Growth Hormone Treatment in Children with Short Stature Born Small for Gestational Age: 5-Year Results of a Randomized, Double-Blind, Dose-Response Trial

Sas, T.

doi:10.1210/jc.84.9.3064

Cited by 137 publications

(233 citation statements)

References 26 publications

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“…Mean age at onset of puberty was normal for the patients in the study, consistent with what has been observed in other studies with hGH treatment (9,10,12,14,30), despite the fact that untreated SGA children have been reported in the past to have an earlier onset of puberty than normal children (19,31,32). The multivariate analysis in this study revealed that children who were older at the onset of puberty had a greater height gain at adult height.…”

Section: Discussionsupporting

confidence: 90%

“…Short-to mid-term studies have demonstrated that catch-up growth can be induced by hGH administration, with height gains ranging from 1.1 to 2.6 SDS depending on the age of the children at treatment initiation, the hGH dosage used, and the duration of hGH therapy (7 -13). However, the pattern of hGH administration is still a matter of debate, as some authors favor continuous treatment (10) while others favor discontinuous treatment (9). Long-term results on adult height are scarce and discordant, with height gains ranging from 0.1 to 1.8 SDS in this patient group (14 -18).…”

Section: Introductionmentioning

confidence: 90%

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Adult height of prepubertal short children born small for gestational age treated with GH

Rosilio¹,

Carel²,

Écosse³

et al. 2005

eur j endocrinol

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Objective: Human GH (hGH) treatment leads to catch-up growth in children with short stature born small for gestational age (SGA). However, long-term efficacy and safety results in this patient group remain scarce. The present study assessed the efficacy and safety of late childhood treatment with biosynthetic hGH (Humatrope) in a group of short children born SGA (height ,22 standard deviation scores (SDS)). Design:Patients in this open-label, Phase III, multicenter study received a daily hGH dose of 0.067 mg/kg for 2 years, and then received no treatment for the following 2 years. After the fourth year on study, patients whose height had decreased more than 0.5 SDS but who still showed growth potential based on bone age were allowed to resume treatment until they reached adult height. Methods: Height gain SDS was assessed for 11 girls and 24 boys (mean age^S.D. 9.6^0.9 years) at the end of the 2 years of hGH treatment, during the subsequent 2-year off-treatment period, and upon reaching adult height. Results: At the end of the initial 2-year treatment period, 83% of patients had reached a height within the normal range, with a mean increase in height SDS vs baseline of 1.3^0.3 (P , 0.001). Adult heights (n ¼ 20) were within the normal range for 50% of patients, and mean height gain from baseline was statistically significant (0.7^0.8 SDS, P , 0.001). Fasting glucose and glycosylated hemoglobin levels were not significantly modified during treatment. Conclusions: High-dose hGH treatment for a minimum of 2 years in short children born SGA was well tolerated and resulted in a significant increase in adolescent and adult height.European Journal of Endocrinology 152 835-843

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Section: Discussionsupporting

confidence: 90%

Section: Introductionmentioning

confidence: 90%

Adult height of prepubertal short children born small for gestational age treated with GH

Rosilio¹,

Carel²,

Écosse³

et al. 2005

eur j endocrinol

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“…Fat mass SDS adjusted for gender and height declined significantly, whereas the increase in lean body mass SDS adjusted for gender and height reflected the normal increase as a result of the increase in height (11). In a randomized clinical trial where prepubertal short SGA children were treated with 1 or 2 mg GH/m 2 per day, no significant differences in BMI SDS, BP, insulin levels, and lipid profile were found between the two GH dosage groups (8,10).…”

Section: Introductionmentioning

confidence: 91%

“…Metabolic effects of GH treatment in prepubertal short SGA children include the development of relative insulin resistance (IR) (8,9) with an improvement of blood pressure (BP) and lipid profile (10). Fat mass SDS adjusted for gender and height declined significantly, whereas the increase in lean body mass SDS adjusted for gender and height reflected the normal increase as a result of the increase in height (11).…”

Section: Introductionmentioning

confidence: 99%

Randomized GH trial with two different dosages in combination with a GnRH analogue in short small for gestational age children: effects on metabolic profile and serum GH, IGF1, and IGFBP3 levels

Kaay¹,

Bakker²,

Hulst³

et al. 2010

European Journal of Endocrinology

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Background: GnRH analogue (GnRHa) combined with GH treatment has been proposed to increase adult height. Effect on metabolic profile and GH, IGF1, and IGFBP3 levels in short small for gestational age (SGA) children is unknown. Objective: To assess fat mass and lean body mass SDS, percentage trunk fat, blood pressure (BP), insulin sensitivity (Si), b-cell function (disposition index, DI), lipid profile, and GH, IGF1, and IGFBP3 levels during 2 years of combined treatment. Subjects: Forty-one pubertal short SGA children with a mean (GS.D.) age of 12.1 (G1.0) years. Design: Children received 3.75 mg of leuprolide acetate depot subcutaneously every 4 weeks, and they were randomly assigned to receive 1 mg (group A) or 2 mg (group B) of GH/m 2 per day. Results: Percentage trunk fat increased in both groups, but to a lower extent in group B. Lean body mass SDS increased only in group B. Changes in BP, Si, DI, and lipids were similar in both groups. Si significantly decreased, but DI remained unchanged. Lipids remained normal. GH and IGF1 levels were significantly higher in group B. Conclusion: Our study is the first to report that 2 years of combined treatment with a GnRHa and either 1 or 2 mg GH/m 2 per day does not adversely affect body composition and metabolic profile of short SGA children who come under medical attention at the onset of puberty. There was a dose-dependent effect on fat mass SDS height , percentage trunk fat, lean body mass SDS height , and GH and IGF1 levels in favor of treatment with GnRHa and the higher GH dose of 2 mg/m 2 per day.

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“…Inclusion criteria have previously been described (15,16). Height, weight, blood pressure, and serum lipids were measured before the start and during 4 years of GH treatment as previously described (17).…”

Section: Subjects and Study Designmentioning

confidence: 99%

The PPAR-γ Pro12Ala polymorphism associates with weight gain during GH-treatment in short children born small for gestational age

Kort

Hokken-Koelega²

2010

European Journal of Endocrinology

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Context: Short children born small for gestational age (SGA) have a lean phenotype with lower insulin sensitivity and higher blood pressure. GH treatment results in weight gain, and a decrease in blood pressure and insulin sensitivity. However, not all children respond in the same way. The Pro12Ala polymorphism of the peroxisome proliferator-activated receptor (PPAR-g) gene is inversely associated with body mass index (BMI), changes in BMI and the risk to develop type 2 diabetes mellitus. Objective: To analyze the contribution of the PPAR-g Pro12Ala polymorphism to GH induced changes in determinants of metabolic and cardiovascular disease in short SGA children. Methods: PPAR-g was genotyped in 238 Caucasian short SGA children (mean age 7.5 years). Height, weight, blood pressure, and serum lipids were measured before start and during 4 years of GH treatment. In addition, glucose homeostasis by homeostasis model assessment insulin resistance ratio (HOMA-IR) (nZ148) and by frequently sampled i.v. glucose tolerance test (nZ51), and body composition by dual energy X-ray absorptiometry (nZ79) were measured. Results: At baseline, the Ala12 allele was not associated with any determinant of metabolic and cardiovascular disease. After 4 years of GH treatment, the increase in weight for height SDS and BMI SDS was significantly greater in carriers of an Ala12 allele than in noncarriers. The change in all other parameters was not associated with Pro12Ala genotype. Conclusion: The Ala12 variant of the PPAR-g gene is associated with higher weight gain during GH treatment but not with changes in determinants of metabolic and cardiovascular diseases in Caucasian subjects born SGA.

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Growth Hormone Treatment in Children with Short Stature Born Small for Gestational Age: 5-Year Results of a Randomized, Double-Blind, Dose-Response Trial

Cited by 137 publications

References 26 publications

Adult height of prepubertal short children born small for gestational age treated with GH

Adult height of prepubertal short children born small for gestational age treated with GH

Randomized GH trial with two different dosages in combination with a GnRH analogue in short small for gestational age children: effects on metabolic profile and serum GH, IGF1, and IGFBP3 levels

The PPAR-γ Pro12Ala polymorphism associates with weight gain during GH-treatment in short children born small for gestational age

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