Effect of growth hormone (GH) treatment on bone in postpubertal GH-deficient patients: a 2-year randomized, controlled, dose-ranging study.

Shalet SM, Shavrikova E, Cromer M, Child CJ, Keller E, Zapletalová J, Moshang T, Blum WF, Chipman JJ, Quigley CA, Attanasio AF

The Journal of clinical endocrinology and metabolism1 Sept 2003Cited by 77 (Europe PMC)

PMID12970274DOI10.1210/jc.2003-030126PepBankPUB-12970274

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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 study12

12 results from studies that gave the peptide. 12 results from people.

01HumanRandomized controlled trialEfficacy outcome
In postpubertal GH-deficient patients, both GH doses increased bone-specific alkaline phosphatase versus control (P = 0.004), without significant dose effects.
In plain wordsIn GH-deficient patients after final height, both growth hormone doses increased bone-specific alkaline phosphatase versus no treatment.
Peptide
HGH (somatotropin)
Outcome
IncreaseBone-specific alkaline phosphatase
Study
n: not reported in source
Comparator
no GH treatment
Outcome group
Bone and joint · Musculoskeletal
Studied dose
12.5 or 25.0 microg/kg x day · 2 yrAs given in this study (human).
Source sentences
Summary
After 2 yr, significant increases were seen with both GH treatments, compared with control in bone-specific alkaline phosphatase (P = 0.004) and type I collagen C-terminal telopeptide:creatinine ratio (P < 0.001), but there were no significant dose effects.
2 context sentences(design, population, supporting numbers)
Summary · context
Because no prospective data specifically prove the role of GH in attainment of peak bone mass, we performed a multinational, controlled, 2-yr study in patients who had terminated pediatric GH at final height.
Summary · context
Patients were randomized to: GH at 25.0 microg/kg x day (pediatric dose, n = 58) or 12.5 microg/kg x day (adult dose, n = 59), or no GH treatment (control, n = 32).
Report a problemFND-1297027401
02HumanRandomized controlled trialEfficacy outcome
In postpubertal GH-deficient patients, both GH doses increased type I collagen C-terminal telopeptide:creatinine ratio versus control (P < 0.001), without significant dose effects.
In plain wordsIn GH-deficient patients after final height, both growth hormone doses increased the collagen breakdown marker ratio versus no treatment.
Peptide
HGH (somatotropin)
Outcome
IncreaseCollagen telopeptide creatinine ratio
Study
n: not reported in source
Comparator
no GH treatment
Outcome group
Bone and joint · Musculoskeletal
Studied dose
12.5 or 25.0 microg/kg x day · 2 yrAs given in this study (human).
Source sentences
Summary
After 2 yr, significant increases were seen with both GH treatments, compared with control in bone-specific alkaline phosphatase (P = 0.004) and type I collagen C-terminal telopeptide:creatinine ratio (P < 0.001), but there were no significant dose effects.
2 context sentences(design, population, supporting numbers)
Summary · context
Because no prospective data specifically prove the role of GH in attainment of peak bone mass, we performed a multinational, controlled, 2-yr study in patients who had terminated pediatric GH at final height.
Summary · context
Patients were randomized to: GH at 25.0 microg/kg x day (pediatric dose, n = 58) or 12.5 microg/kg x day (adult dose, n = 59), or no GH treatment (control, n = 32).
Report a problemFND-1297027402
03HumanRandomized controlled trialEfficacy outcome
In postpubertal GH-deficient patients, total bone mineral content increased 9.5 +/- 8.4% with adult-dose GH versus 5.6 +/- 8.4% in controls.
In plain wordsIn GH-deficient patients after final height, adult-dose growth hormone increased bone mineral content more than no treatment.
Peptide
HGH (somatotropin)
Outcome
IncreaseTotal bone mineral content adult dose
Study
n: not reported in source
Comparator
no GH treatment
Outcome group
Bone and joint · Musculoskeletal
Studied dose
12.5 microg/kg x day · 2 yrAs given in this study (human).
Measurements
change in total bone mineral content
9.5%
adult dose group
SD of change in total bone mineral content
8.4%
adult dose group
change in total bone mineral content
5.6%
control group
SD of change in total bone mineral content
8.4%
control group
Source sentences
Summary
Total BMC increased by 9.5 +/- 8.4% in the adult dose group, 8.1 +/- 7.6% in the pediatric dose group, and 5.6 +/- 8.4% in controls (analysis of covariance, P = 0.008), with no significant GH dose effect.
2 context sentences(design, population, supporting numbers)
Summary · context
Because no prospective data specifically prove the role of GH in attainment of peak bone mass, we performed a multinational, controlled, 2-yr study in patients who had terminated pediatric GH at final height.
Summary · context
Patients were randomized to: GH at 25.0 microg/kg x day (pediatric dose, n = 58) or 12.5 microg/kg x day (adult dose, n = 59), or no GH treatment (control, n = 32).
Report a problemFND-1297027403
04HumanRandomized controlled trialEfficacy outcome
In postpubertal GH-deficient patients, total bone mineral content increased 8.1 +/- 7.6% with pediatric-dose GH versus 5.6 +/- 8.4% in controls.
In plain wordsIn GH-deficient patients after final height, pediatric-dose growth hormone increased bone mineral content more than no treatment.
Peptide
HGH (somatotropin)
Outcome
IncreaseTotal bone mineral content pediatric dose
Study
n: not reported in source
Comparator
no GH treatment
Outcome group
Bone and joint · Musculoskeletal
Studied dose
25.0 microg/kg x day · 2 yrAs given in this study (human).
Measurements
change in total bone mineral content
8.1%
pediatric dose group
SD of change in total bone mineral content
7.6%
pediatric dose group
change in total bone mineral content
5.6%
control group
SD of change in total bone mineral content
8.4%
control group
Source sentences
Summary
Total BMC increased by 9.5 +/- 8.4% in the adult dose group, 8.1 +/- 7.6% in the pediatric dose group, and 5.6 +/- 8.4% in controls (analysis of covariance, P = 0.008), with no significant GH dose effect.
2 context sentences(design, population, supporting numbers)
Summary · context
Because no prospective data specifically prove the role of GH in attainment of peak bone mass, we performed a multinational, controlled, 2-yr study in patients who had terminated pediatric GH at final height.
Summary · context
Patients were randomized to: GH at 25.0 microg/kg x day (pediatric dose, n = 58) or 12.5 microg/kg x day (adult dose, n = 59), or no GH treatment (control, n = 32).
Report a problemFND-1297027404
05HumanRandomized controlled trialEfficacy outcome
In postpubertal GH-deficient patients, total bone mineral content showed no significant GH dose effect despite an overall treatment effect (P = 0.008).
In plain wordsIn GH-deficient patients after final height, bone mineral content changes did not differ significantly between growth hormone doses.
Peptide
HGH (somatotropin)
Outcome
No significant changeTotal bone mineral content dose effect
Study
n: not reported in source
Comparator
adult GH dose
Outcome group
Bone and joint · Musculoskeletal
Studied dose
Dose not stated · 2 yrAs given in this study (human).
Measurements
change in total bone mineral content
9.5%
adult dose group
SD of change in total bone mineral content
8.4%
adult dose group
change in total bone mineral content
8.1%
pediatric dose group
SD of change in total bone mineral content
7.6%
pediatric dose group
Source sentences
Summary
Total BMC increased by 9.5 +/- 8.4% in the adult dose group, 8.1 +/- 7.6% in the pediatric dose group, and 5.6 +/- 8.4% in controls (analysis of covariance, P = 0.008), with no significant GH dose effect.
2 context sentences(design, population, supporting numbers)
Summary · context
Because no prospective data specifically prove the role of GH in attainment of peak bone mass, we performed a multinational, controlled, 2-yr study in patients who had terminated pediatric GH at final height.
Summary · context
Patients were randomized to: GH at 25.0 microg/kg x day (pediatric dose, n = 58) or 12.5 microg/kg x day (adult dose, n = 59), or no GH treatment (control, n = 32).
Report a problemFND-1297027405
06HumanRandomized controlled trialEfficacy outcome
In postpubertal GH-deficient patients, pediatric-dose GH increased IGF-I more than adult-dose GH (P = 0.023).
In plain wordsIn GH-deficient patients after final height, the pediatric growth hormone dose increased IGF-I more than the adult dose.
Peptide
HGH (somatotropin)
Outcome
IncreaseIGF-I dose comparison
Study
n: not reported in source
Comparator
adult dose
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
25.0 microg/kg x day · 2 yrAs given in this study (human).
Measurements
increase in IGF-I
178.5 microg/liter
pediatric dose group
SD of increase in IGF-I
143.7 microg/liter
pediatric dose group
increase in IGF-I
114.5 microg/liter
adult dose group
SD of increase in IGF-I
119.4 microg/liter
adult dose group
Source sentences
Summary
In contrast, a significant dose-dependent increase was seen in IGF-I concentrations (adult dose: 114.5 +/- 119.4 microg/liter; pediatric dose: 178.5 +/- 143.7 microg/liter; P = 0.023).
2 context sentences(design, population, supporting numbers)
Summary · context
Because no prospective data specifically prove the role of GH in attainment of peak bone mass, we performed a multinational, controlled, 2-yr study in patients who had terminated pediatric GH at final height.
Summary · context
Patients were randomized to: GH at 25.0 microg/kg x day (pediatric dose, n = 58) or 12.5 microg/kg x day (adult dose, n = 59), or no GH treatment (control, n = 32).
Report a problemFND-1297027409
07HumanRandomized controlled trialEfficacy outcome
In female postpubertal GH-deficient patients, pediatric-dose GH increased IGF-I more than adult-dose GH (P < 0.001).
In plain wordsIn female GH-deficient patients after final height, the pediatric growth hormone dose increased IGF-I more than the adult dose.
Peptide
HGH (somatotropin)
Outcome
IncreaseFemale IGF-I dose comparison
Study
n: not reported in source
Comparator
adult dose
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
Dose not stated · 2 yrAs given in this study (human).
Source sentences
Summary
There were no gender-related differences in BMC changes with either dose, whereas the IGF-I increase was significantly higher with the pediatric than with the adult dose in females (P < 0.001) but not males (P = 0.606).
2 context sentences(design, population, supporting numbers)
Summary · context
Because no prospective data specifically prove the role of GH in attainment of peak bone mass, we performed a multinational, controlled, 2-yr study in patients who had terminated pediatric GH at final height.
Summary · context
Patients were randomized to: GH at 25.0 microg/kg x day (pediatric dose, n = 58) or 12.5 microg/kg x day (adult dose, n = 59), or no GH treatment (control, n = 32).
Report a problemFND-1297027411
08HumanRandomized controlled trialEfficacy outcome
In male postpubertal GH-deficient patients, IGF-I increases did not differ significantly between GH doses (P = 0.606).
In plain wordsIn male GH-deficient patients after final height, IGF-I increases did not differ significantly between growth hormone doses.
Peptide
HGH (somatotropin)
Outcome
No significant changeMale IGF-I dose comparison
Study
n: not reported in source
Comparator
adult dose
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
Dose not stated · 2 yrAs given in this study (human).
Source sentences
Summary
There were no gender-related differences in BMC changes with either dose, whereas the IGF-I increase was significantly higher with the pediatric than with the adult dose in females (P < 0.001) but not males (P = 0.606).
2 context sentences(design, population, supporting numbers)
Summary · context
Because no prospective data specifically prove the role of GH in attainment of peak bone mass, we performed a multinational, controlled, 2-yr study in patients who had terminated pediatric GH at final height.
Summary · context
Patients were randomized to: GH at 25.0 microg/kg x day (pediatric dose, n = 58) or 12.5 microg/kg x day (adult dose, n = 59), or no GH treatment (control, n = 32).
Report a problemFND-1297027412
09HumanNon-randomized trialEfficacy outcome
In postpubertal GH-deficient patients, bone mineral content increased predominantly at the lumbar spine (11.0 +/- 10.6%, P = 0.015) rather than the femoral neck or hip.
In plain wordsIn GH-deficient patients after final height given growth hormone, bone mineral content increased mainly at the lumbar spine.
Peptide
HGH (somatotropin)
Outcome
IncreaseLumbar spine bone mineral content
Study
n: not reported in source
Outcome group
Bone and joint · Musculoskeletal
Studied dose
Dose not stated · 2 yrAs given in this study (human).
Measurements
increase in bone mineral content at lumbar spine
11%
group not specified in abstract
SD of increase in bone mineral content at lumbar spine
10.6%
group not specified in abstract
Source sentences
Summary
BMC increased predominantly at the lumbar spine (11.0 +/- 10.6%, P = 0.015) rather than at the femoral neck or hip.
2 context sentences(design, population, supporting numbers)
Summary · context
Because no prospective data specifically prove the role of GH in attainment of peak bone mass, we performed a multinational, controlled, 2-yr study in patients who had terminated pediatric GH at final height.
Summary · context
Patients were randomized to: GH at 25.0 microg/kg x day (pediatric dose, n = 58) or 12.5 microg/kg x day (adult dose, n = 59), or no GH treatment (control, n = 32).
Report a problemFND-1297027406
10HumanNon-randomized trialEfficacy outcome
In postpubertal GH-deficient patients, adult-dose GH increased IGF-I by 114.5 +/- 119.4 microg/liter.
In plain wordsIn GH-deficient patients after final height, IGF-I increased during adult-dose growth hormone treatment.
Peptide
HGH (somatotropin)
Outcome
IncreaseIGF-I adult dose
Study
n: not reported in source
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
12.5 microg/kg x day · 2 yrAs given in this study (human).
Measurements
increase in IGF-I
114.5 microg/liter
adult dose group
SD of increase in IGF-I
119.4 microg/liter
adult dose group
Source sentences
Summary
In contrast, a significant dose-dependent increase was seen in IGF-I concentrations (adult dose: 114.5 +/- 119.4 microg/liter; pediatric dose: 178.5 +/- 143.7 microg/liter; P = 0.023).
2 context sentences(design, population, supporting numbers)
Summary · context
Because no prospective data specifically prove the role of GH in attainment of peak bone mass, we performed a multinational, controlled, 2-yr study in patients who had terminated pediatric GH at final height.
Summary · context
Patients were randomized to: GH at 25.0 microg/kg x day (pediatric dose, n = 58) or 12.5 microg/kg x day (adult dose, n = 59), or no GH treatment (control, n = 32).
Report a problemFND-1297027407
11HumanNon-randomized trialEfficacy outcome
In postpubertal GH-deficient patients, pediatric-dose GH increased IGF-I by 178.5 +/- 143.7 microg/liter.
In plain wordsIn GH-deficient patients after final height, IGF-I increased during pediatric-dose growth hormone treatment.
Peptide
HGH (somatotropin)
Outcome
IncreaseIGF-I pediatric dose
Study
n: not reported in source
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
25.0 microg/kg x day · 2 yrAs given in this study (human).
Measurements
increase in IGF-I
178.5 microg/liter
pediatric dose group
SD of increase in IGF-I
143.7 microg/liter
pediatric dose group
Source sentences
Summary
In contrast, a significant dose-dependent increase was seen in IGF-I concentrations (adult dose: 114.5 +/- 119.4 microg/liter; pediatric dose: 178.5 +/- 143.7 microg/liter; P = 0.023).
2 context sentences(design, population, supporting numbers)
Summary · context
Because no prospective data specifically prove the role of GH in attainment of peak bone mass, we performed a multinational, controlled, 2-yr study in patients who had terminated pediatric GH at final height.
Summary · context
Patients were randomized to: GH at 25.0 microg/kg x day (pediatric dose, n = 58) or 12.5 microg/kg x day (adult dose, n = 59), or no GH treatment (control, n = 32).
Report a problemFND-1297027408
12HumanObservational studyEfficacy outcome
In postpubertal GH-deficient patients, bone mineral content changes showed no gender-related differences with either GH dose.
In plain wordsIn GH-deficient patients after final height, bone mineral content changes did not differ between sexes with either growth hormone dose.
Peptide
HGH (somatotropin)
Outcome
No significant changeBone mineral content sex comparison
Study
n: not reported in source
Comparator
other sex
Outcome group
Bone and joint · Musculoskeletal
Studied dose
Dose not stated · 2 yrAs given in this study (human).
Source sentences
Summary
There were no gender-related differences in BMC changes with either dose, whereas the IGF-I increase was significantly higher with the pediatric than with the adult dose in females (P < 0.001) but not males (P = 0.606).
2 context sentences(design, population, supporting numbers)
Summary · context
Because no prospective data specifically prove the role of GH in attainment of peak bone mass, we performed a multinational, controlled, 2-yr study in patients who had terminated pediatric GH at final height.
Summary · context
Patients were randomized to: GH at 25.0 microg/kg x day (pediatric dose, n = 58) or 12.5 microg/kg x day (adult dose, n = 59), or no GH treatment (control, n = 32).
Report a problemFND-1297027410

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Version history

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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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Effect of growth hormone (GH) treatment on bone in postpubertal GH-deficient patients: a 2-year randomized, controlled, dose-ranging study.

Summary

Results from this study12

Version history

Subjects

Publication types

MeSH terms