The Australian Multicenter Trial of Growth Hormone (GH) Treatment in GH-Deficient Adults.

Cuneo RC, Judd S, Wallace JD, Perry-Keene D, Burger H, Lim-Tio S, Strauss B, Stockigt J, Topliss D, Alford F, Hew L, Bode H and 6 more

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Conway A, Handelsman D, Dunn S, Boyages S, Cheung NW, Hurley D

The Journal of clinical endocrinology and metabolism1 Jan 1998Cited by 154 (Europe PMC)

PMID9435425DOI10.1210/jcem.83.1.4482PepBankPUB-09435425

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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 study18

18 results from studies that gave the peptide. 18 results from people.

01HumanRandomized controlled trialSafety outcome
In GH-deficient adults, adverse effects occurred in 84% with GH versus 75% with placebo during the initial 6 months.
In plain wordsIn GH-deficient adults, adverse effects occurred in 84% with GH versus 75% with placebo.
Peptide
HGH (somatotropin)
Outcome
IncreaseAdverse effects
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Adverse events · Whole body
Studied dose
0.125 U/kg per week for 1 month, then 0.25 U/kg per week for 5 months · 6 monthsAs given in this study (human).
Measurements
Participants with adverse effects
84%
GH group, first 6 months
Participants with adverse effects
75%
placebo group, first 6 months
Source sentences
Summary
In the initial 6 months, adverse effects were reported by 84% of patients in the GH and 75% in the placebo group, with more symptoms relating to fluid retention in the GH group (48% vs. 30%; P = 0.016).
2 context sentences(design, population, supporting numbers)
Summary · context
We report the results of an Australian multicenter, randomized, double-blind, placebo-controlled trial of the effects of recombinant human GH treatment in adults with GH deficiency.
Summary · context
Patients were randomly assigned to receive either GH (0.125 U/kg per week for 1 month and 0.25 U/kg per week for 5 months) or placebo.
Report a problemFND-0943542515
02HumanRandomized controlled trialSafety outcome
In GH-deficient adults, fluid-retention symptoms occurred in 48% with GH versus 30% with placebo (P = 0.016).
In plain wordsIn GH-deficient adults, GH increased fluid-retention symptoms compared with placebo.
Peptide
HGH (somatotropin)
Outcome
IncreaseFluid-retention symptoms
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Adverse events · Whole body
Studied dose
0.125 U/kg per week for 1 month, then 0.25 U/kg per week for 5 months · 6 monthsAs given in this study (human).
Measurements
Participants with fluid-retention symptoms
48%
GH group, first 6 months
Participants with fluid-retention symptoms
30%
placebo group, first 6 months
Source sentences
Summary
In the initial 6 months, adverse effects were reported by 84% of patients in the GH and 75% in the placebo group, with more symptoms relating to fluid retention in the GH group (48% vs. 30%; P = 0.016).
2 context sentences(design, population, supporting numbers)
Summary · context
We report the results of an Australian multicenter, randomized, double-blind, placebo-controlled trial of the effects of recombinant human GH treatment in adults with GH deficiency.
Summary · context
Patients were randomly assigned to receive either GH (0.125 U/kg per week for 1 month and 0.25 U/kg per week for 5 months) or placebo.
Report a problemFND-0943542516
03HumanNon-randomized trialEfficacy outcome
In GH-deficient adults receiving GH, IGF-I SD score rose from -2.64 +/- 0.27 to +1.08 +/- 2.87 at 6 months.
In plain wordsIn GH-deficient adults receiving GH, IGF-I SD score increased at six months.
Peptide
HGH (somatotropin)
Outcome
IncreaseIGF-I SD score
Study
n = 78
Analysis
Primary
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
0.125 U/kg per week for 1 month, then 0.25 U/kg per week for 5 months · 6 monthsAs given in this study (human).
Measurements
Serum IGF-I SD score
−2.64 SD score
baseline, GH/GH group, n=78, +/- 0.27 as reported
Serum IGF-I SD score range
−8.8 to 3.82 SD score
baseline, GH/GH group
Serum IGF-I SD score
1.08 SD score
6 months, GH/GH group, +/- 2.87 as reported
Serum IGF-I SD score range
−7.21 to 6.42 SD score
6 months, GH/GH group
Source sentences
Summary
Serum insulin-like growth factor-I (IGF-I) increased from a standard deviation score of -2.64 +/- 0.27 (range -8.8 +3.82; n = 78) to +1.08 +/- 2.87 (range -7.21 to +6.42) at 6 months in the GH/GH group;
2 context sentences(design, population, supporting numbers)
Summary · context
We report the results of an Australian multicenter, randomized, double-blind, placebo-controlled trial of the effects of recombinant human GH treatment in adults with GH deficiency.
Summary · context
Patients were randomly assigned to receive either GH (0.125 U/kg per week for 1 month and 0.25 U/kg per week for 5 months) or placebo.
Report a problemFND-0943542501
04HumanNon-randomized trialEfficacy outcome
In GH-deficient adults, fat-free mass measured by bioelectrical impedance increased during the first 6 months of GH treatment (P < 0.001).
In plain wordsIn GH-deficient adults, fat-free mass measured by bioelectrical impedance increased during GH treatment.
Peptide
HGH (somatotropin)
Outcome
IncreaseFat-free mass by bioelectrical impedance
Study
n: not reported in source
Analysis
Primary
Outcome group
Body composition · Metabolic and weight
Studied dose
0.125 U/kg per week for 1 month, then 0.25 U/kg per week for 5 months · 6 monthsAs given in this study (human).
Source sentences
Summary
Fat-free mass increased in the first 6 months whether measured by bioelectrical impedance (P < 0.001) or dual energy x-ray absorptiometry (DEXA; P < 0.001).
2 context sentences(design, population, supporting numbers)
Summary · context
We report the results of an Australian multicenter, randomized, double-blind, placebo-controlled trial of the effects of recombinant human GH treatment in adults with GH deficiency.
Summary · context
Patients were randomly assigned to receive either GH (0.125 U/kg per week for 1 month and 0.25 U/kg per week for 5 months) or placebo.
Report a problemFND-0943542505
05HumanNon-randomized trialEfficacy outcome
In GH-deficient adults, fat-free mass measured by DEXA increased during the first 6 months of GH treatment (P < 0.001).
In plain wordsIn GH-deficient adults, fat-free mass measured by DEXA increased during GH treatment.
Peptide
HGH (somatotropin)
Outcome
IncreaseFat-free mass by DEXA
Study
n: not reported in source
Analysis
Primary
Outcome group
Body composition · Metabolic and weight
Studied dose
0.125 U/kg per week for 1 month, then 0.25 U/kg per week for 5 months · 6 monthsAs given in this study (human).
Source sentences
Summary
Fat-free mass increased in the first 6 months whether measured by bioelectrical impedance (P < 0.001) or dual energy x-ray absorptiometry (DEXA; P < 0.001).
2 context sentences(design, population, supporting numbers)
Summary · context
We report the results of an Australian multicenter, randomized, double-blind, placebo-controlled trial of the effects of recombinant human GH treatment in adults with GH deficiency.
Summary · context
Patients were randomly assigned to receive either GH (0.125 U/kg per week for 1 month and 0.25 U/kg per week for 5 months) or placebo.
Report a problemFND-0943542506
06HumanNon-randomized trialEfficacy outcome
In GH-deficient adults, total-body water measured by bioelectrical impedance increased during the first 6 months of GH treatment (P < 0.001).
In plain wordsIn GH-deficient adults, total-body water measured by bioelectrical impedance increased during GH treatment.
Peptide
HGH (somatotropin)
Outcome
IncreaseTotal-body water by bioelectrical impedance
Study
n: not reported in source
Analysis
Primary
Outcome group
Body composition · Metabolic and weight
Studied dose
0.125 U/kg per week for 1 month, then 0.25 U/kg per week for 5 months · 6 monthsAs given in this study (human).
Source sentences
Summary
Total-body water increased in the first 6 months whether measured by bioelectrical impedance (P < 0.001) or deuterium dilution (P = 0.002).
2 context sentences(design, population, supporting numbers)
Summary · context
We report the results of an Australian multicenter, randomized, double-blind, placebo-controlled trial of the effects of recombinant human GH treatment in adults with GH deficiency.
Summary · context
Patients were randomly assigned to receive either GH (0.125 U/kg per week for 1 month and 0.25 U/kg per week for 5 months) or placebo.
Report a problemFND-0943542507
07HumanNon-randomized trialEfficacy outcome
In GH-deficient adults, total-body water measured by deuterium dilution increased during the first 6 months of GH treatment (P = 0.002).
In plain wordsIn GH-deficient adults, total-body water measured by deuterium dilution increased during GH treatment.
Peptide
HGH (somatotropin)
Outcome
IncreaseTotal-body water by deuterium dilution
Study
n: not reported in source
Analysis
Primary
Outcome group
Body composition · Metabolic and weight
Studied dose
0.125 U/kg per week for 1 month, then 0.25 U/kg per week for 5 months · 6 monthsAs given in this study (human).
Source sentences
Summary
Total-body water increased in the first 6 months whether measured by bioelectrical impedance (P < 0.001) or deuterium dilution (P = 0.002).
2 context sentences(design, population, supporting numbers)
Summary · context
We report the results of an Australian multicenter, randomized, double-blind, placebo-controlled trial of the effects of recombinant human GH treatment in adults with GH deficiency.
Summary · context
Patients were randomly assigned to receive either GH (0.125 U/kg per week for 1 month and 0.25 U/kg per week for 5 months) or placebo.
Report a problemFND-0943542508
08HumanNon-randomized trialEfficacy outcome
In GH-deficient adults, fat mass measured by DEXA decreased during the first 6 months of GH treatment (P < 0.001).
In plain wordsIn GH-deficient adults, fat mass decreased during GH treatment.
Peptide
HGH (somatotropin)
Outcome
DecreaseFat mass by DEXA
Study
n: not reported in source
Analysis
Primary
Outcome group
Body composition · Metabolic and weight
Studied dose
0.125 U/kg per week for 1 month, then 0.25 U/kg per week for 5 months · 6 monthsAs given in this study (human).
Source sentences
Summary
Fat mass measured by DEXA (P < 0.001), skinfold thicknesses (P < 0.001), and waist/hip ratio (P = 0.001) decreased in the first 6 months.
2 context sentences(design, population, supporting numbers)
Summary · context
We report the results of an Australian multicenter, randomized, double-blind, placebo-controlled trial of the effects of recombinant human GH treatment in adults with GH deficiency.
Summary · context
Patients were randomly assigned to receive either GH (0.125 U/kg per week for 1 month and 0.25 U/kg per week for 5 months) or placebo.
Report a problemFND-0943542509
09HumanNon-randomized trialEfficacy outcome
In GH-deficient adults, skinfold thicknesses decreased during the first 6 months of GH treatment (P < 0.001).
In plain wordsIn GH-deficient adults, skinfold thicknesses decreased during GH treatment.
Peptide
HGH (somatotropin)
Outcome
DecreaseSkinfold thicknesses
Study
n: not reported in source
Analysis
Primary
Outcome group
Body composition · Metabolic and weight
Studied dose
0.125 U/kg per week for 1 month, then 0.25 U/kg per week for 5 months · 6 monthsAs given in this study (human).
Source sentences
Summary
Fat mass measured by DEXA (P < 0.001), skinfold thicknesses (P < 0.001), and waist/hip ratio (P = 0.001) decreased in the first 6 months.
2 context sentences(design, population, supporting numbers)
Summary · context
We report the results of an Australian multicenter, randomized, double-blind, placebo-controlled trial of the effects of recombinant human GH treatment in adults with GH deficiency.
Summary · context
Patients were randomly assigned to receive either GH (0.125 U/kg per week for 1 month and 0.25 U/kg per week for 5 months) or placebo.
Report a problemFND-0943542510
10HumanNon-randomized trialEfficacy outcome
In GH-deficient adults, waist/hip ratio decreased during the first 6 months of GH treatment (P = 0.001).
In plain wordsIn GH-deficient adults, waist/hip ratio decreased during GH treatment.
Peptide
HGH (somatotropin)
Outcome
DecreaseWaist/hip ratio
Study
n: not reported in source
Analysis
Primary
Outcome group
Body composition · Metabolic and weight
Studied dose
0.125 U/kg per week for 1 month, then 0.25 U/kg per week for 5 months · 6 monthsAs given in this study (human).
Source sentences
Summary
Fat mass measured by DEXA (P < 0.001), skinfold thicknesses (P < 0.001), and waist/hip ratio (P = 0.001) decreased in the first 6 months.
2 context sentences(design, population, supporting numbers)
Summary · context
We report the results of an Australian multicenter, randomized, double-blind, placebo-controlled trial of the effects of recombinant human GH treatment in adults with GH deficiency.
Summary · context
Patients were randomly assigned to receive either GH (0.125 U/kg per week for 1 month and 0.25 U/kg per week for 5 months) or placebo.
Report a problemFND-0943542511
11HumanNon-randomized trialEfficacy outcome
In GH-deficient adults, GH did not affect whole-body bone mineral density.
In plain wordsIn GH-deficient adults, GH did not affect whole-body bone mineral density.
Peptide
HGH (somatotropin)
Outcome
No significant changeWhole-body bone mineral density
Study
n: not reported in source
Analysis
Primary
Outcome group
Bone and joint · Musculoskeletal
Studied dose
0.125 U/kg per week for 1 month, then 0.25 U/kg per week for 5 months · 6 monthsAs given in this study (human).
Source sentences
Summary
Whole-body bone mineral density (BMD) (by DEXA) was unaffected by GH treatment.
2 context sentences(design, population, supporting numbers)
Summary · context
We report the results of an Australian multicenter, randomized, double-blind, placebo-controlled trial of the effects of recombinant human GH treatment in adults with GH deficiency.
Summary · context
Patients were randomly assigned to receive either GH (0.125 U/kg per week for 1 month and 0.25 U/kg per week for 5 months) or placebo.
Report a problemFND-0943542513
12HumanNon-randomized trialEfficacy outcome
In GH-deficient adults, GH had beneficial effects on energy, pain and emotional reaction assessed by the Nottingham Health Profile.
In plain wordsIn GH-deficient adults, GH improved energy, pain and emotional reaction scores.
Peptide
HGH (somatotropin)
Outcome
IncreaseQuality of life domains
Study
n: not reported in source
Analysis
Primary
Outcome group
Quality of life · Whole body
Studied dose
0.125 U/kg per week for 1 month, then 0.25 U/kg per week for 5 months · 6 monthsAs given in this study (human).
Source sentences
Summary
Self-reported quality of life was considered good before treatment, and beneficial treatment effects were observed for energy, pain, and emotional reaction as assessed by the Nottingham Health Profile.
2 context sentences(design, population, supporting numbers)
Summary · context
We report the results of an Australian multicenter, randomized, double-blind, placebo-controlled trial of the effects of recombinant human GH treatment in adults with GH deficiency.
Summary · context
Patients were randomly assigned to receive either GH (0.125 U/kg per week for 1 month and 0.25 U/kg per week for 5 months) or placebo.
Report a problemFND-0943542514
13HumanNon-randomized trialSafety outcome
In GH-deficient adults, fluid-retention symptoms were mild and resolved in 70% despite continued GH treatment.
In plain wordsIn GH-deficient adults, mild fluid-retention symptoms resolved in 70% despite continued GH treatment.
Peptide
HGH (somatotropin)
Outcome
Not applicableFluid-retention symptom resolution
Study
n: not reported in source
Analysis
Primary
Outcome group
Adverse events · Whole body
Studied dose
0.125 U/kg per week for 1 month, then 0.25 U/kg per week for 5 months · 6 monthsAs given in this study (human).
Measurements
Fluid-retention symptoms resolved
70%
patients with such symptoms, despite continued treatment
Source sentences
Summary
Such symptoms were mild and resolved in 70% of patients despite continued treatment.
3 context sentences(design, population, supporting numbers)
Summary · context
In the initial 6 months, adverse effects were reported by 84% of patients in the GH and 75% in the placebo group, with more symptoms relating to fluid retention in the GH group (48% vs. 30%; P = 0.016).
Summary · context
We report the results of an Australian multicenter, randomized, double-blind, placebo-controlled trial of the effects of recombinant human GH treatment in adults with GH deficiency.
Summary · context
Patients were randomly assigned to receive either GH (0.125 U/kg per week for 1 month and 0.25 U/kg per week for 5 months) or placebo.
Report a problemFND-0943542517
14HumanNon-randomized trialEfficacy outcome
In GH-deficient adults, total cholesterol decreased over the first 6 months of GH treatment (P = 0.042).
In plain wordsIn GH-deficient adults, total cholesterol decreased during GH treatment.
Peptide
HGH (somatotropin)
Outcome
DecreaseTotal cholesterol
Study
n: not reported in source
Outcome group
Lipids · Metabolic and weight
Studied dose
0.125 U/kg per week for 1 month, then 0.25 U/kg per week for 5 months · 6 monthsAs given in this study (human).
Source sentences
Summary
Fasting total cholesterol (P = 0.042) and low-density lipoprotein cholesterol (P = 0.006) decreased over the first 6 months.
2 context sentences(design, population, supporting numbers)
Summary · context
We report the results of an Australian multicenter, randomized, double-blind, placebo-controlled trial of the effects of recombinant human GH treatment in adults with GH deficiency.
Summary · context
Patients were randomly assigned to receive either GH (0.125 U/kg per week for 1 month and 0.25 U/kg per week for 5 months) or placebo.
Report a problemFND-0943542503
15HumanNon-randomized trialEfficacy outcome
In GH-deficient adults, LDL cholesterol decreased over the first 6 months of GH treatment (P = 0.006).
In plain wordsIn GH-deficient adults, LDL cholesterol decreased during GH treatment.
Peptide
HGH (somatotropin)
Outcome
DecreaseLDL cholesterol
Study
n: not reported in source
Outcome group
Lipids · Metabolic and weight
Studied dose
0.125 U/kg per week for 1 month, then 0.25 U/kg per week for 5 months · 6 monthsAs given in this study (human).
Source sentences
Summary
Fasting total cholesterol (P = 0.042) and low-density lipoprotein cholesterol (P = 0.006) decreased over the first 6 months.
2 context sentences(design, population, supporting numbers)
Summary · context
We report the results of an Australian multicenter, randomized, double-blind, placebo-controlled trial of the effects of recombinant human GH treatment in adults with GH deficiency.
Summary · context
Patients were randomly assigned to receive either GH (0.125 U/kg per week for 1 month and 0.25 U/kg per week for 5 months) or placebo.
Report a problemFND-0943542504
16HumanNon-randomized trialEfficacy outcome
In GH-deficient adults, most body composition changes were complete by 3 months of GH and maintained to 12 months.
In plain wordsIn GH-deficient adults, most body composition changes occurred by three months of GH and persisted to twelve months.
Peptide
HGH (somatotropin)
Outcome
Not applicableBody composition response maintenance
Study
n: not reported in source
Outcome group
Body composition · Metabolic and weight
Studied dose
Dose not stated · 12 monthsAs given in this study (human).
Source sentences
Summary
Most changes in body composition were complete by 3 months of treatment and maintained to 12 months.
2 context sentences(design, population, supporting numbers)
Summary · context
We report the results of an Australian multicenter, randomized, double-blind, placebo-controlled trial of the effects of recombinant human GH treatment in adults with GH deficiency.
Summary · context
Patients were randomly assigned to receive either GH (0.125 U/kg per week for 1 month and 0.25 U/kg per week for 5 months) or placebo.
Report a problemFND-0943542512
17HumanNon-randomized trialEfficacy outcome
In GH-deficient adults, resting blood pressure did not change during the initial 6 months of treatment.
In plain wordsIn GH-deficient adults, resting blood pressure did not change during the initial six months of treatment.
Peptide
HGH (somatotropin)
Outcome
No significant changeResting blood pressure
Study
n: not reported in source
Outcome group
Blood pressure · Cardiovascular
Studied dose
0.125 U/kg per week for 1 month, then 0.25 U/kg per week for 5 months · 6 monthsAs given in this study (human).
Source sentences
Summary
Resting blood pressure did not change over the initial 6 months.
2 context sentences(design, population, supporting numbers)
Summary · context
We report the results of an Australian multicenter, randomized, double-blind, placebo-controlled trial of the effects of recombinant human GH treatment in adults with GH deficiency.
Summary · context
Patients were randomly assigned to receive either GH (0.125 U/kg per week for 1 month and 0.25 U/kg per week for 5 months) or placebo.
Report a problemFND-0943542518
18HumanObservational studyEfficacy outcome
In GH-treated GH-deficient adults, 38% of the whole group were above the age-specific IGF-I reference range after treatment, with 17.6% and 68.9% respectively among those with subnormal or normal pretreatment levels.
In plain wordsIn GH-treated GH-deficient adults, 38% had IGF-I above the age-specific reference range after treatment.
Peptide
HGH (somatotropin)
Outcome
Not applicableIGF-I above reference range
Study
n: not reported in source
Analysis
Primary
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
0.125 U/kg per week for 1 month, then 0.25 U/kg per week for 5 months · 6 monthsAs given in this study (human).
Measurements
Patients above age-specific IGF-I reference range after treatment
38%
whole group
Above IGF-I reference range after treatment
17.6%
subnormal (< 2 SD) pretreatment IGF-I
Above IGF-I reference range after treatment
68.9%
normal (+/- 2 SD) pretreatment IGF-I
Source sentences
Summary
38% of the whole group were above the age-specific reference range following treatment [17.6% and 68.9% with subnormal (< 2 SD) or normal (+/- 2 SD) pretreatment levels, respectively].
2 context sentences(design, population, supporting numbers)
Summary · context
We report the results of an Australian multicenter, randomized, double-blind, placebo-controlled trial of the effects of recombinant human GH treatment in adults with GH deficiency.
Summary · context
Patients were randomly assigned to receive either GH (0.125 U/kg per week for 1 month and 0.25 U/kg per week for 5 months) or placebo.
Report a problemFND-0943542502

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedNot applicableNCT00136032

Growth Hormone Administration and Its Effects on Cardiovascular Risk Factors in Growth Hormone Deficient Women

Massachusetts General Hospitaln = 63Jan 2002 to Nov 2006

Growth Hormone Deficiency

Trial page ClinicalTrials.govUpdated 18 Feb 2008

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

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