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The purpose of this study is to evaluate the efficacy and the safety of Risedronate, cholecalciferol combination tablet in patients with Osteoporosis.
The purpose of this study is to evaluate the efficacy and the safety of Risedronate with and without cholecalciferol on vitamin D status, Bone Mineral Density (BMD) and bone markers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Risendronate/Cholecalciferol combination | Experimental | Risendronate/Cholecalciferol combination Risenex Plus tablet: one tablet once a week for 12months |
|
| Risedronate | Active Comparator | Sedron tablet: one tablet once a week for 12months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risedronate/Cholecalciferol combination | Drug | Risendronate/Cholecalciferol combination once a week |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Change of Bone Mineral Density (BMD) Value | Higher Bone Mineral Density(BMD) value mean a better outcome. | baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| The Change of 25OHD(25-hydroxyvitamin D) | range of 25OHD: 4.80~52.80 Higher 25OHD scores mean a better outcome. If there is missing data, LOCF(Last Observation Carried Forward) was applied and analyzed. | baseline, 6months, 12months |
| PTH(Parathyroid Hormone Value) |
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Inclusion Criteria:
Male osteoporosis patients over 19 years of age
Female osteoporosis patients with menopause
Definition of osteoporosis
Definition of menopause(can be one of three condition)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hyoung-Moo Park, MD | Chung-Ang University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chung-ang university hospital | Seoul | 156-755 | South Korea |
wash out 7~14days
medical clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | Risendronate/Cholecalciferol Combination | Experimental: Administer Risendronate/Cholecalciferol combination one tablet once a week for 12months. Risedronate/Cholecalciferol combination: once a week |
| FG001 | Risedronate | Active comparator: Administer Risendronate one tablet once a week for 12months. Risedronate: once a week |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Risendronate/Cholecalciferol Combination | Risendronate/Cholecalciferol combination Risenex Plus tablet: one tablet once a week for 12months Risedronate/Cholecalciferol combination: Risendronate/Cholecalciferol combination once a week |
| BG001 | Risedronate |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | The Change of Bone Mineral Density (BMD) Value | Higher Bone Mineral Density(BMD) value mean a better outcome. | Posted | Mean | Standard Deviation | g/cm^2 | baseline and 12 months |
|
12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
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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 | Risendronate/Cholecalciferol Combination | Experimental: Administer Risendronate/Cholecalciferol combination one tablet once a week for 12months. Risedronate/Cholecalciferol combination: once a week |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspepsia | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
Multiple centers proceded clinical study do not use the same measuring instrument.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Unit | Hanlim Pharma | 82-2-3489-6297 | yrsong@hanlim.com |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068296 | Risedronic Acid |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| Risedronate | Drug | Risedronate once a week |
|
|
range of PTH: 13~54 Higher PTH scores mean a worse outcome. If there is missing data, LOCF(Last Observation Carried Forward) was applied and analyzed. |
| baseline, 6months, 12months |
Sedron tablet: one tablet once a week for 12months Risedronate: Risedronate once a week |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Osteoporosis disease period | Mean | Standard Deviation | years |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | The Change of 25OHD(25-hydroxyvitamin D) | range of 25OHD: 4.80~52.80 Higher 25OHD scores mean a better outcome. If there is missing data, LOCF(Last Observation Carried Forward) was applied and analyzed. | Posted | Mean | Standard Deviation | ng/ml | baseline, 6months, 12months |
|
|
|
| Secondary | PTH(Parathyroid Hormone Value) | range of PTH: 13~54 Higher PTH scores mean a worse outcome. If there is missing data, LOCF(Last Observation Carried Forward) was applied and analyzed. | Posted | Mean | Standard Deviation | pg/ml | baseline, 6months, 12months |
|
|
|
| 9 |
| 806 |
| 61 |
| 806 |
| 61 |
| 806 |
| EG001 | Risedronate | Active comparator: Administer Risendronate one tablet once a week for 12months. Risedronate: once a week | 1 | 247 | 19 | 247 | 29 | 247 |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
|
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
|
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
|
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
|
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
|
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
|
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
|
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Still's disease adult onset | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Chronic sinusitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Infectious pleural effusion | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
|
| Gallbladder cancer stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
|
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
|
| Pyogenic granuloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
|
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
|
| Thyroid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
|
| Tonsil cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
|
| Brain oedema | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
|
| Carotid artery stenosis | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
|
| Hydrocephalus | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Distal intestinal obstruction syndrome | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Gastric polyps | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Rectal prolapse | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Coronary artery stenosis | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
|
| Prinzmetal angina | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (18.0) | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA (18.0) | Systematic Assessment |
|
| Elderly | Social circumstances | MedDRA (18.0) | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA (18.0) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (18.0) | Systematic Assessment |
|
| Ketoacidosis | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
|
| Completed suicide | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
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| D009750 |
| Nutritional and Metabolic Diseases |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| 25OHD(12months) |
|
| 25OHD change(6months-baseline) |
|
| 25OHD change(12months-baseline) |
|
| PTH(12months) |
|
| PTH change(6months-baseline) |
|
| PTH change(12months-baseline) |
|