Efficacy and safety of oxandrolone in growth hormone-treated girls with Turner syndrome
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CONTEXT AND OBJECTIVE: GH therapy increases growth and adult height in Turner syndrome (TS). The benefit to risk ratio of adding the weak androgen oxandrolone (Ox) to GH is unclear. DESIGN AND PARTICIPANTS: A randomized, placebo-controlled, double-blind, dose-response study was performed in 10 centers in The Netherlands. One hundred thirty-three patients with TS were included in age group 1 (2-7.99 yr), 2 (8-11.99 yr), or 3 (12-15.99 yr). Patients were treated with GH (1.33 mg/m(2) . d) from baseline, combined with placebo (Pl) or Ox in low (0.03 mg/kg . d) or conventional (0.06 mg/kg . d) dose from the age of 8 yr and estrogens from the age of 12 yr. Adult height gain (adult height minus predicted adult height) and safety parameters were systematically assessed. RESULTS: Compared with GH+Pl, GH+Ox 0.03 increased adult height gain in the intention-to-treat analysis (mean +/- sd, 9.5 +/- 4.7 vs. 7.2 +/- 4.0 cm, P = 0.02) and per-protocol analysis (9.8 +/- 4.9 vs. 6.8 +/- 4.4 cm, P = 0.02). Partly due to accelerated bone maturation (P < 0.001), adult height gain on GH+Ox 0.06 was not significantly different from that on GH+Pl (8.3 +/- 4.7 vs. 7.2 +/- 4.0 cm, P = 0.3). Breast development was slower on GH+Ox (GH+Ox 0.03, P = 0.02; GH+Ox 0.06, P = 0.05), and more girls reported virilization on GH+Ox 0.06 than on GH+Pl (P < 0.001). CONCLUSIONS: In GH-treated girls with TS, we discourage the use of the conventional Ox dosage (0.06 mg/kg . d) because of its low benefit to risk ratio. The addition of Ox 0.03 mg/kg . d modestly increases adult height gain and has a fairly good safety profile, except for some deceleration of breast development.
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Addition of oxandrolone produces synergistic increases in growth response during GH treatment.
“Addition of oxandrolone, which has been used off-label for decades, produces synergistic increases in growth response during GH treatment,245-249”
From Clinical practice guidelines for the care of girls and women with Turner syndrome. (2024) · cites this paper as [245]
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Çocuklarda ve Ergenlerde Büyüme Hormonu Tedavisi Endikasyonları
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Self-citation
- Authors
- Menke, L. A., Sas, T. C. J., de Muinck Keizer-Schrama, S. M. P. F., Zandwijken, G. R. J., de Ridder, M. A. J., Odink, R. J., Jansen, M., Delemarre-van de Waal, H. A., Stokvis-Brantsma, W. H., Waelkens, J. J., Westerlaken, C., Reeser, H. M., van Trotsenburg, A. S. P., Gevers, E. F., van Buuren, S., DeJonckere, P. H., Hokken-Koelega, A. C. S., Otten, B. J., & Wit, J. M.
- Affiliations
- Leiden University Medical Center (NL)
- Erasmus Medical Center (S.M.P.F.d.M.K.-S., A.C.S.H.-K.), Sophia Children’s Hospital, 3000 CA Rotterdam, The Netherlands
- Dutch Growth Research Foundation (L.A.M., G.R.J.Z., M.A.J.d.R., A.C.S.H.-K.), 3001 KB Rotterdam, The Netherlands
- University Medical Center Groningen (NL)
- University Medical Center Utrecht (NL)
- Department of Pediatrics (H.A.D.-v.d.W.), Free University Medical Center, 1007 MB Amsterdam, The Netherlands
- Catharina Ziekenhuis (NL)
- Canisius-Wilhelmina Ziekenhuis (NL)
- Haga Hospital (NL)
- Academic Medical Center (A.S.P.v.T.), Emma Children’s Hospital, 1100 DE Amsterdam, The Netherlands
- National Institute for Medical Research (GB)
- Department of Statistics (S.v.B.), TNO Quality of Life, 2333 AL Leiden, The Netherlands
- Wilhelmina Children's Hospital (NL)
- Erasmus MC (NL)
- Radboud University Medical Center (NL)
- ORCID
- Venue
- The Journal of Clinical Endocrinology & Metabolism
- Publisher
- The Endocrine Society
- Published
- 2010-03-01
- Volume
- 95
- Issue
- 3
- Pages
- 1151-1160
- ISSN
- 0021-972X (ISSN-L)
- 1945-7197
- OpenAlex
- W2123947372
- Cited by
- 94
- References
- 44
- Citations by year
- 2026: 1 · 2025: 1 · 2024: 6 · 2023: 1 · 2021: 9 · 2020: 3 · 2019: 7 · 2018: 6 · 2017: 4 · 2016: 3 · 2015: 15 · 2014: 6 · 2013: 8 · 2012: 7
- FWCI
- 7.75
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- The Journal of Clinical Endocrinology & Metabolism (publishedVersion)
- PubMed (publishedVersion)
- Pure Amsterdam UMC (publishedVersion)
- EUR Research Repository (Erasmus University Rotterdam) (publishedVersion)
- TNO Repository (submittedVersion)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- EUR Research Repository (Erasmus University Rotterdam) (submittedVersion)
- RePub (Erasmus University Rotterdam) (submittedVersion, other-oa)
- Leiden Repository (Leiden University) (submittedVersion)
- Utrecht University Repository (Utrecht University) (submittedVersion, other-oa)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion)
- Radboud Repository (Radboud University) (submittedVersion)
- RePub (Erasmus University Rotterdam) (submittedVersion)
- Repository hosted by TU Delft Library (TU Delft) (submittedVersion)
- Funders
- Eli Lilly and Company
- Pfizer
- Universiteit Leiden
- Novo Nordisk
- Leids Universitair Medisch Centrum
- Ipsen
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Growth Hormone and Insulin-like Growth Factors
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Genetic and Clinical Aspects of Sex Determination and Chromosomal Abnormalities
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Sexual Differentiation and Disorders
- Keywords
- Turner syndrome, oxandrolone, growth hormone therapy, androgen therapy, skeletal maturation, breast development, masculinization, dose-response relationship, girls, risk-benefit ratio, estrogen, safety profile, puberty timing
- MeSH terms
- Adolescent, Age Factors, Androgens, Blood Pressure, Body Height, Child, Child, Preschool, Dose-Response Relationship, Drug, Double-Blind Method, Drug Therapy, Combination, Female, Humans, Netherlands, Oxandrolone, Puberty, Recombinant Proteins, Turner Syndrome, Virilism, Chi-Square Distribution, Treatment Outcome, Human Growth Hormone
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