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

Primary Purpose

Postmenopausal Osteoporosis

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
menatetranone
alfacalcidol
Sponsored by
Eisai Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postmenopausal Osteoporosis focused on measuring Postmenopausal, osteoporosis

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)Female

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 12, 2005
Last Updated
July 11, 2014
Sponsor
Eisai Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00165698
Brief Title
Efficacy and Safety Study on Menatetrenone in the Treatment of Postmenopausal Osteoporosis Women
Official Title
Efficacy and Safety Study on Menatetrenone in the Treatment of Postmenopausal Osteoporosis Women
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Eisai Co., Ltd.

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopausal Osteoporosis
Keywords
Postmenopausal, osteoporosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
menatetranone
Intervention Description
15 mg three times a day orally for 12 months
Intervention Type
Drug
Intervention Name(s)
alfacalcidol
Intervention Description
0.25 μg twice a day orally for 12 months
Primary Outcome Measure Information:
Title
Bone Mineral Density BMD (Percentage) Change in Lumber Spine After 12 Months
Time Frame
Baseline and 12 months
Title
Bone Mineral Density BMD (Percentage) Change in Collum Femoris After 12 Months
Time Frame
Baseline and 12 months
Title
Bone Mineral Density BMD (Percentage) Change in Trochiter After 12 Months
Time Frame
Baseline and 12 months
Secondary Outcome Measure Information:
Title
Bone Mineral Content BMC (Percentage) Change in Lumber Spine After 12 Months
Time Frame
Baseline and 12 months
Title
Bone Mineral Content BMC (Percentage) Change in Collum Femoris After 12 Months
Time Frame
Baseline and 12 months
Title
Bone Biomarker Osteocalcin (OC) Percentage Change After 12 Months
Time Frame
Baseline and 12 months
Title
Bone Biomarker Undercarboxylated Osteocalcin (UCOC) Percentage Change After 12 Months
Time Frame
Baseline and 12 months
Title
Bone Biomarker Undercarboxylated Osteocalcin/Osteocalcin (UCOC/OC) Percentage Change After 12 Months
Time Frame
Baseline and 12 months
Title
New Fracture and Fall
Time Frame
12 months
Title
Height (Meter)
Time Frame
Baseline and 12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hong Di
Organizational Affiliation
Eisai China Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Hospital
City
Beijing
Country
China
Facility Name
Chinese PLA General Hospital
City
Beijing
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
Country
China
Facility Name
Hua Dong Hospital
City
Shanghai
Country
China
Facility Name
The Sixth People's Hospital affiliated to Shanghai Jiaopong University
City
Shanghai
Country
China

12. IPD Sharing Statement

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

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