Study

Comparing Growth Hormone Treatments for Children with Short Stature

In this study, we are comparing two growth hormone treatments, lonapegsomatropin and somatropin, for children with short stature due to Turner syndrome, SHOX deficiency, being born small for gestational age, or idiopathic short stature. We want to learn how safe these treatments are and how well they help children grow.

Why this Research Matters

Growth hormone treatment may help some children with short stature grow taller. Lonapegsomatropin and somatropin have the same active ingredient, but they stay in the body for different amounts of time. If you/your child are interested in joining this study, you will first come to a screening visit. At this visit, we will ask questions and do tests to see if you/your child can join the study. If eligible, you/your child will be randomly assigned to one of two study groups, like flipping a coin. You/your child will be in the study for about 2 years. One group will receive lonapegsomatropin as an injection once a week. The other group will receive somatropin as an injection once a day for the first year of the study and then change to the once weekly longapegsomatropin for the second year of the study. You/your child will give the injections at home. The study team will teach you how to do this. You will come to 10 study visits at Children's Hospital Colorado. At these visits, we will ask questions about you/your child's health and growth. We will also do physical exams and measure height and weight. We will collect blood samples, do eye examinations, and take X-rays to look at bone growth. You/your child will also fill out surveys about health, growth, and your experience with the study treatment. There is no cost to take part in the study. You/your child will not be paid for being in this study. If you have expenses related to attending study visits, you may be reimbursed.

Who can Participate

Child and Teen

You/your child may be able to join this study if you are between 2 and 18 years old and have short stature due to Turner syndrome, SHOX deficiency, being born small for gestational age, or an unknown reason (idiopathic short stature). You may not be able to join if you have received growth hormone treatment before or have certain health conditions or take medicines that affect growth. The study team will review all requirements with you at the screening visit.