Gault, E.J., Perry, R.J., Cole, T.J., Casey, S., Paterson, W.M., Hindmarsh, P.J., Betts, P., Dunger, D.B. and Donaldson, M.D.C. (2011) The impact of oxandolone and timing of pubertal induction on final height in Turner sydrome: a randomised, double-blind, placebo-controlled trial. British Medical Journal, 342(d1980), pp. 1-9. (doi: 10.1136/bmj.d1980)
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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/m2/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.
| Item Type: | Articles |
|---|---|
| Status: | Published |
| Refereed: | Yes |
| Glasgow Author(s) Enlighten ID: | Donaldson, Dr Malcolm and Gault, Miss Emma-Jane |
| Authors: | Gault, E.J., Perry, R.J., Cole, T.J., Casey, S., Paterson, W.M., Hindmarsh, P.J., Betts, P., Dunger, D.B., and Donaldson, M.D.C. |
| College/School: | College of Medical Veterinary and Life Sciences > School of Medicine, Dentistry & Nursing > Clinical Specialities |
| Journal Name: | British Medical Journal |
| Journal Abbr.: | BMJ |
| Publisher: | BMJ Publishing Group |
| ISSN: | 0959-535X |
| ISSN (Online): | 1756-1833 |
| Published Online: | 14 April 2011 |
| Copyright Holders: | Copyright © 2011 The Authors |
| First Published: | First published in British Medical Journal 342:d1980 |
| Publisher Policy: | Reproduced under Creative Commons License |
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