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The study will evaluate the efficacy and safety of transitioning postmenopausal women on current alendronate therapy to denosumab. Endpoints studied will include bone mineral density, bone turnover markers and bone histology in a subset of subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| denosumab | Experimental |
| |
| alendronate | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alendronate | Drug | 70 mg oral QW |
| |
| Denosumab (AMG 162) |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Total Hip Bone Mineral Density | Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change calculated using [(12 month value - baseline value) / baseline value]*100. | Baseline, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Lumbar Spine Bone Mineral Density | Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change calculated using [(12 month value - baseline value) / baseline value]*100. | Baseline, 12 months |
| Percent Change From Baseline in Serum C-Telopeptide-I (CTX-I) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19594293 | Result | Kendler DL, Roux C, Benhamou CL, Brown JP, Lillestol M, Siddhanti S, Man HS, San Martin J, Bone HG. Effects of denosumab on bone mineral density and bone turnover in postmenopausal women transitioning from alendronate therapy. J Bone Miner Res. 2010 Jan;25(1):72-81. doi: 10.1359/jbmr.090716. | |
| 31776637 | Derived |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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First Subject Enrolled: 02-Oct-2006 Last Subject Enrolled: 07-Mar-2007
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| ID | Title | Description |
|---|---|---|
| FG000 | Alendronate 70 mg QW | 70 mg alendronate once weekly (QW) orally plus placebo for denosumab subcutaneously once every 6 months (Q6M) |
| FG001 | Denosumab 60 mg Q6M | 60 mg denosumab administered subcutaneously once every 6 months (Q6M) plus placebo for alendronate once weekly (QW) orally |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Alendronate 70 mg QW | 70 mg alendronate once weekly (QW) orally plus placebo for denosumab subcutaneously once every 6 months (Q6M) |
| BG001 | Denosumab 60 mg Q6M | 60 mg denosumab administered subcutaneously once every 6 months (Q6M) plus placebo for alendronate once weekly (QW) orally |
| 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 | Percent Change From Baseline in Total Hip Bone Mineral Density | Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change calculated using [(12 month value - baseline value) / baseline value]*100. | Participants with non-missing baseline evaluation and at least 1 non-missing post-baseline evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Percent Change | Baseline, 12 months |
|
12 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
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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 | Alendronate 70 mg QW |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
| 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 |
|---|---|
| D019386 | Alendronate |
| D000069448 | Denosumab |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| Drug |
60 mg SC q 6 mos |
|
Percent Change From Baseline to Month 3 in Serum CTX-I. Percent change calculated using [(3 month value - baseline value) / baseline value]*100. |
| Baseline, 3 months |
| Miller PD, Pannacciulli N, Malouf-Sierra J, Singer A, Czerwinski E, Bone HG, Wang C, Huang S, Chines A, Lems W, Brown JP. Efficacy and safety of denosumab vs. bisphosphonates in postmenopausal women previously treated with oral bisphosphonates. Osteoporos Int. 2020 Jan;31(1):181-191. doi: 10.1007/s00198-019-05233-x. Epub 2019 Nov 28. |
| 22152181 | Derived | Gold DT, Horne R, Coon CD, Price MA, Borenstein J, Varon SF, Satram-Hoang S, Macarios D. Development, reliability, and validity of a new Preference and Satisfaction Questionnaire. Value Health. 2011 Dec;14(8):1109-16. doi: 10.1016/j.jval.2011.06.010. Epub 2011 Oct 1. |
| 20533525 | Derived | Reid IR, Miller PD, Brown JP, Kendler DL, Fahrleitner-Pammer A, Valter I, Maasalu K, Bolognese MA, Woodson G, Bone H, Ding B, Wagman RB, San Martin J, Ominsky MS, Dempster DW; Denosumab Phase 3 Bone Histology Study Group. Effects of denosumab on bone histomorphometry: the FREEDOM and STAND studies. J Bone Miner Res. 2010 Oct;25(10):2256-65. doi: 10.1002/jbmr.149. |
| Death |
|
| Lost to Follow-up |
|
| Protocol Violation |
|
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
|
|
|
| Secondary | Percent Change From Baseline in Lumbar Spine Bone Mineral Density | Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change calculated using [(12 month value - baseline value) / baseline value]*100. | Participants with non-missing baseline evaluation and at least 1 non-missing post-baseline evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Percent Change | Baseline, 12 months |
|
|
|
|
| Secondary | Percent Change From Baseline in Serum C-Telopeptide-I (CTX-I) | Percent Change From Baseline to Month 3 in Serum CTX-I. Percent change calculated using [(3 month value - baseline value) / baseline value]*100. | Participants with non-missing baseline evaluation and non-missing post-baseline evaluation at month 3. | Posted | Median | Inter-Quartile Range | Percent Change | Baseline, 3 months |
|
|
|
|
| 16 |
| 249 |
| 101 |
| 249 |
| EG001 | Denosumab 60 mg Q6M | 15 | 253 | 103 | 253 |
| Atrial fibrillation | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Sick sinus syndrome | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Appendicitis perforated | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Loose tooth | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hyperpyrexia | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Inflammation | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Anaphylactic reaction | Immune system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Gingival infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Lobar pneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Periodontal infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Ameloblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
|
| Nodular fasciitis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
|
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
|
| Carotid artery stenosis | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cystocele | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
|
| Uterine prolapse | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
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 |
| D061067 |
| Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |