Study Evaluating Bazedoxifene Dose-Response in Japanese Patients With Postmenopausal Osteoporosis.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

375 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-31

Study Completion Date

2007-03-31

Brief Summary

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Dose-response in Japanese patients with postmenopausal osteoporosis.

Detailed Description

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Conditions

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Postmenopausal Osteoporosis

Keywords

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Postmenopausal Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Interventions

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Bazedoxifene

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

References

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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.

Reference Type DERIVED

PMID: 20839291 (View on PubMed)

Other Identifiers

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3068A1-207

Identifier Type: -

Identifier Source: org_study_id