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

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

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

Conditions
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Postmenopausal Osteoporosis

Intervention / Treatment
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* Drug: menatetranone
* Drug: alfacalcidol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postmenopausal, osteoporosis