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

Overview

Dose-response in Japanese patients with postmenopausal osteoporosis.

Full Title of Study: “Bone Mineral Density Increase and Safety of TSE-424 Compared to Placebo in Osteoporotic Postmenopausal Women”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Masking: Double

Interventions

  • Drug: Bazedoxifene
  • Drug: Placebo

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Wyeth is now a wholly owned subsidiary of Pfizer
  • Overall Official(s)
    • Medical Monitor, Study Director, Wyeth is now a wholly owned subsidiary of Pfizer

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