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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-004972-74 | EudraCT Number |
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The primary objective of this study is to evaluate the pharmacokinetics (PK) profile following multiple subcutaneous (SC) doses of romosozumab in children and adolescents with Osteogenesis Imperfecta (OI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Romosozumab: 12 - < 18 Years of Age | Experimental | Participants will receive 1 of 3 dose levels of romosozumab. All participants also received calcium and vitamin D. |
|
| Romosozumab: 5 - < 12 Years of Age | Experimental | Participants will receive 1 of 3 dose levels of romosozumab. All participants also received calcium and vitamin D. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Romosozumab | Drug | Participants will receive multiple doses of romosozumab via a SC injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) of Romosozumab | Mean Cmax values following Days 1 and 57 are presented. | Single blood samples were taken on days 1, 8, 15, 29, 57, 64, 71, 85, 113, and 169 (end of study); pre-specified PK analysis took place on Days 1 and 57 |
| Time to Cmax (Tmax) of Romosozumab | Median tmax values following Days 1 and 57 are presented. | Single blood samples were taken on days 1, 8, 15, 29, 57, 64, 71, 85, 113, and 169 (end of study); pre-specified PK analysis took place on Days 1 and 57 |
| Area Under the Serum Concentration Time Curve (AUC) From Time 0 to Day 28 (AUC[0-28]) of Romosozumab | Mean AUC(0-28) values following Days 1 and 57 are presented. | Single blood samples were taken on days 1, 8, 15, 29, 57, 64, 71, and 85; pre-specified PK analysis took place on Days 1 and 57 |
| Accumulation Ratio of Romosozumab | The accumulation ratio was calculated as AUC(0-28) at Day 57/AUC(0-28) at Day 1. Mean accumulation ratio values based on analysis at Days 1 and 57 are presented, as pre-specified. | Single blood samples were taken on days 1, 8, 15, 29, 57, 64, 71, and 85; pre-specified PK analysis took place on Days 1 and 57 |
| Terminal Half-life of Romosozumab | Median terminal half-life values at Day 57 are presented. | Single blood samples were taken on days 1, 8, 15, 29, 57, 64, 71, 85, 113, and 169 (end of study); pre-specified PK analysis took place on Day 57 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | TEAEs were adverse events (AEs) that started on or after first dose of investigational product up to the end of study (up to Day 169). Any clinically significant changes in vital signs, electrocardiogram parameters, physical exam findings, and clinical laboratory parameters were reported as TEAEs. Injection site reactions were events of interest (EOI) for this study. |
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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 |
|---|---|---|---|---|---|---|
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | United States | ||
| Vanderbilt University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38261781 | Derived | Tabaie SA, O'Mara AE, Sheppard ED, Tosi LL. A Comprehensive Review of Bone Health in a Child: From Birth to Adulthood. J Am Acad Orthop Surg. 2024 May 1;32(9):363-372. doi: 10.5435/JAAOS-D-23-00853. Epub 2024 Jan 23. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Ambulatory children (5 to < 12 years of age) and adolescents (12 to < 18 years of age) with osteogenesis imperfecta were enrolled to receive 1 of 3 subcutaneous (SC) dose levels of romosozumab. Specific doses are blinded due to the protection of propriety information.
Participants were enrolled at 15 study centers in Austria, Germany, Greece, Hungary, Italy, Spain, Turkey, and the United States, and participated from 21 January 2021 until 30 March 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Participants received multiple SC doses of romosozumab Dose A (low dose). |
| FG001 | Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 28, 2023 | Oct 18, 2023 |
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| Calcium | Dietary Supplement | All participants will receive daily supplements of elemental calcium. |
|
| Vitamin D | Dietary Supplement | All participants will receive daily supplementation with vitamin D. |
|
| Day 1 to end of study (up to Day 169); median duration on study was 5.55 months |
| Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Facial nerve (cranial nerve VII) function was assessed clinically by facial symmetry inspection at rest, followed by assessment of the symmetry of specific facial movements: raising eyebrows, closing the eyes, blowing out the cheeks, smiling, pursing and closing the lips. Results of the cranial nerve examination were classed as 0 = Normal; 1 = Abnormal not clinically significant; and 2 = Abnormal clinically significant. An increase from baseline indicates an increase in abnormal clinical findings on the cranial nerve VII examination. | Baseline (Day 1), Day 57, Day 85, and Day 169 |
| Number of Participants With Anti-romosozumab Antibodies | Treatment-boosted anti-romosozumab antibody was defined as binding antibody positive at baseline with a >4 x increase in magnitude post-baseline. Transient results were defined as negative results at the participant's last time point tested within the study period. | Blood samples for anti-romosozumab antibodies were taken Day 1, Day 15, Day 29, Day 85, and Day 169 |
| Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Serum concentrations of the bone turnover marker CTX were determined at pre-specified time points. | Blood samples were taken Days 1 (baseline), 8, 15, 29, 57, 64, 71, 85, 113, and 169 |
| Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Serum concentrations of the bone turnover marker P1NP were determined at pre-specified time points. | Blood samples were taken Days 1 (baseline), 8, 15, 29, 57, 64, 71, 85, 113, and 169 |
| Percentage Change From Baseline in Bone Mineral Density (BMD) of the Lumbar Spine | BMD was assessed by dual energy X-ray absorptiometry (DXA) scans of the anteroposterior lumbar spine (L1 through L4) and analyzed by a central imaging laboratory. At least 2 lumbar vertebrae from L1 - L4 must be evaluable by DXA. | DXA scans were during screening (baseline) and at Day 85 and Day 169 |
| Percentage Change From Baseline in Bone Mineral Content (BMC) of the Lumbar Spine | BMC was assessed by DXA scans of the anteroposterior lumbar spine (L1 through L4) and analyzed by a central imaging laboratory. At least 2 lumbar vertebrae from L1 - L4 must be evaluable by DXA. | DXA scans were during screening (baseline) and at Day 85 and Day 169 |
| Percentage Change From Baseline in Lumbar Spine Bone Area | Bone area was assessed by DXA scans of the anteroposterior lumbar spine (L1 through L4) and analyzed by a central imaging laboratory. At least 2 lumbar vertebrae from L1 - L4 must be evaluable by DXA. | DXA scans were during screening (baseline) and at Day 85 and Day 169 |
| Mean Change From Baseline in Lumbar Spine BMD Z-Score | Lumbar spine BMD was assessed by DXA scans. The results were then converted to Z-scores. The Z-score indicated the number of standard deviations away from the reference population and a score of 0 is equal to the mean. Positive changes from baseline indicated an improvement in lumbar spine BMD. | DXA scans were during screening (baseline) and at Day 85 and Day 169 |
| Nashville |
| Tennessee |
| 37212-3157 |
| United States |
| The Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Kepler Universitaetsklinikum GmbH | Linz | 4020 | Austria |
| Uniklinik Köln | Cologne | 50937 | Germany |
| General Children Hospital Panagioti and Aglaias Kyriakou | Athens | 11527 | Greece |
| Semmelweis Egyetem | Budapest | 1094 | Hungary |
| IRCCS Ospedale Pediatrico Bambino Gesu | Roma | 00165 | Italy |
| Hospital de Cruces | Barakaldo | Basque Country | 48903 | Spain |
| Hospital Sant Joan de Deu | Esplugues de Llobregat | Catalonia | 08950 | Spain |
| Hospital Universitario de Getafe | Getafe | Madrid | 28905 | Spain |
| Hospital Universitari i Politecnic La Fe | Valencia | Valencia | 46026 | Spain |
| Gazi Universitesi Tip Fakultesi | Ankara | 06500 | Turkey (Türkiye) |
| Koc Universitesi Hastanesi | Istanbul | 34010 | Turkey (Türkiye) |
| Ege Universitesi Ilac Gelistirme ve Farmakokinetik Arastirma Uygulama Merkezi (ARGEFAR) | Izmir | 35100 | Turkey (Türkiye) |
Participants received multiple SC doses of romosozumab Dose A (low dose).
| FG002 | Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Participants received multiple SC doses of romosozumab Dose B (medium dose). |
| FG003 | Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Participants received multiple SC doses of romosozumab Dose B (medium dose). |
| FG004 | Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Participants received multiple SC doses of romosozumab Dose C (high dose). |
| FG005 | Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Participants received multiple SC doses of romosozumab Dose C (high dose). |
| Received at Least 1 Dose Romosozumab |
|
| Received All Doses of Romosozumab |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Participants received multiple SC doses of romosozumab Dose A (low dose). |
| BG001 | Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Participants received multiple SC doses of romosozumab Dose A (low dose). |
| BG002 | Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Participants received multiple SC doses of romosozumab Dose B (medium dose). |
| BG003 | Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Participants received multiple SC doses of romosozumab Dose B (medium dose). |
| BG004 | Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Participants received multiple SC doses of romosozumab Dose C (high dose). |
| BG005 | Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Participants received multiple SC doses of romosozumab Dose C (high dose). |
| BG006 | 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 |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| 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 | Maximum Observed Serum Concentration (Cmax) of Romosozumab | Mean Cmax values following Days 1 and 57 are presented. | Pharmacokinetic (PK) Analysis Set: all participants for whom at least 1 PK parameter or endpoint could be adequately tested. | Posted | Mean | Standard Deviation | μg/mL | Single blood samples were taken on days 1, 8, 15, 29, 57, 64, 71, 85, 113, and 169 (end of study); pre-specified PK analysis took place on Days 1 and 57 |
|
|
| ||||||||||||||||||||||||||||||||||||||||
| Primary | Time to Cmax (Tmax) of Romosozumab | Median tmax values following Days 1 and 57 are presented. | PK Analysis Set: all participants for whom at least 1 PK parameter or endpoint could be adequately tested. | Posted | Median | Full Range | day | Single blood samples were taken on days 1, 8, 15, 29, 57, 64, 71, 85, 113, and 169 (end of study); pre-specified PK analysis took place on Days 1 and 57 |
| ||||||||||||||||||||||||||||||||||||||||||
| Primary | Area Under the Serum Concentration Time Curve (AUC) From Time 0 to Day 28 (AUC[0-28]) of Romosozumab | Mean AUC(0-28) values following Days 1 and 57 are presented. | PK Analysis Set: all participants for whom at least 1 PK parameter or endpoint could be adequately tested. | Posted | Mean | Standard Deviation | day*μg/mL | Single blood samples were taken on days 1, 8, 15, 29, 57, 64, 71, and 85; pre-specified PK analysis took place on Days 1 and 57 |
| ||||||||||||||||||||||||||||||||||||||||||
| Primary | Accumulation Ratio of Romosozumab | The accumulation ratio was calculated as AUC(0-28) at Day 57/AUC(0-28) at Day 1. Mean accumulation ratio values based on analysis at Days 1 and 57 are presented, as pre-specified. | PK Analysis Set: all participants for whom at least 1 PK parameter or endpoint could be adequately tested. | Posted | Mean | Standard Deviation | ratio | Single blood samples were taken on days 1, 8, 15, 29, 57, 64, 71, and 85; pre-specified PK analysis took place on Days 1 and 57 |
| ||||||||||||||||||||||||||||||||||||||||||
| Primary | Terminal Half-life of Romosozumab | Median terminal half-life values at Day 57 are presented. | PK Analysis Set: all participants for whom at least 1 PK parameter or endpoint could be adequately tested. Data is presented for participants with evaluable data. | Posted | Median | Full Range | day | Single blood samples were taken on days 1, 8, 15, 29, 57, 64, 71, 85, 113, and 169 (end of study); pre-specified PK analysis took place on Day 57 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | TEAEs were adverse events (AEs) that started on or after first dose of investigational product up to the end of study (up to Day 169). Any clinically significant changes in vital signs, electrocardiogram parameters, physical exam findings, and clinical laboratory parameters were reported as TEAEs. Injection site reactions were events of interest (EOI) for this study. | Safety Analysis Set: all participants enrolled in the study who received at least 1 dose of investigational product. | Posted | Count of Participants | Participants | Day 1 to end of study (up to Day 169); median duration on study was 5.55 months |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Facial nerve (cranial nerve VII) function was assessed clinically by facial symmetry inspection at rest, followed by assessment of the symmetry of specific facial movements: raising eyebrows, closing the eyes, blowing out the cheeks, smiling, pursing and closing the lips. Results of the cranial nerve examination were classed as 0 = Normal; 1 = Abnormal not clinically significant; and 2 = Abnormal clinically significant. An increase from baseline indicates an increase in abnormal clinical findings on the cranial nerve VII examination. | Safety Analysis Set: all participants enrolled in the study who received at least 1 dose of investigational product. Participants with data available at each time point are presented. | Posted | Count of Participants | Participants | Baseline (Day 1), Day 57, Day 85, and Day 169 |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Anti-romosozumab Antibodies | Treatment-boosted anti-romosozumab antibody was defined as binding antibody positive at baseline with a >4 x increase in magnitude post-baseline. Transient results were defined as negative results at the participant's last time point tested within the study period. | Safety Analysis Set: all participants enrolled in the study who received at least 1 dose of investigational product. | Posted | Count of Participants | Participants | Blood samples for anti-romosozumab antibodies were taken Day 1, Day 15, Day 29, Day 85, and Day 169 |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Serum concentrations of the bone turnover marker CTX were determined at pre-specified time points. | PD Analysis Set: all participants for whom at least 1 PD parameter or endpoint could be adequately estimated. Participants with data available at each time point are presented. | Posted | Mean | Standard Deviation | percentage change | Blood samples were taken Days 1 (baseline), 8, 15, 29, 57, 64, 71, 85, 113, and 169 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Serum concentrations of the bone turnover marker P1NP were determined at pre-specified time points. | PD Analysis Set: all participants for whom at least 1 PD parameter or endpoint could be adequately estimated. Participants with data available at each time point are presented. | Posted | Mean | Standard Deviation | percentage change | Blood samples were taken Days 1 (baseline), 8, 15, 29, 57, 64, 71, 85, 113, and 169 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage Change From Baseline in Bone Mineral Density (BMD) of the Lumbar Spine | BMD was assessed by dual energy X-ray absorptiometry (DXA) scans of the anteroposterior lumbar spine (L1 through L4) and analyzed by a central imaging laboratory. At least 2 lumbar vertebrae from L1 - L4 must be evaluable by DXA. | The BMD Analysis Set: all participants who have a baseline lumbar spine DXA BMD measurement and at least 1 post-baseline lumbar spine DXA BMD measurement. Participants with data available at each time point are presented. | Posted | Mean | Standard Deviation | percentage change | DXA scans were during screening (baseline) and at Day 85 and Day 169 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage Change From Baseline in Bone Mineral Content (BMC) of the Lumbar Spine | BMC was assessed by DXA scans of the anteroposterior lumbar spine (L1 through L4) and analyzed by a central imaging laboratory. At least 2 lumbar vertebrae from L1 - L4 must be evaluable by DXA. | The BMD Analysis Set: all participants who have a baseline lumbar spine DXA BMD measurement and at least 1 post-baseline lumbar spine DXA BMD measurement. Participants with data available at each time point are presented. | Posted | Mean | Standard Deviation | percentage change | DXA scans were during screening (baseline) and at Day 85 and Day 169 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage Change From Baseline in Lumbar Spine Bone Area | Bone area was assessed by DXA scans of the anteroposterior lumbar spine (L1 through L4) and analyzed by a central imaging laboratory. At least 2 lumbar vertebrae from L1 - L4 must be evaluable by DXA. | The BMD Analysis Set: all participants who have a baseline lumbar spine DXA BMD measurement and at least 1 post-baseline lumbar spine DXA BMD measurement. | Posted | Mean | Standard Deviation | percentage change | DXA scans were during screening (baseline) and at Day 85 and Day 169 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Lumbar Spine BMD Z-Score | Lumbar spine BMD was assessed by DXA scans. The results were then converted to Z-scores. The Z-score indicated the number of standard deviations away from the reference population and a score of 0 is equal to the mean. Positive changes from baseline indicated an improvement in lumbar spine BMD. | The BMD Analysis Set: all participants who have a baseline lumbar spine DXA BMD measurement and at least 1 post-baseline lumbar spine DXA BMD measurement. Participants with data available at each time point are presented. | Posted | Mean | Standard Deviation | Z-score | DXA scans were during screening (baseline) and at Day 85 and Day 169 |
|
All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
Not provided
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 | Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Participants received multiple SC doses of romosozumab Dose A (low dose). | 0 | 4 | 0 | 4 | 1 | 4 |
| EG001 | Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Participants received multiple SC doses of romosozumab Dose A (low dose). | 0 | 4 | 1 | 4 | 0 | 4 |
| EG002 | Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Participants received multiple SC doses of romosozumab Dose B (medium dose). | 0 | 4 | 0 | 4 | 2 | 4 |
| EG003 | Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Participants received multiple SC doses of romosozumab Dose B (medium dose). | 0 | 5 | 1 | 5 | 4 | 5 |
| EG004 | Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Participants received multiple SC doses of romosozumab Dose C (high dose). | 0 | 4 | 0 | 4 | 1 | 4 |
| EG005 | Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Participants received multiple SC doses of romosozumab Dose C (high dose). | 0 | 4 | 0 | 4 | 3 | 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ocular hyperaemia | Eye disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abnormal faeces | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Neck injury | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Muscle contracture | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Muscle swelling | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Catarrh | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Increased upper airway secretion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 26.0 | 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 | medinfo@amgen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 15, 2023 | Oct 18, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D010013 | Osteogenesis Imperfecta |
| ID | Term |
|---|---|
| D010009 | Osteochondrodysplasias |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C557282 | romosozumab |
| D002118 | Calcium |
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
| D001779 | Blood Coagulation Factors |
| D001685 | Biological Factors |
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| White |
|
| Other |
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| Day 57 |
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| OG004 | Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Participants received multiple SC doses of romosozumab Dose C (high dose). |
| OG005 | Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Participants received multiple SC doses of romosozumab Dose C (high dose). |
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| OG004 | Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Participants received multiple SC doses of romosozumab Dose C (high dose). |
| OG005 | Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Participants received multiple SC doses of romosozumab Dose C (high dose). |
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Participants received multiple SC doses of romosozumab Dose B (medium dose).
| OG004 | Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Participants received multiple SC doses of romosozumab Dose C (high dose). |
| OG005 | Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Participants received multiple SC doses of romosozumab Dose C (high dose). |
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| OG004 | Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Participants received multiple SC doses of romosozumab Dose C (high dose). |
| OG005 | Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Participants received multiple SC doses of romosozumab Dose C (high dose). |
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| OG003 |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) |
Participants received multiple SC doses of romosozumab Dose B (medium dose). |
| OG004 | Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Participants received multiple SC doses of romosozumab Dose C (high dose). |
| OG005 | Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Participants received multiple SC doses of romosozumab Dose C (high dose). |
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Participants received multiple SC doses of romosozumab Dose B (medium dose). |
| OG003 | Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Participants received multiple SC doses of romosozumab Dose B (medium dose). |
| OG004 | Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Participants received multiple SC doses of romosozumab Dose C (high dose). |
| OG005 | Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Participants received multiple SC doses of romosozumab Dose C (high dose). |
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Participants received multiple SC doses of romosozumab Dose B (medium dose). |
| OG004 | Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Participants received multiple SC doses of romosozumab Dose C (high dose). |
| OG005 | Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Participants received multiple SC doses of romosozumab Dose C (high dose). |
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Participants received multiple SC doses of romosozumab Dose B (medium dose). |
| OG004 | Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Participants received multiple SC doses of romosozumab Dose C (high dose). |
| OG005 | Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Participants received multiple SC doses of romosozumab Dose C (high dose). |
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Participants received multiple SC doses of romosozumab Dose B (medium dose). |
| OG004 | Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Participants received multiple SC doses of romosozumab Dose C (high dose). |
| OG005 | Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Participants received multiple SC doses of romosozumab Dose C (high dose). |
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| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) |
Participants received multiple SC doses of romosozumab Dose B (medium dose). |
| OG004 | Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Participants received multiple SC doses of romosozumab Dose C (high dose). |
| OG005 | Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Participants received multiple SC doses of romosozumab Dose C (high dose). |
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| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) |
Participants received multiple SC doses of romosozumab Dose B (medium dose). |
| OG004 | Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Participants received multiple SC doses of romosozumab Dose C (high dose). |
| OG005 | Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Participants received multiple SC doses of romosozumab Dose C (high dose). |
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Participants received multiple SC doses of romosozumab Dose B (medium dose). |
| OG004 | Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Participants received multiple SC doses of romosozumab Dose C (high dose). |
| OG005 | Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Participants received multiple SC doses of romosozumab Dose C (high dose). |
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| OG003 |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) |
Participants received multiple SC doses of romosozumab Dose B (medium dose). |
| OG004 | Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Participants received multiple SC doses of romosozumab Dose C (high dose). |
| OG005 | Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Participants received multiple SC doses of romosozumab Dose C (high dose). |
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