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

Bone Mineral Density Increase and Safety of TSE-424 Compared to Placebo in Osteoporotic Postmenopausal Women

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00238745

Enrollment

375

Registered

2005-10-13

Start date

2003-08-31

Completion date

2007-03-31

Last updated

2007-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postmenopausal Osteoporosis

Keywords

Postmenopausal Osteoporosis

Brief summary

Dose-response in Japanese patients with postmenopausal osteoporosis.

Interventions

DRUGBazedoxifene

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

No minimum to 85 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Bone mineral density of lumbar spine (L1-L4) at 2 years.	—

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026