Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002948-24 | EudraCT Number |
Not provided
Not provided
Not provided
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The primary objective of the study was to evaluate the effect of 12 months of treatment with romosozumab compared with teriparatide on total hip bone mineral density (BMD) in postmenopausal women with osteoporosis who were previously treated with bisphosphonate therapy.
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Romosozumab | Experimental | Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months. |
|
| Teriparatide | Active Comparator | Participants received 20 μg/day teriparatide administered by subcutaneous injection for 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Romozosumab | Drug | Administered by subcutaneous injection once a month. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline Through Month 12 in Total Hip Bone Mineral Density (BMD) | Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA). Percent change from baseline through month 12 is the average of the treatment effect at months 6 and 12. | Baseline, month 6 and month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Total Hip BMD at Month 6 | Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA). | Baseline and month 6 |
| Percent Change From Baseline in Total Hip BMD at Month 12 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Gainesville | Georgia | 30501 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28755782 | Background | Langdahl BL, Libanati C, Crittenden DB, Bolognese MA, Brown JP, Daizadeh NS, Dokoupilova E, Engelke K, Finkelstein JS, Genant HK, Goemaere S, Hyldstrup L, Jodar-Gimeno E, Keaveny TM, Kendler D, Lakatos P, Maddox J, Malouf J, Massari FE, Molina JF, Ulla MR, Grauer A. Romosozumab (sclerostin monoclonal antibody) versus teriparatide in postmenopausal women with osteoporosis transitioning from oral bisphosphonate therapy: a randomised, open-label, phase 3 trial. Lancet. 2017 Sep 30;390(10102):1585-1594. doi: 10.1016/S0140-6736(17)31613-6. Epub 2017 Jul 26. | |
| 31707465 |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
Not provided
A total of 777 subjects were screened for participation; 341 (43.9%) were excluded prior to randomization, primarily due to not meeting inclusion/exclusion criteria (306 [39.4%] subjects). A total of 436 participants were randomized into the study.
The study was conducted at 46 sites in North America, Latin America, and Europe. Participants were enrolled from 31 January 2013 to 29 April 2014.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Teriparatide | Participants received 20 μg/day teriparatide administered by subcutaneous injection for 12 months. |
| FG001 | Romosozumab | Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Teriparatide | Drug | Administered by subcutaneous injection once a day. |
|
|
Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).
| Baseline and month 12 |
| Percent Change From Baseline in Cortical BMD by Quantitative Computed Tomography (QCT) at the Total Hip at Month 6 | Cortical BMD was measured by quantitative computed tomography (QCT) at the total hip. | Baseline and month 6 |
| Percent Change From Baseline in Cortical BMD by QCT at the Total Hip at Month 12 | Cortical BMD was measured by quantitative computed tomography (QCT) at the total hip. | Baseline and month 12 |
| Percent Change From Baseline in Integral BMD by QCT at the Total Hip at Month 6 | Integral BMD was measured by quantitative computed tomography (QCT) at the total hip. | Baseline and month 6 |
| Percent Change From Baseline in Integral BMD by QCT at the Total Hip at Month 12 | Integral BMD was measured by quantitative computed tomography (QCT) at the total hip. | Baseline and month 12 |
| Percent Change From Baseline in Estimated Strength at the Total Hip at Month 6 | Total hip estimated strength was assessed by finite element analysis (FEA) of QCT scans. | Baseline and month 6 |
| Percent Change From Baseline in Estimated Strength at the Total Hip at Month 12 | Total hip estimated strength was assessed by finite element analysis (FEA) of QCT scans. | Baseline and month 12 |
| Percent Change From Baseline in Total Hip Integral Bone Mineral Content (BMC) by QCT at Month 6 | Total hip integral BMC was measured using quantitative computed tomography (QCT). | Baseline and month 6 |
| Percent Change From Baseline in Total Hip Integral Bone Mineral Content (BMC) by QCT at Month 12 | Total hip integral BMC was measured using quantitative computed tomography (QCT). | Baseline and month 12 |
| Percent Change From Baseline in Femoral Neck BMD at Month 6 | Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA). | Baseline and month 6 |
| Percent Change From Baseline in Femoral Neck BMD at Month 12 | Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA). | Baseline and month 12 |
| Percent Change From Baseline in Lumbar Spine BMD at Month 6 | Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA). | Baseline and month 6 |
| Percent Change From Baseline in Lumbar Spine BMD at Month 12 | Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA). | Baseline and month 12 |
| Bethesda |
| Maryland |
| 20817 |
| United States |
| Research Site | Boston | Massachusetts | 02114 | United States |
| Research Site | Boston | Massachusetts | 02131 | United States |
| Research Site | Detroit | Michigan | 48236 | United States |
| Research Site | Ciudad Autonoma de Buenos Aires | Buenos Aires | C1012AAR | Argentina |
| Research Site | Ciudad Autonoma de Buenos Aires | Buenos Aires | C1128AAF | Argentina |
| Research Site | Córdoba | Córdoba Province | X5000BNB | Argentina |
| Research Site | Genk | 3600 | Belgium |
| Research Site | Ghent | 9000 | Belgium |
| Research Site | Leuven | 3000 | Belgium |
| Research Site | Liège | 4000 | Belgium |
| Research Site | Calgary | Alberta | T2N 4Z6 | Canada |
| Research Site | Vancouver | British Columbia | V6H 3X8 | Canada |
| Research Site | Toronto | Ontario | M5C 2T2 | Canada |
| Research Site | Toronto | Ontario | M5G 2C4 | Canada |
| Research Site | Québec | Quebec | G1V 3M7 | Canada |
| Research Site | Medellín | Antioquia | Colombia |
| Research Site | Barranquilla | Atlántico | 08001000 | Colombia |
| Research Site | Brno | 602 00 | Czechia |
| Research Site | Ostrava | 702 00 | Czechia |
| Research Site | Pilsen | 305 99 | Czechia |
| Research Site | Praha 11 - Chodov | 148 00 | Czechia |
| Research Site | Uherské Hradiště | 686 01 | Czechia |
| Research Site | Aalborg | 9000 | Denmark |
| Research Site | Aarhus C | 8000 | Denmark |
| Research Site | Ballerup Municipality | 2750 | Denmark |
| Research Site | Esbjerg | 6700 | Denmark |
| Research Site | Hillerød | 3400 | Denmark |
| Research Site | Hvidovre | 2650 | Denmark |
| Research Site | Odense | 5000 | Denmark |
| Research Site | Budapest | 1036 | Hungary |
| Research Site | Budapest | 1083 | Hungary |
| Research Site | Budapest | 1123 | Hungary |
| Research Site | Gdynia | 81-384 | Poland |
| Research Site | Katowice | 40-040 | Poland |
| Research Site | Warsaw | 01-192 | Poland |
| Research Site | Wroclaw | 50-088 | Poland |
| Research Site | Granada | Andalusia | 18012 | Spain |
| Research Site | Barcelona | Catalonia | 08041 | Spain |
| Research Site | LHospitalet de Llobregat | Catalonia | 08907 | Spain |
| Research Site | Pozuelo de Alarcón | Madrid | 28223 | Spain |
| Research Site | Madrid | 28041 | Spain |
| Research Site | Madrid | 28046 | Spain |
| Research Site | Cardiff | CF14 5GJ | United Kingdom |
| Research Site | Chorley | PR7 7NA | United Kingdom |
| Research Site | Liverpool | L22 0LG | United Kingdom |
| Research Site | Northwood | HA6 2RN | United Kingdom |
| Research Site | Reading | RG2 0TG | United Kingdom |
| Research Site | Sidcup | DA14 6LT | United Kingdom |
| Background |
| Takada J, Dinavahi R, Miyauchi A, Hamaya E, Hirama T, Libanati C, Nakamura Y, Milmont CE, Grauer A. Relationship between P1NP, a biochemical marker of bone turnover, and bone mineral density in patients transitioned from alendronate to romosozumab or teriparatide: a post hoc analysis of the STRUCTURE trial. J Bone Miner Metab. 2020 May;38(3):310-315. doi: 10.1007/s00774-019-01057-1. Epub 2019 Nov 9. |
| Received Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Teriparatide | Participants received 20 μg/day teriparatide administered by subcutaneous injection for 12 months. |
| BG001 | Romosozumab | Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Prior Fracture | Count of Participants | Participants |
| ||||||||||||||||
| Lumbar Spine BMD T-score | The T-score is the bone mineral density (BMD) at the site when compared to that of a healthy thirty-year-old. Normal is a T-score of -1.0 or higher; Osteopenia is defined as between -1.0 and -2.5; Osteoporosis is defined as -2.5 or lower, meaning a bone density that is two and a half standard deviations below the mean of a thirty-year-old man/woman. | Mean | Standard Deviation | T-score |
| ||||||||||||||
| Total Hip BMD T-score | Mean | Standard Deviation | T-score |
| |||||||||||||||
| Femoral Neck BMD T-score | Mean | Standard Deviation | T-score |
| |||||||||||||||
| Serum Type 1 Collagen C-telopeptide (sCTX) | Mean | Standard Deviation | ng/L |
|
| 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 Through Month 12 in Total Hip Bone Mineral Density (BMD) | Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA). Percent change from baseline through month 12 is the average of the treatment effect at months 6 and 12. | The primary efficacy analysis set includes randomized participants with a non-missing baseline and at least one post-baseline measurement. | Posted | Least Squares Mean | Standard Error | percent change | Baseline, month 6 and month 12 |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Total Hip BMD at Month 6 | Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA). | The primary efficacy analysis set with values at baseline and month 6 | Posted | Least Squares Mean | Standard Error | percent change | Baseline and month 6 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Total Hip BMD at Month 12 | Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA). | The primary efficacy analysis set with values at baseline and month 12 | Posted | Least Squares Mean | Standard Error | percent change | Baseline and month 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Cortical BMD by Quantitative Computed Tomography (QCT) at the Total Hip at Month 6 | Cortical BMD was measured by quantitative computed tomography (QCT) at the total hip. | The primary efficacy analysis set with values at baseline and month 6 | Posted | Least Squares Mean | Standard Error | percent change | Baseline and month 6 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Cortical BMD by QCT at the Total Hip at Month 12 | Cortical BMD was measured by quantitative computed tomography (QCT) at the total hip. | The primary efficacy analysis set with values at baseline and month 12 | Posted | Least Squares Mean | Standard Error | percent change | Baseline and month 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Integral BMD by QCT at the Total Hip at Month 6 | Integral BMD was measured by quantitative computed tomography (QCT) at the total hip. | The primary efficacy analysis set with values at baseline and month 6 | Posted | Least Squares Mean | Standard Error | percent change | Baseline and month 6 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Integral BMD by QCT at the Total Hip at Month 12 | Integral BMD was measured by quantitative computed tomography (QCT) at the total hip. | The primary efficacy analysis set with values at baseline and month 12 | Posted | Least Squares Mean | Standard Error | percent change | Baseline and month 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Estimated Strength at the Total Hip at Month 6 | Total hip estimated strength was assessed by finite element analysis (FEA) of QCT scans. | The primary efficacy analysis set with values at baseline and month 6 | Posted | Least Squares Mean | Standard Error | percent change | Baseline and month 6 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Estimated Strength at the Total Hip at Month 12 | Total hip estimated strength was assessed by finite element analysis (FEA) of QCT scans. | The primary efficacy analysis set with values at baseline and month 12 | Posted | Least Squares Mean | Standard Error | percent change | Baseline and month 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Total Hip Integral Bone Mineral Content (BMC) by QCT at Month 6 | Total hip integral BMC was measured using quantitative computed tomography (QCT). | The primary efficacy analysis set with values at baseline and month 6 | Posted | Least Squares Mean | Standard Error | percent change | Baseline and month 6 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Total Hip Integral Bone Mineral Content (BMC) by QCT at Month 12 | Total hip integral BMC was measured using quantitative computed tomography (QCT). | The primary efficacy analysis set with values at baseline and month 12 | Posted | Least Squares Mean | Standard Error | percent change | Baseline and month 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Femoral Neck BMD at Month 6 | Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA). | The primary efficacy analysis set with values at baseline and month 6 | Posted | Least Squares Mean | Standard Error | percent change | Baseline and month 6 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Femoral Neck BMD at Month 12 | Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA). | The primary efficacy analysis set with values at baseline and month 12 | Posted | Least Squares Mean | Standard Error | percent change | Baseline and month 12 |
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| Secondary | Percent Change From Baseline in Lumbar Spine BMD at Month 6 | Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA). | The primary efficacy analysis set with values at baseline and month 6 | Posted | Least Squares Mean | Standard Error | percent change | Baseline and month 6 |
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| Secondary | Percent Change From Baseline in Lumbar Spine BMD at Month 12 | Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA). | The primary efficacy analysis set with values at baseline and month 12 | Posted | Least Squares Mean | Standard Error | percent change | Baseline and month 12 |
|
|
12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Teriparatide | Participants received 20 μg/day teriparatide administered by subcutaneous injection for 12 months. | 23 | 214 | 76 | 214 | ||
| EG001 | Romosozumab | Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months. | 17 | 218 | 79 | 218 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Arrhythmia supraventricular | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Bifascicular block | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Large intestinal ulcer | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Urinary tract infection fungal | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Muscle rupture | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Procedural nausea | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Benign soft tissue neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
| |
| Colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
| |
| Keratoacanthoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
| |
| Myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
| |
| Ovarian cancer stage III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Radicular pain | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Radicular syndrome | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| VIIth nerve paralysis | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Medical device removal | Surgical and medical procedures | MedDRA 18.0 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.0 | 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 multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C557282 | romosozumab |
| D019379 | Teriparatide |
| ID | Term |
|---|---|
| D010281 | Parathyroid Hormone |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
| ≥ 65 to < 75 years |
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| ≥ 75 years |
|
| Male |
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| Other |
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| American Indian or Alaska Native |
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| Asian |
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| Multiple |
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| No |
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A two-step, step-down, fixed-sequential testing procedure was used to test the primary and key secondary efficacy endpoints for the comparison of romosozumab to teriparatide in the order presented for multiplicity adjustment to maintain the overall significance level at 0.05. The Key Secondary Efficacy Endpoints are the first 8 secondary endpoints reported below. |
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