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

July 11, 2014 updated by: Eisai Co., Ltd.
To determine the effect and safety of menatetrenone on treatment of postmenopausal osteoporosis comparing with alfacalcidol.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Chinese PLA General Hospital
      • Beijing, China
        • Beijing Hospital
      • Beijing, China
        • Peking Union Medical College Hospital
      • Shanghai, China
        • Hua Dong Hospital
      • Shanghai, China
        • The Sixth People's Hospital affiliated to Shanghai Jiaopong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Description

Inclusion criteria :

  • Postmenopausal women with menopause duration more than 5 years and with age between 45-75 years old (menopausal age ≥40), or if hysterectomy operated before natural menopause, the age of women between 60-75 years old.
  • Subject with BMD (L2-4 or neck of femur) being more than 2 Standard Deviation (SD) below the young female adult mean (According to the standard of each center)
  • BMI between 18 kg/m2-30 kg/m2.
  • The anatomic structure of lumbar spine must be available for Dual-energy X-ray Absorptiometry (DEXA) examination, patient with serious scoliosis, bone trauma or sequela after orthopedics surgery, which makes BMD measurement difficult, should be excluded
  • Subject who have given informed consent prior to participation in the trial and who undertake to comply with the protocol.

Exclusion Criteria

  • Subject with conditions that are considered to effect osteoporosis, such as clear definite diabetes mellitus, rheumatoid arthritis, rheumatoid arthritis, hyperparathyroidism or other bone metabolic diseases.
  • Subjects who have received treatment with active-type vitamin D3 preparation, other vitamin D preparations (>1000IU per day）, calcitonin, corticosteroid hormone, androgen, estrogen, other hormone, vitamin K preparation, in the 3 months prior to inanition of this study; Subjects who have received treatment with bisphosphonate preparation or Sodium Fluoride in the 1 year prior to inanition of this study; Subjects who have received treatment with Selective Estrogen Receptor Modulator (SERM) in the 6 months prior to inanition of this study
  • Concurrent serious renal disease, hepatic disease, uncontrolled hypertension （≥150/100mmHg）, symptomatic ischemic heart disease, cerebral infarction or arteriosclerosis obliterans.
  • Cancer history within 5 years.
  • Subjects who take antacid containing aluminum in the preparation, warfarin or thrombolytic agents.
  • Subject with any known abnormality in laboratory tests, which is deemed to be clinically significant by the investigator, which include:
  • Serum alkaline phosphatace (ALP) > upper normal limit 10% (calculated according to the range of normal values of each center);
  • Glutamic Oxalacetic Transaminase (AST)/ Glutamic Pyruvic Transaminase (ALT) > upper normal limit 50％(calculated according to the range of normal values of each center);
  • Serum creatinine >1.5mg/dL (133μmol/L);
  • Blood-fasting sugar ≥ 7mmol/L (126mg/L)
  • Inability of subject to return for scheduled visits or to comply with any other aspect of the protocol.
  • Subject who, in the opinion of the investigator, are poor medical candidates or pose any other risk for therapy with an investigational drug.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 2
Drug: alfacalcidol
0.25 μg twice a day orally for 12 months
Active Comparator: 1
Drug: menatetranone
15 mg three times a day orally for 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bone Mineral Density BMD (Percentage) Change in Lumber Spine After 12 Months
Time Frame: Baseline and 12 months
Baseline and 12 months
Bone Mineral Density BMD (Percentage) Change in Collum Femoris After 12 Months
Time Frame: Baseline and 12 months
Baseline and 12 months
Bone Mineral Density BMD (Percentage) Change in Trochiter After 12 Months
Time Frame: Baseline and 12 months
Baseline and 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Co., Ltd.

Investigators

  • Study Director: Hong Di, Eisai China Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 14, 2005

Study Record Updates

Last Update Posted (Estimate)

July 22, 2014

Last Update Submitted That Met QC Criteria

July 11, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AS-012 (GLA-CHN-05-01)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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