NCT00238745

Brief Summary

Dose-response in Japanese patients with postmenopausal osteoporosis.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
375

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2003

Typical duration for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

October 12, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 13, 2005

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

December 20, 2007

Status Verified

December 1, 2007

First QC Date

October 12, 2005

Last Update Submit

December 17, 2007

Conditions

Postmenopausal Osteoporosis

Keywords

Postmenopausal Osteoporosis

Outcome Measures

Primary Outcomes (1)

  • Bone mineral density of lumbar spine (L1-L4) at 2 years.

Secondary Outcomes (1)

  • Bone metabolic makers, bone fracture, bone mineral density of lumbar spine (L2-L4) and lip, lipid parameters, height and adverse events.

Interventions

BazedoxifeneDRUG
PlaceboDRUG

Eligibility Criteria

AgeUp to 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Diseases which possibly induce secondary osteoporosis or osteopenia and affect on bone metabolism.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 20839291DERIVED

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

bazedoxifene

Condition Hierarchy (Ancestors)

OsteoporosisBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 12, 2005

First Posted

October 13, 2005

Study Start

August 1, 2003

Study Completion

March 1, 2007

Last Updated

December 20, 2007

Record last verified: 2007-12