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Trial record 1 of 1 for:    NCT00238745
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Study Evaluating Bazedoxifene Dose-Response in Japanese Patients With Postmenopausal Osteoporosis.

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ClinicalTrials.gov Identifier: NCT00238745
Recruitment Status : Completed
First Posted : October 13, 2005
Last Update Posted : December 20, 2007
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE October 12, 2005
First Posted Date  ICMJE October 13, 2005
Last Update Posted Date December 20, 2007
Study Start Date  ICMJE August 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 12, 2005)
Bone mineral density of lumbar spine (L1-L4) at 2 years.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00238745 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 12, 2005)
Bone metabolic makers, bone fracture, bone mineral density of lumbar spine (L2-L4) and lip, lipid parameters, height and adverse events.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating Bazedoxifene Dose-Response in Japanese Patients With Postmenopausal Osteoporosis.
Official Title  ICMJE Bone Mineral Density Increase and Safety of TSE-424 Compared to Placebo in Osteoporotic Postmenopausal Women
Brief Summary Dose-response in Japanese patients with postmenopausal osteoporosis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Condition  ICMJE Postmenopausal Osteoporosis
Intervention  ICMJE
  • Drug: Bazedoxifene
  • Drug: Placebo
Study Arms  ICMJE Not Provided
Publications * Itabashi A, Yoh K, Chines AA, Miki T, Takada M, Sato H, Gorai I, Sugimoto T, Mizunuma H, Ochi H, Constantine GD, Ohta H. Effects of bazedoxifene on bone mineral density, bone turnover, and safety in postmenopausal Japanese women with osteoporosis. J Bone Miner Res. 2011 Mar;26(3):519-29. doi: 10.1002/jbmr.252.

*   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
Enrollment  ICMJE
 (submitted: October 12, 2005)
375
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Must be postmenopausal and diagnosed as osteoporosis based on bone mineral density and/or vertebral fracture.

Exclusion Criteria:

  • Diseases which possibly induce secondary osteoporosis or osteopenia and affect on bone metabolism.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE up to 85 Years   (Child, 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 NCT00238745
Other Study ID Numbers  ICMJE 3068A1-207
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 Monitor Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date December 2007

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