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

Phase 2CompletedNCT00238745

Wyeth is now a wholly owned subsidiary of Pfizer375 enrolled

Overview

Dose-response in Japanese patients with postmenopausal osteoporosis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

375

Conditions

Postmenopausal Osteoporosis

Interventions

BazedoxifeneDRUG

PlaceboDRUG

Eligibility

Sex: FEMALEMax age: 85 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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