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Spanish multicentre trial on somatrem (1985-1986)
E Vicens-Calvet1, J M Cuatrecasas-Membrado
1Endocrinology Unit, Children's Hospital Vall d'Hebron, Barcelona, Spain.
Acta Paediatrica Scandinavica. Supplement
|January 1, 1987
Summary
Somatrem treatment in children with human growth hormone (hGH) deficiency showed effective catch-up growth, particularly in younger patients. The study confirmed somatrem
Area of Science:
- Pediatric Endocrinology
- Biopharmaceuticals
- Clinical Trials
Background:
- Human growth hormone (hGH) deficiency impacts childhood growth.
- Previous treatments with pituitary-derived hGH have been used.
- Somatrem represents a recombinant form of hGH.
Purpose of the Study:
- To evaluate the safety and efficacy of somatrem in children with hGH deficiency.
- To compare outcomes in previously treated versus treatment-naïve patients.
- To assess growth response and antibody formation.
Main Methods:
- Open, multicenter trial.
- Somatrem administered intramuscularly at 4 IU, three times weekly for 12 months.
- Patients stratified by age (young vs. prepubertal) and treatment history.
Main Results:
- Greater catch-up growth observed in younger patients.
- Bone age progression aligned with chronological age in both naïve and previously treated groups.
- Lower incidence of anti-hGH antibodies in previously treated patients compared to naïve patients.
Conclusions:
- Somatrem is a safe and effective treatment for various degrees of hGH deficiency in children.
- Treatment benefits are more pronounced in younger, prepubertal children.
- Previous treatment history may influence antibody response to somatrem.