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To determine the effect and safety of menatetrenone on treatment of postmenopausal osteoporosis comparing with alfacalcidol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| menatetranone | Drug | 15 mg three times a day orally for 12 months |
| |
| 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 |
| 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 |
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Inclusion criteria :
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Hong Di | Eisai China Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Hospital | Beijing | China | ||||
| Chinese PLA General Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Menatetrenone | 15 mg t.i.d. orally for 12 months |
| FG001 | Alfacalcidol | 0.25 μg b.i.d. orally for 12 months |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Menatetrenone | 15 mg t.i.d. orally for 12 months |
| BG001 | Alfacalcidol | 0.25 μg b.i.d. orally for 12 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Baseline Participants are Full Anaylsis Set (FAS) Population |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Bone Mineral Density BMD (Percentage) Change in Lumber Spine After 12 Months | Per Protocol Set (PPS) | Posted | Median | Full Range | percentage of BMD | Baseline and 12 months |
|
|
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Safety Population
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Menatetrenone | 15 mg t.i.d. orally for 12 months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin damage | Skin and subcutaneous tissue disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal on skin and its subsidiary tissues | Skin and subcutaneous tissue disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Takao Ishii, Asia regulatory affaires | Eisai Co., Ltd. | 81-3-3817-3914 |
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| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C008088 | alfacalcidol |
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| alfacalcidol |
| Drug |
0.25 μg twice a day orally for 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 |
| Beijing |
| China |
| Peking Union Medical College Hospital | Beijing | China |
| Hua Dong Hospital | Shanghai | China |
| The Sixth People's Hospital affiliated to Shanghai Jiaopong University | Shanghai | China |
| Withdrawal by Subject |
|
| Protocol Violation |
|
| Not Taken/Lost the medicine |
|
| BG002 |
| Total |
Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Race | Number | participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Primary | Bone Mineral Density BMD (Percentage) Change in Collum Femoris After 12 Months | Per Protocol Set (PPS) | Posted | Median | Full Range | percentage of BMD | Baseline and 12 months |
|
|
|
|
| Primary | Bone Mineral Density BMD (Percentage) Change in Trochiter After 12 Months | Per Protocol Set (PPS) | Posted | Median | Full Range | percentage of BMD | Baseline and 12 months |
|
|
|
|
| Secondary | Bone Mineral Content BMC (Percentage) Change in Lumber Spine After 12 Months | Per Protocol Set (PPS) | Posted | Median | Full Range | percentage of BMC | Baseline and 12 months |
|
|
|
|
| Secondary | Bone Mineral Content BMC (Percentage) Change in Collum Femoris After 12 Months | Per Protocol Set (PPS) | Posted | Median | Full Range | percentage of BMC | Baseline and 12 months |
|
|
|
|
| Secondary | Bone Biomarker Osteocalcin (OC) Percentage Change After 12 Months | Per Protocol Set (PPS) | Posted | Median | Inter-Quartile Range | percentage of OC | Baseline and 12 months |
|
|
|
|
| Secondary | Bone Biomarker Undercarboxylated Osteocalcin (UCOC) Percentage Change After 12 Months | Per Protocol Set (PPS) | Posted | Median | Inter-Quartile Range | percentage of UCOC | Baseline and 12 months |
|
|
|
|
| Secondary | Bone Biomarker Undercarboxylated Osteocalcin/Osteocalcin (UCOC/OC) Percentage Change After 12 Months | Per Protocol Set (PPS) | Posted | Median | Inter-Quartile Range | percentage of UCOC/OC | Baseline and 12 months |
|
|
|
|
| Secondary | New Fracture and Fall | Per Protocol Set (PPS) | Posted | Number | participants | 12 months |
|
|
|
| Secondary | Height (Meter) | Per Protocol Set (PPS) | Posted | Mean | Standard Deviation | meters | Baseline and 12 months |
|
|
|
| 8 |
| 117 |
| 81 |
| 117 |
| EG001 | Alfacalcidol | 0.25 μg b.i.d. orally for 12 months | 6 | 118 | 74 | 118 |
| Bone fracture | Musculoskeletal and connective tissue disorders |
|
| Tendon damage | Musculoskeletal and connective tissue disorders |
|
| Dizziness | Nervous system disorders |
|
| Parathyroid malignant tumor | Endocrine disorders |
|
| NTT | Endocrine disorders |
|
| Goiter | Endocrine disorders |
|
| Hypertension | Vascular disorders |
|
| Chest distress | Cardiac disorders |
|
| Coronary artery disease | Cardiac disorders |
|
| Angina | Cardiac disorders |
|
| Arrhythmia | Cardiac disorders |
|
| Breast cancer | Reproductive system and breast disorders |
|
| Nerve sheath tumor surgery | Surgical and medical procedures |
|
| Uterus resection | Surgical and medical procedures |
|
| Musculoskeletal system abnormalities | Musculoskeletal and connective tissue disorders |
|
| Central and peripheral nervous system abnormalities | Nervous system disorders |
|
| Gastrointestinal disorders | Gastrointestinal disorders |
|
| Abnormal liver system | Hepatobiliary disorders |
|
| Metabolism and nutrition disorders | Metabolism and nutrition disorders |
|
| Abnormal Cardiovascular system | Cardiac disorders |
|
| Heart rate and rhythm disorders | Cardiac disorders |
|
| Respiratory abnormalities | Respiratory, thoracic and mediastinal disorders |
|
| Urinary system abnormalities | Renal and urinary disorders |
|
| Systemic anomalies | General disorders |
|
| Others | General disorders |
|
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| D009750 |
| Nutritional and Metabolic Diseases |