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Study Evaluating Bazedoxifene Acetate In Osteoporosis In Postmenopausal Women

Last updated on November 14, 2019

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Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35233 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Osteoporosis
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
55-80 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Must be at least 2 years postmenopausal

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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00205777
Pfizer
Completed
Study Evaluating Bazedoxifene Acetate In Osteoporosis In Postmenopausal Women

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Descriptive Information
Brief Title  ICMJE Study Evaluating Bazedoxifene Acetate In Osteoporosis In Postmenopausal Women
Official Title  ICMJE Fracture Incidence Reduction And Safety Of TSE-424 (Bazedoxifene Acetate) Compared To Placebo And Raloxifene In Osteoporotic Postmenopausal Women
Brief SummaryThe purpose of this study is to determine whether bazedoxifene acetate is safe and effective in the treatment of osteoporosis in postmenopausal women.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Osteoporosis
Intervention  ICMJE
  • Drug: Bazedoxifene Acetate
    BZA 20mg, daily, oral
  • Other: Placebo
    Placebo, daily, oral
Study Arms  ICMJE
  • Active Comparator: A
    Intervention: Drug: Bazedoxifene Acetate
  • Placebo Comparator: B
    Intervention: Other: Placebo
Publications *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.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 16, 2005)
7609
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion DateSeptember 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 55 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   Croatia,   Denmark,   Estonia,   Finland,   France,   Germany,   Greece,   Hong Kong,   Hungary,   Italy,   Lithuania,   Mexico,   Netherlands,   New Zealand,   Norway,   Poland,   Romania,   Russian Federation,   Slovakia,   South Africa,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00205777
Other Study ID Numbers  ICMJE 3068A1-301
B1781001
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateFebruary 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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