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

Phase 3

Completed

• Conditions: Postmenopausal Osteoporosis
• Interventions: Drug: menatetranone; Drug: alfacalcidol

• Registration Number: NCT00165698
• Lead Sponsor: Eisai Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-14
• Primary Completion: 2007-01
• Study Completion: 2007-07
• Results First Submitted: 2010-12-02
• Results First Submitted QC: 2011-07-18
• Results First Posted: 2011-08-11
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-11
• Last Update Posted: 2014-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 240

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	menatetranone	-
2	alfacalcidol	-

Primary Outcome Measures

Name	Time	Method
Bone Mineral Density BMD (Percentage) Change in Lumber Spine After 12 Months	Baseline and 12 months
Bone Mineral Density BMD (Percentage) Change in Trochiter After 12 Months	Baseline and 12 months
Bone Mineral Density BMD (Percentage) Change in Collum Femoris After 12 Months	Baseline and 12 months

Secondary Outcome Measures

Name	Time	Method
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 Biomarker Undercarboxylated Osteocalcin (UCOC) 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

Trial Locations

Locations (5)

Beijing Hospital; 🇨🇳 Beijing, China

Hua Dong Hospital; 🇨🇳 Shanghai, China

Chinese PLA General Hospital; 🇨🇳 Beijing, China

The Sixth People's Hospital affiliated to Shanghai Jiaopong University; 🇨🇳 Shanghai, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, China