Growth hormone (GH) replacement therapy in adult-onset gh deficiency: effects on body composition in men and women in a double-blind, randomized, placebo-controlled trial.

Hoffman AR, Kuntze JE, Baptista J, Baum HB, Baumann GP, Biller BM, Clark RV, Cook D, Inzucchi SE, Kleinberg D, Klibanski A, Phillips LS and 6 more

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Ridgway EC, Robbins RJ, Schlechte J, Sharma M, Thorner MO, Vance ML

The Journal of clinical endocrinology and metabolism1 May 2004Cited by 117 (Europe PMC)

PMID15126520DOI10.1210/jc.2003-030346PepBankPUB-15126520

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Summary

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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 adults with GH deficiency, growth hormone had no significant treatment effect on strength versus placebo.
In plain wordsIn adults with GH deficiency, growth hormone did not significantly change strength versus placebo.
Peptide
HGH (somatotropin)
Outcome
No significant changeStrength
Study
n: not reported in source
Comparator
placebo
Analysis
Primary
Outcome group
Exercise and physical function · Musculoskeletal
Studied dose
0.0125 mg/kg.d, adjusted to 0.025 or 0.00625 mg/kg.d · 12 monthsAs given in this study (human).
Source sentences
Summary
No significant treatment effects were observed in strength and endurance, quality of life, or bone mineral density.
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a randomized, double-blind, placebo-controlled, multicenter study in 166 subjects with AGHD to assess the effects of GH on these outcomes.
Summary · context
GH was initiated at 0.0125 mg/kg.d, increased to 0.025 mg/kg.d as tolerated, or decreased to 0.00625 mg/kg.d for 12 months.
Report a problemFND-1512652008
02HumanRandomized controlled trialEfficacy outcome
In adults with GH deficiency, growth hormone had no significant treatment effect on endurance versus placebo.
In plain wordsIn adults with GH deficiency, growth hormone did not significantly change endurance versus placebo.
Peptide
HGH (somatotropin)
Outcome
No significant changeEndurance
Study
n: not reported in source
Comparator
placebo
Analysis
Primary
Outcome group
Exercise and physical function · Musculoskeletal
Studied dose
0.0125 mg/kg.d, adjusted to 0.025 or 0.00625 mg/kg.d · 12 monthsAs given in this study (human).
Source sentences
Summary
No significant treatment effects were observed in strength and endurance, quality of life, or bone mineral density.
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a randomized, double-blind, placebo-controlled, multicenter study in 166 subjects with AGHD to assess the effects of GH on these outcomes.
Summary · context
GH was initiated at 0.0125 mg/kg.d, increased to 0.025 mg/kg.d as tolerated, or decreased to 0.00625 mg/kg.d for 12 months.
Report a problemFND-1512652009
03HumanRandomized controlled trialEfficacy outcome
In adults with GH deficiency, growth hormone had no significant treatment effect on quality of life versus placebo.
In plain wordsIn adults with GH deficiency, growth hormone did not significantly change quality of life versus placebo.
Peptide
HGH (somatotropin)
Outcome
No significant changeQuality of life
Study
n: not reported in source
Comparator
placebo
Analysis
Primary
Outcome group
Quality of life · Whole body
Studied dose
0.0125 mg/kg.d, adjusted to 0.025 or 0.00625 mg/kg.d · 12 monthsAs given in this study (human).
Source sentences
Summary
No significant treatment effects were observed in strength and endurance, quality of life, or bone mineral density.
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a randomized, double-blind, placebo-controlled, multicenter study in 166 subjects with AGHD to assess the effects of GH on these outcomes.
Summary · context
GH was initiated at 0.0125 mg/kg.d, increased to 0.025 mg/kg.d as tolerated, or decreased to 0.00625 mg/kg.d for 12 months.
Report a problemFND-1512652010
04HumanRandomized controlled trialActivity measurement
In GH-treated adults, male IGF-I SD scores exceeded age-adjusted normal ranges, while women had a smaller response at similar doses.
In plain wordsIn adults given growth hormone, men's mean IGF-I scores exceeded age-adjusted normal ranges, while women had smaller responses at similar doses.
Peptide
HGH (somatotropin)
Outcome
MixedIGF-I sex difference
Study
n: not reported in source
Comparator
women receiving similar GH doses and age-adjusted normal ranges
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
0.0125 mg/kg.d, adjusted to 0.025 or 0.00625 mg/kg.d · 12 monthsAs given in this study (human).
Source sentences
Summary
In GH-treated men, mean IGF-I SD scores exceeded age-adjusted normal ranges, whereas similar doses produced a smaller response in women.
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a randomized, double-blind, placebo-controlled, multicenter study in 166 subjects with AGHD to assess the effects of GH on these outcomes.
Summary · context
GH was initiated at 0.0125 mg/kg.d, increased to 0.025 mg/kg.d as tolerated, or decreased to 0.00625 mg/kg.d for 12 months.
Report a problemFND-1512652005
05HumanRandomized controlled trialEfficacy outcome
In adults with GH deficiency, growth hormone had no significant treatment effect on bone mineral density versus placebo.
In plain wordsIn adults with GH deficiency, growth hormone did not significantly change bone mineral density versus placebo.
Peptide
HGH (somatotropin)
Outcome
No significant changeBone mineral density
Study
n: not reported in source
Comparator
placebo
Outcome group
Bone and joint · Musculoskeletal
Studied dose
0.0125 mg/kg.d, adjusted to 0.025 or 0.00625 mg/kg.d · 12 monthsAs given in this study (human).
Source sentences
Summary
No significant treatment effects were observed in strength and endurance, quality of life, or bone mineral density.
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a randomized, double-blind, placebo-controlled, multicenter study in 166 subjects with AGHD to assess the effects of GH on these outcomes.
Summary · context
GH was initiated at 0.0125 mg/kg.d, increased to 0.025 mg/kg.d as tolerated, or decreased to 0.00625 mg/kg.d for 12 months.
Report a problemFND-1512652011
06HumanNon-randomized trialEfficacy outcome
In men and women with adult GH deficiency, growth hormone significantly decreased total body fat from baseline.
In plain wordsIn adults with GH deficiency, total body fat decreased significantly from baseline during growth hormone treatment.
Peptide
HGH (somatotropin)
Outcome
DecreaseTotal body fat
Study
n: not reported in source
Analysis
Primary
Outcome group
Body composition · Metabolic and weight
Studied dose
0.0125 mg/kg.d, adjusted to 0.025 or 0.00625 mg/kg.d · 12 monthsAs given in this study (human).
Source sentences
Summary
GH-treated men and women demonstrated significant decreases in total body and trunk fat and increases in lean body mass over baseline.
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a randomized, double-blind, placebo-controlled, multicenter study in 166 subjects with AGHD to assess the effects of GH on these outcomes.
Summary · context
GH was initiated at 0.0125 mg/kg.d, increased to 0.025 mg/kg.d as tolerated, or decreased to 0.00625 mg/kg.d for 12 months.
Report a problemFND-1512652002
07HumanNon-randomized trialEfficacy outcome
In men and women with adult GH deficiency, growth hormone significantly decreased trunk fat from baseline.
In plain wordsIn adults with GH deficiency, trunk fat decreased significantly from baseline during growth hormone treatment.
Peptide
HGH (somatotropin)
Outcome
DecreaseTrunk fat
Study
n: not reported in source
Analysis
Primary
Outcome group
Body composition · Metabolic and weight
Studied dose
0.0125 mg/kg.d, adjusted to 0.025 or 0.00625 mg/kg.d · 12 monthsAs given in this study (human).
Source sentences
Summary
GH-treated men and women demonstrated significant decreases in total body and trunk fat and increases in lean body mass over baseline.
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a randomized, double-blind, placebo-controlled, multicenter study in 166 subjects with AGHD to assess the effects of GH on these outcomes.
Summary · context
GH was initiated at 0.0125 mg/kg.d, increased to 0.025 mg/kg.d as tolerated, or decreased to 0.00625 mg/kg.d for 12 months.
Report a problemFND-1512652003
08HumanNon-randomized trialEfficacy outcome
In men and women with adult GH deficiency, growth hormone significantly increased lean body mass from baseline.
In plain wordsIn adults with GH deficiency, lean body mass increased significantly from baseline during growth hormone treatment.
Peptide
HGH (somatotropin)
Outcome
IncreaseLean body mass
Study
n: not reported in source
Analysis
Primary
Outcome group
Body composition · Metabolic and weight
Studied dose
0.0125 mg/kg.d, adjusted to 0.025 or 0.00625 mg/kg.d · 12 monthsAs given in this study (human).
Source sentences
Summary
GH-treated men and women demonstrated significant decreases in total body and trunk fat and increases in lean body mass over baseline.
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a randomized, double-blind, placebo-controlled, multicenter study in 166 subjects with AGHD to assess the effects of GH on these outcomes.
Summary · context
GH was initiated at 0.0125 mg/kg.d, increased to 0.025 mg/kg.d as tolerated, or decreased to 0.00625 mg/kg.d for 12 months.
Report a problemFND-1512652004
09HumanNon-randomized trialEfficacy outcome
In adults with GH deficiency, growth hormone treatment was associated with significant improvement in total cholesterol (P < 0.05).
In plain wordsIn adults with GH deficiency, growth hormone treatment was linked to significant improvement in total cholesterol.
Peptide
HGH (somatotropin)
Outcome
DecreaseTotal cholesterol
Study
n: not reported in source
Outcome group
Lipids · Metabolic and weight
Studied dose
0.0125 mg/kg.d, adjusted to 0.025 or 0.00625 mg/kg.d · 12 monthsAs given in this study (human).
Measurements
P value
< 0.05 P
total cholesterol
Source sentences
Summary
GH treatment was associated with significant improvements in total cholesterol and low-density lipoprotein (P < 0.05 for all).
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a randomized, double-blind, placebo-controlled, multicenter study in 166 subjects with AGHD to assess the effects of GH on these outcomes.
Summary · context
GH was initiated at 0.0125 mg/kg.d, increased to 0.025 mg/kg.d as tolerated, or decreased to 0.00625 mg/kg.d for 12 months.
Report a problemFND-1512652006
10HumanNon-randomized trialEfficacy outcome
In adults with GH deficiency, growth hormone treatment was associated with significant improvement in low-density lipoprotein (P < 0.05).
In plain wordsIn adults with GH deficiency, growth hormone treatment was linked to significant improvement in low-density lipoprotein.
Peptide
HGH (somatotropin)
Outcome
DecreaseLow-density lipoprotein
Study
n: not reported in source
Outcome group
Lipids · Metabolic and weight
Studied dose
0.0125 mg/kg.d, adjusted to 0.025 or 0.00625 mg/kg.d · 12 monthsAs given in this study (human).
Measurements
P value
< 0.05 P
low-density lipoprotein
Source sentences
Summary
GH treatment was associated with significant improvements in total cholesterol and low-density lipoprotein (P < 0.05 for all).
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a randomized, double-blind, placebo-controlled, multicenter study in 166 subjects with AGHD to assess the effects of GH on these outcomes.
Summary · context
GH was initiated at 0.0125 mg/kg.d, increased to 0.025 mg/kg.d as tolerated, or decreased to 0.00625 mg/kg.d for 12 months.
Report a problemFND-1512652007
11HumanNon-randomized trialSafety outcome
In adults with GH deficiency, growth hormone was generally well tolerated.
In plain wordsIn adults with GH deficiency, growth hormone was generally well tolerated.
Peptide
HGH (somatotropin)
Outcome
Not applicableTolerability
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
0.0125 mg/kg.d, adjusted to 0.025 or 0.00625 mg/kg.d · 12 monthsAs given in this study (human).
Source sentences
Summary
GH treatment was generally well tolerated.
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a randomized, double-blind, placebo-controlled, multicenter study in 166 subjects with AGHD to assess the effects of GH on these outcomes.
Summary · context
GH was initiated at 0.0125 mg/kg.d, increased to 0.025 mg/kg.d as tolerated, or decreased to 0.00625 mg/kg.d for 12 months.
Report a problemFND-1512652012

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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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