Osteogenesis Imperfecta
Conditions
Brief summary
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).
Interventions
DRUGRomosozumab
Participants will receive multiple doses of romosozumab via a SC injection.
DIETARY_SUPPLEMENTCalcium
All participants will receive daily supplements of elemental calcium.
DIETARY_SUPPLEMENTVitamin D
All participants will receive daily supplementation with vitamin D.
Sponsors
Amgen
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Ambulatory male or female children 5 to less than 18 years of age upon entry into screening * Clinical diagnosis of OI defined as a clinical history consistent with type I-IV OI as determined by presence of expected phenotype and lack of additional features unrelated to type I-IV OI
Exclusion criteria
* History of an electrophoresis pattern inconsistent with type I to type IV OI * History of known mutation in a gene other than collagen type I alpha 1/collagen type I alpha 2 (COL1AI/COL1A2) causing OI or other metabolic bone disease * History of other bone diseases that affect bone metabolism (eg, osteoporosis pseudoglioma syndrome, idiopathic juvenile osteoporosis, osteopetrosis, hypophosphatasia) * History of Kawasaki disease, rheumatic myocarditis, ischemic cardiomyopathy, inherited cardiomyopathies, nephrotic syndrome, familial hypercholesterolemia, stroke, or any thromboembolic disorder * Unhealed fracture as defined by orthopedic opinion * Symptoms associated with skull abnormalities such as basilar invagination, basilar impression or Chiari malformation * Prior treatment with anti-sclerostin antibody, fluoride or strontium, parathyroid hormone (PTH) within 12 months prior to screening, denosumab within 12 months or zoledronic acid within 6 months prior to first dose * Less than 2 evaluable vertebrae by DXA evaluation in the region of interest, L1 - L4, as confirmed by the central imaging laboratory. * Clinically significant valvular heart disease based on local echocardiogram (ECHO) results.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) of Romosozumab | 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 | Mean Cmax values following Days 1 and 57 are presented. |
| Time to Cmax (Tmax) of Romosozumab | 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 | Median tmax values following Days 1 and 57 are presented. |
| Area Under the Serum Concentration Time Curve (AUC) From Time 0 to Day 28 (AUC[0-28]) of Romosozumab | 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 | Mean AUC(0-28) values following Days 1 and 57 are presented. |
| Accumulation Ratio of Romosozumab | 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 | 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. |
| Terminal Half-life of Romosozumab | 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 | Median terminal half-life values at Day 57 are presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change From Baseline in Bone Mineral Density (BMD) of the Lumbar Spine | DXA scans were during screening (baseline) and at Day 85 and Day 169 | 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. |
| Percentage Change From Baseline in Bone Mineral Content (BMC) of the Lumbar Spine | DXA scans were during screening (baseline) and at Day 85 and Day 169 | 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. |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Day 1 to end of study (up to Day 169); median duration on study was 5.55 months | 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. |
| Mean Change From Baseline in Lumbar Spine BMD Z-Score | DXA scans were during screening (baseline) and at Day 85 and Day 169 | 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. |
| Percentage Change From Baseline in Lumbar Spine Bone Area | DXA scans were during screening (baseline) and at Day 85 and Day 169 | 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. |
| Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Baseline (Day 1), 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. |
| Number of Participants With Anti-romosozumab Antibodies | Blood samples for anti-romosozumab antibodies were taken Day 1, Day 15, Day 29, Day 85, and Day 169 | 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. |
| Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Blood samples were taken Days 1 (baseline), 8, 15, 29, 57, 64, 71, 85, 113, and 169 | Serum concentrations of the bone turnover marker CTX were determined at pre-specified time points. |
| Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Blood samples were taken Days 1 (baseline), 8, 15, 29, 57, 64, 71, 85, 113, and 169 | Serum concentrations of the bone turnover marker P1NP were determined at pre-specified time points. |
Countries
Austria, Germany, Greece, Hungary, Italy, Spain, Turkey (Türkiye), United States
Participant flow
Recruitment details
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.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) Participants received multiple SC doses of romosozumab Dose A (low dose). | 4 |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) Participants received multiple SC doses of romosozumab Dose A (low dose). | 4 |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) Participants received multiple SC doses of romosozumab Dose B (medium dose). | 4 |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) Participants received multiple SC doses of romosozumab Dose B (medium dose). | 5 |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) Participants received multiple SC doses of romosozumab Dose C (high dose). | 4 |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) Participants received multiple SC doses of romosozumab Dose C (high dose). | 4 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Total | Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 14.3 years STANDARD_DEVIATION 1.9 | 10.5 years STANDARD_DEVIATION 4 | 6.5 years STANDARD_DEVIATION 0.6 | 14.0 years STANDARD_DEVIATION 1.8 | 8.4 years STANDARD_DEVIATION 2.4 | 14.3 years STANDARD_DEVIATION 0.5 | 6.0 years STANDARD_DEVIATION 1.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 3 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 22 Participants | 4 Participants | 3 Participants | 3 Participants | 4 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 4 Participants | 22 Participants | 2 Participants | 4 Participants | 4 Participants | 4 Participants | 4 Participants |
| Sex: Female, Male Female | 1 Participants | 9 Participants | 1 Participants | 2 Participants | 4 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Male | 3 Participants | 16 Participants | 3 Participants | 2 Participants | 1 Participants | 3 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 5 | 0 / 4 | 0 / 4 |
| other Total, other adverse events | 1 / 4 | 0 / 4 | 2 / 4 | 4 / 5 | 1 / 4 | 3 / 4 |
| serious Total, serious adverse events | 0 / 4 | 1 / 4 | 0 / 4 | 1 / 5 | 0 / 4 | 0 / 4 |
Outcome results
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.
Time frame: 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
Population: PK Analysis Set: all participants for whom at least 1 PK parameter or endpoint could be adequately tested.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Accumulation Ratio of Romosozumab | 0.885 ratio | Standard Deviation 0.487 |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Accumulation Ratio of Romosozumab | 3.6 ratio | Standard Deviation 2.56 |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Accumulation Ratio of Romosozumab | 0.922 ratio | Standard Deviation 0.0673 |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Accumulation Ratio of Romosozumab | 0.724 ratio | Standard Deviation 0.392 |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Accumulation Ratio of Romosozumab | 0.843 ratio | Standard Deviation 0.26 |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Accumulation Ratio of Romosozumab | 0.935 ratio | Standard Deviation 0.283 |
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.
Time frame: 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
Population: PK Analysis Set: all participants for whom at least 1 PK parameter or endpoint could be adequately tested.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Area Under the Serum Concentration Time Curve (AUC) From Time 0 to Day 28 (AUC[0-28]) of Romosozumab | Day 1 | 30.9 day*μg/mL | Standard Deviation 13.5 |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Area Under the Serum Concentration Time Curve (AUC) From Time 0 to Day 28 (AUC[0-28]) of Romosozumab | Day 57 | 27.4 day*μg/mL | Standard Deviation 15.1 |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Area Under the Serum Concentration Time Curve (AUC) From Time 0 to Day 28 (AUC[0-28]) of Romosozumab | Day 1 | 16.9 day*μg/mL | Standard Deviation 5.78 |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Area Under the Serum Concentration Time Curve (AUC) From Time 0 to Day 28 (AUC[0-28]) of Romosozumab | Day 57 | 50.5 day*μg/mL | Standard Deviation 20.7 |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Area Under the Serum Concentration Time Curve (AUC) From Time 0 to Day 28 (AUC[0-28]) of Romosozumab | Day 1 | 163 day*μg/mL | Standard Deviation 89.1 |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Area Under the Serum Concentration Time Curve (AUC) From Time 0 to Day 28 (AUC[0-28]) of Romosozumab | Day 57 | 153 day*μg/mL | Standard Deviation 86.7 |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Area Under the Serum Concentration Time Curve (AUC) From Time 0 to Day 28 (AUC[0-28]) of Romosozumab | Day 1 | 113 day*μg/mL | Standard Deviation 50.3 |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Area Under the Serum Concentration Time Curve (AUC) From Time 0 to Day 28 (AUC[0-28]) of Romosozumab | Day 57 | 95.1 day*μg/mL | Standard Deviation 76.1 |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Area Under the Serum Concentration Time Curve (AUC) From Time 0 to Day 28 (AUC[0-28]) of Romosozumab | Day 1 | 344 day*μg/mL | Standard Deviation 106 |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Area Under the Serum Concentration Time Curve (AUC) From Time 0 to Day 28 (AUC[0-28]) of Romosozumab | Day 57 | 293 day*μg/mL | Standard Deviation 134 |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Area Under the Serum Concentration Time Curve (AUC) From Time 0 to Day 28 (AUC[0-28]) of Romosozumab | Day 1 | 234 day*μg/mL | Standard Deviation 93.7 |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Area Under the Serum Concentration Time Curve (AUC) From Time 0 to Day 28 (AUC[0-28]) of Romosozumab | Day 57 | 203 day*μg/mL | Standard Deviation 40.7 |
Primary
Maximum Observed Serum Concentration (Cmax) of Romosozumab
Mean Cmax values following Days 1 and 57 are presented.
Time frame: 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
Population: Pharmacokinetic (PK) Analysis Set: all participants for whom at least 1 PK parameter or endpoint could be adequately tested.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Maximum Observed Serum Concentration (Cmax) of Romosozumab | Day 1 | 2.64 μg/mL | Standard Deviation 1.06 |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Maximum Observed Serum Concentration (Cmax) of Romosozumab | Day 57 | 2.43 μg/mL | Standard Deviation 1.36 |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Maximum Observed Serum Concentration (Cmax) of Romosozumab | Day 1 | 1.74 μg/mL | Standard Deviation 0.825 |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Maximum Observed Serum Concentration (Cmax) of Romosozumab | Day 57 | 5.55 μg/mL | Standard Deviation 2.11 |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Maximum Observed Serum Concentration (Cmax) of Romosozumab | Day 1 | 13.8 μg/mL | Standard Deviation 6.32 |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Maximum Observed Serum Concentration (Cmax) of Romosozumab | Day 57 | 12.8 μg/mL | Standard Deviation 6.31 |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Maximum Observed Serum Concentration (Cmax) of Romosozumab | Day 1 | 10.3 μg/mL | Standard Deviation 1.7 |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Maximum Observed Serum Concentration (Cmax) of Romosozumab | Day 57 | 9.14 μg/mL | Standard Deviation 7.5 |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Maximum Observed Serum Concentration (Cmax) of Romosozumab | Day 1 | 25.7 μg/mL | Standard Deviation 3.02 |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Maximum Observed Serum Concentration (Cmax) of Romosozumab | Day 57 | 22.8 μg/mL | Standard Deviation 10.5 |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Maximum Observed Serum Concentration (Cmax) of Romosozumab | Day 1 | 21.3 μg/mL | Standard Deviation 6.45 |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Maximum Observed Serum Concentration (Cmax) of Romosozumab | Day 57 | 19.4 μg/mL | Standard Deviation 2.14 |
Primary
Terminal Half-life of Romosozumab
Median terminal half-life values at Day 57 are presented.
Time frame: 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
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Terminal Half-life of Romosozumab | 9.41 day |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Terminal Half-life of Romosozumab | 7.01 day |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Terminal Half-life of Romosozumab | 6.11 day |
Primary
Time to Cmax (Tmax) of Romosozumab
Median tmax values following Days 1 and 57 are presented.
Time frame: 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
Population: PK Analysis Set: all participants for whom at least 1 PK parameter or endpoint could be adequately tested.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Time to Cmax (Tmax) of Romosozumab | Day 57 | 7.0 day |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Time to Cmax (Tmax) of Romosozumab | Day 1 | 6.5 day |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Time to Cmax (Tmax) of Romosozumab | Day 1 | 7.9 day |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Time to Cmax (Tmax) of Romosozumab | Day 57 | 7.0 day |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Time to Cmax (Tmax) of Romosozumab | Day 1 | 6.9 day |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Time to Cmax (Tmax) of Romosozumab | Day 57 | 7.0 day |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Time to Cmax (Tmax) of Romosozumab | Day 1 | 6.9 day |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Time to Cmax (Tmax) of Romosozumab | Day 57 | 8.0 day |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Time to Cmax (Tmax) of Romosozumab | Day 1 | 7.0 day |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Time to Cmax (Tmax) of Romosozumab | Day 57 | 7.0 day |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Time to Cmax (Tmax) of Romosozumab | Day 1 | 7.5 day |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Time to Cmax (Tmax) of Romosozumab | Day 57 | 7.5 day |
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.
Time frame: DXA scans were during screening (baseline) and at Day 85 and Day 169
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Mean Change From Baseline in Lumbar Spine BMD Z-Score | Day 85 | 0.20 Z-score | Standard Deviation 0.39 |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Mean Change From Baseline in Lumbar Spine BMD Z-Score | Day 169 | 0.33 Z-score | Standard Deviation 0.46 |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Mean Change From Baseline in Lumbar Spine BMD Z-Score | Day 85 | 0.45 Z-score | Standard Deviation 0.37 |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Mean Change From Baseline in Lumbar Spine BMD Z-Score | Day 169 | 0.48 Z-score | Standard Deviation 0.51 |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Mean Change From Baseline in Lumbar Spine BMD Z-Score | Day 85 | 0.50 Z-score | Standard Deviation 0.12 |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Mean Change From Baseline in Lumbar Spine BMD Z-Score | Day 169 | 0.48 Z-score | Standard Deviation 0.21 |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Mean Change From Baseline in Lumbar Spine BMD Z-Score | Day 85 | 0.33 Z-score | Standard Deviation 0.53 |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Mean Change From Baseline in Lumbar Spine BMD Z-Score | Day 169 | 0.25 Z-score | Standard Deviation 0.39 |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Mean Change From Baseline in Lumbar Spine BMD Z-Score | Day 85 | 0.33 Z-score | Standard Deviation 0.26 |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Mean Change From Baseline in Lumbar Spine BMD Z-Score | Day 169 | 0.23 Z-score | Standard Deviation 0.56 |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Mean Change From Baseline in Lumbar Spine BMD Z-Score | Day 85 | 0.53 Z-score | Standard Deviation 0.79 |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Mean Change From Baseline in Lumbar Spine BMD Z-Score | Day 169 | 0.50 Z-score | Standard Deviation 0.62 |
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.
Time frame: Blood samples for anti-romosozumab antibodies were taken Day 1, Day 15, Day 29, Day 85, and Day 169
Population: Safety Analysis Set: all participants enrolled in the study who received at least 1 dose of investigational product.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Number of Participants With Anti-romosozumab Antibodies | Neutralizing antibody positive post-baseline with a negative/no result at baseline | 0 Participants |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Number of Participants With Anti-romosozumab Antibodies | Transient neutralizing antibody positive post-baseline with a negative/no result at baseline | 0 Participants |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Number of Participants With Anti-romosozumab Antibodies | Binding antibody positive at/before baseline | 0 Participants |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Number of Participants With Anti-romosozumab Antibodies | Binding antibody positive post-baseline with negative/no results at baseline | 0 Participants |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Number of Participants With Anti-romosozumab Antibodies | Transient binding antibody positive post-baseline with negative/no results at baseline | 0 Participants |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Number of Participants With Anti-romosozumab Antibodies | Treatment-boosted antibody positive | 0 Participants |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Number of Participants With Anti-romosozumab Antibodies | Neutralizing antibody positive anytime | 0 Participants |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Number of Participants With Anti-romosozumab Antibodies | Binding antibody positive anytime | 0 Participants |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Number of Participants With Anti-romosozumab Antibodies | Neutralizing antibody positive at/before baseline | 0 Participants |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Number of Participants With Anti-romosozumab Antibodies | Transient neutralizing antibody positive post-baseline with a negative/no result at baseline | 0 Participants |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Number of Participants With Anti-romosozumab Antibodies | Binding antibody positive post-baseline with negative/no results at baseline | 1 Participants |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Number of Participants With Anti-romosozumab Antibodies | Neutralizing antibody positive anytime | 0 Participants |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Number of Participants With Anti-romosozumab Antibodies | Binding antibody positive at/before baseline | 0 Participants |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Number of Participants With Anti-romosozumab Antibodies | Binding antibody positive anytime | 1 Participants |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Number of Participants With Anti-romosozumab Antibodies | Neutralizing antibody positive post-baseline with a negative/no result at baseline | 0 Participants |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Number of Participants With Anti-romosozumab Antibodies | Neutralizing antibody positive at/before baseline | 0 Participants |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Number of Participants With Anti-romosozumab Antibodies | Transient binding antibody positive post-baseline with negative/no results at baseline | 0 Participants |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Number of Participants With Anti-romosozumab Antibodies | Treatment-boosted antibody positive | 0 Participants |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Number of Participants With Anti-romosozumab Antibodies | Neutralizing antibody positive anytime | 2 Participants |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Number of Participants With Anti-romosozumab Antibodies | Binding antibody positive post-baseline with negative/no results at baseline | 2 Participants |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Number of Participants With Anti-romosozumab Antibodies | Neutralizing antibody positive at/before baseline | 0 Participants |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Number of Participants With Anti-romosozumab Antibodies | Neutralizing antibody positive post-baseline with a negative/no result at baseline | 2 Participants |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Number of Participants With Anti-romosozumab Antibodies | Transient neutralizing antibody positive post-baseline with a negative/no result at baseline | 0 Participants |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Number of Participants With Anti-romosozumab Antibodies | Binding antibody positive at/before baseline | 0 Participants |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Number of Participants With Anti-romosozumab Antibodies | Transient binding antibody positive post-baseline with negative/no results at baseline | 0 Participants |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Number of Participants With Anti-romosozumab Antibodies | Treatment-boosted antibody positive | 0 Participants |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Number of Participants With Anti-romosozumab Antibodies | Binding antibody positive anytime | 2 Participants |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Number of Participants With Anti-romosozumab Antibodies | Binding antibody positive post-baseline with negative/no results at baseline | 0 Participants |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Number of Participants With Anti-romosozumab Antibodies | Binding antibody positive anytime | 0 Participants |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Number of Participants With Anti-romosozumab Antibodies | Neutralizing antibody positive anytime | 0 Participants |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Number of Participants With Anti-romosozumab Antibodies | Binding antibody positive at/before baseline | 0 Participants |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Number of Participants With Anti-romosozumab Antibodies | Neutralizing antibody positive at/before baseline | 0 Participants |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Number of Participants With Anti-romosozumab Antibodies | Treatment-boosted antibody positive | 0 Participants |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Number of Participants With Anti-romosozumab Antibodies | Transient binding antibody positive post-baseline with negative/no results at baseline | 0 Participants |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Number of Participants With Anti-romosozumab Antibodies | Neutralizing antibody positive post-baseline with a negative/no result at baseline | 0 Participants |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Number of Participants With Anti-romosozumab Antibodies | Transient neutralizing antibody positive post-baseline with a negative/no result at baseline | 0 Participants |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Number of Participants With Anti-romosozumab Antibodies | Treatment-boosted antibody positive | 0 Participants |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Number of Participants With Anti-romosozumab Antibodies | Neutralizing antibody positive at/before baseline | 0 Participants |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Number of Participants With Anti-romosozumab Antibodies | Transient binding antibody positive post-baseline with negative/no results at baseline | 0 Participants |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Number of Participants With Anti-romosozumab Antibodies | Binding antibody positive at/before baseline | 0 Participants |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Number of Participants With Anti-romosozumab Antibodies | Transient neutralizing antibody positive post-baseline with a negative/no result at baseline | 0 Participants |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Number of Participants With Anti-romosozumab Antibodies | Neutralizing antibody positive post-baseline with a negative/no result at baseline | 1 Participants |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Number of Participants With Anti-romosozumab Antibodies | Neutralizing antibody positive anytime | 1 Participants |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Number of Participants With Anti-romosozumab Antibodies | Binding antibody positive anytime | 1 Participants |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Number of Participants With Anti-romosozumab Antibodies | Binding antibody positive post-baseline with negative/no results at baseline | 1 Participants |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Number of Participants With Anti-romosozumab Antibodies | Binding antibody positive anytime | 1 Participants |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Number of Participants With Anti-romosozumab Antibodies | Neutralizing antibody positive at/before baseline | 0 Participants |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Number of Participants With Anti-romosozumab Antibodies | Binding antibody positive post-baseline with negative/no results at baseline | 1 Participants |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Number of Participants With Anti-romosozumab Antibodies | Transient neutralizing antibody positive post-baseline with a negative/no result at baseline | 0 Participants |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Number of Participants With Anti-romosozumab Antibodies | Neutralizing antibody positive post-baseline with a negative/no result at baseline | 0 Participants |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Number of Participants With Anti-romosozumab Antibodies | Transient binding antibody positive post-baseline with negative/no results at baseline | 0 Participants |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Number of Participants With Anti-romosozumab Antibodies | Binding antibody positive at/before baseline | 0 Participants |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Number of Participants With Anti-romosozumab Antibodies | Treatment-boosted antibody positive | 0 Participants |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Number of Participants With Anti-romosozumab Antibodies | Neutralizing antibody positive anytime | 0 Participants |
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.
Time frame: Baseline (Day 1), Day 57, Day 85, and Day 169
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Blowing out of cheeks - No change (0) | 4 Participants |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Blowing out of cheeks - Undetermined | 0 Participants |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Closing eyes - No change (0) | 4 Participants |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Closing eyes - Undetermined | 0 Participants |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Closing of lips - No change (0) | 4 Participants |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Closing of lips - Undetermined | 0 Participants |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Pursing of lips - No change (0) | 4 Participants |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Pursing of lips - Undetermined | 0 Participants |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Raising eyebrows - No change (0) | 4 Participants |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Raising eyebrows - Undetermined | 0 Participants |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Smiling - No change (0) | 4 Participants |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Smiling - Undetermined | 0 Participants |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Blowing out of cheeks - No change (0) | 4 Participants |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Blowing out of cheeks - Undetermined | 0 Participants |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Closing eyes - No change (0) | 4 Participants |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Closing eyes - Undetermined | 0 Participants |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Closing of lips - No change (0) | 4 Participants |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Closing of lips - Increase (to 1) | 0 Participants |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Closing of lips - Undetermined | 0 Participants |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Pursing of lips - No change (0) | 4 Participants |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Pursing of lips - Undetermined | 0 Participants |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Raising eyebrows - No change (0) | 4 Participants |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Raising eyebrows - Undetermined | 0 Participants |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Smiling - No change (0) | 4 Participants |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Smiling - Undetermined | 0 Participants |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Blowing out of cheeks - No change (0) | 4 Participants |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Blowing out of cheeks - Undetermined | 0 Participants |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Closing eyes - No change (0) | 4 Participants |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Closing eyes - Undetermined | 0 Participants |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Closing of lips - No change (0) | 4 Participants |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Closing of lips - Undetermined | 0 Participants |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Pursing of lips - No change (0) | 4 Participants |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Pursing of lips - Undetermined | 0 Participants |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Raising eyebrows - No change (0) | 4 Participants |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Raising eyebrows - Undetermined | 0 Participants |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Smiling - No change (0) | 4 Participants |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Smiling - Undetermined | 0 Participants |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Pursing of lips - No change (0) | 4 Participants |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Smiling - Undetermined | 0 Participants |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Closing eyes - Undetermined | 0 Participants |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Pursing of lips - No change (0) | 4 Participants |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Smiling - No change (0) | 4 Participants |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Raising eyebrows - Undetermined | 0 Participants |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Pursing of lips - Undetermined | 0 Participants |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Raising eyebrows - Undetermined | 0 Participants |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Raising eyebrows - Undetermined | 0 Participants |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Raising eyebrows - No change (0) | 4 Participants |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Closing of lips - Undetermined | 0 Participants |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Smiling - Undetermined | 0 Participants |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Smiling - No change (0) | 4 Participants |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Pursing of lips - Undetermined | 0 Participants |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Closing eyes - No change (0) | 4 Participants |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Pursing of lips - No change (0) | 4 Participants |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Smiling - Undetermined | 0 Participants |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Blowing out of cheeks - Undetermined | 0 Participants |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Blowing out of cheeks - No change (0) | 4 Participants |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Blowing out of cheeks - No change (0) | 4 Participants |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Closing of lips - Undetermined | 0 Participants |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Blowing out of cheeks - Undetermined | 0 Participants |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Closing of lips - No change (0) | 4 Participants |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Raising eyebrows - No change (0) | 4 Participants |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Closing eyes - No change (0) | 4 Participants |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Closing of lips - No change (0) | 4 Participants |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Closing eyes - Undetermined | 0 Participants |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Closing eyes - Undetermined | 0 Participants |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Pursing of lips - Undetermined | 0 Participants |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Closing eyes - No change (0) | 4 Participants |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Raising eyebrows - No change (0) | 4 Participants |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Closing of lips - No change (0) | 3 Participants |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Blowing out of cheeks - Undetermined | 0 Participants |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Closing of lips - Increase (to 1) | 1 Participants |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Smiling - No change (0) | 4 Participants |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Blowing out of cheeks - No change (0) | 4 Participants |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Closing of lips - Undetermined | 0 Participants |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Blowing out of cheeks - No change (0) | 4 Participants |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Smiling - Undetermined | 0 Participants |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Pursing of lips - No change (0) | 4 Participants |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Closing of lips - Undetermined | 0 Participants |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Closing eyes - No change (0) | 4 Participants |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Pursing of lips - No change (0) | 4 Participants |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Pursing of lips - Undetermined | 0 Participants |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Smiling - No change (0) | 4 Participants |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Smiling - Undetermined | 0 Participants |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Blowing out of cheeks - No change (0) | 4 Participants |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Blowing out of cheeks - Undetermined | 0 Participants |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Pursing of lips - Undetermined | 0 Participants |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Closing of lips - No change (0) | 4 Participants |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Raising eyebrows - Undetermined | 0 Participants |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Closing of lips - No change (0) | 4 Participants |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Raising eyebrows - Undetermined | 0 Participants |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Closing of lips - Increase (to 1) | 0 Participants |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Raising eyebrows - No change (0) | 4 Participants |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Closing eyes - Undetermined | 0 Participants |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Raising eyebrows - Undetermined | 0 Participants |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Closing of lips - Undetermined | 0 Participants |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Pursing of lips - No change (0) | 4 Participants |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Closing eyes - No change (0) | 4 Participants |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Closing of lips - No change (0) | 4 Participants |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Closing eyes - No change (0) | 4 Participants |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Smiling - No change (0) | 4 Participants |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Raising eyebrows - No change (0) | 4 Participants |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Closing eyes - Undetermined | 0 Participants |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Smiling - No change (0) | 4 Participants |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Blowing out of cheeks - Undetermined | 0 Participants |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Raising eyebrows - No change (0) | 4 Participants |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Smiling - Undetermined | 0 Participants |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Pursing of lips - Undetermined | 0 Participants |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Blowing out of cheeks - Undetermined | 0 Participants |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Blowing out of cheeks - No change (0) | 4 Participants |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Closing eyes - Undetermined | 0 Participants |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Closing of lips - Undetermined | 0 Participants |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Raising eyebrows - No change (0) | 4 Participants |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Pursing of lips - No change (0) | 3 Participants |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Pursing of lips - Undetermined | 2 Participants |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Raising eyebrows - No change (0) | 3 Participants |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Raising eyebrows - Undetermined | 2 Participants |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Pursing of lips - Undetermined | 1 Participants |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Smiling - No change (0) | 3 Participants |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Smiling - Undetermined | 2 Participants |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Blowing out of cheeks - No change (0) | 4 Participants |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Blowing out of cheeks - Undetermined | 1 Participants |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Closing eyes - No change (0) | 4 Participants |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Closing eyes - Undetermined | 1 Participants |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Raising eyebrows - No change (0) | 4 Participants |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Closing of lips - No change (0) | 4 Participants |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Closing of lips - Increase (to 1) | 0 Participants |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Closing of lips - Undetermined | 1 Participants |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Smiling - Undetermined | 1 Participants |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Pursing of lips - No change (0) | 4 Participants |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Pursing of lips - Undetermined | 1 Participants |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Raising eyebrows - Undetermined | 1 Participants |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Raising eyebrows - Undetermined | 1 Participants |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Smiling - No change (0) | 4 Participants |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Smiling - Undetermined | 1 Participants |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Blowing out of cheeks - No change (0) | 4 Participants |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Blowing out of cheeks - Undetermined | 1 Participants |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Closing eyes - No change (0) | 4 Participants |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Smiling - No change (0) | 4 Participants |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Closing eyes - Undetermined | 1 Participants |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Closing of lips - No change (0) | 4 Participants |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Closing of lips - Undetermined | 1 Participants |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Blowing out of cheeks - No change (0) | 3 Participants |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Blowing out of cheeks - Undetermined | 2 Participants |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Closing eyes - No change (0) | 3 Participants |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Closing eyes - Undetermined | 2 Participants |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Pursing of lips - No change (0) | 4 Participants |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Closing of lips - No change (0) | 3 Participants |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Closing of lips - Undetermined | 2 Participants |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Closing eyes - No change (0) | 4 Participants |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Smiling - Undetermined | 0 Participants |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Blowing out of cheeks - No change (0) | 4 Participants |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Closing of lips - Increase (to 1) | 0 Participants |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Raising eyebrows - No change (0) | 4 Participants |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Closing of lips - Undetermined | 0 Participants |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Blowing out of cheeks - Undetermined | 0 Participants |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Closing of lips - No change (0) | 4 Participants |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Closing eyes - Undetermined | 0 Participants |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Smiling - Undetermined | 0 Participants |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Pursing of lips - Undetermined | 0 Participants |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Closing eyes - No change (0) | 4 Participants |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Closing eyes - Undetermined | 0 Participants |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Smiling - No change (0) | 4 Participants |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Blowing out of cheeks - Undetermined | 0 Participants |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Closing of lips - No change (0) | 4 Participants |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Closing of lips - No change (0) | 4 Participants |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Blowing out of cheeks - No change (0) | 4 Participants |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Closing of lips - Undetermined | 0 Participants |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Pursing of lips - No change (0) | 4 Participants |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Blowing out of cheeks - No change (0) | 4 Participants |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Smiling - Undetermined | 0 Participants |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Pursing of lips - Undetermined | 0 Participants |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Blowing out of cheeks - Undetermined | 0 Participants |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Smiling - No change (0) | 4 Participants |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Pursing of lips - No change (0) | 4 Participants |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Closing eyes - No change (0) | 4 Participants |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Raising eyebrows - Undetermined | 0 Participants |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Raising eyebrows - No change (0) | 4 Participants |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Pursing of lips - Undetermined | 0 Participants |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Raising eyebrows - No change (0) | 4 Participants |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Raising eyebrows - Undetermined | 0 Participants |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Raising eyebrows - Undetermined | 0 Participants |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Pursing of lips - No change (0) | 4 Participants |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Smiling - No change (0) | 4 Participants |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Closing of lips - Undetermined | 0 Participants |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Closing eyes - Undetermined | 0 Participants |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Closing of lips - Undetermined | 0 Participants |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Smiling - Undetermined | 0 Participants |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Pursing of lips - Undetermined | 0 Participants |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Raising eyebrows - No change (0) | 4 Participants |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Closing of lips - Increase (to 1) | 0 Participants |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Closing eyes - Undetermined | 0 Participants |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Smiling - Undetermined | 0 Participants |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Blowing out of cheeks - No change (0) | 4 Participants |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Pursing of lips - No change (0) | 4 Participants |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Raising eyebrows - No change (0) | 4 Participants |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Closing of lips - No change (0) | 4 Participants |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Blowing out of cheeks - No change (0) | 4 Participants |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Smiling - Undetermined | 0 Participants |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Blowing out of cheeks - Undetermined | 0 Participants |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Raising eyebrows - No change (0) | 4 Participants |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Closing eyes - Undetermined | 0 Participants |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Pursing of lips - Undetermined | 0 Participants |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Pursing of lips - Undetermined | 0 Participants |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Pursing of lips - No change (0) | 4 Participants |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Closing eyes - No change (0) | 4 Participants |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Raising eyebrows - Undetermined | 0 Participants |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Closing eyes - No change (0) | 4 Participants |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Blowing out of cheeks - Undetermined | 0 Participants |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Closing of lips - Undetermined | 0 Participants |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Smiling - No change (0) | 4 Participants |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Closing eyes - Undetermined | 0 Participants |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Pursing of lips - No change (0) | 4 Participants |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Blowing out of cheeks - Undetermined | 0 Participants |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Raising eyebrows - Undetermined | 0 Participants |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Closing of lips - Undetermined | 0 Participants |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Raising eyebrows - Undetermined | 0 Participants |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Closing of lips - No change (0) | 4 Participants |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 169: Smiling - No change (0) | 4 Participants |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Blowing out of cheeks - No change (0) | 4 Participants |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Closing eyes - No change (0) | 4 Participants |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 57: Closing of lips - No change (0) | 4 Participants |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169 | Day 85: Smiling - No change (0) | 4 Participants |
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.
Time frame: Day 1 to end of study (up to Day 169); median duration on study was 5.55 months
Population: Safety Analysis Set: all participants enrolled in the study who received at least 1 dose of investigational product.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Any TEAE | 1 Participants |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Any Treatment-emergent EOI | 0 Participants |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Any TEAE | 1 Participants |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Any Treatment-emergent EOI | 0 Participants |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Any TEAE | 2 Participants |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Any Treatment-emergent EOI | 0 Participants |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Any TEAE | 4 Participants |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Any Treatment-emergent EOI | 0 Participants |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Any TEAE | 1 Participants |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Any Treatment-emergent EOI | 1 Participants |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Any TEAE | 3 Participants |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Any Treatment-emergent EOI | 1 Participants |
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.
Time frame: DXA scans were during screening (baseline) and at Day 85 and Day 169
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Percentage Change From Baseline in Bone Mineral Content (BMC) of the Lumbar Spine | Day 85 | 7.68 percentage change | Standard Deviation 8.1 |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Percentage Change From Baseline in Bone Mineral Content (BMC) of the Lumbar Spine | Day 169 | 12.64 percentage change | Standard Deviation 4.07 |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Percentage Change From Baseline in Bone Mineral Content (BMC) of the Lumbar Spine | Day 85 | 10.13 percentage change | Standard Deviation 6.05 |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Percentage Change From Baseline in Bone Mineral Content (BMC) of the Lumbar Spine | Day 169 | 11.40 percentage change | Standard Deviation 7.82 |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Percentage Change From Baseline in Bone Mineral Content (BMC) of the Lumbar Spine | Day 85 | 18.16 percentage change | Standard Deviation 7.86 |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Percentage Change From Baseline in Bone Mineral Content (BMC) of the Lumbar Spine | Day 169 | 21.29 percentage change | Standard Deviation 11.31 |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Percentage Change From Baseline in Bone Mineral Content (BMC) of the Lumbar Spine | Day 85 | 8.41 percentage change | Standard Deviation 6.9 |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Percentage Change From Baseline in Bone Mineral Content (BMC) of the Lumbar Spine | Day 169 | 7.98 percentage change | Standard Deviation 7.77 |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Percentage Change From Baseline in Bone Mineral Content (BMC) of the Lumbar Spine | Day 85 | 14.62 percentage change | Standard Deviation 3.39 |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Percentage Change From Baseline in Bone Mineral Content (BMC) of the Lumbar Spine | Day 169 | 14.27 percentage change | Standard Deviation 5.52 |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Percentage Change From Baseline in Bone Mineral Content (BMC) of the Lumbar Spine | Day 85 | 16.03 percentage change | Standard Deviation 8.32 |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Percentage Change From Baseline in Bone Mineral Content (BMC) of the Lumbar Spine | Day 169 | 12.42 percentage change | Standard Deviation 10.72 |
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.
Time frame: DXA scans were during screening (baseline) and at Day 85 and Day 169
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Percentage Change From Baseline in Bone Mineral Density (BMD) of the Lumbar Spine | Day 85 | 4.84 percentage change | Standard Deviation 3.29 |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Percentage Change From Baseline in Bone Mineral Density (BMD) of the Lumbar Spine | Day 169 | 7.80 percentage change | Standard Deviation 2.23 |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Percentage Change From Baseline in Bone Mineral Density (BMD) of the Lumbar Spine | Day 85 | 7.94 percentage change | Standard Deviation 5.32 |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Percentage Change From Baseline in Bone Mineral Density (BMD) of the Lumbar Spine | Day 169 | 9.24 percentage change | Standard Deviation 7.98 |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Percentage Change From Baseline in Bone Mineral Density (BMD) of the Lumbar Spine | Day 85 | 12.91 percentage change | Standard Deviation 2.6 |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Percentage Change From Baseline in Bone Mineral Density (BMD) of the Lumbar Spine | Day 169 | 15.04 percentage change | Standard Deviation 4.32 |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Percentage Change From Baseline in Bone Mineral Density (BMD) of the Lumbar Spine | Day 85 | 7.78 percentage change | Standard Deviation 9.16 |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Percentage Change From Baseline in Bone Mineral Density (BMD) of the Lumbar Spine | Day 169 | 7.09 percentage change | Standard Deviation 7.03 |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Percentage Change From Baseline in Bone Mineral Density (BMD) of the Lumbar Spine | Day 85 | 7.88 percentage change | Standard Deviation 1.99 |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Percentage Change From Baseline in Bone Mineral Density (BMD) of the Lumbar Spine | Day 169 | 7.10 percentage change | Standard Deviation 6.58 |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Percentage Change From Baseline in Bone Mineral Density (BMD) of the Lumbar Spine | Day 85 | 13.07 percentage change | Standard Deviation 13.45 |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Percentage Change From Baseline in Bone Mineral Density (BMD) of the Lumbar Spine | Day 169 | 12.70 percentage change | Standard Deviation 12.86 |
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.
Time frame: DXA scans were during screening (baseline) and at Day 85 and Day 169
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Percentage Change From Baseline in Lumbar Spine Bone Area | Day 169 | 4.53 percentage change | Standard Deviation 4.92 |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Percentage Change From Baseline in Lumbar Spine Bone Area | Day 85 | 2.72 percentage change | Standard Deviation 6.99 |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Percentage Change From Baseline in Lumbar Spine Bone Area | Day 85 | 2.03 percentage change | Standard Deviation 1.62 |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Percentage Change From Baseline in Lumbar Spine Bone Area | Day 169 | 1.92 percentage change | Standard Deviation 0.66 |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Percentage Change From Baseline in Lumbar Spine Bone Area | Day 85 | 4.60 percentage change | Standard Deviation 5 |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Percentage Change From Baseline in Lumbar Spine Bone Area | Day 169 | 5.30 percentage change | Standard Deviation 6.06 |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Percentage Change From Baseline in Lumbar Spine Bone Area | Day 85 | 0.80 percentage change | Standard Deviation 4.62 |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Percentage Change From Baseline in Lumbar Spine Bone Area | Day 169 | 0.82 percentage change | Standard Deviation 1.95 |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Percentage Change From Baseline in Lumbar Spine Bone Area | Day 85 | 6.23 percentage change | Standard Deviation 2.15 |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Percentage Change From Baseline in Lumbar Spine Bone Area | Day 169 | 6.87 percentage change | Standard Deviation 5.14 |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Percentage Change From Baseline in Lumbar Spine Bone Area | Day 169 | -0.09 percentage change | Standard Deviation 4.27 |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Percentage Change From Baseline in Lumbar Spine Bone Area | Day 85 | 3.44 percentage change | Standard Deviation 11.05 |
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.
Time frame: Blood samples were taken Days 1 (baseline), 8, 15, 29, 57, 64, 71, 85, 113, and 169
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 113 | -1.13 percentage change | Standard Deviation 13.42 |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 169 | -6.62 percentage change | Standard Deviation 30.96 |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 29 | 5.24 percentage change | Standard Deviation 12.87 |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 71 | 12.19 percentage change | Standard Deviation 21.37 |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 85 | -7.34 percentage change | Standard Deviation 22.5 |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 64 | 14.82 percentage change | Standard Deviation 28.86 |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 15 | 11.03 percentage change | Standard Deviation 13.94 |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 8 | 19.81 percentage change | Standard Deviation 20.96 |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 57 | -2.11 percentage change | Standard Deviation 20.26 |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 169 | -3.13 percentage change | Standard Deviation 10.54 |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 71 | -5.72 percentage change | Standard Deviation 28.5 |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 15 | 12.43 percentage change | Standard Deviation 13.07 |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 29 | 6.18 percentage change | Standard Deviation 18.64 |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 8 | 12.75 percentage change | Standard Deviation 13.03 |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 113 | -13.75 percentage change | Standard Deviation 19.11 |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 57 | -22.37 percentage change | Standard Deviation 19.82 |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 85 | -23.50 percentage change | Standard Deviation 13.42 |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 64 | 19.12 percentage change | Standard Deviation 40.48 |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 15 | 52.25 percentage change | Standard Deviation 29.71 |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 71 | 49.37 percentage change | Standard Deviation 37.99 |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 57 | 14.57 percentage change | Standard Deviation 36.09 |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 113 | 21.10 percentage change | Standard Deviation 40.61 |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 169 | 18.10 percentage change | Standard Deviation 57.53 |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 29 | 21.52 percentage change | Standard Deviation 25.01 |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 85 | 26.12 percentage change | Standard Deviation 48.97 |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 64 | 39.63 percentage change | Standard Deviation 31.92 |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 8 | 65.12 percentage change | Standard Deviation 17.75 |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 71 | 16.79 percentage change | Standard Deviation 12.29 |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 8 | 31.77 percentage change | Standard Deviation 11.69 |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 15 | 10.52 percentage change | Standard Deviation 14.72 |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 29 | 1.96 percentage change | Standard Deviation 9.22 |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 57 | -6.36 percentage change | Standard Deviation 17.51 |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 64 | 25.42 percentage change | Standard Deviation 16.73 |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 85 | -0.72 percentage change | Standard Deviation 21.29 |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 113 | 2.53 percentage change | Standard Deviation 42.46 |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 169 | -2.24 percentage change | Standard Deviation 23.99 |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 64 | 77.17 percentage change | Standard Deviation 109.07 |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 57 | 19.07 percentage change | Standard Deviation 56.24 |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 85 | 5.79 percentage change | Standard Deviation 23.45 |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 29 | 32.13 percentage change | Standard Deviation 59.1 |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 169 | -14.30 percentage change | Standard Deviation 19.41 |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 113 | -5.02 percentage change | Standard Deviation 21 |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 15 | 58.58 percentage change | Standard Deviation 54.61 |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 8 | 35.91 percentage change | Standard Deviation 21.89 |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 71 | 42.16 percentage change | Standard Deviation 59.39 |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 8 | 35.35 percentage change | Standard Deviation 47.08 |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 57 | -14.26 percentage change | Standard Deviation 12.93 |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 71 | 5.12 percentage change | Standard Deviation 29.54 |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 169 | -21.85 percentage change | Standard Deviation 16.18 |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 113 | -26.95 percentage change | Standard Deviation 10.23 |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 85 | -11.78 percentage change | Standard Deviation 30.09 |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 29 | -11.54 percentage change | Standard Deviation 11.35 |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 64 | 17.51 percentage change | Standard Deviation 35.74 |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 15 | 28.35 percentage change | Standard Deviation 55 |
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.
Time frame: Blood samples were taken Days 1 (baseline), 8, 15, 29, 57, 64, 71, 85, 113, and 169
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Day 113 | -3.83 percentage change | Standard Deviation 22.3 |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Day 169 | -6.15 percentage change | Standard Deviation 54.87 |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Day 29 | -4.67 percentage change | Standard Deviation 21.35 |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Day 71 | 18.20 percentage change | Standard Deviation 53.85 |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Day 85 | -10.56 percentage change | Standard Deviation 22.18 |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Day 64 | -13.37 percentage change | Standard Deviation 36.33 |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Day 15 | 12.26 percentage change | Standard Deviation 28.2 |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Day 8 | 2.65 percentage change | Standard Deviation 27.91 |
| Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Day 57 | 1.03 percentage change | Standard Deviation 34.14 |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Day 169 | -29.78 percentage change | Standard Deviation 31.6 |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Day 71 | -25.30 percentage change | Standard Deviation 50.43 |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Day 15 | -3.24 percentage change | Standard Deviation 41.3 |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Day 29 | -6.67 percentage change | Standard Deviation 39.99 |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Day 8 | -19.93 percentage change | Standard Deviation 33.97 |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Day 113 | -30.38 percentage change | Standard Deviation 19.59 |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Day 57 | -7.34 percentage change | Standard Deviation 25.32 |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Day 85 | -37.50 percentage change | Standard Deviation 14.12 |
| Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Day 64 | -18.26 percentage change | Standard Deviation 49.19 |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Day 15 | -2.14 percentage change | Standard Deviation 52.91 |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Day 71 | 35.26 percentage change | Standard Deviation 68.16 |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Day 57 | -0.32 percentage change | Standard Deviation 32.21 |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Day 113 | 25.94 percentage change | Standard Deviation 39.76 |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Day 169 | -1.72 percentage change | Standard Deviation 40.42 |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Day 29 | 26.00 percentage change | Standard Deviation 15.11 |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Day 85 | 9.95 percentage change | Standard Deviation 30.71 |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Day 64 | 19.91 percentage change | Standard Deviation 43.95 |
| Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Day 8 | 8.79 percentage change | Standard Deviation 19.21 |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Day 71 | -3.37 percentage change | Standard Deviation 8.25 |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Day 8 | -19.38 percentage change | Standard Deviation 20.01 |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Day 15 | -20.24 percentage change | Standard Deviation 21.12 |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Day 29 | -7.43 percentage change | Standard Deviation 18.63 |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Day 57 | -7.66 percentage change | Standard Deviation 13.16 |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Day 64 | -10.60 percentage change | Standard Deviation 36.12 |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Day 85 | 5.08 percentage change | Standard Deviation 24.34 |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Day 113 | 6.98 percentage change | Standard Deviation 37.98 |
| Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Day 169 | 11.08 percentage change | Standard Deviation 16.19 |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Day 64 | 10.95 percentage change | Standard Deviation 23.38 |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Day 57 | -1.40 percentage change | Standard Deviation 38.1 |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Day 85 | 0.71 percentage change | Standard Deviation 44.55 |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Day 29 | -16.09 percentage change | Standard Deviation 27.05 |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Day 169 | -8.07 percentage change | Standard Deviation 16.73 |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Day 113 | 7.03 percentage change | Standard Deviation 40.23 |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Day 15 | -17.22 percentage change | Standard Deviation 17.39 |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Day 8 | -12.33 percentage change | Standard Deviation 12.93 |
| Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Day 71 | 15.14 percentage change | Standard Deviation 51.39 |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Day 8 | 7.14 percentage change | Standard Deviation 29.89 |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Day 57 | 44.17 percentage change | Standard Deviation 95.3 |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Day 71 | 60.12 percentage change | Standard Deviation 106.28 |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Day 169 | 8.08 percentage change | Standard Deviation 49.45 |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Day 113 | -19.58 percentage change | Standard Deviation 10.98 |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Day 85 | 15.77 percentage change | Standard Deviation 58.4 |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Day 29 | 3.76 percentage change | Standard Deviation 24.72 |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Day 64 | -28.14 percentage change | Standard Deviation 11.51 |
| Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age) | Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX) | Day 15 | 42.62 percentage change | Standard Deviation 54.95 |