Long-term therapy with recombinant human growth hormone (Saizen (R)) in children with idiopathic and organic growth hormone deficiency

in an open-label study, 69 children with organic or idiopathic growth hormo ne deficiency (GHD) were treated with recombinant human growth hormone (Sai zen (R)) for an average of 64.4 mo, with treatment periods as long as 140.9 mo. Auxologic measurements, including height velocity, height standard dev iation score, and bone age, were made on a regular basis. The data suggest that long-term treatment with Saizen in children with GHD results in a posi tive catch-up growth response and proportionate changes in bone age vs heig ht age during treatment. In addition, long-term Saizen therapy was well tol erated, with the majority of adverse events related to common childhood dis orders or existing baseline medical conditions and not to study treatment. There were no significant changes in laboratory safety data or vital signs, and no positive antibody tests for Saizen.