- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00625872
Neuromuscular Changes In Small For Gestational Age Children During Somatropin Therapy (SGA-POWER)
January 27, 2012 updated by: Pfizer
Neuromuscular Changes In Small For Gestational Age (SGA) Children During Somatropin Therapy - A Prospective Randomized, Controlled, Open-Label Multicenter Trial
The planned study focuses on the effect of a one year Somatropin treatment (0.035 mg/kg/d or 0.067 mg/kg/d) in short children born SGA on neuromuscular function and cognitive performance.
Study Overview
Status
Terminated
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Berlin, Germany, 13353
- Pfizer Investigational Site
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Bonn, Germany, 53113
- Pfizer Investigational Site
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Datteln, Germany, 45711
- Pfizer Investigational Site
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Dresden, Germany, 01307
- Pfizer Investigational Site
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Erlangen, Germany, 91054
- Pfizer Investigational Site
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Essen, Germany, 45122
- Pfizer Investigational Site
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Heidelberg, Germany, 69120
- Pfizer Investigational Site
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Kiel, Germany, 24105
- Pfizer Investigational Site
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Koeln, Germany, 50937
- Pfizer Investigational Site
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Muenchen, Germany, 80337
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 10 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Pre-pubertal boys between 6 and 10 years of age or girls between 6 and 9 years of age.
- Birth length- and/or birth weight-SDS adjusted to gestational age < -2.0 (Voigt et al. 2002, Voigt et al. 2006 or Lawrence et al. 1989).
- Current height-SDS < -2.5 (Brandt/Reinken 1992) and parental adjusted height-SDS below -1 (Hermanussen and Cole 2003).
- Growth velocity SDS < 0 during the last year before inclusion (Brandt/Reinken 1988).
Exclusion Criteria:
- Severe SGA (birth weight or length < -4 SD) and clinically relevant dysmorphic features.
- Severe pre-maturity (GA < 32 weeks of gestation).
- Severe perinatal complications like asphyxia, sepsis, necrotizing enterocolitis (NEC), respiratory distress syndrome, if associated with long-term sequelae (like short bowel syndrome, bronchopulmonary dysplasia (BPD), cerebral palsy etc).
- Inability to perform one- or two leg jumps from a standing position.
- Prior GH treatment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Treatment Group
Somatropin for 12 months
|
Patients will be randomized at baseline in a 1:1 ratio into treatment group or control group.
After six months the control group will undergo GH therapy with a higher dose of 0.067 mg/kg/day, too.
All patients are treated with growth hormone for 12 months.
|
Other: Control Group
In the first 6 months no intervention, afterwards Somatropin for 12 months
|
Patients will be randomized at baseline in a 1:1 ratio into treatment group or control group.
After six months the control group will undergo GH therapy with a higher dose of 0.067 mg/kg/day, too.
All patients are treated with growth hormone for 12 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Peak Jump Power Standard Deviation Score (PJP-SDS; Two-leg-jump) in Full Analysis Set (FAS) Population at Month 6
Time Frame: Baseline and Month 6
|
Peak jump power (PJP) was defined as the peak of the calculated power (force multiplied by velocity).
It was measured by Leonardo Jumping Platform during two-leg jump.
The participant performs 3 jumps and the highest peak (PJP) of the 3 recordings was selected for further calculations.
The SDS indicates how similar the participant was to the reference population.
|
Baseline and Month 6
|
Change From Baseline in Peak Jump Power Standard Deviation Score (PJP-SDS; Two-leg-jump) in Per Protocol (PP) Population at Month 6
Time Frame: Baseline and Month 6
|
PJP was defined as the peak of the calculated power (force multiplied by velocity).
It was measured by Leonardo Jumping Platform during two-leg jump.
The participant performs 3 jumps and the highest peak (PJP) of the 3 recordings was selected for further calculations.
The SDS indicates how similar the participant was to the reference population.
|
Baseline and Month 6
|
Change From Baseline in Peak Jump Force Standard Deviation Score (PJF-SDS; Two-leg-jump) in Full Analysis Set (FAS) Population at Month 6
Time Frame: Baseline and Month 6
|
PJF was defined as the maximum of force of the ascending part of the jump which the participant performed as a counter-movement jump with freely moving arms and as high as possible with the head and chest.
It was measured by Leonardo Jumping Platform during two-leg jump.
The SDS indicates how similar the participant was to the reference population.
|
Baseline and Month 6
|
Change From Baseline in Peak Jump Force Standard Deviation Score (PJF-SDS; Two-leg-jump) in Per Protocol (PP) Population at Month 6
Time Frame: Baseline and Month 6
|
PJF was defined as the maximum of force of the ascending part of the jump which the participant performed as a counter-movement jump with freely moving arms and as high as possible with the head and chest.
It was measured by Leonardo Jumping Platform during two-leg jump.
The SDS indicates how similar the participant was to the reference population.
|
Baseline and Month 6
|
Change From Baseline in Maximum Jump Velocity (Vmax; Two-leg-jump) in Full Analysis Set (FAS) Population at Month 6
Time Frame: Baseline and Month 6
|
Vmax was measured by Leonardo Jumping Platform during two-leg jump.
|
Baseline and Month 6
|
Change From Baseline in Maximum Jump Velocity (Vmax; Two-leg-jump) in Per Protocol (PP) Population at Month 6
Time Frame: Baseline and Month 6
|
Vmax was measured by Leonardo Jumping Platform during two-leg jump.
|
Baseline and Month 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Intellectual Performance of Children Using Kaufmann-Assessment Battery for Children (K-ABC) Test Global Scales at Month 6
Time Frame: Baseline and Month 6
|
K-ABC was assessed in children between 2.5-12.5 years.
Comprised of 16 subtests; 10 mental processing (intelligence) and 6 achievement subtests.
Achievement subtests: expressive vocabulary, faces&places, arithmetic, riddles, reading/decoding, reading/comprehension.
Sixteen subtests were weighted accordingly to form 5 global scales: sequential processing, simultaneous processing, achievement, non-verbal and mental processing composite.
Scores were rated as upper extreme [greater than (>) 131], above average (116-130), average (85-115), below average (70-84), lower extreme [less than (<) 69].
|
Baseline and Month 6
|
Change From Baseline in Intellectual Performance of Children Using Kaufmann-Assessment Battery for Children (K-ABC) Test Global Scales at Months 12 and 18
Time Frame: Baseline, Month 12 and Month 18
|
K-ABC was assessed in children between 2.5-12.5 years.
Comprised of 16 subtests; 10 mental processing (intelligence) and 6 achievement subtests.
Achievement subtests: expressive vocabulary, faces&places, arithmetic, riddles, reading/decoding, reading/comprehension.
Sixteen subtests were weighted accordingly to form 5 global scales: sequential processing, simultaneous processing, achievement, non-verbal and mental processing composite.
Scores were rated as upper extreme [greater than (>) 131], above average (116-130), average (85-115), below average (70-84), lower extreme [less than (<) 69].
|
Baseline, Month 12 and Month 18
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Change From Baseline in Intellectual Performance of Children Using Kinderversion Der Testbatterie Zur Aufmerksamkeitsprüfung für Kinder (KITAP) Test at Month 6
Time Frame: Baseline and Month 6
|
The KITAP is a computer aided standardized neuro-cognitive development test which allows examination of a wide range of attention and executive functions such as shift of attention (Distractibility); simple reaction time (Alertness); "Sustained Attention", change of reaction (Flexibility); "Divided Attention", controlled reaction disposition (Go/No go) and "Vigilance".
It has been designed appropriately for children between the age of 6 to 10 years to allow optimal motivation during testing and to increase validity of results.
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Baseline and Month 6
|
Change From Baseline in Intellectual Performance of Children Using Kinderversion Der Testbatterie Zur Aufmerksamkeitsprüfung für Kinder (KITAP) Test at Months 12 and 18
Time Frame: Baseline, Month 12 and Month 18
|
The KITAP is a computer aided standardized neuro-cognitive development test which allows examination of a wide range of attention and executive functions such as shift of attention (Distractibility); simple reaction time (Alertness); "Sustained Attention", change of reaction (Flexibility); "Divided Attention", controlled reaction disposition (Go/No go) and "Vigilance".
It has been designed appropriately for children between the age of 6 to 10 years to allow optimal motivation during testing and to increase validity of results.
|
Baseline, Month 12 and Month 18
|
Change From Baseline in Intellectual Performance of Children Using Non-verbal Learning Test (NVLT) at Month 6
Time Frame: Baseline and Month 6
|
NVLT was assessed for visual memorization that was difficult to verbalize.
Test recorded instability index, T-scores[sum of differences of correct {C} - incorrect {IC} "Yes" answers(1);sum of C "Yes" answers(2);sum of IC "Yes" answers(3);sum of differences of C-IC "Yes" answers with high associative items{ 87%-95%}(4);sum of differences of C-IC "Yes" answers with low associative items{ 54%-64%}(5); difference between difference values for high and low associative items(6)].Scores were rated as below average(<40), average(40-60), above average(>60) and working time ranging between 9-12 minutes.
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Baseline and Month 6
|
Change From Baseline in Intellectual Performance of Children Using Non-verbal Learning Test (NVLT) at Months 12 and 18
Time Frame: Baseline, Month 12 and Month 18
|
NVLT was assessed for visual memorization that was difficult to verbalize.
Test recorded instability index, T-scores[sum of differences of correct {C} - incorrect {IC} "Yes" answers(1);sum of C "Yes" answers(2);sum of IC "Yes" answers(3);sum of differences of C-IC "Yes" answers with high associative items{ 87%-95%}(4);sum of differences of C-IC "Yes" answers with low associative items{ 54%-64%}(5); difference between difference values for high and low associative items(6)].Scores were rated as below average(<40), average(40-60), above average(>60) and working time ranging between 9-12 minutes.
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Baseline, Month 12 and Month 18
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Change From Baseline in Intellectual Performance of Children Using Child Behavior Checklist 4-18 Years (CBCL 4-18) at Months 6, 12 and 18
Time Frame: Baseline, Month 6, Month 12 and Month 18
|
CBCL was standardized for children ages 4 to 18 years and measured child internalizing and externalizing behaviors and total problems.
The 4-18 years' checklist contains 140 questions and responses were recorded on a Likert scale: 0 = Not True, 1 = Somewhat or Sometimes True, 2 = Very True or Often True.
The range of possible values was 0-280 (0=good to 280=worst).
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Baseline, Month 6, Month 12 and Month 18
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Change From Baseline in Peak Jump Power Standard Deviation Score (PJP-SDS; One-leg-jump) at Months 6, 12 and 18
Time Frame: Baseline, Month 6 , Month 12 and Month 18
|
PJP was defined as the peak of the calculated power (force multiplied by velocity).
It was measured by Leonardo Jumping Platform during one leg jump.
The participant performs 3 jumps and the highest peak (PJP) of the 3 recordings was selected for further calculations.
The SDS indicates how similar the participant was to the reference population.
|
Baseline, Month 6 , Month 12 and Month 18
|
Change From Baseline in Peak Jump Force Standard Deviation Score (PJF-SDS; One-leg-jump) at Months 6, 12 and 18
Time Frame: Baseline, Month 6, Month 12 and Month 18
|
PJF was defined as the maximum of force of the ascending part of the jump which the participant performed as a counter-movement jump with freely moving arms and as high as possible with the head and chest.
It was measured by Leonardo Jumping Platform during one leg jump.
The SDS indicates how similar the participant was to the reference population.
|
Baseline, Month 6, Month 12 and Month 18
|
Change From Baseline in Maximum Jump Velocity (Vmax; One-leg-jump) at Months 6, 12 and 18
Time Frame: Baseline, Month 6, Month 12 and Month 18
|
Vmax was measured by Leonardo Jumping Platform during one leg jump.
|
Baseline, Month 6, Month 12 and Month 18
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Change From Baseline in Five-chair Rising Test- Peak Jump Power (PJP) at Month 6
Time Frame: Baseline and Month 6
|
The Chair rising test is a performance test (total power output) to measure neuromuscular function of complex movement in standing up.
Test allows diagnostics of movement deficits using Leonardo jump plate.
Five stand up test: five repetitions of rising from a chair on jump plate as quickly as possible with arms crossed over the chest (time to perform the tasks, maximal PJP, maximal velocity and maximal PJF).
PJP is defined as the peak of the calculated power (force multiplied by velocity).
|
Baseline and Month 6
|
Change From Baseline in Five-chair Rising Test-Peak Jump Power (PJP) at Months 12 and 18
Time Frame: Baseline, Month 12 and Month 18
|
The Chair rising test is a performance test (total power output) to measure neuromuscular function of complex movement in standing up.
Test allows diagnostics of movement deficits using Leonardo jump plate.
Five stand up test: five repetitions of rising from a chair on jump plate as quickly as possible with arms crossed over the chest (time to perform the tasks, maximal PJP, maximal velocity and maximal PJF).
PJP is defined as the peak of the calculated power (force multiplied by velocity).
|
Baseline, Month 12 and Month 18
|
Change From Baseline in Five-chair Rising Test-Peak Jump Force (PJF) at Month 6
Time Frame: Baseline and Month 6
|
The Chair rising test is a performance test (total power output) to measure neuromuscular function of complex movement in standing up.
Test allows diagnostics of movement deficits using Leonardo jump plate.
Five stand up test: five repetitions of rising from a chair on jump plate as quickly as possible with arms crossed over the chest (time to perform the tasks, maximal PJP, maximal velocity and maximal PJF).
PJF is the maximum force of the ascending part of the jump which the participant performed as a counter-movement jump with freely moving arms as high as possible with the head and chest.
|
Baseline and Month 6
|
Change From Baseline in Five-chair Rising Test-Peak Jump Force (PJF) at Months 12 and 18
Time Frame: Baseline, Month 12 and Month 18
|
The Chair rising test is a performance test (total power output) to measure neuromuscular function of complex movement in standing up.
Test allows diagnostics of movement deficits using Leonardo jump plate.
Five stand up test: five repetitions of rising from a chair on jump plate as quickly as possible with arms crossed over the chest (time to perform the tasks, maximal PJP, maximal velocity and maximal PJF).
PJF is the maximum force of the ascending part of the jump which the participant performed as a counter-movement jump with freely moving arms as high as possible with the head and chest.
|
Baseline, Month 12 and Month 18
|
Change From Baseline in Five-chair Rising Test-Maximum Jump Velocity (Vmax) at Month 6
Time Frame: Baseline and Month 6
|
The Chair rising test is a performance test (total power output) to measure neuromuscular function of complex movement in standing up.
Test allows diagnostics of movement deficits using Leonardo jump plate.
Five stand up test: five repetitions of rising from a chair on jump plate as quickly as possible with arms crossed over the chest (time to perform the tasks, maximal PJP, maximal velocity and maximal PJF).
Vmax is defined as the maximum jump velocity.
|
Baseline and Month 6
|
Change From Baseline in Five-chair Rising Test-Maximum Jump Velocity (Vmax) at Months 12 and 18
Time Frame: Baseline, Month 12 and Month 18
|
The Chair rising test is a performance test (total power output) to measure neuromuscular function of complex movement in standing up.
Test allows diagnostics of movement deficits using Leonardo jump plate.
Five stand up test: five repetitions of rising from a chair on jump plate as quickly as possible with arms crossed over the chest (time to perform the tasks, maximal PJP, maximal velocity and maximal PJF).
Vmax is defined as the maximum jump velocity.
|
Baseline, Month 12 and Month 18
|
Change From Baseline in Five-chair Rising Test (Time to Perform the Tasks) at Month 6
Time Frame: Baseline and Month 6
|
Chair rising test is performance test (total power output) to measure neuromuscular function of complex movement in standing up.
Test allows diagnostics of movement deficits using Leonardo jump plate.
Five stand up test: 5 repetitions of rising from a chair on jump plate as quickly as possible with arms crossed over chest (time to perform tasks, maximal PJP, maximal velocity and maximal PJF).
Time to perform task includes: Average (avg) rise time which is avg time to perform 1 rise, avg time per test is the avg time to perform 1 test (rise and sitting down) and total time to perform 5 tests.
|
Baseline and Month 6
|
Change From Baseline in Five-chair Rising Test (Time to Perform the Tasks) at Months 12 and 18
Time Frame: Baseline, Month 12 and Month 18
|
Chair rising test is performance test (total power output) to measure neuromuscular function of complex movement in standing up.
Test allows diagnostics of movement deficits using Leonardo jump plate.
Five stand up test: 5 repetitions of rising from a chair on jump plate as quickly as possible with arms crossed over chest (time to perform tasks, maximal PJP, maximal velocity and maximal PJF).
Time to perform task includes: Average (avg) rise time which is avg time to perform 1 rise, avg time per test is the avg time to perform 1 test (rise and sitting down) and total time to perform 5 tests.
|
Baseline, Month 12 and Month 18
|
Change From Baseline in One-chair Rising Test-Peak Jump Power (PJP) at Months 6, 12 and 18
Time Frame: Baseline, Month 6 , Month 12 and Month 18
|
The Chair rising test is a performance test (total power output) to measure neuromuscular function of complex movement to stand up.
Test allows diagnostics of movement deficits using Leonardo jump plate.
One stand up test: rising from a chair on the jump plate as quickly as possible with arms crossed over the chest (analysis of time, PJP, PJF and time of fastest rising).
PJP is defined as the peak of the calculated power (force multiplied by velocity).
|
Baseline, Month 6 , Month 12 and Month 18
|
Change From Baseline in One-chair Rising Test-Peak Jump Force (PJF) at Months 6, 12 and 18
Time Frame: Baseline, Month 6 , Month 12 and Month 18
|
The Chair rising test is a performance test (total power output) to measure neuromuscular function of complex movement to stand up.
Test allows diagnostics of movement deficits using Leonardo jump plate.
One stand up test: rising from a chair on the jump plate as quickly as possible with arms crossed over the chest (analysis of time, PJP, PJF and time of fastest rising).
PJF is the maximum force of the ascending part of the jump which the participant performed as a counter-movement jump with freely moving arms as high as possible with the head and chest.
|
Baseline, Month 6 , Month 12 and Month 18
|
Change From Baseline in One-chair Rising Test (Time to Perform the Tasks) at Months 6, 12 and 18
Time Frame: Baseline, Month 6 , Month 12 and Month 18
|
The Chair rising test is a performance test (total power output) to measure neuromuscular function of complex movement to stand up.
Test allows diagnostics of movement deficits using Leonardo jump plate.
One stand up test: rising from a chair on the jump plate as quickly as possible with arms crossed over the chest (analysis of time, PJP, PJF and time of fastest rising).
|
Baseline, Month 6 , Month 12 and Month 18
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Change From Baseline in Maximal Isometric Grip Force-Standard Deviation Score (MIGF-SDS) at Month 6
Time Frame: Baseline and Month 6
|
MIGF was assessed using standard adjustable Jamar dynamometer.
MIGF (in Newtons) was calculated by multiplying the dynamometer reading (in kilograms) by a factor of 9.81.
The SDS indicates how similar the participant was to the reference population.
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Baseline and Month 6
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Change From Baseline in Maximal Isometric Grip Force-Standard Deviation Score (MIGF-SDS) at Months 12 and 18
Time Frame: Baseline, Month 12 and Month 18
|
MIGF was assessed using standard adjustable Jamar dynamometer.
MIGF (in Newtons) was calculated by multiplying the dynamometer reading (in kilograms) by a factor of 9.81.
The SDS indicates how similar the participant was to the reference population.
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Baseline, Month 12 and Month 18
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Mean Upper Arm Circumference
Time Frame: Baseline, Month 6, Month 12 and Month 18
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Baseline, Month 6, Month 12 and Month 18
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Mean Thigh Circumference
Time Frame: Baseline, Month 6, Month 12 and Month 18
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Thigh measurements were taken as a mean of 3 consecutive measurements at upper thigh about an inch down from the crotch line.
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Baseline, Month 6, Month 12 and Month 18
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Mean Calf Circumference
Time Frame: Baseline, Month 6, Month 12 and Month 18
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Calf measurements were taken as a mean of 3 consecutive measurements at largest part of calf muscle, usually about 4 inches down from below the knee.
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Baseline, Month 6, Month 12 and Month 18
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Mean Height at Month 6
Time Frame: Month 6
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Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer.
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Month 6
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Mean Height at Months 12 and 18
Time Frame: Month 12 and Month 18
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Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer.
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Month 12 and Month 18
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Mean Growth Velocity at Month 6
Time Frame: Month 6
|
Growth velocity measures the annual rate of increase in height.
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Month 6
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Mean Growth Velocity at Months 12 and 18
Time Frame: Month 12 and Month 18
|
Growth velocity measures the annual rate of increase in height.
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Month 12 and Month 18
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Mean Height-Standard Deviation Score (SDS) at Month 6
Time Frame: Month 6
|
Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer.
The SDS indicates how similar the participant was to the reference population.
|
Month 6
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Mean Height-Standard Deviation Score (SDS) at Months 12 and 18
Time Frame: Month 12 and Month 18
|
Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer.
The SDS indicates how similar the participant was to the reference population.
|
Month 12 and Month 18
|
Mean Growth Velocity-Standard Deviation Score (SDS) at Month 6
Time Frame: Month 6
|
Growth velocity measures the annual rate of increase in height.
The SDS indicates how similar the participant is to the reference population.
|
Month 6
|
Mean Growth Velocity-Standard Deviation Score (SDS) at Months 12 and 18
Time Frame: Month 12 and Month 18
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Month 12 and Month 18
|
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Change From Baseline in Height-Standard Deviation Score (SDS) at Month 6
Time Frame: Baseline and Month 6
|
Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer.
The SDS indicates how similar the participant was to the reference population.
|
Baseline and Month 6
|
Change From Baseline in Height-Standard Deviation Score (SDS) at Months 12 and 18
Time Frame: Baseline, Month 12 and Month 18
|
Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer.
The SDS indicates how similar the participant was to the reference population.
|
Baseline, Month 12 and Month 18
|
Change From Baseline in Growth Velocity-Standard Deviation Score (SDS) at Month 6
Time Frame: Baseline and Month 6
|
Growth velocity measures the annual rate of increase in height.
The SDS indicates how similar the participant is to the reference population.
|
Baseline and Month 6
|
Change From Baseline in Growth Velocity-Standard Deviation Score (SDS) at Months 12 and 18
Time Frame: Baseline, Month 12 and Month 18
|
Growth velocity measures the annual rate of increase in height.
The SDS indicates how similar the participant is to the reference population.
|
Baseline, Month 12 and Month 18
|
Sitting Height-Standard Deviation Score (SDS)
Time Frame: Baseline, Month 6, Month 12 and Month 18
|
Sitting height was measured using a stadiometer with a specialized chair.
The SDS indicates how similar the participant was to the reference population.
|
Baseline, Month 6, Month 12 and Month 18
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Body Mass Index-Standard Deviation Score (BMI-SDS)
Time Frame: Baseline, Month 6, Month 12 and Month 18
|
The BMI was used to measure body fat based on height and weight.
It was calculated by body weight (kg) divided by the height (m) squared.
The SDS indicates how similar the participant was to the reference population.
|
Baseline, Month 6, Month 12 and Month 18
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Change From Baseline in Head Circumference at Months 6, 12 and 18
Time Frame: Baseline, Month 6, Month 12 and Month 18
|
The maximum head circumference (usually horizontal just above the eyebrow ridges), was measured from just above the glabella area to the area near the top of the occipital bone (opisthocranion).
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Baseline, Month 6, Month 12 and Month 18
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Change From Baseline in Head Circumference-Standard Deviation Score (SDS) at Months 6, 12 and 18
Time Frame: Baseline, Month 6, Month 12 and Month 18
|
The maximum head circumference (usually horizontal just above the eyebrow ridges), was measured from just above the glabella area to the area near the top of the occipital bone (opisthocranion).
The SDS indicates how similar the participant was to the reference population.
|
Baseline, Month 6, Month 12 and Month 18
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Change From Baseline in Skinfold Thickness-Standard Deviation Score (SDS) at Month 6
Time Frame: Baseline and Month 6
|
Triceps, supra-iliac and subscapular skinfolds were measured on the right side of the body to the nearest 0.1 mm with a Holtain skinfold caliper.
The measurement was performed at the left side of the participant.
Triceps skinfold thickness was measured halfway down the left upper arm, while the arm was hanging relaxed at the participant's side.
Suprascapular skinfold was measured laterally just below the angle of the left scapula.
Suprailiac skinfold was measured just above the iliac crest in the middle-axillary line.
SDS indicates how similar the participant was to the reference population.
|
Baseline and Month 6
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Change From Baseline in Skinfold Thickness-Standard Deviation Score (SDS) at Months 12 and 18
Time Frame: Baseline, Month 12 and Month 18
|
Triceps, supra-iliac and subscapular skinfolds were measured on the right side of the body to the nearest 0.1 mm with a Holtain skinfold caliper.
The measurement was performed at the left side of the participant.
Triceps skinfold thickness was measured halfway down the left upper arm, while the arm was hanging relaxed at the participant's side.
Suprascapular skinfold was measured laterally just below the angle of the left scapula.
Suprailiac skinfold was measured just above the iliac crest in the middle-axillary line.
SDS indicates how similar the participant was to the reference population.
|
Baseline, Month 12 and Month 18
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Bone Density Using Peripheral Quantitative Computed Tomography (pqCT) at 6 or 12 or 18 Months
Time Frame: Baseline, Month 6, Month 12 and Month 18
|
Bone Mineral Density (BMD) was measured by pqCT.
The Z-score measures the distance of the measured BMD value from the appropriate normal age matched population mean value in units of standard deviation of this population.
More negative scores indicate less BMD compared to age matched population and more positive scores indicate higher BMD compared to age matched population.
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Baseline, Month 6, Month 12 and Month 18
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Change From Baseline in Bone Structure Using Peripheral Quantitative Computed Tomography (pqCT) at 6 or 12 or 18 Months
Time Frame: Baseline, Month 6, Month 12 and Month 18
|
Bone structure was measured by pqCT.Parameters included:total area,cortical area,marrow area,cortical thickness,cortical density of the radius,bone strength,cross-sectional muscle and fat area,total bone density,bone mineral count,trabecular BMD,bone cross-sectional area.Baseline and post-baseline SDS values transformed to age and sex specific z-score([Ln(test result/M)]/S);Ln=natural logarithm;M=age-/height- and sex-specific mean value;S=age-/height- and sex-specific coefficient of variation).Positive values are above the average for participant's age and sex;negative values are below.
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Baseline, Month 6, Month 12 and Month 18
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Change From Baseline in Bone Stability Using Peripheral Quantitative Computed Tomography (pqCT) at 6 or 12 or 18 Months
Time Frame: Baseline, Month 6, Month 12 and Month 18
|
Bone stability was measured by pqCT.
Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)]/S); Ln=natural logarithm; M=age- (or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated.
Positive values are above the average for participant's age and sex; negative values are below the average.
|
Baseline, Month 6, Month 12 and Month 18
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (Actual)
March 1, 2011
Study Completion (Actual)
March 1, 2011
Study Registration Dates
First Submitted
February 19, 2008
First Submitted That Met QC Criteria
February 19, 2008
First Posted (Estimate)
February 28, 2008
Study Record Updates
Last Update Posted (Estimate)
February 29, 2012
Last Update Submitted That Met QC Criteria
January 27, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- A6281283
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Infant, Small for Gestational Age
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GeneScience Pharmaceuticals Co., Ltd.The First Affiliated Hospital with Nanjing Medical University; Tongji Hospital and other collaboratorsUnknownSmall for Gestational Age InfantChina
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Eli Lilly and CompanyCompletedInfant, Small for Gestational AgeGermany
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Dong-A ST Co., Ltd.CompletedInfant, Small for Gestational AgeKorea, Republic of
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PfizerCompletedInfant, Small for Gestational AgeCzech Republic, Spain, Sweden, Netherlands, Belgium, France, Germany, Italy, Switzerland
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GeneScience Pharmaceuticals Co., Ltd.The First Affiliated Hospital with Nanjing Medical University; Tongji Hospital and other collaboratorsCompletedSmall for Gestational Age InfantChina
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Merck KGaA, Darmstadt, GermanyMerck Serono S.P.A., ItalyTerminated
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PfizerWithdrawnInfant, Small for Gestational Age
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International Centre for Diarrhoeal Disease Research...University of California, DavisCompletedSmall for Gestational Age at Delivery | Post-term Infant, Not Heavy-for-datesBangladesh
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Merck KGaA, Darmstadt, GermanyMerck Serono S.A.S, FranceCompletedInfant, Small for Gestational AgeFrance
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Tel-Aviv Sourasky Medical CenterUnknownSmall for Gestational Age Infants | Appropriate for Gestational Age InfantsIsrael
Clinical Trials on Somatropin
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Xiamen Amoytop Biotech Co., Ltd.Peking Union Medical College HospitalCompleted
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PfizerActive, not recruitingPrader-Willi SyndromeJapan
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GeneScience Pharmaceuticals Co., Ltd.The First Affiliated Hospital with Nanjing Medical University; Tongji Hospital and other collaboratorsActive, not recruiting
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PfizerCompletedGrowth Hormone DeficiencyFrance
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Novo Nordisk A/SCompletedNoonan Syndrome | Genetic DisorderSweden
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Novo Nordisk A/SCompletedNoonan Syndrome | Genetic DisorderJapan
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LG ChemCompletedBioavailability, Safety and Tolerability Among Different Eutropin Formulations in Healthy VolunteersKorea, Republic of
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Novo Nordisk A/SCompletedFoetal Growth Problem | Small for Gestational AgeJapan
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Novo Nordisk A/SCompletedAchondroplasia | Genetic DisorderJapan
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Novo Nordisk A/SCompletedNoonan Syndrome | Genetic DisorderSweden