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The purpose of this trial is to evaluate AMG 162 in the treatment of bone loss in subjects undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMG 162 / Denosumab | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | 60 mg (1.0 mL) administered subcutaneously every six months, beginning on Study Day 1, for a total treatment period of 24 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 6 | Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. | 6 months |
| Total Hip Bone Mineral Density Percent Change From Baseline at Month 12 |
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Other criteria also apply.
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19308727 | Background | Ellis GK, Bone HG, Chlebowski R, Paul D, Spadafora S, Fan M, Kim D. Effect of denosumab on bone mineral density in women receiving adjuvant aromatase inhibitors for non-metastatic breast cancer: subgroup analyses of a phase 3 study. Breast Cancer Res Treat. 2009 Nov;118(1):81-7. doi: 10.1007/s10549-009-0352-y. Epub 2009 Mar 24. | |
| 18725648 |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Denosumab 60 mg Q6M | |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Denosumab 60 mg Q6M | |
| BG001 | Placebo | |
| BG002 | Total |
| 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. | Subjects with non-missing baseline and >= 1 non-missing post-baseline evaluation. Using Last Observation Carried Forward as imputation. | Posted | Least Squares 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 |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 9.0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 9.0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin 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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| AMG 162 / Denosumab | Drug | 60 mg (1.0 mL) administered subcutaneously every six months, beginning on Study Day 1, for a total treatment period of 24 months |
|
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
| 12 months |
| Total Hip Bone Mineral Density Percent Change From Baseline at Month 6 | Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. | 6 months |
| Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12 | Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. | 12 months |
| Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 6 | Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. | 6 months |
| Ellis GK, Bone HG, Chlebowski R, Paul D, Spadafora S, Smith J, Fan M, Jun S. Randomized trial of denosumab in patients receiving adjuvant aromatase inhibitors for nonmetastatic breast cancer. J Clin Oncol. 2008 Oct 20;26(30):4875-82. doi: 10.1200/JCO.2008.16.3832. Epub 2008 Aug 25. |
| 38979716 | Derived | Adams A, Jakob T, Huth A, Monsef I, Ernst M, Kopp M, Caro-Valenzuela J, Wockel A, Skoetz N. Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD013451. doi: 10.1002/14651858.CD013451.pub2. |
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Disease progression |
|
| Ineligibility determined |
|
| Noncompliance |
|
| Other |
|
Total of all reporting groups
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
|
| Secondary | Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 6 | Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. | Posted | Least Squares Mean | 95% Confidence Interval | Percent Change from Baseline | 6 months |
|
|
|
| Secondary | Total Hip Bone Mineral Density Percent Change From Baseline at Month 12 | Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. | Posted | Least Squares Mean | 95% Confidence Interval | Percent Change from Baseline | 12 months |
|
|
|
| Secondary | Total Hip Bone Mineral Density Percent Change From Baseline at Month 6 | Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. | Posted | Least Squares Mean | 95% Confidence Interval | Percent Change from Baseline | 6 months |
|
|
|
| Secondary | Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12 | Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. | Posted | Least Squares Mean | 95% Confidence Interval | Percent Change from Baseline | 12 months |
|
|
|
| Secondary | Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 6 | Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. | Posted | Least Squares Mean | 95% Confidence Interval | Percent Change from Baseline | 6 months |
|
|
|
| 11 |
| 120 |
| 108 |
| 120 |
| EG001 | Denosumab 60 mg Q6M | 19 | 129 | 117 | 129 |
| Atrial fibrillation | Cardiac disorders | MedDRA 9.0 |
|
| Atrioventricular block second degree | Cardiac disorders | MedDRA 9.0 |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 9.0 |
|
| Myocardial infarction | Cardiac disorders | MedDRA 9.0 |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA 9.0 |
|
| Goitre | Endocrine disorders | MedDRA 9.0 |
|
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 9.0 |
|
| Diverticulum | Gastrointestinal disorders | MedDRA 9.0 |
|
| Faecaloma | Gastrointestinal disorders | MedDRA 9.0 |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 9.0 |
|
| Large intestine perforation | Gastrointestinal disorders | MedDRA 9.0 |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 9.0 |
|
| Pelvic mass | General disorders | MedDRA 9.0 |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 9.0 |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 9.0 |
|
| Cellulitis | Infections and infestations | MedDRA 9.0 |
|
| Diverticulitis | Infections and infestations | MedDRA 9.0 |
|
| Labyrinthitis | Infections and infestations | MedDRA 9.0 |
|
| Pneumonia | Infections and infestations | MedDRA 9.0 |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 9.0 |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA 9.0 |
|
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA 9.0 |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 9.0 |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 9.0 |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 9.0 |
|
| Benign breast neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 |
|
| Benign ovarian tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 |
|
| Breast cancer in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 |
|
| Breast cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 |
|
| Colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 |
|
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 |
|
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 |
|
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 |
|
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 9.0 |
|
| Rectocele | Reproductive system and breast disorders | MedDRA 9.0 |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 9.0 |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 9.0 |
|
| Nausea | Gastrointestinal disorders | MedDRA 9.0 |
|
| Vomiting | Gastrointestinal disorders | MedDRA 9.0 |
|
| Fatigue | General disorders | MedDRA 9.0 |
|
| Oedema peripheral | General disorders | MedDRA 9.0 |
|
| Bronchitis | Infections and infestations | MedDRA 9.0 |
|
| Sinusitis | Infections and infestations | MedDRA 9.0 |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 9.0 |
|
| Urinary tract infection | Infections and infestations | MedDRA 9.0 |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 9.0 |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 9.0 |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 9.0 |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 9.0 |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 9.0 |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 9.0 |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 9.0 |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 9.0 |
|
| Shoulder pain | Musculoskeletal and connective tissue disorders | MedDRA 9.0 |
|
| Headache | Nervous system disorders | MedDRA 9.0 |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 9.0 |
|
| Anxiety | Psychiatric disorders | MedDRA 9.0 |
|
| Depression | Psychiatric disorders | MedDRA 9.0 |
|
| Insomnia | Psychiatric disorders | MedDRA 9.0 |
|
| Breast pain | Reproductive system and breast disorders | MedDRA 9.0 |
|
| Vulvovaginal dryness | Reproductive system and breast disorders | MedDRA 9.0 |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 9.0 |
|
| Hot flush | Vascular disorders | MedDRA 9.0 |
|
| Hypertension | Vascular disorders | MedDRA 9.0 |
|
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.
| D017437 |
| Skin and Connective Tissue Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |