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| ID | Type | Description | Link |
|---|---|---|---|
| NOT APPRICABLE |
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The primary objective of this study is to assess the effect of AMG 162 (denosumab) treatment on the lumbar spine BMD at month 12 and safety profile across the dose range tested (14, 60 and 100 mg SC once every 6 months) in Japanese postmenopausal osteoporotic subjects compared with those treated with placebo over 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 100 mg AMG 162 | Active Comparator |
| |
| 60 mg AMG 162 | Active Comparator |
| |
| Placebo | Placebo Comparator |
| |
| 14 mg AMG 162 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 100 mg AMG 162 | Drug | 100 mg AMG 162 (denosumab) SC every 6 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 | Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. | 12 months |
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Inclusion Criteria: - Ambulatory postmenopausal women. - BMD values (g/cm2, Hologic) must be lower than 0.714 at lumbar spine, 0.515 at femoral neck, 0.588 at total hip. - BMD values must not be lower than 0.535 at the lumbar spine, 0.406 at the femoral neck and 0.478 at the total hip. Exclusion Criteria: - Oral bisphosphonate treatments, PTH or PTH derivatives use within the last 12 months and administration of any of anti-osteoporotic treatments within the last 3 months before initial administration of the investigational product. - History of hypocalcemia. - More than two moderate vertebral fractures or any severe vertebral fracture.
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21927920 | Result | Nakamura T, Matsumoto T, Sugimoto T, Shiraki M. Dose-response study of denosumab on bone mineral density and bone turnover markers in Japanese postmenopausal women with osteoporosis. Osteoporos Int. 2012 Mar;23(3):1131-40. doi: 10.1007/s00198-011-1786-8. Epub 2011 Sep 17. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Denosumab 14 mg Q6M | |
| FG001 | Denosumab 60 mg Q6M | |
| FG002 | Denosumab 100 mg Q6M | |
| FG003 | Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Denosumab 14 mg Q6M | |
| BG001 | Denosumab 60 mg Q6M | |
| BG002 | Denosumab 100 mg Q6M |
| 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 | Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 | Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. | All subjects who received >= 1 dose of investigational product and have a baseline and >= 1 post baseline measurement at the lumbar spine. | Posted | Mean | 95% Confidence Interval | Percent Change from Baseline | 12 months |
|
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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 | Placebo |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 10.0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 10.0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
| 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 |
|---|---|
| D000069448 | Denosumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| 60 mg AMG 162 |
| Drug |
60 mg AMG 162 (denosumab) SC every 6 months |
|
| 14 mg AMG 162 | Drug | 14 mg AMG 162 (denosumab) SC every 6 months |
|
| Placebo | Drug | Placebo SC every 6 months |
|
| Adverse Event |
|
| Withdrawal by Subject |
|
| Ineligibility determined |
|
| Other |
|
| BG003 | Placebo |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Denosumab 100 mg Q6M |
|
|
|
| 4 |
| 54 |
| 49 |
| 54 |
| EG001 | Denosumab 14 mg Q6M | 6 | 53 | 50 | 53 |
| EG002 | Denosumab 60 mg Q6M | 4 | 54 | 47 | 54 |
| EG003 | Denosumab 100 mg Q6M | 2 | 51 | 48 | 51 |
| Meniere's disease | Ear and labyrinth disorders | MedDRA 10.0 |
|
| Colitis | Gastrointestinal disorders | MedDRA 10.0 |
|
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 10.0 |
|
| Colonic polyp | Gastrointestinal disorders | MedDRA 10.0 |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 10.0 |
|
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA 10.0 |
|
| Hepatitis C | Infections and infestations | MedDRA 10.0 |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 10.0 |
|
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 10.0 |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 10.0 |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 |
|
| Cerebral artery embolism | Nervous system disorders | MedDRA 10.0 |
|
| Cerebral infarction | Nervous system disorders | MedDRA 10.0 |
|
| Hypotension | Vascular disorders | MedDRA 10.0 |
|
| Varicose vein | Vascular disorders | MedDRA 10.0 |
|
| Cataract | Eye disorders | MedDRA 10.0 |
|
| Constipation | Gastrointestinal disorders | MedDRA 10.0 |
|
| Dental caries | Gastrointestinal disorders | MedDRA 10.0 |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 |
|
| Gastritis | Gastrointestinal disorders | MedDRA 10.0 |
|
| Gingivitis | Gastrointestinal disorders | MedDRA 10.0 |
|
| Periodontitis | Gastrointestinal disorders | MedDRA 10.0 |
|
| Stomach discomfort | Gastrointestinal disorders | MedDRA 10.0 |
|
| Vomiting | Gastrointestinal disorders | MedDRA 10.0 |
|
| Malaise | General disorders | MedDRA 10.0 |
|
| Seasonal allergy | Immune system disorders | MedDRA 10.0 |
|
| Bronchitis | Infections and infestations | MedDRA 10.0 |
|
| Cystitis | Infections and infestations | MedDRA 10.0 |
|
| Gastroenteritis | Infections and infestations | MedDRA 10.0 |
|
| Herpes zoster | Infections and infestations | MedDRA 10.0 |
|
| Hordeolum | Infections and infestations | MedDRA 10.0 |
|
| Nasopharyngitis | Infections and infestations | MedDRA 10.0 |
|
| Oral herpes | Infections and infestations | MedDRA 10.0 |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 10.0 |
|
| Joint sprain | Injury, poisoning and procedural complications | MedDRA 10.0 |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 10.0 |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 10.0 |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 10.0 |
|
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 |
|
| Headache | Nervous system disorders | MedDRA 10.0 |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 10.0 |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 10.0 |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 10.0 |
|
| Hypertension | Vascular disorders | MedDRA 10.0 |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multi-center studies, the investigator agrees not to publish any results before the first multi-center publication.
| D009750 |
| Nutritional and Metabolic Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |