Endocrine System Diseases
Conditions
Brief summary
* To evaluate the effect of increasing the growth hormone dose on the statural response * To assess the value of early treatment during the course of arthritic disease by comparing the height acquired in the medium term by children in the two groups: treated from the start, or 1 year to 15 months after the diagnosis of CJA, or treated for 4 years after the diagnosis
Detailed description
This trial terminated on 10-Jun-2011 due to prolonged issues with drug accountability and data collection discrepancies. The decision to terminate was not based on any safety concerns.
Interventions
DRUGSomatropin
Liquid, daily to final height Maximum Dosage: 50 µg/kg/day
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
* This study will be proposed to all patients previously included in study CTN 97-8129-016
Exclusion criteria
* Discontinuation of corticosteroid therapy for more than a year during study CTN 97-8129-016 * Patients withdrawing from the study prematurely
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Predicted Height Standard Deviation Score (SDS) at Final Height | Baseline, final height (assessed up to Year 9.5) | Predicted height was calculated according to Greulich and Pyle using Bayley Pinneau method. Predicted height SDS was obtained by calculating the predicted height, subtracting chronological age- and gender-appropriate mean predicted height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population. |
| Change From Baseline in Annual Rate of Growth Standard Deviation Score (SDS) at Year 3 | Baseline, Year 3 | Annual rate of growth SDS was obtained by measuring the annual growth rate, subtracting chronological age- and gender-appropriate mean annual growth rate and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population. |
| Change From Baseline in Annual Rate of Growth Standard Deviation Score (SDS) at Final Height | Baseline, final height (assessed up to Year 9.5) | Annual rate of growth SDS was obtained by measuring the annual growth rate, subtracting chronological age- and gender-appropriate mean annual growth rate and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population. |
| Change From Baseline in Height Standard Deviation Score (SDS) at Year 3 | Baseline, Year 3 | Height was measured using a wall mounted device (example, Harpenden stadiometer). Height SDS was obtained by measuring the height, subtracting chronological age- and gender-appropriate mean height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population. |
| Change From Baseline in Height Standard Deviation Score (SDS) at Final Height | Baseline, final height (assessed up to Year 9.5) | Height was measured using a wall mounted device (example, Harpenden stadiometer). Height SDS was obtained by measuring the height, subtracting chronological age- and gender-appropriate mean height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population. |
| Change From Baseline in Predicted Height Standard Deviation Score (SDS) at Year 3 | Baseline, Year 3 | Predicted height was calculated according to Greulich and Pyle using Bayley Pinneau method. Predicted height SDS was obtained by calculating the predicted height, subtracting chronological age- and gender-appropriate mean predicted height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Baseline, Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9 | — |
| Change From Baseline in Insulin-like Growth Factor Binding Protein 3 (IGFBP3) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Baseline, Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9 | — |
| Change From Baseline in Lean Mass and Fat Mass at Year 1, 2, 3, 4, 5, 6, 7, 8 and 9 | Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9 | Lean mass and fat mass: measurements of body composition assessed using Dual Energy X-ray Absorptiometry (DEXA) scan. |
| Change From Baseline in Bone Mineralization at Year 1, 2, 3, 4, 5, 6, 7, 8 and 9 | Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9 | Bone mineralization, an estimate of the amount of mineral (such as calcium) in the bone, was assessed using DEXA scan. |
| Change From Baseline in Weight Standard Deviation Score (SDS) at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Baseline, Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9 | Body weight was measured using a balance scale. Weight SDS was obtained by measuring the weight, subtracting age- and gender- appropriate mean weight and dividing the result by standard deviation of that mean (as obtained from age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population. |
| Change From Baseline in Corticosteroid Dose at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Baseline, Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9 | — |
Countries
France
Participant flow
Recruitment details
Participants included in previous study CTN 97-8129-016 were eligible for this study.
Participants by arm
| Arm | Count |
|---|---|
| Somatropin (With Previous Somatropin Exposure) Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls. | 11 |
| Somatropin (Without Previous Somatropin Exposure) Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls. | 10 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Protocol Violation | 0 | 2 |
| Overall Study | Study terminated by sponsor | 1 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 3 |
Baseline characteristics
| Characteristic | Somatropin (With Previous Somatropin Exposure) | Somatropin (Without Previous Somatropin Exposure) | Total |
|---|---|---|---|
| Age Continuous | 8.3 years STANDARD_DEVIATION 2.6 | 8.5 years STANDARD_DEVIATION 3.3 | 8.4 years STANDARD_DEVIATION 2.9 |
| Sex: Female, Male Female | 6 Participants | 4 Participants | 10 Participants |
| Sex: Female, Male Male | 5 Participants | 6 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 11 / 11 | 9 / 10 |
| serious Total, serious adverse events | 6 / 11 | 2 / 10 |
Outcome results
Primary
Change From Baseline in Annual Rate of Growth Standard Deviation Score (SDS) at Final Height
Annual rate of growth SDS was obtained by measuring the annual growth rate, subtracting chronological age- and gender-appropriate mean annual growth rate and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.
Time frame: Baseline, final height (assessed up to Year 9.5)
Population: Data was not analyzed because of change in planned analysis after early termination of the study.
Primary
Change From Baseline in Annual Rate of Growth Standard Deviation Score (SDS) at Year 3
Annual rate of growth SDS was obtained by measuring the annual growth rate, subtracting chronological age- and gender-appropriate mean annual growth rate and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.
Time frame: Baseline, Year 3
Population: Full Analysis Set (FAS) included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Annual Rate of Growth Standard Deviation Score (SDS) at Year 3 | Baseline | -0.21 SDS |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Annual Rate of Growth Standard Deviation Score (SDS) at Year 3 | Change at Year 3 | 1.34 SDS |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Annual Rate of Growth Standard Deviation Score (SDS) at Year 3 | Baseline | -2.96 SDS |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Annual Rate of Growth Standard Deviation Score (SDS) at Year 3 | Change at Year 3 | 3.52 SDS |
Primary
Change From Baseline in Height Standard Deviation Score (SDS) at Final Height
Height was measured using a wall mounted device (example, Harpenden stadiometer). Height SDS was obtained by measuring the height, subtracting chronological age- and gender-appropriate mean height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.
Time frame: Baseline, final height (assessed up to Year 9.5)
Population: FAS included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Height Standard Deviation Score (SDS) at Final Height | Baseline | 0.96 SDS |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Height Standard Deviation Score (SDS) at Final Height | Change at Final Height | -0.43 SDS |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Height Standard Deviation Score (SDS) at Final Height | Baseline | -0.94 SDS |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Height Standard Deviation Score (SDS) at Final Height | Change at Final Height | 0.08 SDS |
Primary
Change From Baseline in Height Standard Deviation Score (SDS) at Year 3
Height was measured using a wall mounted device (example, Harpenden stadiometer). Height SDS was obtained by measuring the height, subtracting chronological age- and gender-appropriate mean height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.
Time frame: Baseline, Year 3
Population: FAS included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Height Standard Deviation Score (SDS) at Year 3 | Baseline | -0.61 SDS |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Height Standard Deviation Score (SDS) at Year 3 | Change at Year 3 | 0.73 SDS |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Height Standard Deviation Score (SDS) at Year 3 | Baseline | -2.34 SDS |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Height Standard Deviation Score (SDS) at Year 3 | Change at Year 3 | 1.21 SDS |
Primary
Change From Baseline in Predicted Height Standard Deviation Score (SDS) at Final Height
Predicted height was calculated according to Greulich and Pyle using Bayley Pinneau method. Predicted height SDS was obtained by calculating the predicted height, subtracting chronological age- and gender-appropriate mean predicted height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.
Time frame: Baseline, final height (assessed up to Year 9.5)
Population: FAS included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Predicted Height Standard Deviation Score (SDS) at Final Height | Baseline | -0.84 SDS |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Predicted Height Standard Deviation Score (SDS) at Final Height | Change at Final Height | -0.67 SDS |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Predicted Height Standard Deviation Score (SDS) at Final Height | Baseline | -1.74 SDS |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Predicted Height Standard Deviation Score (SDS) at Final Height | Change at Final Height | 0.71 SDS |
Primary
Change From Baseline in Predicted Height Standard Deviation Score (SDS) at Year 3
Predicted height was calculated according to Greulich and Pyle using Bayley Pinneau method. Predicted height SDS was obtained by calculating the predicted height, subtracting chronological age- and gender-appropriate mean predicted height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.
Time frame: Baseline, Year 3
Population: FAS included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Predicted Height Standard Deviation Score (SDS) at Year 3 | Baseline | -0.76 SDS |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Predicted Height Standard Deviation Score (SDS) at Year 3 | Change at Year 3 | 0.68 SDS |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Predicted Height Standard Deviation Score (SDS) at Year 3 | Baseline | -2.43 SDS |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Predicted Height Standard Deviation Score (SDS) at Year 3 | Change at Year 3 | 1.63 SDS |
Secondary
Change From Baseline in Bone Mineralization at Year 1, 2, 3, 4, 5, 6, 7, 8 and 9
Bone mineralization, an estimate of the amount of mineral (such as calcium) in the bone, was assessed using DEXA scan.
Time frame: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9
Population: FAS included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Bone Mineralization at Year 1, 2, 3, 4, 5, 6, 7, 8 and 9 | Baseline (n = 11, 10) | 643.00 grams |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Bone Mineralization at Year 1, 2, 3, 4, 5, 6, 7, 8 and 9 | Change at Year 1 (n = 11, 10) | 118.40 grams |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Bone Mineralization at Year 1, 2, 3, 4, 5, 6, 7, 8 and 9 | Change at Year 2 (n = 10, 9) | 231.30 grams |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Bone Mineralization at Year 1, 2, 3, 4, 5, 6, 7, 8 and 9 | Change at Year 3 (n = 7, 8) | 403.80 grams |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Bone Mineralization at Year 1, 2, 3, 4, 5, 6, 7, 8 and 9 | Change at Year 4 (n = 4, 3) | 903.20 grams |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Bone Mineralization at Year 1, 2, 3, 4, 5, 6, 7, 8 and 9 | Change at Year 5 (n = 4, 7) | 938.30 grams |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Bone Mineralization at Year 1, 2, 3, 4, 5, 6, 7, 8 and 9 | Change at Year 6 (n = 4, 5) | 998.05 grams |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Bone Mineralization at Year 1, 2, 3, 4, 5, 6, 7, 8 and 9 | Change at Year 7 (n = 1, 5) | 1408.50 grams |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Bone Mineralization at Year 1, 2, 3, 4, 5, 6, 7, 8 and 9 | Change at Year 8 (n = 0, 2) | NA grams |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Bone Mineralization at Year 1, 2, 3, 4, 5, 6, 7, 8 and 9 | Change at Year 9 (n = 2, 1) | 1210.15 grams |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Bone Mineralization at Year 1, 2, 3, 4, 5, 6, 7, 8 and 9 | Change at Year 7 (n = 1, 5) | 1206.10 grams |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Bone Mineralization at Year 1, 2, 3, 4, 5, 6, 7, 8 and 9 | Baseline (n = 11, 10) | 565.40 grams |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Bone Mineralization at Year 1, 2, 3, 4, 5, 6, 7, 8 and 9 | Change at Year 5 (n = 4, 7) | 829.00 grams |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Bone Mineralization at Year 1, 2, 3, 4, 5, 6, 7, 8 and 9 | Change at Year 1 (n = 11, 10) | 104.67 grams |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Bone Mineralization at Year 1, 2, 3, 4, 5, 6, 7, 8 and 9 | Change at Year 9 (n = 2, 1) | 1376.30 grams |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Bone Mineralization at Year 1, 2, 3, 4, 5, 6, 7, 8 and 9 | Change at Year 2 (n = 10, 9) | 272.70 grams |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Bone Mineralization at Year 1, 2, 3, 4, 5, 6, 7, 8 and 9 | Change at Year 6 (n = 4, 5) | 818.40 grams |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Bone Mineralization at Year 1, 2, 3, 4, 5, 6, 7, 8 and 9 | Change at Year 3 (n = 7, 8) | 375.27 grams |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Bone Mineralization at Year 1, 2, 3, 4, 5, 6, 7, 8 and 9 | Change at Year 8 (n = 0, 2) | 1376.05 grams |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Bone Mineralization at Year 1, 2, 3, 4, 5, 6, 7, 8 and 9 | Change at Year 4 (n = 4, 3) | 518.70 grams |
Secondary
Change From Baseline in Corticosteroid Dose at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9
Time frame: Baseline, Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9
Population: FAS included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Corticosteroid Dose at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 2.5 (n = 8, 7) | 0.04 mg |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Corticosteroid Dose at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 5 (n = 5, 7) | -3.50 mg |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Corticosteroid Dose at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 1.5 (n = 11, 8) | 0.00 mg |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Corticosteroid Dose at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 5.5 (n = 4, 5) | -1.83 mg |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Corticosteroid Dose at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 3 (n = 7, 7) | 0.00 mg |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Corticosteroid Dose at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 6 (n = 4, 5) | -1.83 mg |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Corticosteroid Dose at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 1 (n = 11, 9) | 0.00 mg |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Corticosteroid Dose at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 6.5 (n = 2, 5) | -2.46 mg |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Corticosteroid Dose at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 3.5 (n = 7, 6) | -0.75 mg |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Corticosteroid Dose at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 7 (n = 1, 5) | -2.50 mg |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Corticosteroid Dose at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 2 (n = 10, 8) | 0.00 mg |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Corticosteroid Dose at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 7.5 (n = 0, 3) | NA mg |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Corticosteroid Dose at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 4 (n = 6, 7) | -1.88 mg |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Corticosteroid Dose at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 8 (n = 0, 2) | NA mg |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Corticosteroid Dose at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 0.5 (n = 9, 10) | 0.00 mg |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Corticosteroid Dose at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 8.5 (n = 0, 1) | NA mg |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Corticosteroid Dose at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 4.5 (n = 5, 6) | -3.40 mg |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Corticosteroid Dose at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 9 (n = 2, 1) | -3.00 mg |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Corticosteroid Dose at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Baseline (n = 11, 10) | 7.50 mg |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Corticosteroid Dose at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 9 (n = 2, 1) | -7.00 mg |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Corticosteroid Dose at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Baseline (n = 11, 10) | 4.75 mg |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Corticosteroid Dose at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 0.5 (n = 9, 10) | 0.00 mg |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Corticosteroid Dose at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 1 (n = 11, 9) | -0.67 mg |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Corticosteroid Dose at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 1.5 (n = 11, 8) | 0.50 mg |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Corticosteroid Dose at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 2 (n = 10, 8) | -0.50 mg |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Corticosteroid Dose at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 2.5 (n = 8, 7) | 1.83 mg |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Corticosteroid Dose at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 3 (n = 7, 7) | 1.75 mg |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Corticosteroid Dose at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 3.5 (n = 7, 6) | 1.83 mg |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Corticosteroid Dose at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 4 (n = 6, 7) | 0.25 mg |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Corticosteroid Dose at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 4.5 (n = 5, 6) | 0.23 mg |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Corticosteroid Dose at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 5 (n = 5, 7) | -2.00 mg |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Corticosteroid Dose at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 5.5 (n = 4, 5) | 0.25 mg |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Corticosteroid Dose at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 6 (n = 4, 5) | -1.00 mg |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Corticosteroid Dose at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 6.5 (n = 2, 5) | -1.00 mg |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Corticosteroid Dose at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 7 (n = 1, 5) | -1.00 mg |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Corticosteroid Dose at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 7.5 (n = 0, 3) | -7.00 mg |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Corticosteroid Dose at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 8 (n = 0, 2) | -3.25 mg |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Corticosteroid Dose at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 8.5 (n = 0, 1) | 0.50 mg |
Secondary
Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9
Time frame: Baseline, Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9
Population: FAS included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 2.5 (n = 8, 8) | 0.0201 milligram per deciliter (mg/dL) |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 5 (n = 5, 7) | 0.0236 milligram per deciliter (mg/dL) |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 1.5 (n = 11, 9) | 0.0066 milligram per deciliter (mg/dL) |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 5.5 (n = 4, 5) | 0.0186 milligram per deciliter (mg/dL) |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 3 (n = 7, 9) | 0.0130 milligram per deciliter (mg/dL) |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 6 (n = 4, 5) | 0.0256 milligram per deciliter (mg/dL) |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 1 (n = 11, 10) | 0.0093 milligram per deciliter (mg/dL) |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 6.5 (n = 2, 5) | 0.0195 milligram per deciliter (mg/dL) |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 3.5 (n = 7, 7) | 0.0100 milligram per deciliter (mg/dL) |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 7 (n = 1, 5) | 0.0254 milligram per deciliter (mg/dL) |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 2 (n = 10, 9) | 0.0221 milligram per deciliter (mg/dL) |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 7.5 (n = 0, 3) | NA milligram per deciliter (mg/dL) |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 4 (n = 6, 7) | 0.0212 milligram per deciliter (mg/dL) |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 8 (n = 0, 2) | NA milligram per deciliter (mg/dL) |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 0.5 (n = 9, 10) | 0.0017 milligram per deciliter (mg/dL) |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 8.5 (n = 0, 1) | NA milligram per deciliter (mg/dL) |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 4.5 (n = 5, 6) | 0.0142 milligram per deciliter (mg/dL) |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 9 (n = 2, 1) | 0.0363 milligram per deciliter (mg/dL) |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Baseline (n = 11, 10) | 0.0361 milligram per deciliter (mg/dL) |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 9 (n = 2, 1) | 0.0403 milligram per deciliter (mg/dL) |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Baseline (n = 11, 10) | 0.0165 milligram per deciliter (mg/dL) |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 0.5 (n = 9, 10) | 0.0255 milligram per deciliter (mg/dL) |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 1 (n = 11, 10) | 0.0329 milligram per deciliter (mg/dL) |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 1.5 (n = 11, 9) | 0.0406 milligram per deciliter (mg/dL) |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 2 (n = 10, 9) | 0.0223 milligram per deciliter (mg/dL) |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 2.5 (n = 8, 8) | 0.0366 milligram per deciliter (mg/dL) |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 3 (n = 7, 9) | 0.0445 milligram per deciliter (mg/dL) |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 3.5 (n = 7, 7) | 0.0396 milligram per deciliter (mg/dL) |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 4 (n = 6, 7) | 0.0453 milligram per deciliter (mg/dL) |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 4.5 (n = 5, 6) | 0.0431 milligram per deciliter (mg/dL) |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 5 (n = 5, 7) | 0.0369 milligram per deciliter (mg/dL) |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 5.5 (n = 4, 5) | 0.0448 milligram per deciliter (mg/dL) |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 6 (n = 4, 5) | 0.0454 milligram per deciliter (mg/dL) |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 6.5 (n = 2, 5) | 0.0593 milligram per deciliter (mg/dL) |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 7 (n = 1, 5) | 0.0424 milligram per deciliter (mg/dL) |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 7.5 (n = 0, 3) | 0.0529 milligram per deciliter (mg/dL) |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 8 (n = 0, 2) | 0.0576 milligram per deciliter (mg/dL) |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 8.5 (n = 0, 1) | 0.0280 milligram per deciliter (mg/dL) |
Secondary
Change From Baseline in Insulin-like Growth Factor Binding Protein 3 (IGFBP3) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9
Time frame: Baseline, Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9
Population: Data were collected and reported in individual participant listing but not statistically summarized due to early termination of the study.
Secondary
Change From Baseline in Lean Mass and Fat Mass at Year 1, 2, 3, 4, 5, 6, 7, 8 and 9
Lean mass and fat mass: measurements of body composition assessed using Dual Energy X-ray Absorptiometry (DEXA) scan.
Time frame: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9
Population: Data were collected and reported in individual participant listing but not statistically summarized due to early termination of the study.
Secondary
Change From Baseline in Weight Standard Deviation Score (SDS) at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9
Body weight was measured using a balance scale. Weight SDS was obtained by measuring the weight, subtracting age- and gender- appropriate mean weight and dividing the result by standard deviation of that mean (as obtained from age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.
Time frame: Baseline, Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9
Population: FAS included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Weight Standard Deviation Score (SDS) at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Baseline (n = 11, 10) | 0.04 SDS |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Weight Standard Deviation Score (SDS) at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 5 (n = 5, 7) | 2.06 SDS |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Weight Standard Deviation Score (SDS) at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 2.5 (n = 8, 8) | 0.77 SDS |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Weight Standard Deviation Score (SDS) at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 5.5 (n = 3, 5) | 2.10 SDS |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Weight Standard Deviation Score (SDS) at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 1 (n = 11, 10) | 0.25 SDS |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Weight Standard Deviation Score (SDS) at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 6 (n = 3, 5) | 1.89 SDS |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Weight Standard Deviation Score (SDS) at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 3 (n = 7, 9) | 0.61 SDS |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Weight Standard Deviation Score (SDS) at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 6.5 (n = 2, 5) | 2.03 SDS |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Weight Standard Deviation Score (SDS) at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 0.5 (n = 9, 10) | 0.06 SDS |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Weight Standard Deviation Score (SDS) at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 7 (n = 1, 5) | 1.7 SDS |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Weight Standard Deviation Score (SDS) at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 3.5 (n = 7, 7) | 0.78 SDS |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Weight Standard Deviation Score (SDS) at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 7.5 (n = 0, 3) | NA SDS |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Weight Standard Deviation Score (SDS) at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 1.5 (n = 11, 9) | 0.34 SDS |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Weight Standard Deviation Score (SDS) at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 8 (n = 0, 2) | NA SDS |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Weight Standard Deviation Score (SDS) at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 4 (n = 6, 7) | 0.58 SDS |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Weight Standard Deviation Score (SDS) at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 8.5 (n = 0, 1) | NA SDS |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Weight Standard Deviation Score (SDS) at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 2 (n = 10, 9) | 0.46 SDS |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Weight Standard Deviation Score (SDS) at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 9 (n = 1, 1) | 2.0 SDS |
| Somatropin (With Previous Somatropin Exposure) | Change From Baseline in Weight Standard Deviation Score (SDS) at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 4.5 (n = 5, 6) | 1.46 SDS |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Weight Standard Deviation Score (SDS) at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 9 (n = 1, 1) | 1.4 SDS |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Weight Standard Deviation Score (SDS) at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Baseline (n = 11, 10) | -2.06 SDS |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Weight Standard Deviation Score (SDS) at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 0.5 (n = 9, 10) | 0.25 SDS |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Weight Standard Deviation Score (SDS) at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 1 (n = 11, 10) | 0.31 SDS |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Weight Standard Deviation Score (SDS) at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 2 (n = 10, 9) | 1.23 SDS |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Weight Standard Deviation Score (SDS) at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 2.5 (n = 8, 8) | 1.51 SDS |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Weight Standard Deviation Score (SDS) at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 3 (n = 7, 9) | 1.48 SDS |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Weight Standard Deviation Score (SDS) at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 3.5 (n = 7, 7) | 1.56 SDS |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Weight Standard Deviation Score (SDS) at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 4 (n = 6, 7) | 1.96 SDS |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Weight Standard Deviation Score (SDS) at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 4.5 (n = 5, 6) | 1.78 SDS |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Weight Standard Deviation Score (SDS) at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 5 (n = 5, 7) | 2.08 SDS |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Weight Standard Deviation Score (SDS) at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 5.5 (n = 3, 5) | 3.25 SDS |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Weight Standard Deviation Score (SDS) at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 6 (n = 3, 5) | 2.95 SDS |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Weight Standard Deviation Score (SDS) at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 6.5 (n = 2, 5) | 3.30 SDS |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Weight Standard Deviation Score (SDS) at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 7 (n = 1, 5) | 2.91 SDS |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Weight Standard Deviation Score (SDS) at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 7.5 (n = 0, 3) | 1.49 SDS |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Weight Standard Deviation Score (SDS) at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 8 (n = 0, 2) | 1.06 SDS |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Weight Standard Deviation Score (SDS) at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 8.5 (n = 0, 1) | 0.7 SDS |
| Somatropin (Without Previous Somatropin Exposure) | Change From Baseline in Weight Standard Deviation Score (SDS) at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Change at Year 1.5 (n = 11, 9) | 0.62 SDS |