Study Evaluating TSE-424/Placebo/Raloxifene in Preventing Osteoporosis in Postmenopausal Women

NCT00481169

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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
45 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Generally healthy women 45 years of age or older who are at least 1 year postmenopausal.

- Subjects must qualify for one of the following categories (a or b): a) Greater than 1 year but less than 5 years postmenopausal with at least one of the osteoporosis risk factors. b) Greater than 5 years postmenopausal with BMD T-score at lumbar spine or femoral neck between -1 and -2.5 (inclusive) with at least one osteoporosis risk factor.

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


- One (1) or more osteoporotic vertebral fractures (T4-L4).


- Diseases that may affect bone metabolism.


- Past history or active nontraumatic venous thromboembolic events, including deep vein
thrombosis, pulmonary embolism, and retinal vein thrombosis.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating TSE-424/Placebo/Raloxifene in Preventing Osteoporosis in Postmenopausal Women
Official Title  ICMJE A Multicenter, Double Blind, Randomized, Placebo and Raloxifene Controlled Study to Assess Safety and Efficacy of TSE-424 (Bazedoxifene Acetate) in the Prevention of Postmenopausal Osteoporosis
Brief Summary The purpose of this study is to determine whether TSE-424 (bazedoxifene acetate), an investigational drug, is safe and effective in the prevention of osteoporosis in postmenopausal women.
Detailed Description

Primary objective: To evaluate the safety and efficacy of 3 doses of TSE-424 (bazedoxifene acetate), an investigational drug, in comparison with those of placebo and raloxifene in preventing osteoporosis in postmenopausal women.

Secondary objective: To evaluate the effect of TSE-424 (bazedoxifene acetate), an investigational drug, in comparison with that of placebo and raloxifene on endometrium, metabolic parameters, vasomotor symptoms, adverse events, and quality of life. Samples will be collected for population pharmacokinetic (PK) analysis.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE Osteoporosis
Intervention  ICMJE Drug: Bazedoxifene Acetate (TSE-424)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   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: August 20, 2009)
1742
Original Enrollment  ICMJE
 (submitted: May 30, 2007)
1735
Actual Study Completion Date  ICMJE September 2004
Actual Primary Completion Date July 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Generally healthy women 45 years of age or older who are at least 1 year postmenopausal.
  • Subjects must qualify for one of the following categories (a or b): a) Greater than 1 year but less than 5 years postmenopausal with at least one of the osteoporosis risk factors. b) Greater than 5 years postmenopausal with BMD T-score at lumbar spine or femoral neck between -1 and -2.5 (inclusive) with at least one osteoporosis risk factor.

Exclusion Criteria:

  • One (1) or more osteoporotic vertebral fractures (T4-L4).
  • Diseases that may affect bone metabolism.
  • Past history or active nontraumatic venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis.
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 45 Years and older   (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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00481169
Other Study ID Numbers  ICMJE 3068A1-300
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP