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Growth Hormone Treatment of Early Growth Failure in Toddlers with Turner Syndrome: A Randomized, Controlled, Multicenter Trial

University of North Carolina (M.L.D.), Chapel Hill, North Carolina 27599; Lilly Research Laboratories (B.J.C., C.L., A.J.Z., C.A.Q.), Indianapolis, Indiana 46285; The Children’s Hospital (S.H.T.), affiliated with the University of Colorado Health Sciences Center, Denver, Colorado 80218; Connecticut Children’s Medical Center (K.R.), Hartford, Connecticut 06106; Thomas Jefferson University (J.L.R.), Philadelphia, Pennsylvania 19107; Children’s Hospital Medical Center (P.Y.F., D.F.G.), Seattle, Washington 98105; The Saban Research Institute of the Children’s Hospital Los Angeles (M.E.G.), Los Angeles, California 90027; University of Arkansas for Medical Sciences (K.T.), Little Rock, Arkansas 72205; and Children’s Mercy Hospital (C.H.), Kansas City, Missouri 64108

Address all correspondence and requests for reprints to: Marsha L. Davenport, M.D., Division of Pediatric Endocrinology, University of North Carolina, CB 7039, 3341 Medical Biomolecular Research Building, Chapel Hill, North Carolina 27599-7039. E-mail: mld{at}med.unc.edu.

Context: Typically, growth failure in Turner syndrome (TS) begins prenatally, and height SD score (SDS) declines progressively from birth.

Objective: This study aimed to determine whether GH treatment initiated before 4 yr of age in girls with TS could prevent subsequent growth failure. Secondary objectives were to identify factors associated with treatment response, to determine whether outcome could be predicted by a regression model using these factors, and to assess the safety of GH treatment in this young cohort.

Design: This study was a prospective, randomized, controlled, open-label, multicenter clinical trial (Toddler Turner Study, August 1999 to August 2003).

Setting: The study was conducted at 11 U.S. pediatric endocrine centers.

Subjects: Eighty-eight girls with TS, aged 9 months to 4 yr, were enrolled.

Interventions: Interventions comprised recombinant GH (50 µg/kg·d; n = 45) or no treatment (n = 43) for 2 yr.

Main Outcome Measure: The main outcome measure was baseline-to-2-yr change in height SDS.

Results: Short stature was evident at baseline (mean length/height SDS = –1.6 ± 1.0 at mean age 24.0 ± 12.1 months). Mean height SDS increased in the GH group from –1.4 ± 1.0 to –0.3 ± 1.1 (1.1 SDS gain), whereas it decreased in the control group from –1.8 ± 1.1 to –2.2 ± 1.2 (0.5 SDS decline), resulting in a 2-yr between-group difference of 1.6 ± 0.6 SDS (P < 0.0001). The baseline variable that correlated most strongly with 2-yr height gain was the difference between mid-parental height SDS and subjects’ height SDS (r = 0.32; P = 0.04). Although attained height SDS at 2 yr could be predicted with good accuracy using baseline variables alone (R² = 0.81; P < 0.0001), prediction of 2-yr change in height SDS required inclusion of initial treatment response data (4-month or 1-yr height velocity) in the model (R² = 0.54; P < 0.0001). No new or unexpected safety signals associated with GH treatment were detected.

Conclusion: Early GH treatment can correct growth failure and normalize height in infants and toddlers with TS.

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