ESPE Abstracts (2014) 82 P-D-1-3-170

The ZOMATRIP Study: 4 Year Combination Therapy of GH and GnRHa in Girls with a Short Predicted Adult Height During Early Puberty: Interim Results at the End of the Treatment Phase

Raoul Roomana,b, Annick Franceb, Claudine Heinrichsc, Sylvie Tenoutassea,c, Cecile Brachetc, Martine Coolsd, Kathleen De Waeled, Guy Masae, Marie-Christine Lebrethonf, Jean-Pierre Bourguignonf, Inge Giesg, Jesse Van Besieng, Christine De Ryckea & Jean De Scheppera,g

aBSGPE, Brussels, Belgium; bUniversity Hospital Antwerp, Edegem, Belgium; cHopital Universitaire des Enfants Reine Fabiola, Brussels, Belgium; dUniversity Hospital Ghent, Ghent, Belgium; eJessa Hospital, Hasselt, Belgium; fUniversity Hospital Liège, Liège, Belgium; gUniversity Hospital Brussels, Brussels, Belgium

Background: A combination of GH and a GnRH agonist is sometimes used to improve adult height in children with a poor height prediction, only few studies support this.

Study design: In this multicenter study, 24 short girls in early puberty, with a bone age below 12.0 years, an adult height prediction below 151.0 cm and normal body proportions were treated with GH (Zomacton) transjections 50 μg/kg per day and triptorelin (Decapeptyl) i.m. (3.75 mg/month) for 4 years. Bone age was calculated by the Greulich and Pyle method and height predictions were made using the Bailey–Pinneau tables.

Results: Eighteen girls completed the treatment phase per protocol (PP). Reasons to drop out were: doping concerns in sports (1), no wish to postpone puberty any further after 2.5 or 3 years (3), poor compliance (1), and premature stop of GH injections (1). In the PP group, height (mean±S.D.) increased from 130.9±4.0 cm to 154.8±4.7 cm so that height at the end of treatment surpassed their initial predicted height by 7.2±3.9. Bone age progressed by 2.4±0.5 from 10.4±0.6 to 12.8±0.6 years. Final height prediction after 4 years of treatment (161.8±5.1 cm) increased by 15.1 cm compared to the prediction at the start of treatment (147.6±2.0 cm). Adverse events were restricted to injection site reactions (pain, bruising, and scarring) and common health problems for this age group. Mean IGF1 levels rose from 316±124 to 695±264 ng/ml (after 3 years of treatment). Fasting insulin levels increased 2.5-fold but fasting glucose and HbA1c levels remained within the normal range.

Conclusion: A 4-year combination treatment of GH and triptorelin was safe and significantly increased height (7.2 cm or 1.2 SDS) above the predicted adult height after the treatment phase. The participants will be followed until final height to determine the full growth promoting effect of this intervention in comparison to historic matched untreated controls.