Primary outcomeLeast squares mean· Baseline to 1 year (Month 12)
Change in Height Standard Deviation Score (SDS) After 1 Year
| Group | Value (centimeters) | Spread |
|---|---|---|
| Somatropin | 1.099 | 0.0714 |
| Control Arm | 0.108 | 0.0783 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataSomatropin Therapy In Children Born Preterm But Appropriate For Gestational Age
Short name AGA
NCTNCT00174460 (opens ClinicalTrials.gov in a new tab)Other idA6281273
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 33 participants (actual)
- Sponsor
- Pfizer · Industry
- Design
- Randomized · Open label (no masking)
- Countries
1 country
Germany
- Start
- Aug 2005
- Primary completion
- Mar 2008
- Completion
- Mar 2010
- First posted
- 15 Sept 2005 (estimated)
- Last update posted
- 5 Apr 2017
- Conditions
- Growth Hormone Therapy · Infant, Very Low Birth Weight
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2005200620072008200920102011
- Ph 2
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- SomatropinDrug
- Control ArmOther
Arms2
Active comparator
Treatment Arm
No intervention
Control Arm
Primary outcomes2
Outcomes the sponsor listed as primary.
Change in Height Standard Deviation Score (SDS) After 1 Year
Time frame · Baseline to 1 year (Month 12)
Registry description
Change in Height SDS after 1 year where SDS=height minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference).
Change in Growth Velocity Standard Deviation Score (SDS) After 1 Year
Time frame · Baseline to 1 year (Month 12)
Registry description
Change in Growth Velocity (GV) SDS after 1 year where SDS=GV minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference).
Secondary outcomes(20)
Change From Baseline in Growth Velocity After 1 Year and After 2 Years
Time frame · Baseline, Month 12, Month 24
Registry description
Growth velocity measured as centimeters per year.
Change From Baseline in Growth Velocity SDS After 2 Years
Time frame · Baseline, Month 24
Registry description
Change in Growth Velocity SDS after 2 years (24 months) where SDS = growth velocity minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference).
Change From Baseline in Height After 1 Year and After 2 Years
Time frame · Baseline, Month 12, Month 24
Change From Baseline in Height SDS After 2 Years
Time frame · Baseline, Month 24
Registry description
Change in Height SDS after 2 years (24 months) where SDS = height minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference).
Change From Baseline in Body Composition (Skinfold Thickness) After 1 Year and After 2 Years: Triceps
Time frame · Baseline, Month 12, Month 24
Registry description
Body composition measured as skinfold thickness at tricep in millimeters (mm); measured halfway down the left upper arm with arm hanging in relaxed position at participant's side.
Change From Baseline in Body Composition (Skinfold Thickness) After 1 Year and After 2 Years: Subscapular
Time frame · Baseline, Month 12, Month 24
Registry description
Body composition measured as subscapular skinfold thickness in millimeters (mm); measured laterally just below the angle of the left scapula.
Change From Baseline in Body Composition (Skinfold Thickness) After 1 Year and After 2 Years: Suprailiac
Time frame · Baseline, Month 12, Month 24
Registry description
Body composition measured as suprailiac skinfold thickness in millimeters (mm); measured just above the iliac crest in the middle-axillary line.
Change From Baseline in Volumetric Cortical Bone Mineral Density (BMD) Using Peripheral Quantitative Computed Tomography (pQCT) After 1 Year and After 2 Years
Time frame · Baseline, Month 12, Month 24
Registry description
Volumetric Cortical BMD measured as milligrams per cubic millimeter (mg/mm3). BMD (proximal radius) SDS (number of standard deviations a participant's BMD differs from the average BMD of their age and sex). 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.
Change From Baseline in Bone Structure Using pQCT After 1 Year and 2 Years: Cortical Cross-sectional Area (CSA)
Time frame · Baseline, Month 12, Month 24
Registry description
Bone structure Cortical CSA measured as millimeters squared (mm2). CSA (proximal radius) SDS (number of standard deviations a participant's CSA differs from the average CSA of their age and sex). 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.
Change From Baseline in Bone Structure Using Peripheral Quantitative Computed Tomography (pQCT) After 1 Year and 2 Years: Total Cross-sectional Area (CSA)
Time frame · Baseline, Month 12, Month 24
Registry description
Bone structure Total CSA measured as millimeters squared (mm2). Total CSA (proximal radius) SDS (number of standard deviations a participant's CSA differs from the average CSA of their age and sex). 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.
Change From Baseline in Bone Structure Using pQCT After 1 Year and 2 Years: Muscle Cross-sectional Area (CSA)
Time frame · Baseline, Month 12, Month 24
Registry description
Bone structure Muscle CSA measured as millimeters squared (mm2). CSA (proximal radius) SDS (number of standard deviations a participant's CSA differs from the average CSA of their age and sex). 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.
Change From Baseline in Bone Structure Using pQCT After 1 Year and 2 Years: Cortical Thickness (CT)
Time frame · Baseline, Month 12, Month 24
Registry description
Cortical Thickness measured as millimeters (mm). CT (proximal radius) SDS (number of standard deviations a participant's CT differs from the average CT of their age and sex). 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.
Change From Baseline in Bone Structure Using pQCT After 1 Year and 2 Years: Marrow Area (MA)
Time frame · Baseline, Month 12, Month 24
Registry description
Marrow Area measured as millimeters squared (mm2). MA (proximal radius) SDS (number of standard deviations a participant's MA differs from the average MA of their age and sex). 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.
Change From Baseline in Bone Stability Using pQCT After 1 Year and After 2 Years: Strength-strain Index (SSI)
Time frame · Baseline, Month 12, Month 24
Registry description
Bone stability expressed as polar SSI in cubic millimeters (mm3). SSI (proximal radius) SDS (number of standard deviations a participant's SSI differs from the average SSI of their age and sex). 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.
Change From Baseline in Muscle Strength: Hand Grip SDS After 1 Year and After 2 Years
Time frame · Baseline, Month 12, Month 24
Registry description
Muscle strength determined by measuring grip force (kilograms) using hand grip dynamometer for participants ≥6 years of age. Baseline and post-baseline SDS values transformed to age and sex specific z-score. Change in hand grip calculated as SDS where SDS = hand grip minus mean (age- and sex-matched reference) divided by SD (age- and sex-matched reference). Positive values are above the average for participant's age and sex; negative values are below the average.
Number of Participants With Change in Insulin Sensitivity: Somatropin
Time frame · Baseline, Month 24
Registry description
Insulin sensitivity calculated as incidence of pathological glucose intolerance assessed prior to randomization (Screening Day -3 to Baseline Day 0) and at final visit (final visit: Somatropin treatment group=Month 24). Pathological glucose intolerance (oral glucose tolerance test) measured as venous (blood or plasma) with range minimum 120 milligrams per deciliter (mg/dL) to \>140 mg/dL; capillary (blood) with range minimum 120 mg/dL to \>120 mg/dL; or method not known with range minimum 120 mg/dL to \>120 mg/dL.
Number of Participants With Change in Insulin Sensitivity: Control Arm
Time frame · Baseline, Month 36
Registry description
Insulin sensitivity calculated as incidence of pathological glucose intolerance assessed prior to randomization (Screening Day -3 to Baseline Day 0) and at final visit (final visit: Control Arm=Month 36). Pathological glucose intolerance (oral glucose tolerance test) measured as venous (blood or plasma) with range minimum 120 milligrams per deciliter (mg/dL) to \>140 mg/dL; capillary (blood) with range minimum 120 mg/dL to \>120 mg/dL; or method not known with range minimum 120 mg/dL to \>120 mg/dL.
Growth Curve Comparison Based on Height SDS
Time frame · Month 12, Month 24
Registry description
Growth curve comparison with height SDS in centimeters as the dependent variable; SDS = height minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference).
Growth Curve Comparison Based on Height SDS: Control Arm
Time frame · Month 36
Registry description
Growth curve comparison with height SDS in centimeters as the dependent variable; SDS = height minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference). Control Arm final visit=Month 36.
Growth Curve Comparison Based on Height
Time frame · Month 12, Month 24
Registry description
Growth curve comparison with height in centimeters as the dependent variable.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeLeast squares mean· Baseline, Month 12, Month 24
Change From Baseline in Growth Velocity After 1 Year and After 2 Years
| Group | Value (centimeters per year) | Spread |
|---|---|---|
| Somatropin | 5.110 | 0.2623 |
| Control Arm | 0.695 | 0.2881 |
Secondary outcomeLeast squares mean· Baseline, Month 24
Change From Baseline in Growth Velocity SDS After 2 Years
| Group | Value (centimeters per year) | Spread |
|---|---|---|
| Somatropin | 4.751 | 0.4716 |
| Control Arm | 5.825 | 0.5177 |
Secondary outcomeLeast squares mean· Baseline, Month 12, Month 24
Change From Baseline in Height After 1 Year and After 2 Years
| Group | Value (centimeters) | Spread |
|---|---|---|
| Somatropin | 10.467 | 0.2439 |
| Control Arm | 5.927 | 0.2677 |
Secondary outcomeLeast squares mean· Baseline, Month 24
Change From Baseline in Height SDS After 2 Years
| Group | Value (centimeters) | Spread |
|---|---|---|
| Somatropin | 1.710 | 0.1075 |
| Control Arm | 0.991 | 0.1179 |
Secondary outcomeLeast squares mean· Baseline, Month 12, Month 24
Change From Baseline in Body Composition (Skinfold Thickness) After 1 Year and After 2 Years: Triceps
| Group | Value (millimeters) | Spread |
|---|---|---|
| Somatropin | -2.20 | 0.341 |
| Control Arm | 0.50 | 0.353 |
Secondary outcomeLeast squares mean· Baseline, Month 12, Month 24
Change From Baseline in Body Composition (Skinfold Thickness) After 1 Year and After 2 Years: Subscapular
| Group | Value (millimeters) | Spread |
|---|---|---|
| Somatropin | 0.08 | 0.276 |
| Control Arm | 0.46 | 0.286 |
Secondary outcomeLeast squares mean· Baseline, Month 12, Month 24
Change From Baseline in Body Composition (Skinfold Thickness) After 1 Year and After 2 Years: Suprailiac
| Group | Value (millimeters) | Spread |
|---|---|---|
| Somatropin | 0.51 | 0.783 |
| Control Arm | 0.45 | 0.849 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| SomatropinThe children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms) | – | 5 / 18 | 13 / 18 |
| Control ArmThe children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram. | – | 1 / 15 | 11 / 15 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 4 Years up to 10 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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 \<= 3ml
* Tanner stage 1 pubic hair development (to exclude confounding effect of adrenarche on growth velocity, insulin sensitivity and body composition).
* (In case of any signs or symptoms of gonadal puberty a GnRH-Test must decide if the subject is still pubertal.)
* Height \<=-2 SD for chronological age (Brandt/Reinken).
* Growth velocity SDS below 0 SD for chronological age (Brandt/Reinken based on 12+/- 3 months observation period before screening).
* Premature born defined as \<=1500 g birth weight.
* GH sufficiency (GH level \> 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 \< -2,5 SDS (Brandt/Reinken) and parent adjusted target height \< -1 SDS (Hermanussen and Cole, 2003)
* length and/or body weight retardations adjusted to gestational age at birth \< -2,0 SDS (Lawrence et al., 1989, Voigt et al., 1996)
* children with chronological age \> = 4 years and
* growth velocity \< 0 SDS during the last year before inclusion.
* Chromosomal aberrations or syndromes.
* Suspected non-compliance or impossibility to follow the two or three year treatment schedule, respectively (e.g. social implications).
* Severe hemiparesis and severe CNS defects
* Retinopathia \> 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.
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