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Study Evaluating Bazedoxifene Acetate In Osteoporosis In Postmenopausal Women

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NCT00205777

Last updated on May 11, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35233 United States
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Contact
1-800-718-1021
[email protected]
Related Links
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.
Show details

- 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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Study Evaluating Bazedoxifene Acetate In Osteoporosis In Postmenopausal Women
Fracture Incidence Reduction And Safety Of TSE-424 (Bazedoxifene Acetate) Compared To Placebo And Raloxifene In Osteoporotic Postmenopausal Women
The purpose of this study is to determine whether bazedoxifene acetate is safe and effective in the treatment of osteoporosis in postmenopausal women.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Osteoporosis
  • Drug: Bazedoxifene Acetate
    BZA 20mg, daily, oral
  • Other: Placebo
    Placebo, daily, oral
  • Active Comparator: A
    Intervention: Drug: Bazedoxifene Acetate
  • Placebo Comparator: B
    Intervention: Other: Placebo
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.
 
Completed
7609
September 2010
September 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
55 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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
 
 
NCT00205777
3068A1-301
B1781001
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2013

ICMJE     Data element required by the

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

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