month 60: WTh, OTh, TbTh, TbSp and CTh
timeFrame: Month 60
measure: Bone Histomorphometric Indices at Month 36: Total Surface (Goldner Slide) [TSG]
timeFrame: Month 36
measure: Bone Histomorphometric Indices at Month 60: TSG
timeFrame: Month 60
measure: Bone Histomorphometric Indices at Month 36: TtAr
timeFrame: Month 36
measure: Bone Histomorphometric Indices at Month 60: TtAr
timeFrame: Month 60
measure: Bone Histomorphometric Indices at Month 36: BFP, RP and RmP
timeFrame: Month 36
measure: Bone Histomorphometric Indices at Month 60: BFP, RP and RmP
timeFrame: Month 60
measure: Bone Histomorphometric Indices at Month 36: SuD
timeFrame: Month 36
measure: Bone Histomorphometric Indices at Month 60: SuD
timeFrame: Month 60
measure: Bone Histomorphometric Indices at Month 36: BFRTS
timeFrame: Month 36
measure: Bone Histomorphometric Indices at Month 60: BFRTS
timeFrame: Month 60
measure: Bone Histomorphometric Indices at Month 36: ACF
timeFrame: Month 36
measure: Bone Histomorphometric Indices at Month 60: ACF
timeFrame: Month 60
measure: Bone Histomorphometric Indices at Month 36: Mlt
timeFrame: Month 36
measure: Bone Histomorphometric Indices at Month 60: Mlt
timeFrame: Month 60
measure: Bone Histomorphometric Indices at Month 36: MAR
timeFrame: Month 36
measure: Bone Histomorphometric Indices at Month 60: MAR
timeFrame: Month 60
measure: Bone Histomorphometric Indices at Month 36: TbN
timeFrame: Month 36
measure: Bone Histomorphometric Indices at Month 60: TbN
timeFrame: Month 60
measure: Bone Histomorphometric Indices at Month 36: BFRBV
timeFrame: Month 36
measure: Bone Histomorphometric Indices at Month 60: BFRBV
timeFrame: Month 60
measure: Women's Health Questionnaire (WHQ)
timeFrame: Baseline
measure: Change From Baseline in Women's Health Questionnaire (WHQ) at Month 12, 24 and 36
timeFrame: Baseline, Months 12, 24, 36
measure: European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO)
timeFrame: Baseline
measure: Change From Baseline in European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO) at Month 12, 24 and 36
timeFrame: Baseline, Months 12, 24, 36
measure: Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)
timeFrame: Baseline
measure: Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Month 12, 24 and 36
timeFrame: Baseline, Months 12, 24, 36
measure: Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score
timeFrame: Baseline
measure: Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score at Month 12, 24 and 36
timeFrame: Baseline, Months 12, 24, 36
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Huntsville
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state: Alabama
city: Mobile
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state: Alabama
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state: Arizona
city: Phoenix
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facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
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facility: Pfizer Investigational Site
state: Arizona
city: Scottsdale
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facility: Pfizer Investigational Site
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city: Scottsdale
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facility: Pfizer Investigational Site
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city: Anaheim
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facility: Pfizer Investigational Site
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city: Berkeley
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state: California
city: Beverly Hills
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state: California
city: Fresno
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facility: Pfizer Investigational Site
state: California
city: Fresno
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facility: Pfizer Investigational Site
state: California
city: La Jolla
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facility: Pfizer Investigational Site
state: California
city: Oakland
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facility: Pfizer Investigational Site
state: California
city: Palm Desert
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facility: Pfizer Investigational Site
state: California
city: Palm Springs
country: United States
facility: Pfizer Investigational Site
state: California
city: Palm Springs
country: United States
facility: Pfizer Investigational Site
state: California
city: Palm Springs
country: United States
facility: Pfizer Investigational Site
state: California
city: Rancho Mirage
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facility: Pfizer Investigational Site
state: California
city: Sacramento
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facility: Pfizer Investigational Site
state: California
city: Sacramento
country: United States
facility: Pfizer Investigational Site
state: California
city: Sacramento
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
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facility: Pfizer Investigational Site
state: California
city: San Diego
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facility: Pfizer Investigational Site
state: California
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city: Hamden
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city: Madison
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facility: Pfizer Investigational Site
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city: Waterbury
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city: Newark
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state: Delaware
city: Washington
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facility: Pfizer Investigational Site
state: District of Columbia
city: Washington
country: United States
facility: Pfizer Investigational Site
state: District of Columbia
city: Washington
country: United States
facility: Pfizer Investigational Site
state: District of Columbia
city: Washington
country: United States
facility: Pfizer Investigational Site
state: District of Columbia
city: Aventura
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Boca Raton
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facility: Pfizer Investigational Site
state: Florida
city: Cape Coral
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facility: Pfizer Investigational Site
state: Florida
city: Clearwater
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Daytona Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Daytona Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Delray Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Fort Myers
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Ft. Myers
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Gainesville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Holiday
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Lake Worth
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Largo
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Ormond Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Palm Beach Gardens
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facility: Pfizer Investigational Site
state: Florida
city: Palm Harbor
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Pembroke Pines
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facility: Pfizer Investigational Site
state: Florida
city: Plantation
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Port Orange
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Sarasota
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Sarasota
country: United States
facility: Pfizer Investigational Site
state: Florida
city: St Petersburg
country: United States
facility: Pfizer Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Augusta
country: United States
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state: Georgia
city: Decatur
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Riverdale
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Boise
country: United States
facility: Pfizer Investigational Site
state: Idaho
city: Boise
country: United States
facility: Pfizer Investigational Site
state: Idaho
city: Boise
country: United States
facility: Pfizer Investigational Site
state: Idaho
city: Cadwell
country: United States
facility: Pfizer Investigational Site
state: Idaho
city: Idaho Falls
country: United States
facility: Pfizer Investigational Site
state: Idaho
city: Meridian
country: United States
facility: Pfizer Investigational Site
state: Idaho
city: Champaign
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Libertyville
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Peoria
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Avon
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Evansville
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Evansville
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Evansville
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Kansas City
country: United States
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state: Kansas
city: Louisville
country: United States
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state: Kentucky
city: Louisville
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state: Kentucky
city: Lousiville
country: United States
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state: Kentucky
city: Bangor
country: United States
facility: Pfizer Investigational Site
state: Maine
city: Bangor
country: United States
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state: Maine
city: Bethesda
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state: Maryland
city: Silver Spring
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state: Maryland
city: Wheaton
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state: Maryland
city: Boston
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state: Massachusetts
city: Brookline
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state: Massachusetts
city: Fall River
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state: Massachusetts
city: Fall River
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Grand Rapids
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Grand Rapids
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Kalamazaoo
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Kalamazoo
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Brooklyn Center
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Robbinsdale
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Shoreview
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Flowood
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Jackson
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Jefferson City
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: St Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Billings
country: United States
facility: Pfizer Investigational Site
state: Montana
city: Bozeman
country: United States
facility: Pfizer Investigational Site
state: Montana
city: Missoula
country: United States
facility: Pfizer Investigational Site
state: Montana
city: Missoula
country: United States
facility: Pfizer Investigational Site
state: Montana
city: Missoula
country: United States
facility: Pfizer Investigational Site
state: Montana
city: Lincoln
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Henderson
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: North Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Reno
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Reno
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Manchester Twp
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Ocean
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Princeton
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: Pfizer Investigational Site
state: New Mexico
city: Albuquerque
country: United States
facility: Pfizer Investigational Site
state: New Mexico
city: Albuquerque
country: United States
facility: Pfizer Investigational Site
state: New Mexico
city: Bronx
country: United States
facility: Pfizer Investigational Site
state: New York
city: New Hyde Park
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Bismarck
country: United States
facility: Pfizer Investigational Site
state: North Dakota
city: Bismark
country: United States
facility: Pfizer Investigational Site
state: North Dakota
city: Bismark
country: United States
facility: Pfizer Investigational Site
state: North Dakota
city: Fargo
country: United States
facility: Pfizer Investigational Site
state: North Dakota
city: Fargo
country: United States
facility: Pfizer Investigational Site
state: North Dakota
city: Jamestown
country: United States
facility: Pfizer Investigational Site
state: North Dakota
city: Minot
country: United States
facility: Pfizer Investigational Site
state: North Dakota
city: Minot
country: United States
facility: Pfizer Investigational Site
state: North Dakota
city: Oakes
country: United States
facility: Pfizer Investigational Site
state: North Dakota
city: Akron
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Akron
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Centerville
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Kettering
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Lyndhurst
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Mayfield Village
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Oklahoma
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Oklahoma
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Yukon
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Altoona
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Camp Hill
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Duncansville
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Johnstown
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Langhome
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Lemoyne
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Newtown
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Sellersville
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: West Reading
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Wyomissing
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Anderson
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Belton
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Mt. Pleasant
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Aberdeen
country: United States
facility: Pfizer Investigational Site
state: South Dakota
city: Sioux Falls
country: United States
facility: Pfizer Investigational Site
state: South Dakota
city: Waterdown
country: United States
facility: Pfizer Investigational Site
state: South Dakota
city: Watertown
country: United States
facility: Pfizer Investigational Site
state: South Dakota
city: Memphis
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Bellaire
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Temple
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Waco
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Norfolk
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Virginia Beach
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Spokane
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Milwaukee
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Milwaukee
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Cheyenne
country: United States
facility: Pfizer Investigational Site
state: Wyoming
city: Provincia de Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Concord
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: St Leonards
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Nedlands
country: Australia
facility: Pfizer Investigational Site
state: Western Australia
city: Herston
country: Australia
facility: Pfizer Investigational Site
city: Keswick
country: Australia
facility: Pfizer Investigational Site
city: Graz
country: Austria
facility: Pfizer Investigational Site
city: Diepenbeek
country: Belgium
facility: Pfizer Investigational Site
city: Genk
country: Belgium
facility: Pfizer Investigational Site
city: Gent
country: Belgium
facility: Pfizer Investigational Site
city: Leuven
country: Belgium
facility: Pfizer Investigational Site
city: Liege
country: Belgium
facility: Pfizer Investigational Site
city: Schiepsebos
country: Belgium
facility: Pfizer Investigational Site
city: Goiania
country: Brazil
facility: Pfizer Investigational Site
state: GO
city: Duque de Caxias - Cuiaba
country: Brazil
facility: Pfizer Investigational Site
state: MT
city: Rio de Janeiro
country: Brazil
facility: Pfizer Investigational Site
state: RJ
city: Rio de Janeiro
country: Brazil
facility: Pfizer Investigational Site
state: RJ
city: Sorocaba
country: Brazil
facility: Pfizer Investigational Site
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Pleven
country: Bulgaria
facility: Pfizer Investigational Site
city: Plovdiv
country: Bulgaria
facility: Pfizer Investigational Site
city: Sofia
country: Bulgaria
facility: Pfizer Investigational Site
city: Sofia
country: Bulgaria
facility: Pfizer Investigational Site
city: Sofia
country: Bulgaria
facility: Pfizer Investigational Site
city: Sofia
country: Bulgaria
facility: Pfizer Investigational Site
city: Sofia
country: Bulgaria
facility: Pfizer Investigational Site
city: Calgary
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Vancouver
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Vancouver
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: Hamilton
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Hawkesbury
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Hawkesbury
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: London
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Gatineau
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Pointe-Claire
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Trois-Rivieres
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Saskatoon
country: Canada
facility: Pfizer Investigational Site
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Pfizer Investigational Site
state: Saskatchewan
city: Quebec
country: Canada
facility: Pfizer Investigational Site
city: Quebec
country: Canada
facility: Pfizer Investigational Site
city: Santiago
country: Chile
facility: Pfizer Investigational Site
city: Zadar
country: Croatia
facility: Pfizer Investigational Site
city: Zagreb
country: Croatia
facility: Pfizer Investigational Site
city: Aalborg
country: Denmark
facility: Pfizer Investigational Site
city: Ballerup
country: Denmark
facility: Pfizer Investigational Site
city: Vejle
country: Denmark
facility: Pfizer Investigational Site
city: Tallinn
country: Estonia
facility: Pfizer Investigational Site
city: Tartu
country: Estonia
facility: Pfizer Investigational Site
city: Tartu
country: Estonia
facility: Pfizer Investigational Site
city: Tartu
country: Estonia
facility: Pfizer Investigational Site
city: Jyvaskyla
country: Finland
facility: Pfizer Investigational Site
state: FIN
city: Jyvaskyla
country: Finland
facility: Pfizer Investigational Site
city: Jyväskylä
country: Finland
facility: Pfizer Investigational Site
city: Kuopio
country: Finland
facility: Pfizer Investigational Site
city: Kuopio
country: Finland
facility: Pfizer Investigational Site
city: Kuopio
country: Finland
facility: Pfizer Investigational Site
city: Lahti
country: Finland
facility: Pfizer Investigational Site
city: Oulu
country: Finland
facility: Pfizer Investigational Site
city: Turku
country: Finland
facility: Pfizer Investigational Site
city: Lyon Cedex 03
country: France
facility: Pfizer Investigational Site
city: Orleans cedex 1
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Zerbst
country: Germany
facility: Pfizer Investigational Site
city: Athens
country: Greece
facility: Pfizer Investigational Site
city: Hong Kong
country: Hong Kong
facility: Pfizer Investigational Site
city: PRC
country: Hong Kong
facility: Pfizer Investigational Site
city: Sai Ying Pung
country: Hong Kong
facility: Pfizer Investigational Site
city: Bekescsaba
country: Hungary
facility: Pfizer Investigational Site
city: H-6720 Szeged
country: Hungary
facility: Pfizer Investigational Site
city: Kecskemet
country: Hungary
facility: Pfizer Investigational Site
city: Mako
country: Hungary
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Siena
country: Italy
facility: Pfizer Investigational Site
city: Kaunas
country: Lithuania
facility: Pfizer Investigational Site
city: Vilnius
country: Lithuania
facility: Pfizer Investigational Site
city: Vilnius
country: Lithuania
facility: Pfizer Investigational Site
city: seccion de Lomas Verdes
country: Mexico
facility: Pfizer Investigational Site
state: Estado de Mexico
city: Mexico City
country: Mexico
facility: Pfizer Investigational Site
city: Mexico D.F.
country: Mexico
facility: Pfizer Investigational Site
city: Emmen
country: Netherlands
facility: Pfizer Investigational Site
state: Dr
city: Nijmegen
country: Netherlands
facility: Pfizer Investigational Site
state: GA
city: Amsterdam
country: Netherlands
facility: Pfizer Investigational Site
state: HV
city: Nijmegen
country: Netherlands
facility: Pfizer Investigational Site
state: SZ
city: Eindhoven
country: Netherlands
facility: Pfizer Investigational Site
city: Rotterdam
country: Netherlands
facility: Pfizer Investigational Site
city: Milford
country: New Zealand
facility: Pfizer Investigational Site
state: Auckland
city: Christchurch
country: New Zealand
facility: Pfizer Investigational Site
state: NZ
city: Auckland
country: New Zealand
facility: Pfizer Investigational Site
city: Dunedin
country: New Zealand
facility: Pfizer Investigational Site
city: Bergen
country: Norway
facility: Pfizer Investigational Site
city: Hamar
country: Norway
facility: Pfizer Investigational Site
city: Oslo
country: Norway
facility: Pfizer Investigational Site
city: Oslo
country: Norway
facility: Pfizer Investigational Site
city: Trondheim
country: Norway
facility: Pfizer Investigational Site
city: Trondheim
country: Norway
facility: Pfizer Investigational Site
city: Katowice
country: Poland
facility: Pfizer Investigational Site
city: Krakow
country: Poland
facility: Pfizer Investigational Site
city: Krakow
country: Poland
facility: Pfizer Investigational Site
city: Krakow
country: Poland
facility: Pfizer Investigational Site
city: Krakow
country: Poland
facility: Pfizer Investigational Site
city: Krakow
country: Poland
facility: Pfizer Investigational Site
city: Lublin
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Wroclaw
country: Poland
facility: Pfizer Investigational Site
city: Cluj-
country: Romania
facility: Pfizer Investigational Site
state: Napoca
city: Bucharesti
country: Romania
facility: Pfizer Investigational Site
city: Bucharest
country: Romania
facility: Pfizer Investigational Site
city: Bucuresti
country: Romania
facility: Pfizer Investigational Site
city: Bucuresti
country: Romania
facility: Pfizer Investigational Site
city: Cluj-Napoca
country: Romania
facility: Pfizer Investigational Site
city: Iasi
country: Romania
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Saint Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: St Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: Piestany
country: Slovakia
facility: Pfizer Investigational Site
state: Slovak Republic
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Groenkloof, 0181
country: South Africa
facility: Pfizer Investigational Site
state: Pretoria
city: Bedford Gardens
country: South Africa
facility: Pfizer Investigational Site
city: Johannesburg 2193
country: South Africa
facility: Pfizer Investigational Site
city: Johannesburg, 2193
country: South Africa
facility: Pfizer Investigational Site
city: Johannesburg
country: South Africa
facility: Pfizer Investigational Site
city: Johannesburg
country: South Africa
facility: Pfizer Investigational Site
city: Parow 7500
country: South Africa
facility: Pfizer Investigational Site
city: Parow
country: South Africa
facility: Pfizer Investigational Site
city: Pretoria, 0042
country: South Africa
facility: Pfizer Investigational Site
city: Pretoria, 0181
country: South Africa
facility: Pfizer Investigational Site
city: Pretoria
country: South Africa
facility: Pfizer Investigational Site
city: Pretoria
country: South Africa
facility: Pfizer Investigational Site
city: Somerset West, 7129
country: South Africa
facility: Pfizer Investigational Site
city: Somerset West, 7130
country: South Africa
facility: Pfizer Investigational Site
city: Somerset West
country: South Africa
facility: Pfizer Investigational Site
city: Stellenbosch 7600
country: South Africa
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1186/1471-2474-11-130.