NCT00680992 · OUTCOME
Mean Serum Denosumab Trough Concentrations
Study of Denosumab in Subjects With Giant Cell Tumor of Bone · Source last updated 2022-09-22
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- nanograms / milliliter
- Interval / dispersion
- Standard Deviation
- Time frame
- Blood samples were collected at baseline (day 1), days 8 and 15 and weeks 5, 9, 13 and 25.
What was measured
Blood samples for determination of serum denosumab concentration levels were obtained from participants included in the pharmacokinetic (PK) substudy at baseline (prior to administration of study drug on day 1) and at scheduled time points during the study up to week 25.
Analysis population: The PK analysis set included all participants who received at least 1 dose of denosumab with baseline PK measurement and at least 1 post-baseline PK measurement. Only participants with available data at each time point were included in the analysis.
Groups in this outcome
Adolescent PK Subset (Denosumab 120 mg Q4W)
Adolescent participants enrolled in the PK substudy who received at least 1 dose of denosumab with baseline PK measurement and at least 1 post-baseline PK measurement were included in the adolescent PK analysis set. Participants received denosumab 120 mg SC Q4W, starting on study day 1, with loading doses of 120 mg SC on days 8 and 15 in the first month of treatment for those enrolled in cohorts 1 or 2.
Adult PK Subset (Denosumab 120 mg Q4W)
Adult participants enrolled in the PK substudy who received at least 1 dose of denosumab with baseline PK measurement and at least 1 post-baseline PK measurement were included in the adult PK analysis set. Participants received denosumab 120 mg SC Q4W, starting on study day 1, with loading doses of 120 mg SC on days 8 and 15 in the first month of treatment for those enrolled in cohorts 1 or 2.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Adolescent PK Subset (Denosumab 120 mg Q4W) | 10 |
|---|
| Adult PK Subset (Denosumab 120 mg Q4W) | 15 |
|---|
Reported measurements
Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Adolescent PK Subset (Denosumab 120 mg Q4W) | 10 |
|---|
| Adult PK Subset (Denosumab 120 mg Q4W) | 15 |
|---|
Values in nanograms / milliliter · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Adolescent PK Subset (Denosumab 120 mg Q4W) | 0.0 | 0.0 | Not reported | Not reported | Not reported |
|---|
| Adult PK Subset (Denosumab 120 mg Q4W) | 0.0 | 0.0 | Not reported | Not reported | Not reported |
|---|
Day 8
Analysis denominator · Participants
| Group | Source count |
|---|
| Adolescent PK Subset (Denosumab 120 mg Q4W) | 9 |
|---|
| Adult PK Subset (Denosumab 120 mg Q4W) | 14 |
|---|
Values in nanograms / milliliter · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Adolescent PK Subset (Denosumab 120 mg Q4W) | 11800 | 4130 | Not reported | Not reported | Not reported |
|---|
| Adult PK Subset (Denosumab 120 mg Q4W) | 12000 | 4300 | Not reported | Not reported | Not reported |
|---|
Day 15
Analysis denominator · Participants
| Group | Source count |
|---|
| Adolescent PK Subset (Denosumab 120 mg Q4W) | 9 |
|---|
| Adult PK Subset (Denosumab 120 mg Q4W) | 13 |
|---|
Values in nanograms / milliliter · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Adolescent PK Subset (Denosumab 120 mg Q4W) | 21800 | 5620 | Not reported | Not reported | Not reported |
|---|
| Adult PK Subset (Denosumab 120 mg Q4W) | 24200 | 9050 | Not reported | Not reported | Not reported |
|---|
Week 5
Analysis denominator · Participants
| Group | Source count |
|---|
| Adolescent PK Subset (Denosumab 120 mg Q4W) | 9 |
|---|
| Adult PK Subset (Denosumab 120 mg Q4W) | 14 |
|---|
Values in nanograms / milliliter · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Adolescent PK Subset (Denosumab 120 mg Q4W) | 30400 | 6150 | Not reported | Not reported | Not reported |
|---|
| Adult PK Subset (Denosumab 120 mg Q4W) | 33500 | 8970 | Not reported | Not reported | Not reported |
|---|
Week 9
Analysis denominator · Participants
| Group | Source count |
|---|
| Adolescent PK Subset (Denosumab 120 mg Q4W) | 9 |
|---|
| Adult PK Subset (Denosumab 120 mg Q4W) | 15 |
|---|
Values in nanograms / milliliter · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Adolescent PK Subset (Denosumab 120 mg Q4W) | 25100 | 6450 | Not reported | Not reported | Not reported |
|---|
| Adult PK Subset (Denosumab 120 mg Q4W) | 30000 | 10300 | Not reported | Not reported | Not reported |
|---|
Week 13
Analysis denominator · Participants
| Group | Source count |
|---|
| Adolescent PK Subset (Denosumab 120 mg Q4W) | 7 |
|---|
| Adult PK Subset (Denosumab 120 mg Q4W) | 12 |
|---|
Values in nanograms / milliliter · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Adolescent PK Subset (Denosumab 120 mg Q4W) | 22300 | 6840 | Not reported | Not reported | Not reported |
|---|
| Adult PK Subset (Denosumab 120 mg Q4W) | 29100 | 10000 | Not reported | Not reported | Not reported |
|---|
Week 17
Analysis denominator · Participants
| Group | Source count |
|---|
| Adolescent PK Subset (Denosumab 120 mg Q4W) | 7 |
|---|
| Adult PK Subset (Denosumab 120 mg Q4W) | 13 |
|---|
Values in nanograms / milliliter · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Adolescent PK Subset (Denosumab 120 mg Q4W) | 23600 | 4370 | Not reported | Not reported | Not reported |
|---|
| Adult PK Subset (Denosumab 120 mg Q4W) | 28300 | 11600 | Not reported | Not reported | Not reported |
|---|
Week 25
Analysis denominator · Participants
| Group | Source count |
|---|
| Adolescent PK Subset (Denosumab 120 mg Q4W) | 8 |
|---|
| Adult PK Subset (Denosumab 120 mg Q4W) | 11 |
|---|
Values in nanograms / milliliter · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Adolescent PK Subset (Denosumab 120 mg Q4W) | 22400 | 6690 | Not reported | Not reported | Not reported |
|---|
| Adult PK Subset (Denosumab 120 mg Q4W) | 25400 | 10800 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.0
- value
- 0.0
- group Id
- OG001
- spread
- 0.0
- value
- 0.0
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 15
- units
- Participants
- title
- Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 4130
- value
- 11800
- group Id
- OG001
- spread
- 4300
- value
- 12000
- denoms
- counts
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 14
- units
- Participants
- title
- Day 8
- categories
- measurements
- group Id
- OG000
- spread
- 5620
- value
- 21800
- group Id
- OG001
- spread
- 9050
- value
- 24200
- denoms
- counts
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 13
- units
- Participants
- title
- Day 15
- categories
- measurements
- group Id
- OG000
- spread
- 6150
- value
- 30400
- group Id
- OG001
- spread
- 8970
- value
- 33500
- denoms
- counts
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 14
- units
- Participants
- title
- Week 5
- categories
- measurements
- group Id
- OG000
- spread
- 6450
- value
- 25100
- group Id
- OG001
- spread
- 10300
- value
- 30000
- denoms
- counts
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 15
- units
- Participants
- title
- Week 9
- categories
- measurements
- group Id
- OG000
- spread
- 6840
- value
- 22300
- group Id
- OG001
- spread
- 10000
- value
- 29100
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 12
- units
- Participants
- title
- Week 13
- categories
- measurements
- group Id
- OG000
- spread
- 4370
- value
- 23600
- group Id
- OG001
- spread
- 11600
- value
- 28300
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 13
- units
- Participants
- title
- Week 17
- categories
- measurements
- group Id
- OG000
- spread
- 6690
- value
- 22400
- group Id
- OG001
- spread
- 10800
- value
- 25400
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 11
- units
- Participants
- title
- Week 25
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 15
- units
- Participants
- description
- Blood samples for determination of serum denosumab concentration levels were obtained from participants included in the pharmacokinetic (PK) substudy at baseline (prior to administration of study drug on day 1) and at scheduled time points during the study up to week 25.
- dispersion Type
- Standard Deviation
- groups
- description
- Adolescent participants enrolled in the PK substudy who received at least 1 dose of denosumab with baseline PK measurement and at least 1 post-baseline PK measurement were included in the adolescent PK analysis set. Participants received denosumab 120 mg SC Q4W, starting on study day 1, with loading doses of 120 mg SC on days 8 and 15 in the first month of treatment for those enrolled in cohorts 1 or 2.
- id
- OG000
- title
- Adolescent PK Subset (Denosumab 120 mg Q4W)
- description
- Adult participants enrolled in the PK substudy who received at least 1 dose of denosumab with baseline PK measurement and at least 1 post-baseline PK measurement were included in the adult PK analysis set. Participants received denosumab 120 mg SC Q4W, starting on study day 1, with loading doses of 120 mg SC on days 8 and 15 in the first month of treatment for those enrolled in cohorts 1 or 2.
- id
- OG001
- title
- Adult PK Subset (Denosumab 120 mg Q4W)
- param Type
- MEAN
- population Description
- The PK analysis set included all participants who received at least 1 dose of denosumab with baseline PK measurement and at least 1 post-baseline PK measurement. Only participants with available data at each time point were included in the analysis.
- reporting Status
- POSTED
- time Frame
- Blood samples were collected at baseline (day 1), days 8 and 15 and weeks 5, 9, 13 and 25.
- title
- Mean Serum Denosumab Trough Concentrations
- type
- SECONDARY
- unit Of Measure
- nanograms / milliliter
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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