High dose recombinant human growth hormone (GH) treatment of GH-deficient patients in puberty increases near-final height: a randomized, multicenter trial. Genentech, Inc., Cooperative Study Group.

Mauras N, Attie KM, Reiter EO, Saenger P, Baptista J

The Journal of clinical endocrinology and metabolism1 Oct 2000Cited by 121 (Europe PMC)

PMID11061518DOI10.1210/jcem.85.10.6906PepBankPUB-11061518

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study11

11 results from studies that gave the peptide. 11 results from people.

01HumanRandomized controlled trialEfficacy outcome
In GH-deficient adolescents, high-dose GH increased near-adult height by 4.6 cm versus standard-dose GH (P < 0.001).
In plain wordsIn GH-deficient adolescents, high-dose GH increased near-adult height more than standard-dose GH.
Peptide
HGH (somatotropin)
Outcome
IncreaseNear-adult height
Study
n = 75
Comparator
Standard dose 0.3 mg/kg x week
Analysis
Primary
Outcome group
Linear growth · Endocrine and hormones
Studied dose
0.7 mg/kg x weekAs given in this study (human).
Measurements
Near-adult height difference, high versus standard dose
4.6 cm
ANCOVA, P < 0.001, n = 75
Source sentences
Summary
This difference was statistically significant at 4.6 cm by analysis of covariance (ANCOVA; P < 0.001; n = 75).
2 context sentences(design, population, supporting numbers)
Summary · context
The primary efficacy analysis was the difference between dose groups for near-adult height, defined as the height attained at a bone age of 16 yr or more in males and 14 yr or more in girls; all subjects who qualified were included in the analysis.
Summary · context
This randomized study was designed to compare the efficacy and safety of standard recombinant human GH (rhGH) therapy (group I, 0.3 mg/kg x week) vs. high dose therapy (group II, 0.7 mg/kg x week) in GH-deficient adolescents previously treated with rhGH for at least 6 months.
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02HumanRandomized controlled trialEfficacy outcome
In GH-deficient adolescents treated for at least 4 yr, high-dose GH increased height by 5.7 cm versus standard-dose GH (P = 0.024).
In plain wordsIn GH-deficient adolescents treated for at least four years, high-dose GH increased height more than standard-dose GH.
Peptide
HGH (somatotropin)
Outcome
IncreaseHeight after at least four years
Study
n = 20
Comparator
Standard dose 0.3 mg/kg x week
Outcome group
Linear growth · Endocrine and hormones
Studied dose
0.7 mg/kg x week · at least 4 yearsAs given in this study (human).
Measurements
Height difference, high versus standard dose
5.7 cm
subjects with at least 4 yr of rhGH treatment, ANCOVA, P = 0.024, n = 20
Source sentences
Summary
For subjects who received at least 4 yr of rhGH treatment, the difference between dose groups at that time point was 5.7 cm (by ANCOVA, P = 0.024; n = 20).
1 context sentence(design, population, supporting numbers)
Summary · context
This randomized study was designed to compare the efficacy and safety of standard recombinant human GH (rhGH) therapy (group I, 0.3 mg/kg x week) vs. high dose therapy (group II, 0.7 mg/kg x week) in GH-deficient adolescents previously treated with rhGH for at least 6 months.
Report a problemFND-1106151803
03HumanRandomized controlled trialSafety outcome
In GH-deficient adolescents, discontinuation frequency was the same with high and standard GH doses.
In plain wordsIn GH-deficient adolescents, discontinuation frequency was the same with high and standard GH doses.
Peptide
HGH (somatotropin)
Outcome
No significant changeDiscontinuation frequency
Study
n: not reported in source
Comparator
Standard dose 0.3 mg/kg x week
Outcome group
Adverse events · Whole body
Studied dose
0.7 mg/kg x weekAs given in this study (human).
Source sentences
Summary
The frequency of patients who discontinued was the same in both groups.
1 context sentence(design, population, supporting numbers)
Summary · context
This randomized study was designed to compare the efficacy and safety of standard recombinant human GH (rhGH) therapy (group I, 0.3 mg/kg x week) vs. high dose therapy (group II, 0.7 mg/kg x week) in GH-deficient adolescents previously treated with rhGH for at least 6 months.
Report a problemFND-1106151801
04HumanRandomized controlled trialEfficacy outcome
In GH-deficient adolescents, near-adult height SD score was 0.0+/-1.2 with high-dose GH versus -0.7+/-0.9 with standard-dose GH.
In plain wordsIn GH-deficient adolescents, near-adult height SD score was higher with high-dose GH than standard-dose GH.
Peptide
HGH (somatotropin)
Outcome
IncreaseNear-adult height SD score
Study
n: not reported in source
Comparator
Standard dose 0.3 mg/kg x week
Outcome group
Linear growth · Endocrine and hormones
Studied dose
0.7 mg/kg x weekAs given in this study (human).
Measurements
Mean height SD score at near-adult height
−0.7 SD score
standard dose group (0.3 mg/kg x week); +/-0.9
Mean height SD score at near-adult height
0 SD score
high dose group (0.7 mg/kg x week); +/-1.2
Source sentences
Summary
The mean height SD score at near-adult height was -0.7+/-0.9 in the standard dose group and 0.0+/-1.2 in the high dose group.
1 context sentence(design, population, supporting numbers)
Summary · context
This randomized study was designed to compare the efficacy and safety of standard recombinant human GH (rhGH) therapy (group I, 0.3 mg/kg x week) vs. high dose therapy (group II, 0.7 mg/kg x week) in GH-deficient adolescents previously treated with rhGH for at least 6 months.
Report a problemFND-1106151804
05HumanRandomized controlled trialEfficacy outcome
In GH-deficient adolescents, height increased 25.1+/-4.9 cm with high-dose GH versus 21.5+/-5.3 cm with standard-dose GH (P < 0.001).
In plain wordsIn GH-deficient adolescents, high-dose GH increased height more than standard-dose GH at 36 months.
Peptide
HGH (somatotropin)
Outcome
IncreaseCumulative height change
Study
n: not reported in source
Comparator
Standard dose 0.3 mg/kg x week
Outcome group
Linear growth · Endocrine and hormones
Studied dose
0.7 mg/kg x week · 36 monthsAs given in this study (human).
Measurements
Cumulative change in height at 36 months
21.5 cm
group I, standard dose; +/-5.3
Cumulative change in height at 36 months
25.1 cm
group II, high dose; +/-4.9; P < 0.001 by ANCOVA
Source sentences
Summary
At 36 months the cumulative change in height (centimeters) was 21.5+/-5.3 cm (group I) vs. 25.1+/-4.9 (group II; P < 0.001, by ANCOVA); the change in Bayley-Pinneau predicted adult height was 4.8+/-4.2 cm (group I) vs. 8.4+/-5.7 (group II; P = 0.032).
1 context sentence(design, population, supporting numbers)
Summary · context
This randomized study was designed to compare the efficacy and safety of standard recombinant human GH (rhGH) therapy (group I, 0.3 mg/kg x week) vs. high dose therapy (group II, 0.7 mg/kg x week) in GH-deficient adolescents previously treated with rhGH for at least 6 months.
Report a problemFND-1106151805
06HumanRandomized controlled trialEfficacy outcome
In GH-deficient adolescents, predicted adult height increased 8.4+/-5.7 cm with high-dose GH versus 4.8+/-4.2 cm with standard-dose GH (P = 0.032).
In plain wordsIn GH-deficient adolescents, high-dose GH increased predicted adult height more than standard-dose GH.
Peptide
HGH (somatotropin)
Outcome
IncreasePredicted adult height change
Study
n: not reported in source
Comparator
Standard dose 0.3 mg/kg x week
Outcome group
Linear growth · Endocrine and hormones
Studied dose
0.7 mg/kg x week · 36 monthsAs given in this study (human).
Measurements
Change in Bayley-Pinneau predicted adult height at 36 months
4.8 cm
group I, standard dose; +/-4.2
Change in Bayley-Pinneau predicted adult height at 36 months
8.4 cm
group II, high dose; +/-5.7; P = 0.032
Source sentences
Summary
At 36 months the cumulative change in height (centimeters) was 21.5+/-5.3 cm (group I) vs. 25.1+/-4.9 (group II; P < 0.001, by ANCOVA); the change in Bayley-Pinneau predicted adult height was 4.8+/-4.2 cm (group I) vs. 8.4+/-5.7 (group II; P = 0.032).
1 context sentence(design, population, supporting numbers)
Summary · context
This randomized study was designed to compare the efficacy and safety of standard recombinant human GH (rhGH) therapy (group I, 0.3 mg/kg x week) vs. high dose therapy (group II, 0.7 mg/kg x week) in GH-deficient adolescents previously treated with rhGH for at least 6 months.
Report a problemFND-1106151806
07HumanRandomized controlled trialEfficacy outcome
In GH-deficient adolescents, median IGF-I at 36 months was 910 microg/L (range 251-1843) with high-dose versus 651 (139-1079) with standard-dose GH (P = NS).
In plain wordsIn GH-deficient adolescents, IGF-I did not differ significantly between high and standard GH doses.
Peptide
HGH (somatotropin)
Outcome
No significant changePlasma IGF-I
Study
n: not reported in source
Comparator
Standard dose 0.3 mg/kg x week
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
0.7 mg/kg x week · 36 monthsAs given in this study (human).
Measurements
Median plasma IGF-I at baseline
427 microg/L
group I, standard dose; range 204-649
Median plasma IGF-I at baseline
435 microg/L
group II, high dose; range 104-837
Median plasma IGF-I at 36 months
651 microg/L
group I, standard dose; range 139-1079
Median plasma IGF-I at 36 months
910 microg/L
group II, high dose; range 251-1843; P = NS
Source sentences
Summary
Median plasma IGF-I concentrations at baseline were 427 microg/L (range, 204-649) in group I and 435 microg/L (range, 104-837) in group II; at 36 months they were 651 microg/L (range, 139-1079) in group I vs. 910 microg/L (range, 251-1843) in group II (P = NS).
1 context sentence(design, population, supporting numbers)
Summary · context
This randomized study was designed to compare the efficacy and safety of standard recombinant human GH (rhGH) therapy (group I, 0.3 mg/kg x week) vs. high dose therapy (group II, 0.7 mg/kg x week) in GH-deficient adolescents previously treated with rhGH for at least 6 months.
Report a problemFND-1106151807
08HumanRandomized controlled trialEfficacy outcome
In GH-deficient adolescents, bone age change did not differ between high and standard GH doses at any interval.
In plain wordsIn GH-deficient adolescents, bone age change did not differ between high and standard GH doses.
Peptide
HGH (somatotropin)
Outcome
No significant changeBone age change
Study
n: not reported in source
Comparator
Standard dose 0.3 mg/kg x week
Outcome group
Linear growth · Endocrine and hormones
Studied dose
0.7 mg/kg x weekAs given in this study (human).
Source sentences
Summary
No difference in change in bone age was detected between groups at any interval.
1 context sentence(design, population, supporting numbers)
Summary · context
This randomized study was designed to compare the efficacy and safety of standard recombinant human GH (rhGH) therapy (group I, 0.3 mg/kg x week) vs. high dose therapy (group II, 0.7 mg/kg x week) in GH-deficient adolescents previously treated with rhGH for at least 6 months.
Report a problemFND-1106151808
09HumanRandomized controlled trialSafety outcome
In GH-deficient adolescents, high-dose GH was well tolerated with a safety profile similar to standard-dose GH.
In plain wordsIn GH-deficient adolescents, high-dose GH had a safety profile similar to standard-dose GH.
Peptide
HGH (somatotropin)
Outcome
No significant changeSafety profile
Study
n: not reported in source
Comparator
Standard dose 0.3 mg/kg x week
Outcome group
Adverse events · Endocrine and hormones
Studied dose
0.7 mg/kg x weekAs given in this study (human).
Source sentences
Summary
High dose rhGH was well tolerated, with a similar safety profile as standard dose treatment and no difference in hemoglobin A1c or glucose concentrations between groups.
1 context sentence(design, population, supporting numbers)
Summary · context
This randomized study was designed to compare the efficacy and safety of standard recombinant human GH (rhGH) therapy (group I, 0.3 mg/kg x week) vs. high dose therapy (group II, 0.7 mg/kg x week) in GH-deficient adolescents previously treated with rhGH for at least 6 months.
Report a problemFND-1106151809
10HumanRandomized controlled trialEfficacy outcome
In GH-deficient adolescents, hemoglobin A1c did not differ between high and standard GH doses.
In plain wordsIn GH-deficient adolescents, hemoglobin A1c did not differ between high and standard GH doses.
Peptide
HGH (somatotropin)
Outcome
No significant changeHemoglobin A1c
Study
n: not reported in source
Comparator
Standard dose 0.3 mg/kg x week
Outcome group
Glycemic control · Endocrine and hormones
Studied dose
0.7 mg/kg x weekAs given in this study (human).
Source sentences
Summary
High dose rhGH was well tolerated, with a similar safety profile as standard dose treatment and no difference in hemoglobin A1c or glucose concentrations between groups.
1 context sentence(design, population, supporting numbers)
Summary · context
This randomized study was designed to compare the efficacy and safety of standard recombinant human GH (rhGH) therapy (group I, 0.3 mg/kg x week) vs. high dose therapy (group II, 0.7 mg/kg x week) in GH-deficient adolescents previously treated with rhGH for at least 6 months.
Report a problemFND-1106151810
11HumanRandomized controlled trialEfficacy outcome
In GH-deficient adolescents, glucose concentrations did not differ between high and standard GH doses.
In plain wordsIn GH-deficient adolescents, glucose concentrations did not differ between high and standard GH doses.
Peptide
HGH (somatotropin)
Outcome
No significant changeGlucose concentration
Study
n: not reported in source
Comparator
Standard dose 0.3 mg/kg x week
Outcome group
Glycemic control · Endocrine and hormones
Studied dose
0.7 mg/kg x weekAs given in this study (human).
Source sentences
Summary
High dose rhGH was well tolerated, with a similar safety profile as standard dose treatment and no difference in hemoglobin A1c or glucose concentrations between groups.
1 context sentence(design, population, supporting numbers)
Summary · context
This randomized study was designed to compare the efficacy and safety of standard recombinant human GH (rhGH) therapy (group I, 0.3 mg/kg x week) vs. high dose therapy (group II, 0.7 mg/kg x week) in GH-deficient adolescents previously treated with rhGH for at least 6 months.
Report a problemFND-1106151811

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Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:36 UTC
First added · source update from Europe PMC

Subjects

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