Efficacy and Safety Study on Menatetrenone in the Treatment of Postmenopausal Osteoporosis Women

Eisai Co., Ltd.5 sites in 1 country240 target enrollmentMay 2005

Overview

Phase: Phase 3
Intervention: menatetranone
Conditions: Postmenopausal Osteoporosis
Sponsor: Eisai Co., Ltd.
Enrollment: 240
Locations: 5
Primary Endpoint: Bone Mineral Density BMD (Percentage) Change in Lumber Spine After 12 Months
Status: Completed
Last Updated: 11 years ago

To determine the effect and safety of menatetrenone on treatment of postmenopausal osteoporosis comparing with alfacalcidol.

Registry

clinicaltrials.gov

Start Date

May 2005

End Date

July 2007

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Sponsor

Intervention: menatetranone

Intervention: alfacalcidol

Bone Mineral Density BMD (Percentage) Change in Lumber Spine After 12 Months

Time Frame: Baseline and 12 months

Bone Mineral Density BMD (Percentage) Change in Trochiter After 12 Months

Time Frame: Baseline and 12 months

Bone Mineral Density BMD (Percentage) Change in Collum Femoris After 12 Months

Time Frame: Baseline and 12 months

Bone Biomarker Undercarboxylated Osteocalcin (UCOC) Percentage Change After 12 Months(Baseline and 12 months)
Bone Mineral Content BMC (Percentage) Change in Lumber Spine After 12 Months(Baseline and 12 months)
Bone Biomarker Osteocalcin (OC) Percentage Change After 12 Months(Baseline and 12 months)
Bone Mineral Content BMC (Percentage) Change in Collum Femoris After 12 Months(Baseline and 12 months)
Height (Meter)(Baseline and 12 months)
Bone Biomarker Undercarboxylated Osteocalcin/Osteocalcin (UCOC/OC) Percentage Change After 12 Months(Baseline and 12 months)
New Fracture and Fall(12 months)