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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-005551-32 | EudraCT Number |
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The study is designed to evaluate if treatment with romosozumab once a month for 12 months compared with placebo is effective in increasing bone mineral density (BMD) at the lumbar spine. Additionally, the study will assess the effect of treatment with romosozumab for 12 months compared with placebo on BMD at the femoral neck and total hip.
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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. |
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| Placebo | Placebo Comparator | Participants received placebo subcutaneous injections once a month for 12 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Romosozumab | Biological | Administered by subcutaneous injection once a month. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12 | Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. | Baseline and month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in BMD at the Total Hip at Month 12 | Total hip bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. | Baseline and month 12 |
| Percent Change From Baseline in BMD at the Femoral Neck at Month 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Lakewood | Colorado | 80227 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29931216 | Background | Lewiecki EM, Blicharski T, Goemaere S, Lippuner K, Meisner PD, Miller PD, Miyauchi A, Maddox J, Chen L, Horlait S. A Phase III Randomized Placebo-Controlled Trial to Evaluate Efficacy and Safety of Romosozumab in Men With Osteoporosis. J Clin Endocrinol Metab. 2018 Sep 1;103(9):3183-3193. doi: 10.1210/jc.2017-02163. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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Participants were randomized in a 2:1 ratio to receive 210 mg romosozumab or matched placebo in a blinded fashion for the duration of the 12-month treatment period. Randomization was stratified by geographic region (Europe, North America, Latin America, and Japan).
This study was conducted at 31 centers in Europe, North America, Latin America, and Japan. Participants were enrolled from 16 June 2014 to 27 January 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo subcutaneous injections once a month (QM) for 12 months. |
| FG001 | Romosozumab 210 mg | Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Drug | Administered by subcutaneous injection once a month. |
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Femoral neck bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. |
| Baseline and month 12 |
| Percent Change From Baseline in Lumbar Spine BMD at Month 6 | Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. | Baseline and month 6 |
| Percent Change From Baseline in BMD at the Total Hip at Month 6 | Bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. | Baseline and month 6 |
| Percent Change From Baseline in BMD at the Femoral Neck at Month 6 | Bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. | Baseline and month 6 |
| Bethesda |
| Maryland |
| 20817 |
| United States |
| Research Site | Albuquerque | New Mexico | 87106 | United States |
| Research Site | Genk | 3600 | Belgium |
| Research Site | Ghent | 9000 | Belgium |
| Research Site | Leuven | 3000 | Belgium |
| Research Site | Liège | 4020 | Belgium |
| Research Site | Medellín | Antioquia | 050021 | Colombia |
| Research Site | Bogota | Cundinamarca | 11001000 | Colombia |
| Research Site | Ostrava-Trebovice | 722 00 | Czechia |
| Research Site | Pilsen | 305 99 | Czechia |
| Research Site | Praha 11 - Chodov | 148 00 | Czechia |
| Research Site | Aalborg | 9000 | Denmark |
| Research Site | Ballerup Municipality | 2750 | Denmark |
| Research Site | Mizunami-shi | Gifu | 509-6134 | Japan |
| Research Site | Yokohama | Kanagawa | 223-0062 | Japan |
| Research Site | Bungoono-shi | Oita Prefecture | 879-7125 | Japan |
| Research Site | Takatsuki-shi | Osaka | 569-1123 | Japan |
| Research Site | Hachioji-shi | Tokyo | 192-0046 | Japan |
| Research Site | Shinagawa-ku | Tokyo | 140-0011 | Japan |
| Research Site | Toshima-ku | Tokyo | 171-0033 | Japan |
| Research Site | Mexicali | Baja California Norte | 21100 | Mexico |
| Research Site | Monterrey | Nuevo León | 64460 | Mexico |
| Research Site | Culiacán | Sinaloa | 80000 | Mexico |
| Research Site | Lodz | 90-558 | Poland |
| Research Site | Świdnik | 21-040 | Poland |
| Research Site | Warsaw | 01-192 | Poland |
| Research Site | Wroclaw | 50-088 | Poland |
| Research Site | Moscow | 101990 | Russia |
| Research Site | Saint Petersburg | 190103 | Russia |
| Research Site | Yaroslavl | 150003 | Russia |
| Research Site | Bern | 3010 | Switzerland |
| Research Site | Zurich | 8063 | Switzerland |
| Research Site | Zurich | 8091 | Switzerland |
| Received Treatment |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo subcutaneous injections once a month (QM) for 12 months. |
| BG001 | Romosozumab 210 mg | 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 |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race | Count of Participants | Participants |
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| Geographic Region | Count of Participants | Participants |
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| Lumbar Spine Bone Mineral Density 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 |
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| Total Hip BMD T-score | Mean | Standard Deviation | T-score |
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| Femoral Neck BMD T-score | Mean | Standard Deviation | T-score |
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| 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 Lumbar Spine Bone Mineral Density (BMD) at Month 12 | Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. | Primary efficacy analysis subset, which includes all randomized participants who had a baseline DXA BMD measurement and at least 1 post-baseline DXA BMD measurement at the lumbar spine; last observation carried forward (LOCF) imputation was used. | Posted | Least Squares Mean | Standard Error | percent change | Baseline and month 12 |
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| Secondary | Percent Change From Baseline in BMD at the Total Hip at Month 12 | Total hip bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. | Primary efficacy analysis subset, which includes all randomized participants who had a baseline DXA BMD measurement and at least 1 post-baseline DXA BMD measurement at the total hip; LOCF imputation was used. | Posted | Least Squares Mean | Standard Error | percent change | Baseline and month 12 |
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| Secondary | Percent Change From Baseline in BMD at the Femoral Neck at Month 12 | Femoral neck bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. | Primary efficacy analysis subset, which includes all randomized participants who had a baseline DXA BMD measurement and at least 1 post-baseline DXA BMD measurement at the femoral neck; LOCF imputation was used. | 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 | Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. | Primary efficacy analysis subset with available data 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 BMD at the Total Hip at Month 6 | Bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. | Primary efficacy analysis subset with available data 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 BMD at the Femoral Neck at Month 6 | Bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. | Primary efficacy analysis subset with available data at baseline and month 6. | Posted | Least Squares Mean | Standard Error | percent change | Baseline and month 6 |
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15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
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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 | Participants received placebo subcutaneous injections once a month (QM) for 12 months. | 10 | 81 | 41 | 81 | ||
| EG001 | Romosozumab 210 mg | Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months. | 23 | 163 | 74 | 163 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina unstable | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
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| Atrial flutter | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
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| Cardiac valve disease | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
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| Cardio-respiratory arrest | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
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| Coronary artery stenosis | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
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| Myocardial ischaemia | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
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| Wolff-Parkinson-White syndrome | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Intra-abdominal haemorrhage | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Death | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Implant site haematoma | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Appendicitis perforated | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Atypical pneumonia | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Device related infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Escherichia sepsis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Pneumonia bacterial | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Anaemia postoperative | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| Femur fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| Laceration | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| Rib fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
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| Oropharyngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
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| Carotid arteriosclerosis | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Carotid artery stenosis | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Cerebral ischaemia | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Dementia Alzheimer's type | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Epilepsy | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Haemorrhagic stroke | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Lacunar infarction | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Vascular encephalopathy | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Depressed mood | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
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| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 19.0 | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
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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 | medinfo@amgen.com |
| ID | Term |
|---|---|
| C557282 | romosozumab |
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| 65 - 74 years |
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| 75 years and over |
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| Male |
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| Asian |
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| Black or African American |
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| Other |
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| Multiple |
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| Japan |
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| Latin America |
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| North America |
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