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Updated: Apr 7, 2026

Comparative Analysis of Human Growth Hormone in Serum Using SPRi, Nano-SPRi and ELISA Assays
Published on: January 7, 2016
[Safety and efficacy of growth hormone treatment: GeNeSIS study in Spain]
C Luzuriaga Tomás1, M Oyarzabal Irigoyen2, E Caveda Cepas3
1Unidad de Endocrinología Pediátrica, Hospital Marqués de Valdecilla, Santander, Cantabria, España.
Insights
Pediatric growth hormone (GH) therapy in Spain improved height gain in children with GH deficiency (GHD). The treatment demonstrated a favorable safety profile, consistent with established knowledge of GH therapy.
Area of Science:
- Pediatric Endocrinology
- Growth Hormone Therapy
- Clinical Research
Background:
- Multi-national studies provide country-specific data on pediatric growth hormone (GH) therapy.
- The Genetics and Neuroendocrinology of Short-stature International Study (GeNeSIS) collected data in Spain.
Purpose of the Study:
- To assess the effectiveness and safety of GH replacement therapy in a Spanish pediatric cohort.
- To analyze height gain and adverse events associated with GH treatment in children.
Main Methods:
- An observational study enrolled 1294 children in Spain (GeNeSIS).
- GH therapy effectiveness was evaluated in children with GH deficiency (GHD).
- Adverse events were monitored in all GH-treated patients.
Main Results:
- GH therapy significantly increased height velocity and improved height standard deviation score (SDS) over 4 years in children with GHD.
- Final height SDS was close to target height SDS.
- The incidence of treatment-emergent adverse events was 8.1%, with a low rate of serious GH-related events.
Conclusions:
- GH replacement therapy is effective in improving height gain for pediatric patients in Spain.
- The safety profile of GH therapy in this cohort aligns with previously reported data.
Introduction:
Country-specific information on pediatric GH therapy is available from multi-national studies.
Methods:
A total of 1294 children in Spain enrolled in the observational Genetics and Neuroendocrinology of Short-stature International Study (GeNeSIS). Adverse events were assessed in all GH-treated patients (n=1267) and effectiveness in those with GH deficiency (GHD, 78%).
Results:
Mean age at time of entry to the study was 9.8 years. GH was initiated at a median (Q1-Q3) 0.22 (0.20-0.25) mg/kg/week and administered for 2.8 (1.6-4.4) years. For 262 patients with GHD and 4-year data, mean (95% CI) height velocity was 4.3 (4.1 - 4.6) cm/year at baseline, 9.0 (8.7 to 9.4) cm/year at 1-year, and 5.5 (5.2 to 5.8) cm/year at 4-years. Height standard deviation score (SDS) was -2.48 (-2.58 to -2.38) at baseline and -1.18 (-1.28 to -1.08) at 4 years. Final height SDS minus target height SDS (n=241) was -0.09 (-0.20 to 0.02). In 1143 GH-treated patients with ≥1 year follow-up, 93 (8.1%) reported treatment-emergent adverse events. Serious events were reported for 7 children, with 2 considered GH-related.
Conclusion:
These data confirm the benefit of GH replacement therapy on height gain for the patients in Spain. The safety profile was consistent with that already known for GH therapy.
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