Effect of oxandrolone and timing of pubertal induction on final height in Turner's syndrome: randomised, double blind, placebo controlled trial

Gault, E. J.; Perry, R. J.; Cole, T. J.; Casey, S.; Paterson, W. F.; Hindmarsh, P. C.; Betts, P.; Dunger, D. B.; Donaldson, M. D. C.; on behalf of the British Society for Paediatric Endocrinology and Diabetes

doi:10.1136/bmj.d1980

Cited by 71Genetic and Clinical Aspects of Sex Determination and Chromosomal AbnormalitiesSexual Differentiation and DisordersGrowth Hormone and Insulin-like Growth Factors

Effect of oxandrolone and timing of pubertal induction on final height in Turner's syndrome: randomised, double blind, placebo controlled trial

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Gault, E. J., Perry, R. J., Cole, T. J., Casey, S., Paterson, W. F., Hindmarsh, P. C., Betts, P., Dunger, D. B. +2 more·2011·BMJ

DOI 10.1136/bmj.d1980PMC PMC3076731

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Abstract

OBJECTIVE: To examine the effect of oxandrolone and the timing of pubertal induction on final height in girls with Turner's syndrome receiving a standard dose of growth hormone. DESIGN: Randomised, double blind, placebo controlled trial. Setting 36 paediatric endocrinology departments in UK hospitals. PARTICIPANTS: Girls with Turner's syndrome aged 7-13 years at recruitment, receiving recombinant growth hormone therapy (10 mg/m(2)/week). INTERVENTIONS: Participants were randomised to oxandrolone (0.05 mg/kg/day, maximum 2.5 mg/day) or placebo from 9 years of age. Those with evidence of ovarian failure at 12 years were further randomised to oral ethinylestradiol (year 1, 2 µg daily; year 2, 4 μg daily; year 3, 4 months each of 6, 8, and 10 μg daily) or placebo; participants who received placebo and those recruited after the age of 12.25 years started ethinylestradiol at age 14. MAIN OUTCOME MEASURE: Final height. Results 106 participants were recruited, of whom 14 withdrew and 82/92 reached final height. Both oxandrolone and late pubertal induction increased final height: by 4.6 (95% confidence interval 1.9 to 7.2) cm (P = 0.001, n = 82) for oxandrolone and 3.8 (0.0 to 7.5) cm (P = 0.05, n = 48) for late pubertal induction with ethinylestradiol. In the 48 children who were randomised twice, the effects on final height (compared with placebo and early induction of puberty) of oxandrolone alone, late induction alone, and oxandrolone plus late induction were similar, averaging 7.1 (3.4 to 10.8) cm (P < 0.001). No cases of virilisation were reported. CONCLUSION: Oxandrolone had a positive effect on final height in girls with Turner's syndrome treated with growth hormone, as did late pubertal induction with ethinylestradiol at age 14 years. However, these effects were not additive, so using both had no advantage. Oxandrolone could, therefore, be offered as an alternative to late pubertal induction for increasing final height in Turner's syndrome. Trial registration Current Controlled Trials ISRCTN50343149.

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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 [249]
Oxandrolone use is not considered standard of care and was reserved for very short girls.
“However, its use is not considered standard of care and was reserved for very short girls.”
From Clinical practice guidelines for the care of girls and women with Turner syndrome. (2024) · cites this paper as [249]
Oxandrolone use in TS to promote growth is well-described.
“Oxandrolone use in TS to promote growth is well-described.249,250”
From Clinical practice guidelines for the care of girls and women with Turner syndrome. (2024) · cites this paper as [249]

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Authors: Gault, E. J., Perry, R. J., Cole, T. J., Casey, S., Paterson, W. F., Hindmarsh, P. C., Betts, P., Dunger, D. B., Donaldson, M. D. C., & on behalf of the British Society for Paediatric Endocrinology and Diabetes
Affiliations: Royal Hospital for Children (GB)
University College London (GB)
University Hospital Southampton NHS Foundation Trust (GB)
University of Cambridge (GB)
Corresponding author: Donaldson, M. D. C.
ORCID: Gault, E. J.
Cole, T. J.
Casey, S.
Hindmarsh, P. C.
Dunger, D. B.
Donaldson, M. D. C.
Venue: BMJ
Publisher: BMJ
Published: 2011-04-14
Volume: 342
Issue: apr14 1
Pages: d1980-d1980
ISSN: 0007-1447 (ISSN-L)
0959-8138
1468-5833
DOI: 10.1136/bmj.d1980
PMC: PMC3076731
OpenAlex: W2087766610
Cited by: 71
References: 45
Citations by year: 2026: 1 · 2025: 1 · 2024: 4 · 2023: 3 · 2022: 3 · 2021: 2 · 2020: 4 · 2019: 8 · 2018: 3 · 2017: 4 · 2016: 7 · 2015: 7 · 2014: 7 · 2013: 3 · 2012: 10
FWCI: 4.58
Type: journal article
Language: en
Open access: hybrid
doi.org
Licence: cc-by-nc
Locations: BMJ (publishedVersion, cc-by-nc)
Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
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Research Explorer (The University of Manchester) (submittedVersion)
Newcastle University ePrints (Newcastle Univesity)
Funders: National Institute for Health and Care Research (NF-SI-0508-10274)
Topics: 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
Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Growth Hormone and Insulin-like Growth Factors
Keywords: Turner syndrome, oxandrolone, adult height, puberty induction, ethinyl estradiol, growth hormone therapy, anabolic steroids, ovarian failure, short stature, timing of puberty, masculinization, puberty suppression, androgen therapy, bone age
MeSH terms: Adolescent, Body Height, Child, Double-Blind Method, Female, Growth Disorders, Humans, Oxandrolone, Puberty, Time Factors, Turner Syndrome, Anabolic Agents

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Effect of oxandrolone and timing of pubertal induction on final height in Turner's syndrome: randomised, double blind, placebo controlled trial

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