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Submitted on July 29, 2005
Accepted on January 20, 2006
Department of Pediatrics, University of Parma, Parma; Paediatric Hospital Bambin Gesu', Department of Paediatric Medicine, Rome; Ospedale Regionale per le Microcitemie, Department of Pediatric Endocrinology, Cagliari, Italy
* To whom correspondence should be addressed. E-mail: lucia.ghizzoni{at}unipr.it.
Context: Gonadotropin-releasing hormone analogs (GnRHa) are considered the treatment of choice for central precocious puberty (CPP). During GnRHa administration, the suppression of the pituitary-gonadal axis results in decreased rates of linear growth and skeletal maturation, and in improved adult height. However, in some patients the growth deceleration is so marked that the expected improvement in predicted adult height is not achieved.
Objective: The objective of this study was to assess whether the addition of oxandrolone (Ox) may affect the height outcome of patients with CPP and growth deceleration during GnRHa treatment.
Design: This was an open-label, clinical study.
Setting: The study was performed at a Pediatric Endocrinology referral clinic.
Patients: Twenty patients with CPP and marked growth deceleration during GnRHa treatment, were studied.
Interventions: Treatment consisted of GnRHa (Leuprorelina, 3.75 mg i.m. every 28 days) alone (10 patients) or in combination with Ox (0.06 mg/kg/day p.o.) (10 patients).
Main Outcome Measure: The main outcome measure is the patients' adult height.
Results: The adult height of the patients treated with GnRHa plus Ox was significantly higher than pre-treatment predicted adult height (PAH) (162.6 ± 2.3 vs. 154.8 ± 1.7 cm, mean ± SEM, P < 0.05), and target height (162.6 ± 2.3 vs. 158.0 ± 1.9, P > 0.05) (TH). Patients treated with GnRHa alone reached an adult height similar to the pre-treatment PAH (151.9 ± 1.2 vs. 155.4 ± 2.1 cm) but significantly lower than TH (151.9 ± 1.2 vs. 156.6 ± 1.4 cm, P < 0.005). No side effects were recorded in either group of patients.
Conclusions: combined GnRHa and Ox therapy is a viable treatment option for children with CPP and marked growth deceleration during treatment with GnRHa alone.
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