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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00205777




Registration number
NCT00205777
Ethics application status
Date submitted
16/09/2005
Date registered
20/09/2005
Date last updated
10/04/2013

Titles & IDs
Public title
Study Evaluating Bazedoxifene Acetate In Osteoporosis In Postmenopausal Women
Scientific title
Fracture Incidence Reduction And Safety Of TSE-424 (Bazedoxifene Acetate) Compared To Placebo And Raloxifene In Osteoporotic Postmenopausal Women
Secondary ID [1] 0 0
B1781001
Secondary ID [2] 0 0
3068A1-301
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Bazedoxifene Acetate
Other interventions - Placebo

Active comparator: A -

Placebo comparator: B -


Treatment: Drugs: Bazedoxifene Acetate
BZA 20mg, daily, oral

Other interventions: Placebo
Placebo, daily, oral
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With New Vertebral Fractures Through Month 36
Timepoint [1] 0 0
Baseline through Month 36
Primary outcome [2] 0 0
Percentage of Participants With New Vertebral Fractures Through Month 60
Timepoint [2] 0 0
Baseline through Month 60
Primary outcome [3] 0 0
Percentage of Participants With New Vertebral Fractures Through Month 84
Timepoint [3] 0 0
Baseline through Month 84
Secondary outcome [1] 0 0
Incidence of Breast Cancer Through Month 36
Timepoint [1] 0 0
Baseline through Month 36
Secondary outcome [2] 0 0
Incidence of Breast Cancer Through Month 60
Timepoint [2] 0 0
Baseline through Month 60
Secondary outcome [3] 0 0
Incidence of Breast Cancer Through Month 84
Timepoint [3] 0 0
Baseline through Month 84
Secondary outcome [4] 0 0
Percentage of Participants With New Clinical Vertebral Fractures Through Month 36
Timepoint [4] 0 0
Baseline through Month 36
Secondary outcome [5] 0 0
Percentage of Participants With New Clinical Vertebral Fractures Through Month 60
Timepoint [5] 0 0
Baseline through Month 60
Secondary outcome [6] 0 0
Percentage of Participants With New Clinical Vertebral Fractures Through Month 84
Timepoint [6] 0 0
Baseline through Month 84
Secondary outcome [7] 0 0
Number of Participants With Worsening Vertebral Fractures Through Month 36
Timepoint [7] 0 0
Baseline through Month 36
Secondary outcome [8] 0 0
Number of Participants With Worsening Vertebral Fractures Through Month 60
Timepoint [8] 0 0
Baseline through Month 60
Secondary outcome [9] 0 0
Number of Participants With Worsening Vertebral Fractures Through Month 84
Timepoint [9] 0 0
Baseline through Month 84
Secondary outcome [10] 0 0
Percentage of Participants With Non-vertebral Fractures Through Month 36
Timepoint [10] 0 0
Baseline through Month 36
Secondary outcome [11] 0 0
Percentage of Participants With Non-vertebral Fractures Through Month 60
Timepoint [11] 0 0
Baseline through Month 60
Secondary outcome [12] 0 0
Percentage of Participants With Non-vertebral Fractures Through Month 84
Timepoint [12] 0 0
Baseline through Month 84
Secondary outcome [13] 0 0
Change From Baseline in Height at Month 36
Timepoint [13] 0 0
Baseline, Month 36
Secondary outcome [14] 0 0
Change From Baseline in Height at Month 60
Timepoint [14] 0 0
Baseline, Month 60
Secondary outcome [15] 0 0
Change From Baseline in Height at Month 84
Timepoint [15] 0 0
Baseline, Month 84
Secondary outcome [16] 0 0
Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36
Timepoint [16] 0 0
Baseline, Months 6, 12, 18, 24, 36
Secondary outcome [17] 0 0
Percent Change From Baseline in Bone Mineral Density (BMD) at Months 48, 60
Timepoint [17] 0 0
Baseline, Month 48, 60
Secondary outcome [18] 0 0
Percent Change From Baseline in Bone Mineral Density (BMD) at Months 72 and 84
Timepoint [18] 0 0
Baseline, Month 72, 84
Secondary outcome [19] 0 0
Percent Change From Baseline in Osteocalcin at Month 3, 6 and 12
Timepoint [19] 0 0
Baseline, Months 3, 6, 12
Secondary outcome [20] 0 0
Percent Change From Baseline in Osteocalcin at Months 36 and 60
Timepoint [20] 0 0
Baseline, Months 36, 60
Secondary outcome [21] 0 0
Percent Change From Baseline in Osteocalcin at Months 72 and 84
Timepoint [21] 0 0
Baseline, Months 72, 84
Secondary outcome [22] 0 0
Percent Change From Baseline in C-telopeptide (CTx) at Month 3, 6 and 12
Timepoint [22] 0 0
Baseline, Months 3, 6, 12
Secondary outcome [23] 0 0
Percent Change From Baseline in C-telopeptide (CTx) at Months 36 and 60
Timepoint [23] 0 0
Baseline, Months 36, 60
Secondary outcome [24] 0 0
Percent Change From Baseline in C-telopeptide (CTx) at Months 72 and 84
Timepoint [24] 0 0
Baseline, Months 72, 84
Secondary outcome [25] 0 0
Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36
Timepoint [25] 0 0
Baseline, Months 6, 12, 24, 36
Secondary outcome [26] 0 0
Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP
Timepoint [26] 0 0
Month 36
Secondary outcome [27] 0 0
Bone Histomorphometric Indices at Month 60: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP
Timepoint [27] 0 0
Month 60
Secondary outcome [28] 0 0
Bone Histomorphometric Indices at Month 36: WTh, OTh, TbTh, TbSp and CTh
Timepoint [28] 0 0
Month 36
Secondary outcome [29] 0 0
Bone Histomorphometric Indices at Month 60: WTh, OTh, TbTh, TbSp and CTh
Timepoint [29] 0 0
Month 60
Secondary outcome [30] 0 0
Bone Histomorphometric Indices at Month 36: Total Surface (Goldner Slide) [TSG]
Timepoint [30] 0 0
Month 36
Secondary outcome [31] 0 0
Bone Histomorphometric Indices at Month 60: TSG
Timepoint [31] 0 0
Month 60
Secondary outcome [32] 0 0
Bone Histomorphometric Indices at Month 36: TtAr
Timepoint [32] 0 0
Month 36
Secondary outcome [33] 0 0
Bone Histomorphometric Indices at Month 60: TtAr
Timepoint [33] 0 0
Month 60
Secondary outcome [34] 0 0
Bone Histomorphometric Indices at Month 36: BFP, RP and RmP
Timepoint [34] 0 0
Month 36
Secondary outcome [35] 0 0
Bone Histomorphometric Indices at Month 60: BFP, RP and RmP
Timepoint [35] 0 0
Month 60
Secondary outcome [36] 0 0
Bone Histomorphometric Indices at Month 36: SuD
Timepoint [36] 0 0
Month 36
Secondary outcome [37] 0 0
Bone Histomorphometric Indices at Month 60: SuD
Timepoint [37] 0 0
Month 60
Secondary outcome [38] 0 0
Bone Histomorphometric Indices at Month 36: BFRTS
Timepoint [38] 0 0
Month 36
Secondary outcome [39] 0 0
Bone Histomorphometric Indices at Month 60: BFRTS
Timepoint [39] 0 0
Month 60
Secondary outcome [40] 0 0
Bone Histomorphometric Indices at Month 36: ACF
Timepoint [40] 0 0
Month 36
Secondary outcome [41] 0 0
Bone Histomorphometric Indices at Month 60: ACF
Timepoint [41] 0 0
Month 60
Secondary outcome [42] 0 0
Bone Histomorphometric Indices at Month 36: Mlt
Timepoint [42] 0 0
Month 36
Secondary outcome [43] 0 0
Bone Histomorphometric Indices at Month 60: Mlt
Timepoint [43] 0 0
Month 60
Secondary outcome [44] 0 0
Bone Histomorphometric Indices at Month 36: MAR
Timepoint [44] 0 0
Month 36
Secondary outcome [45] 0 0
Bone Histomorphometric Indices at Month 60: MAR
Timepoint [45] 0 0
Month 60
Secondary outcome [46] 0 0
Bone Histomorphometric Indices at Month 36: TbN
Timepoint [46] 0 0
Month 36
Secondary outcome [47] 0 0
Bone Histomorphometric Indices at Month 60: TbN
Timepoint [47] 0 0
Month 60
Secondary outcome [48] 0 0
Bone Histomorphometric Indices at Month 36: BFRBV
Timepoint [48] 0 0
Month 36
Secondary outcome [49] 0 0
Bone Histomorphometric Indices at Month 60: BFRBV
Timepoint [49] 0 0
Month 60
Secondary outcome [50] 0 0
Women's Health Questionnaire (WHQ)
Timepoint [50] 0 0
Baseline
Secondary outcome [51] 0 0
Change From Baseline in Women's Health Questionnaire (WHQ) at Month 12, 24 and 36
Timepoint [51] 0 0
Baseline, Months 12, 24, 36
Secondary outcome [52] 0 0
European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO)
Timepoint [52] 0 0
Baseline
Secondary outcome [53] 0 0
Change From Baseline in European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO) at Month 12, 24 and 36
Timepoint [53] 0 0
Baseline, Months 12, 24, 36
Secondary outcome [54] 0 0
Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)
Timepoint [54] 0 0
Baseline
Secondary outcome [55] 0 0
Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Month 12, 24 and 36
Timepoint [55] 0 0
Baseline, Months 12, 24, 36
Secondary outcome [56] 0 0
Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score
Timepoint [56] 0 0
Baseline
Secondary outcome [57] 0 0
Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score at Month 12, 24 and 36
Timepoint [57] 0 0
Baseline, Months 12, 24, 36

Eligibility
Key inclusion criteria
* Must be at least 2 years postmenopausal
* Osteoporotic subjects without vertebral fracture who meet BMD criteria, or Osteoporotic subjects with vertebral fracture
Minimum age
55 Years
Maximum age
80 Years
Sex
Females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2001
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2010
Sample size
Target
Accrual to date
Final
7609
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Concord
Recruitment hospital [2] 0 0
Pfizer Investigational Site - St Leonards
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Nedlands
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Herston
Recruitment hospital [5] 0 0
Pfizer Investigational Site - Keswick
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment postcode(s) [4] 0 0
QLD 4029 - Herston
Recruitment postcode(s) [5] 0 0
- Keswick
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Delaware
Country [7] 0 0
United States of America
State/province [7] 0 0
District of Columbia
Country [8] 0 0
United States of America
State/province [8] 0 0
Florida
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United States of America
State/province [9] 0 0
Georgia
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United States of America
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Idaho
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Illinois
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Indiana
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Kansas
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Kentucky
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United States of America
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Maine
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United States of America
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Mississippi
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Missouri
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Montana
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Nebraska
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Nevada
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New Jersey
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New Mexico
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New York
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North Carolina
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North Dakota
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Ohio
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Oklahoma
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Pennsylvania
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South Carolina
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Tennessee
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Utah
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GO
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Tartu
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FIN
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Finland
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Kuopio
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Lahti
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Turku
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Lyon Cedex 03
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Muenchen
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Zerbst
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PRC
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Sai Ying Pung
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Bekescsaba
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H-6720 Szeged
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Kecskemet
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Roma
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Siena
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Lithuania
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Kaunas
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Lithuania
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Dr
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GA
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Netherlands
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HV
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Netherlands
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SZ
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Netherlands
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Eindhoven
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Netherlands
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Rotterdam
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Auckland
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New Zealand
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NZ
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New Zealand
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Dunedin
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Norway
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Bergen
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Norway
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Hamar
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Oslo
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Trondheim
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Poland
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Krakow
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Lublin
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Warszawa
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Wroclaw
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Romania
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Napoca
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Romania
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Bucharesti
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Romania
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Bucharest
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Romania
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Bucuresti
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Romania
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Cluj-Napoca
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Russian Federation
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Slovakia
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Bratislava
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South Africa
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Pretoria
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South Africa
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Bedford Gardens
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South Africa
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Johannesburg 2193
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South Africa
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Johannesburg, 2193
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South Africa
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Johannesburg
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South Africa
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Parow 7500
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South Africa
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Parow
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South Africa
State/province [137] 0 0
Pretoria, 0042
Country [138] 0 0
South Africa
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Pretoria, 0181
Country [139] 0 0
South Africa
State/province [139] 0 0
Somerset West, 7129
Country [140] 0 0
South Africa
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Somerset West, 7130
Country [141] 0 0
South Africa
State/province [141] 0 0
Somerset West
Country [142] 0 0
South Africa
State/province [142] 0 0
Stellenbosch 7600
Country [143] 0 0
Spain
State/province [143] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00205777