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Departments of Pediatrics (D.S.H., C.P., J.R.) and Biostatistics and Clinical Science (B.A.-H.), University of Texas Southwestern Medical School, Dallas, Texas 75390; University of South Carolina School of Medicine (D.B.), Columbia, South Carolina 29203; University of Utah (B.C.), Salt Lake City, Utah 84132; Cook Children’s Hospital (M.D.), Fort Worth, Texas 76104; Department of Pediatrics (T.F., R.S.), Washington University School of Medicine, St. Louis, Missouri 63110; Indiana University School of Medicine (M.H.), Indianapolis, Indiana 46202; Vanderbilt School of Medicine (J.S.), Nashville, Tennessee 37232; Dayton Children’s Hospital (F.R.), Dayton, Ohio 46404; Texas Children’s Hospital/Baylor College of Medicine (D.K.S.), Houston, Texas 77030
Address all correspondence and requests for reprints to: Dana S. Hardin, M.D., Chief of Pediatric Endocrinology, The Ohio State University, Columbus Children’s Hospital, 700 Children’s Drive, ED 543, Columbus, Ohio 43205-2696. E-mail: hardind{at}pediatrics.ohio-state.edu.
Context: This multicenter, randomized, controlled, crossover trial of prepubertal children with cystic fibrosis (CF) tests the hypotheses that recombinant human GH (rhGH) treatment 1) improves height, weight, lean mass, and bone content irrespective of baseline measures; 2) improves clinical status and quality of life; and 3) has continued effect after cessation after 1 yr of treatment.
Methods: Sixty-one prepubertal subjects (
25th percentile for height and weight) were randomized into two groups: daily rhGH treatment or no treatment groups for 1 yr. In yr 2, treatments were crossed over. Outcome measures included serial standardized height and weight, number of hospitalizations and antibiotic courses, random blood glucose levels, lean mass, bone mineral content, pulmonary function, nutritional intake, and CF quality of life questionnaires.
Results: Groups were similar at baseline and prepubertal during the entire study. After 1 yr, GH showed significantly greater gain in height, weight, lean mass, and bone mineral content. Gain in height was similar regardless of baseline. There were fewer hospitalizations in the rhGH-treated group and improvement in CF quality of life questionnaires measures of weight and body image. There was no difference in pulmonary function between groups. Results were similar in those treated with rhGH the second year. After cessation of rhGH treatment, there was sustained effect for increased height and weight velocity, as well as accrual of bone mineral.
Conclusion: rhGH therapy improves height and weight, decreases the number of hospitalizations, and improves quality of life in prepubertal children with CF. These effects are sustained after rhGH is discontinued.
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