Trial · NCT02352753
Multicenter,Single-arm Study to Evaluate Efficacy, Safety, & Pharmacokinetics of Denosumab in Children w/ OI
NCT02352753, Phase 3, Terminated, Amgen; results first posted 2022-12-28
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Multicenter,Single-arm Study to Evaluate Efficacy, Safety, & Pharmacokinetics of Denosumab in Children w/ OI. Trials, record NCT02352753. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02352753
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Multicenter,Single-arm Study to Evaluate Efficacy, Safety, & Pharmacokinetics of Denosumab in Children w/ OI
- NCT number
- NCT02352753
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 153 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Osteogenesis Imperfecta
- Interventions
- Denosumab
- First posted
- 2015-02-02
- Last updated
- 2022-12-28
- Other registries' IDs
- eudract:2014-000184-40
- Results first posted
- 2022-12-28
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) Z-Score at 12 Months | Baseline and 12 months | Lumbar spine BMD was measured by dual-energy X-ray absorptiometry (DXA) adjusted for age, sex, and race/ethnicity. 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. |
| Secondary | Change From Baseline in Lumbar Spine BMD Z-score at 6 Months | Baseline and 6 months | Lumbar spine BMD was measured by DXA adjusted for age, sex, and race/ethnicity. 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. |
| Secondary | Change From Baseline in Proximal Femur BMD Z-score at 6 and 12 Months | Baseline, 6 and 12 months | Proximal femur (total hip and femoral neck) BMD Z-score was measured by DXA adjusted for age, sex, and race/ethnicity. 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. |
| Secondary | Percentage of Participants With at Least 1 X-ray Confirmed Long Bone or New and Worsening Vertebral Fracture | Q6M Dosing Regimen: Last 12 months of treatment (median treatment duration was 730.0 days); Q3M Dosing Regimen: Day 1 up to 12 months | |
| Secondary | Percentage of Participants With at Least 1 X-ray Confirmed New and Worsening Vertebral Fracture | Q6M Dosing Regimen: Last 12 months of treatment (median treatment duration was 730.0 days); Q3M Dosing Regimen: Day 1 up to 12 months | |
| Secondary | Percentage of Participants With at Least 1 X-ray Confirmed New Vertebral Fracture | Q6M Dosing Regimen: Last 12 months of treatment (median treatment duration was 730.0 days); Q3M Dosing Regimen: Day 1 up to 12 months | |
| Secondary | Percentage of Participants Wth at Least 1 X-ray Confirmed Improving Vertebral Fracture | Q3M Dosing Regimen: Baseline up to 12 months | |
| Secondary | Percentage of Participants With at Least 1 Vertebral and Nonvertebral Fracture | Q6M Dosing Regimen: Last 12 months of treatment (median treatment duration was 730.0 days); Q3M Dosing Regimen: Day 1 up to 12 months | |
| Secondary | Change From Baseline in Child Health Questionnaire-Parent Form Physical Summary Score (CHQ-PF-50) at 12 Months | Baseline and 12 months | The CHQ-PF-50 was a 50-item questionnaire completed by the parents or guardians of children between 5 and 18 years of age. The 50 questions measure 14 domains which were summarized as the physical and psychological summary scores. Each summary score was transformed and could range from 0 to 100, with higher score indicating better physical and psychosocial health. A negative change from Baseline indicates decreased well-being. |
| Secondary | Change From Baseline in CHQ-PF-50 Psychological Summary Score at 12 Months | Baseline and 12 months | The CHQ-PF-50 was a 50-item questionnaire completed by the parents or guardians of children between 5 and 18 years of age. The 50 questions measure 14 domains which were summarized as the physical and psychological summary scores. Each summary score was transformed and could range from 0 to 100, with higher score indicating better physical and psychosocial health. A positive change from Baseline indicates improved well-being. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) Z-Score at 12 Months | Baseline and 12 months | DXA Analysis Set included all participants in the FAS with Baseline and Month 12 DXA assessment on the Q3M dosing regimen for lumbar spine as provided by the central imaging vendor. | Z-score | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Lumbar Spine BMD Z-score at 6 Months | Baseline and 6 months | DXA Analysis Set included all participants in the FAS with Baseline and Month 6 DXA assessment on the Q3M dosing regimen for lumbar spine as provided by the central imaging vendor. | Z-score | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Proximal Femur BMD Z-score at 6 and 12 Months | Baseline, 6 and 12 months | DXA Analysis Set included all participants in the FAS with Baseline, Month 6 and Month 12 DXA assessment on the Q3M dosing regimen for lumbar spine as provided by the central imaging vendor. Only participants 5 years of age or older are included. | Z score | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With at Least 1 X-ray Confirmed Long Bone or New and Worsening Vertebral Fracture | Q6M Dosing Regimen: Last 12 months of treatment (median treatment duration was 730.0 days); Q3M Dosing Regimen: Day 1 up to 12 months | Q3M Dosing Regimen Safety Analysis Set: includes all participants in the FAS who received ≥ 1 dose of Q3M dosing regimen. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With at Least 1 X-ray Confirmed New and Worsening Vertebral Fracture | Q6M Dosing Regimen: Last 12 months of treatment (median treatment duration was 730.0 days); Q3M Dosing Regimen: Day 1 up to 12 months | The Vertebral Fracture Analysis Set: includes all participants in the FAS who had a readable non-missing baseline and ≥1 non-missing postbaseline X-ray vertebral evaluation on the Q3M dosing regimen as provided by the central imaging vendor. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With at Least 1 X-ray Confirmed New Vertebral Fracture | Q6M Dosing Regimen: Last 12 months of treatment (median treatment duration was 730.0 days); Q3M Dosing Regimen: Day 1 up to 12 months | The Vertebral Fracture Analysis Set: includes all participants in the FAS who had a readable non-missing baseline and ≥1 non-missing postbaseline X-ray vertebral evaluation on the Q3M dosing regimen as provided by the central imaging vendor. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Wth at Least 1 X-ray Confirmed Improving Vertebral Fracture | Q3M Dosing Regimen: Baseline up to 12 months | The Vertebral Fracture Analysis Set: includes all participants in the FAS who had a readable non-missing baseline and ≥1 non-missing postbaseline X-ray vertebral evaluation on the Q3M dosing regimen as provided by the central imaging vendor. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With at Least 1 Vertebral and Nonvertebral Fracture | Q6M Dosing Regimen: Last 12 months of treatment (median treatment duration was 730.0 days); Q3M Dosing Regimen: Day 1 up to 12 months | Q3M Dosing Regimen Safety Analysis Set: includes all participants in the FAS who received ≥ 1 dose of Q3M dosing regimen. Only participants 5 years of age or older are included. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Child Health Questionnaire-Parent Form Physical Summary Score (CHQ-PF-50) at 12 Months | Baseline and 12 months | Patient Reported Outcomes (PRO) Analysis Set: includes all participants in the FAS who had a baseline and ≥ 1 postbaseline valid PRO response on Q3M dosing regimen for the CHQ-PF-50. The CHQ-PF-50 analysis set only includes participants 5 years of age and older at screening. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in CHQ-PF-50 Psychological Summary Score at 12 Months | Baseline and 12 months | PRO Analysis Set includes all participants in the FAS who had a baseline and ≥ 1 postbaseline valid PRO response on Q3M dosing regimen for the CHQ-PF-50. The CHQ-PF-50 analysis set only includes participants 5 years of age and older at screening | Score on a scale | MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group51
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) Z-Score at 12 Months | Denosumab 3-Month Dosing Regimen | 1.009 | Standard Error 0.119 | Z-score | |
| Change From Baseline in Lumbar Spine BMD Z-score at 6 Months | Denosumab 3-Month Dosing Regimen | 0.925 | Standard Error 0.078 | Z-score | |
| Change From Baseline in Proximal Femur BMD Z-score at 6 and 12 Months | Denosumab 3-Month Dosing Regimen | Total hip BMD Z-score - 6 Months | 0.799 | Standard Error 0.082 | Z score |
| Change From Baseline in Proximal Femur BMD Z-score at 6 and 12 Months | Denosumab 3-Month Dosing Regimen | Total hip BMD Z-score - 12 Months | 0.793 | Standard Error 0.154 | Z score |
| Change From Baseline in Proximal Femur BMD Z-score at 6 and 12 Months | Denosumab 3-Month Dosing Regimen | Femoral neck BMD Z-score - 6 Months | 0.769 | Standard Error 0.067 | Z score |
| Change From Baseline in Proximal Femur BMD Z-score at 6 and 12 Months | Denosumab 3-Month Dosing Regimen | Femoral neck BMD Z-score - 12 Months | 0.689 | Standard Error 0.131 | Z score |
| Percentage of Participants With at Least 1 X-ray Confirmed Long Bone or New and Worsening Vertebral Fracture | Denosumab 6-Month Dosing Regimen | 28.3 | Percentage of participants | ||
| Percentage of Participants With at Least 1 X-ray Confirmed Long Bone or New and Worsening Vertebral Fracture | Denosumab 3-Month Dosing Regimen | 26.7 | Percentage of participants | ||
| Percentage of Participants With at Least 1 X-ray Confirmed New and Worsening Vertebral Fracture | Denosumab 6-Month Dosing Regimen | 12.8 | Percentage of participants | ||
| Percentage of Participants With at Least 1 X-ray Confirmed New and Worsening Vertebral Fracture | Denosumab 3-Month Dosing Regimen | 8.5 | Percentage of participants |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| 6-Month Dosing Period | STARTED | Denosumab | 153 | |
| 6-Month Dosing Period | Received Investigational Product | Denosumab | 153 | |
| 6-Month Dosing Period | COMPLETED | Denosumab | 55 | |
| 6-Month Dosing Period | NOT COMPLETED | Denosumab | 98 | |
| 3-Month Dosing Period | STARTED | Denosumab | 60 | |
| 3-Month Dosing Period | Received Investigational Product | Denosumab | 60 | |
| 3-Month Dosing Period | COMPLETED | Denosumab | 40 | |
| 3-Month Dosing Period | NOT COMPLETED | Denosumab | 20 |
Source ClinicalTrials.gov
Adverse events156
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 | Gastrointestinal disorders | Denosumab 6-Month Dosing Regimen | 13 | 153 | |
| other | Abdominal pain | Gastrointestinal disorders | Denosumab 3-Month Dosing Regimen | 0 | 60 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Denosumab 6-Month Dosing Regimen | 9 | 153 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Denosumab 3-Month Dosing Regimen | 2 | 60 | |
| other | Dental caries | Gastrointestinal disorders | Denosumab 6-Month Dosing Regimen | 9 | 153 | |
| other | Dental caries | Gastrointestinal disorders | Denosumab 3-Month Dosing Regimen | 1 | 60 | |
| other | Vomiting | Gastrointestinal disorders | Denosumab 6-Month Dosing Regimen | 13 | 153 | |
| other | Vomiting | Gastrointestinal disorders | Denosumab 3-Month Dosing Regimen | 2 | 60 | |
| other | Pain | General disorders | Denosumab 6-Month Dosing Regimen | 12 | 153 | |
| other | Pain | General disorders | Denosumab 3-Month Dosing Regimen | 2 | 60 |
1 to 10 of 156Source ClinicalTrials.gov
See all 156 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Denosumab 6-Month Dosing Regimen | 0 | 153 |
| Total, all-cause mortality | Denosumab 3-Month Dosing Regimen | 0 | 60 |
| Total, other adverse events | Denosumab 6-Month Dosing Regimen | 141 | 153 |
| Total, other adverse events | Denosumab 3-Month Dosing Regimen | 38 | 60 |
| Total, serious adverse events | Denosumab 6-Month Dosing Regimen | 52 | 153 |
| Total, serious adverse events | Denosumab 3-Month Dosing Regimen | 12 | 60 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Denosumab 6-Month Dosing Regimen vs Denosumab 3-Month Dosing Regimen: deaths from any cause | Trial comparisons |
| Denosumab 6-Month Dosing Regimen vs Denosumab 3-Month Dosing Regimen: serious adverse events | Trial comparisons |
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/NCT02352753
GET https://conductscience.org/api/trials/v1/NCT02352753/results?page=2