Phase 2
N=33
Somatropin Therapy In Children Born Preterm But Appropriate For Gestational Age
Growth Hormone Therapy · Infant, Very Low Birth Weight
Bottom Line
View on ClinicalTrials.gov: NCT00174460 ↗Enrolled (actual)
33
Serious AEs
18.2%
Results posted
May 2009
Primary outcome: Primary: Change in Height Standard Deviation Score (SDS) After 1 Year — 1.099; 0.108 centimeters — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Somatropin (Drug); Control Arm (Other)
- Age
- Pediatric · 4+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Mar 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Height Standard Deviation Score (SDS) After 1 Year |
1.099; 0.108 | <0.001 sig |
| PRIMARY Change in Growth Velocity Standard Deviation Score (SDS) After 1 Year |
7.117; 1.502 | <0.001 sig |
| SECONDARY Change From Baseline in Growth Velocity After 1 Year and After 2 Years |
5.110; 0.695; 3.049; 3.934 | <0.001 sig |
| SECONDARY Change From Baseline in Growth Velocity SDS After 2 Years |
4.751; 5.825 | 0.141 |
| SECONDARY Change From Baseline in Height After 1 Year and After 2 Years |
10.467; 5.927; 18.908; 14.844 | <0.001 sig |
| SECONDARY Change From Baseline in Height SDS After 2 Years |
1.710; 0.991 | <0.001 sig |
| SECONDARY Change From Baseline in Body Composition (Skinfold Thickness) After 1 Year and After 2 Years: Triceps |
-2.20; 0.50; -1.30; -0.83 | <0.001 sig |
| SECONDARY Change From Baseline in Body Composition (Skinfold Thickness) After 1 Year and After 2 Years: Subscapular |
0.08; 0.46; 0.27; 0.50 | 0.364 |
| SECONDARY Change From Baseline in Body Composition (Skinfold Thickness) After 1 Year and After 2 Years: Suprailiac |
0.51; 0.45; 0.90; 0.79 | 0.959 |
| SECONDARY Change From Baseline in Volumetric Cortical Bone Mineral Density (BMD) Using Peripheral Quantitative Computed Tomography (pQCT) After 1 Year and After 2 Years |
-1.055; -0.162; 0.284; -0.433 | 0.336 |
| SECONDARY Change From Baseline in Bone Structure Using pQCT After 1 Year and 2 Years: Cortical Cross-sectional Area (CSA) |
-0.465; 0.017; -0.595; 0.609 | 0.653 |
| SECONDARY Change From Baseline in Bone Structure Using Peripheral Quantitative Computed Tomography (pQCT) After 1 Year and 2 Years: Total Cross-sectional Area (CSA) |
0.375; 0.239; 0.243; -0.049 | 0.914 |
| SECONDARY Change From Baseline in Bone Structure Using pQCT After 1 Year and 2 Years: Muscle Cross-sectional Area (CSA) |
2.084; -0.227; 2.402; 0.776 | 0.007 sig |
| SECONDARY Change From Baseline in Bone Structure Using pQCT After 1 Year and 2 Years: Cortical Thickness (CT) |
— | — |
| SECONDARY Change From Baseline in Bone Structure Using pQCT After 1 Year and 2 Years: Marrow Area (MA) |
— | — |
| SECONDARY Change From Baseline in Bone Stability Using pQCT After 1 Year and After 2 Years: Strength-strain Index (SSI) |
0.648; 0.088; 0.477; 0.363 | 0.331 |
| SECONDARY Change From Baseline in Muscle Strength: Hand Grip SDS After 1 Year and After 2 Years |
0.37; 0.28; 1.14; 0.92 | 0.844 |
| SECONDARY Number of Participants With Change in Insulin Sensitivity: Somatropin |
18; 0; 16; 0 | — |
| SECONDARY Number of Participants With Change in Insulin Sensitivity: Control Arm |
14; 1; 11; 2 | — |
| SECONDARY Growth Curve Comparison Based on Height SDS |
-2.260; -3.259; -1.638; -2.327 | <0.001 sig |
| SECONDARY Growth Curve Comparison Based on Height SDS: Control Arm |
-1.794 | — |
| SECONDARY Growth Curve Comparison Based on Height |
114.228; 109.644; 123.351; 119.788 | <0.001 sig |
| SECONDARY Growth Curve Comparison Based on Height: Control Arm |
128.049 | — |
Summary
Safety and efficacy of Somatropin will be evaluated in short children born with a list weight below 1500 g and that did not catch up to normal height at the age of 4.
Eligibility Criteria
Inclusion Criteria
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
- Prepubertal caucasian boys between 4 and 10 years of age and girls between 4 and 9 years of age.
- Girls: Tanner stage 1 breast development
- Boys: Testis volume 7 ug/l following any routine GH stimulation test).
- Written informed consent of both parents (legal guardians) and oral/written consent of subject due to age specific information.
Exclusion Criteria
Subjects presenting with any of the following will not be included in the trial:
- Other endocrine diseases except for well substituted hypothyroidism.
- Severe chronic diseases or medication that might influence linear growth or insulin sensitivity (e.g. Glucocorticoids).
- Positive GAD and IA-2 antibodies (for type 1 diabetes).
- History of malignancy
- Children who meet all of the following 4 criteria:
- actual body height = 4 years and
- growth velocity third degree or laser treatment as newborns.
- Participation in any other clinical trial during active treatment phase.
- Other severe acute or chronic medical or psychiatric condition or clinically relevant laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial.
Data sourced from ClinicalTrials.gov (NCT00174460). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.