Trial · NCT03638128
Open-label Extension of Study 20130173 of Denosumab in Children and Young Adults With Osteogenesis Imperfecta
NCT03638128, Phase 3, Terminated, Amgen; results first posted 2022-12-20
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Open-label Extension of Study 20130173 of Denosumab in Children and Young Adults With Osteogenesis Imperfecta. Trials, record NCT03638128. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03638128
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-label Extension of Study 20130173 of Denosumab in Children and Young Adults With Osteogenesis Imperfecta
- NCT number
- NCT03638128
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 75 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Osteogenesis Imperfecta (OI)
- Interventions
- Denosumab, Alternative osteoporosis medications
- First posted
- 2018-08-20
- Last updated
- 2022-12-20
- Other registries' IDs
- eudract:2018-000550-21
- Results first posted
- 2022-12-20
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest | 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. | A Serious Adverse Event is defined as any untoward medical occurrence that met at least 1 of the following serious criteria: * Resulted in death (fatal) * Immediately life-threatening * Required in-patient hospitalization or prolongation of existing hospitalization * Resulted in persistent or significant disability/incapacity * Was a congenital anomaly/birth defect * Other medically important serious event that may have jeopardized the participant or require medical or surgical intervention to prevent 1 of the outcomes listed above. Adverse events of special interest included hypocalcemia, hypersensitivity, bacterial cellulitis, osteonecrosis of the jaw (ONJ), hypercalcemia, and typical osteogenesis imperfecta (OI) femur fractures. |
| Primary | Number of Participants With Anti-denosumab 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 | 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. |
| Primary | Number of Participants With Clinical Laboratory Toxicities Grade ≥ 3 | 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 | 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. |
| Primary | Number of Participants With Clinically Significant Vital Sign Findings | 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 | 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. |
| Primary | Number of Participants With Metaphyseal Index Z-score Above Age-appropriate Normal Range | Baseline, month 12 and month 24 | 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. |
| Primary | Number of Participants With Abnormal Molar Eruption of the First or Second Molar Based on Radiological Findings | Baseline, month 12, and month 24 | 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: * A participant was age 7 to 12 years and appeared to have an unerupted upper or lower first molar (ie, not all 4 first molars were visible/detectable). * A participant was age 13 years or older and appeared to have an unerupted upper or lower (first or) second molar (ie, not all 4 first molars and all 4 second molars were visible/detectable). 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. |
| Primary | Percent Change From Baseline in Mandibular Shaping Parameters | Baseline and month 12 and month 24 | 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). |
| Secondary | Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) Z-score | Baseline and months 6, 12, and 24 | 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. |
| Secondary | Change From Baseline in Total Hip BMD Z-score | Baseline, months 6, 12, and 24 | 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. |
| Secondary | Change From Baseline in Femoral Neck BMD Z-score | Baseline and months 6, 12, and 24 | 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. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest | 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. | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Anti-denosumab 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 | Safety analysis set participants who received at least one dose of denosumab in this study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinical Laboratory Toxicities Grade ≥ 3 | 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 | Safety analysis set | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Vital Sign Findings | 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 | Safety analysis set | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Metaphyseal Index Z-score Above Age-appropriate Normal Range | Baseline, month 12 and month 24 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormal Molar Eruption of the First or Second Molar Based on Radiological Findings | Baseline, month 12, and month 24 | Safety analysis set participants with radiologic assessments at each time point. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Percent Change From Baseline in Mandibular Shaping Parameters | Baseline and month 12 and month 24 | Safety analysis set participants with radiologic assessments at baseline and each time point | percent change | MEAN |
| SECONDARY | Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) Z-score | Baseline and months 6, 12, and 24 | 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. | Z-score | MEAN |
| SECONDARY | Change From Baseline in Total Hip BMD Z-score | Baseline, months 6, 12, and 24 | 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. | Z-score | MEAN |
| SECONDARY | Change From Baseline in Femoral Neck BMD Z-score | Baseline and months 6, 12, and 24 | 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. | Z-score | MEAN |
Source ClinicalTrials.gov
Results by group83
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest | Alternative Medications / Observational | Any adverse event | 18 | Participants | |
| Number of Participants With Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest | Denosumab 1 mg/kg Q6M | Any adverse event | 22 | Participants | |
| Number of Participants With Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest | Denosumab 1 mg/kg Q3M | Any adverse event | 19 | Participants | |
| Number of Participants With Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest | Alternative Medications / Observational | Serious adverse events | 6 | Participants | |
| Number of Participants With Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest | Denosumab 1 mg/kg Q6M | Serious adverse events | 5 | Participants | |
| Number of Participants With Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest | Denosumab 1 mg/kg Q3M | Serious adverse events | 6 | Participants | |
| Number of Participants With Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest | Alternative Medications / Observational | Adverse events of special interest | 5 | Participants | |
| Number of Participants With Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest | Denosumab 1 mg/kg Q6M | Adverse events of special interest | 5 | Participants | |
| Number of Participants With Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest | Denosumab 1 mg/kg Q3M | Adverse events of special interest | 9 | Participants | |
| Number of Participants With Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest | Alternative Medications / Observational | Hypocalcemia | 0 | Participants |
1 to 10 of 83Source ClinicalTrials.gov
See all 83 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Alternative Medications / Observational | 21 | |
| Overall Study | STARTED | Denosumab 1 mg/kg Q6M | 27 | |
| Overall Study | STARTED | Denosumab 1 mg/kg Q3M | 27 | |
| Overall Study | COMPLETED | Alternative Medications / Observational | 5 | |
| Overall Study | COMPLETED | Denosumab 1 mg/kg Q6M | 8 | |
| Overall Study | COMPLETED | Denosumab 1 mg/kg Q3M | 1 | |
| Overall Study | NOT COMPLETED | Alternative Medications / Observational | 16 | |
| Overall Study | NOT COMPLETED | Denosumab 1 mg/kg Q6M | 19 | |
| Overall Study | NOT COMPLETED | Denosumab 1 mg/kg Q3M | 26 |
Source ClinicalTrials.gov
Adverse events81
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain upper | Gastrointestinal disorders | Alternative Medications / Observational | 2 | 21 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Denosumab 1 mg/kg Q6M | 0 | 27 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Denosumab 1 mg/kg Q3M | 0 | 27 | |
| other | Pyrexia | General disorders | Alternative Medications / Observational | 0 | 21 | |
| other | Pyrexia | General disorders | Denosumab 1 mg/kg Q6M | 0 | 27 | |
| other | Pyrexia | General disorders | Denosumab 1 mg/kg Q3M | 2 | 27 | |
| other | COVID-19 | Infections and infestations | Alternative Medications / Observational | 1 | 21 | |
| other | COVID-19 | Infections and infestations | Denosumab 1 mg/kg Q6M | 1 | 27 | |
| other | COVID-19 | Infections and infestations | Denosumab 1 mg/kg Q3M | 2 | 27 | |
| other | Ankle fracture | Injury, poisoning and procedural complications | Alternative Medications / Observational | 0 | 21 |
1 to 10 of 81Source ClinicalTrials.gov
See all 81 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Alternative Medications / Observational | 0 | 21 |
| Total, all-cause mortality | Denosumab 1 mg/kg Q6M | 0 | 27 |
| Total, all-cause mortality | Denosumab 1 mg/kg Q3M | 0 | 27 |
| Total, other adverse events | Alternative Medications / Observational | 15 | 21 |
| Total, other adverse events | Denosumab 1 mg/kg Q6M | 21 | 27 |
| Total, other adverse events | Denosumab 1 mg/kg Q3M | 13 | 27 |
| Total, serious adverse events | Alternative Medications / Observational | 6 | 21 |
| Total, serious adverse events | Denosumab 1 mg/kg Q6M | 5 | 27 |
| Total, serious adverse events | Denosumab 1 mg/kg Q3M | 6 | 27 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03638128
GET https://conductscience.org/api/trials/v1/NCT03638128/results?page=2