Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2018-000550-21 | EudraCT Number |
Not provided
Not provided
Not provided
The study was stopped earlier than planned due to safety concerns about high levels of calcium in the blood of the participants
Not provided
Not provided
Not provided
Not provided
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To evaluate long-term safety of denosumab in children/young adults with pediatric osteogenesis imperfecta (OI) who completed the prior study 20130173 (NCT02352753).
All participants who completed the prior denosumab study 20130173 (NCT02352753) were offered participation in this study (20170534). Participants could continue to receive denosumab once every 3 months (Q3M) or could receive denosumab once every 6 months (Q6M) or off-treatment observation only at the investigator's discretion. The study design allowed subjects to discontinue denosumab, resume denosumab, initiate alternative osteoporosis medication, discontinue alternative osteoporosis medication, or receive no treatment (observation only) at any time. Therefore results of this study were analyzed according to both baseline treatment and subsequent treatment trajectories.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alternative Medications / Observational | Other | Participants who received non-denosumab alternative therapy during the study or who were not receiving any medication at baseline. Alternative osteoporosis medication(s) were determined at the investigator's discretion and per standard of care and local guidelines. |
|
| Denosumab 1 mg/kg Q6M | Experimental | Participants who received at least 1 dose of 1 mg/kg denosumab administered once every 6 months (Q6M) by subcutaneous injection, but no Q3M denosumab during this study. |
|
| Denosumab 1 mg/kg Q3M | Experimental | Participants who received at least one dose of 1 mg/kg denosumab administered once every 3 months (Q3M) by subcutaneous injection during this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Denosumab | Drug | Solution for injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest | A Serious Adverse Event is defined as any untoward medical occurrence that met at least 1 of the following serious criteria:
Adverse events of special interest included hypocalcemia, hypersensitivity, bacterial cellulitis, osteonecrosis of the jaw (ONJ), hypercalcemia, and typical osteogenesis imperfecta (OI) femur fractures. | From enrollment to end of study, including 24 weeks after last dose of denosumab for participants who received denosumab; the maximum time on study was 24 months. |
| Number of Participants With Anti-denosumab Antibodies | Blood samples were collected (from denosumab treated participants only) for the measurement of anti-denosumab binding antibodies. Samples positive for anti-denosumab binding antibodies were further tested for neutralizing antibodies. | From enrollment to end of study, including 24 weeks after last dose of denosumab for participants who received denosumab; the maximum time on study was 24 months |
| Number of Participants With Clinical Laboratory Toxicities Grade ≥ 3 | Laboratory abnormalities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0. The grades refer to the severity of the finding: Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe or medically significant; Grade 4 = Life-threatening consequences, urgent intervention indicated. | From enrollment to end of study, including 24 weeks after last dose of denosumab for participants who received denosumab; the maximum time on study was 24 months |
| Number of Participants With Clinically Significant Vital Sign Findings |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) Z-score | Bone densitometry assessments of the lumbar spine were performed using dual X-ray absorptiometry (DXA). The Z-score indicates the number of standard deviations away from the mean of an average person of the same age, sex, race, and weight. A Z-score of 0 is equal to the mean of the matched population, negative Z-scores indicate a BMD lower than the mean of the matched population, and positive Z-scores indicate a higher BMD than that of the matched population. A positive change from baseline indicates an improvement in lumbar spine BMD. |
Not provided
Inclusion Criteria:
Subject has provided informed consent/assent prior to initiation of any Study 20170534 specific activities/procedures. Subject's legally acceptable representative has provided informed consent when the subject is legally too young to provide informed consent and the subject has provided written assent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated.
Subject is currently/was enrolled in Study 20130173 and
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Childrens Hospital of Los Angeles | Los Angeles | California | 90027 | United States | ||
| Indiana University - Riley Hospital for Children |
Not provided
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
Not provided
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 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. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. 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.
Participants who rolled over into Study 20170534 could continue to receive denosumab Q3M or could receive alternative osteoporosis medication, including commercial denosumab every 6 months (Q6M), or off-treatment observation only at the investigator's discretion. At any time during the study, participants could discontinue, resume, or initiate 1 of the above treatments based on the medical judgment of the investigator and per local standard of care.
This study was conducted at 22 centers in North America, Europe, and Australia from July 2018 to March 2022.
The study was an open-label extension of study 20130173 (NCT02352753). Participants who completed the end of study visit or who withdrew consent or assent to transition to every 3 months (Q3M) dosing regimen in Study 20130173 were offered participation in this study.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Alternative Medications / Observational | Participants who received non-denosumab alternative therapy during the study or who were not receiving any medication at baseline. Alternative osteoporosis medication(s) were determined at the investigator's discretion and per standard of care and local guidelines. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 2, 2022 | Oct 24, 2022 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Alternative osteoporosis medications | Drug | Alternative osteoporosis medication/s at the discretion of the investigator. |
|
Vital sign measurements included systolic and diastolic blood pressure, heart rate, respiratory rate, and temperature. The investigator assessed vital sign results and determined whether any abnormal changes represented a clinically significant change from the participant's baseline values. |
| From enrollment to end of study, including 24 weeks after last dose of denosumab for participants who received denosumab; the maximum time on study was 24 months |
| Number of Participants With Metaphyseal Index Z-score Above Age-appropriate Normal Range | Anteroposterior radiographs of both knees (unless prohibited by the presence of hardware such as implants) were used to calculate the metaphyseal index Z-score of each knee in participants with open growth plates; the knee selected for assessment during the study was the knee with the higher Z-score at baseline. The metaphyseal index (MI) was calculated by the central imaging vendor as the ratio of femoral width over distal femoral growth plate width, and the Z-score for each participant, relative to the participant's age as: MI Z-score = (participant value - mean)/SD, where mean and standard deviation (SD) are the corresponding values based on a reference population for the participant's age group at the time of the assessment. Metaphyseal index Z-score above age-appropriate normal range is defined as a MI Z-score > 2. | Baseline, month 12 and month 24 |
| Number of Participants With Abnormal Molar Eruption of the First or Second Molar Based on Radiological Findings | Participants underwent a visual inspection under natural light for the presence of the first and second molars. Participants were referred to a dentist to perform radiographic assessment of the unerupted molar(s) if:
Abnormal molar eruptions includes the number of participants 7 to 12 years of age with 1st unerupted or partially erupted molars and participants 13 years of age or older with 2nd unerupted or partially erupted molars. | Baseline, month 12, and month 24 |
| Percent Change From Baseline in Mandibular Shaping Parameters | Lateral cephalogram was performed to enable assessment of mandibular shaping. The lateral cephalogram is a profile X-ray of the skull and soft tissues and is used to assess the relation of the teeth in the jaws, the relation of the jaws to the skull, and the relation of the soft tissues to the teeth and jaws. The following anatomical angles and dimensions were measured to evaluate the correct proportions of the mandible and its position relative to the skull/maxilla: Gonial angle; Sella-Nasion-A Point Angle (SNA angle); Sella-Nasion-B Point Angle (SNB angle); and A Point - Nasion-B Point Angle (ANB Angle). | Baseline and month 12 and month 24 |
| Baseline and months 6, 12, and 24 |
| Change From Baseline in Total Hip BMD Z-score | Bone densitometry assessments of the hip were performed using dual X-ray absorptiometry (DXA). The Z-score indicates the number of standard deviations away from the mean of an average person of the same age, sex, race, and weight. A Z-score of 0 is equal to the mean of the matched population, negative Z-scores indicate a BMD lower than the mean of the matched population, and positive Z-scores indicate a higher BMD than that of the matched population. A positive change from baseline indicates an improvement in total hip BMD. | Baseline, months 6, 12, and 24 |
| Change From Baseline in Femoral Neck BMD Z-score | Bone densitometry assessments of the femoral neck were performed using dual X-ray absorptiometry (DXA). The Z-score indicates the number of standard deviations away from the mean of an average person of the same age, sex, race, and weight. A Z-score of 0 is equal to the mean of the matched population, negative Z-scores indicate a BMD lower than the mean of the matched population, and positive Z-scores indicate a higher BMD than that of the matched population. A positive change from baseline indicates an improvement in femoral neck BMD. | Baseline and months 6, 12, and 24 |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| The Childrens Hospital at Westmead | Westmead | New South Wales | 2145 | Australia |
| Perth Childrens Hospital | Nedlands | Western Australia | 6909 | Australia |
| Universite Catholique de Louvain Cliniques Universitaires Saint Luc | Brussels | 1200 | Belgium |
| Childrens Hospital of Eastern Ontario | Ottawa | Ontario | K1H 8L1 | Canada |
| The Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| Shriners Hospital for Children | Montreal | Quebec | H4A 0A9 | Canada |
| Fakultni nemocnice Plzen | Pilsen | 305 99 | Czechia |
| Thomayerova nemocnice | Prague | 140 59 | Czechia |
| Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin | Bordeaux | 33076 | France |
| Hopital Necker Enfants Malades | Paris | 75743 | France |
| Uniklinik Köln | Cologne | 50931 | Germany |
| Semmelweis Egyetem | Budapest | 1094 | Hungary |
| Azienda Ospedaliera Policlinico Umberto I | Roma | 00161 | Italy |
| SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi | Lodz | 91-738 | Poland |
| Hospital Sant Joan de Deu | Esplugues de Llobregat | Catalonia | 08950 | Spain |
| Hospital Universitari i Politecnic La Fe | Valencia | Valencia | 46026 | Spain |
| Birmingham Childrens Hospital | Birmingham | B4 6NH | United Kingdom |
| Bristol Royal Hospital for Children | Bristol | BS2 8AE | United Kingdom |
| Royal Hospital for Children | Glasgow | G51 4TF | United Kingdom |
| Sheffield Childrens Hospital | Sheffield | S10 2TH | United Kingdom |
| Denosumab 1 mg/kg Q6M |
Participants who received at least 1 dose of 1 mg/kg denosumab administered once every 6 months (Q6M) administered by subcutaneous injection, but no Q3M denosumab during this study. |
| FG002 | Denosumab 1 mg/kg Q3M | Participants who received at least one dose of 1 mg/kg denosumab administered once every 3 months (Q3M) by subcutaneous injection during this study. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Alternative Medications / Observational | Participants who received non-denosumab alternative therapy during the study or who were not receiving any medication at baseline. Alternative osteoporosis medication(s) were determined at the investigator's discretion and per standard of care and local guidelines. |
| BG001 | Denosumab 1 mg/kg Q6M | Participants who received at least 1 dose of 1 mg/kg denosumab administered once every 6 months (Q6M) administered by subcutaneous injection, but no Q3M denosumab during this study. |
| BG002 | Denosumab 1 mg/kg Q3M | Participants who received at least one dose of 1 mg/kg denosumab administered once every 3 months (Q3M) by subcutaneous injection during this study. |
| BG003 | 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 | Number of Participants With Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest | A Serious Adverse Event is defined as any untoward medical occurrence that met at least 1 of the following serious criteria:
Adverse events of special interest included hypocalcemia, hypersensitivity, bacterial cellulitis, osteonecrosis of the jaw (ONJ), hypercalcemia, and typical osteogenesis imperfecta (OI) femur fractures. | The safety analysis set includes all enrolled participants who provided informed consent/assent, had a non-missing enrollment date, and received at least 1 dose of denosumab during Study 20130173. | Posted | Count of Participants | Participants | From enrollment to end of study, including 24 weeks after last dose of denosumab for participants who received denosumab; the maximum time on study was 24 months. |
|
|
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Anti-denosumab Antibodies | Blood samples were collected (from denosumab treated participants only) for the measurement of anti-denosumab binding antibodies. Samples positive for anti-denosumab binding antibodies were further tested for neutralizing antibodies. | Safety analysis set participants who received at least one dose of denosumab in this study. | Posted | Count of Participants | Participants | From enrollment to end of study, including 24 weeks after last dose of denosumab for participants who received denosumab; the maximum time on study was 24 months |
|
| |||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Clinical Laboratory Toxicities Grade ≥ 3 | Laboratory abnormalities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0. The grades refer to the severity of the finding: Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe or medically significant; Grade 4 = Life-threatening consequences, urgent intervention indicated. | Safety analysis set | Posted | Count of Participants | Participants | From enrollment to end of study, including 24 weeks after last dose of denosumab for participants who received denosumab; the maximum time on study was 24 months |
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Clinically Significant Vital Sign Findings | Vital sign measurements included systolic and diastolic blood pressure, heart rate, respiratory rate, and temperature. The investigator assessed vital sign results and determined whether any abnormal changes represented a clinically significant change from the participant's baseline values. | Safety analysis set | Posted | Count of Participants | Participants | From enrollment to end of study, including 24 weeks after last dose of denosumab for participants who received denosumab; the maximum time on study was 24 months |
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Metaphyseal Index Z-score Above Age-appropriate Normal Range | Anteroposterior radiographs of both knees (unless prohibited by the presence of hardware such as implants) were used to calculate the metaphyseal index Z-score of each knee in participants with open growth plates; the knee selected for assessment during the study was the knee with the higher Z-score at baseline. The metaphyseal index (MI) was calculated by the central imaging vendor as the ratio of femoral width over distal femoral growth plate width, and the Z-score for each participant, relative to the participant's age as: MI Z-score = (participant value - mean)/SD, where mean and standard deviation (SD) are the corresponding values based on a reference population for the participant's age group at the time of the assessment. Metaphyseal index Z-score above age-appropriate normal range is defined as a MI Z-score > 2. | The metaphyseal analysis set includes participants with open growth plates and no hardware preventing accurate calculation of MI at baseline, and X-ray of the knee at baseline and postbaseline. | Posted | Count of Participants | Participants | Baseline, month 12 and month 24 |
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Abnormal Molar Eruption of the First or Second Molar Based on Radiological Findings | Participants underwent a visual inspection under natural light for the presence of the first and second molars. Participants were referred to a dentist to perform radiographic assessment of the unerupted molar(s) if:
Abnormal molar eruptions includes the number of participants 7 to 12 years of age with 1st unerupted or partially erupted molars and participants 13 years of age or older with 2nd unerupted or partially erupted molars. | Safety analysis set participants with radiologic assessments at each time point. | Posted | Count of Participants | Participants | Baseline, month 12, and month 24 |
| ||||||||||||||||||||||||||||||||||||
| Primary | Percent Change From Baseline in Mandibular Shaping Parameters | Lateral cephalogram was performed to enable assessment of mandibular shaping. The lateral cephalogram is a profile X-ray of the skull and soft tissues and is used to assess the relation of the teeth in the jaws, the relation of the jaws to the skull, and the relation of the soft tissues to the teeth and jaws. The following anatomical angles and dimensions were measured to evaluate the correct proportions of the mandible and its position relative to the skull/maxilla: Gonial angle; Sella-Nasion-A Point Angle (SNA angle); Sella-Nasion-B Point Angle (SNB angle); and A Point - Nasion-B Point Angle (ANB Angle). | Safety analysis set participants with radiologic assessments at baseline and each time point | Posted | Mean | Standard Deviation | percent change | Baseline and month 12 and month 24 |
| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) Z-score | Bone densitometry assessments of the lumbar spine were performed using dual X-ray absorptiometry (DXA). The Z-score indicates the number of standard deviations away from the mean of an average person of the same age, sex, race, and weight. A Z-score of 0 is equal to the mean of the matched population, negative Z-scores indicate a BMD lower than the mean of the matched population, and positive Z-scores indicate a higher BMD than that of the matched population. A positive change from baseline indicates an improvement in lumbar spine BMD. | The DXA analysis set includes all participants with baseline and ≥ 1 postbaseline valid DXA assessments for lumbar spine as provided by the central imaging vendor. BMD endpoints were pre-specified to be analyzed for combined treatment groups. | Posted | Mean | Standard Deviation | Z-score | Baseline and months 6, 12, and 24 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Total Hip BMD Z-score | Bone densitometry assessments of the hip were performed using dual X-ray absorptiometry (DXA). The Z-score indicates the number of standard deviations away from the mean of an average person of the same age, sex, race, and weight. A Z-score of 0 is equal to the mean of the matched population, negative Z-scores indicate a BMD lower than the mean of the matched population, and positive Z-scores indicate a higher BMD than that of the matched population. A positive change from baseline indicates an improvement in total hip BMD. | The DXA analysis set includes all participants with baseline and ≥ 1 postbaseline valid DXA assessments for the total hip as provided by the central imaging vendor. BMD endpoints were pre-specified to be analyzed for combined treatment groups. | Posted | Mean | Standard Deviation | Z-score | Baseline, months 6, 12, and 24 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Femoral Neck BMD Z-score | Bone densitometry assessments of the femoral neck were performed using dual X-ray absorptiometry (DXA). The Z-score indicates the number of standard deviations away from the mean of an average person of the same age, sex, race, and weight. A Z-score of 0 is equal to the mean of the matched population, negative Z-scores indicate a BMD lower than the mean of the matched population, and positive Z-scores indicate a higher BMD than that of the matched population. A positive change from baseline indicates an improvement in femoral neck BMD. | The DXA analysis set includes all participants with baseline and ≥ 1 postbaseline valid DXA assessments for the femoral neck as provided by the central imaging vendor. BMD endpoints were pre-specified to be analyzed for combined treatment groups. | Posted | Mean | Standard Deviation | Z-score | Baseline and months 6, 12, and 24 |
|
|
From enrollment to end of study, including 24 weeks after last dose of denosumab for participants who received denosumab; the maximum time on study was 24 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 | Alternative Medications / Observational | Participants who received non-denosumab alternative therapy during the study or who were not receiving any medication at baseline. Alternative osteoporosis medication(s) were determined at the investigator's discretion and per standard of care and local guidelines. | 0 | 21 | 6 | 21 | 15 | 21 |
| EG001 | Denosumab 1 mg/kg Q6M | Participants who received at least 1 dose of 1 mg/kg denosumab administered once every 6 months (Q6M) administered by subcutaneous injection, but no Q3M denosumab during this study. | 0 | 27 | 5 | 27 | 21 | 27 |
| EG002 | Denosumab 1 mg/kg Q3M | Participants who received at least one dose of 1 mg/kg denosumab administered once every 3 months (Q3M) by subcutaneous injection during this study. | 0 | 27 | 6 | 27 | 13 | 27 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Surgical failure | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypercalciuria | Renal and urinary disorders | MedDRA 25.0 | 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 27, 2022 | Oct 24, 2022 | SAP_001.pdf |
Not provided
| 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 |
|---|---|
| D000069448 | Denosumab |
| ID | Term |
|---|---|
| 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 |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African American |
|
| White |
|
| Other |
|
| Multiple |
|
|
| Adverse events of special interest |
|
| Hypocalcemia |
|
| Hypercalcemia |
|
| Hypersensitivity |
|
| Bacterial cellulitis (skin infection) |
|
| Typical osteogenesis imperfecta femur fractures |
|
| Positively adjudicated osteonecrosis of the jaw |
|
|
Participants who received at least one dose of 1 mg/kg denosumab administered once every 3 months (Q3M) by subcutaneous injection during this study.
|
|
|
|
Participants who received at least 1 dose of 1 mg/kg denosumab administered once every 6 months (Q6M) administered by subcutaneous injection, but no Q3M denosumab during this study. |
| OG002 | Denosumab 1 mg/kg Q3M | Participants who received at least one dose of 1 mg/kg denosumab administered once every 3 months (Q3M) by subcutaneous injection during this study. |
|
|
| OG002 | Denosumab 1 mg/kg Q3M | Participants who received at least one dose of 1 mg/kg denosumab administered once every 3 months (Q3M) by subcutaneous injection during this study. |
|
|
| OG002 | Denosumab 1 mg/kg Q3M | Participants who received at least one dose of 1 mg/kg denosumab administered once every 3 months (Q3M) by subcutaneous injection during this study. |
|
|
|
|
|