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Effects of an oral contraceptive (norgestimate/ethinyl estradiol) on bone mineral density in adolescent females with anorexia nervosa: a double-blind, placebo-controlled study.

AbstractPURPOSE:
To evaluate the effect of an oral contraceptive (OC) on bone mineral density (BMD) in adolescent females with anorexia nervosa (AN) or eating disorder not otherwise specified (EDNOS).
METHODS:
Females 11-17 years of age with AN or EDNOS entered the study. Subjects were randomized equally to treatment with a triphasic OC containing norgestimate (NGM) 180-250 microg and ethinyl estradiol (EE) 35 microg or placebo for 13 28-day cycles. Dual energy x-ray absorptiometry scans (DXA) of the lumbosacral spine (LS) and hip were obtained at baseline and after 6 and 13 cycles.
RESULTS:
Demographic characteristics of the 112 subjects (NGM/EE 53; Placebo 59) who received study drug and had at least one on-treatment DXA were similar between groups for age (mean: 15 years in each group) and body mass index (mean: NGM/EE 17.9 kg/m2; Placebo 17.6 kg/m2). At the end of Cycle 6, there was a significant increase in the mean LS BMD in the NGM/EE group compared with placebo (.020 g/cm2 vs. .008 g/cm2; p = .021); however, at the end of Cycle 13 the mean increase in LS BMD in the NGM/EE group compared with placebo was no longer significant (.026 g/cm2 vs. .019 g/cm2, p = .244). There was no significant difference in change in hip BMD between groups. The incidence of adverse events was similar between groups.
CONCLUSIONS:
In a group of adolescent females with AN or EDNOS, treatment with a triphasic OC for 13 cycles did not have a statistically significant effect on LS or hip BMD.
AuthorsGary R Strokosch, Andrew J Friedman, Shu-Chen Wu, Marc Kamin
JournalThe Journal of adolescent health : official publication of the Society for Adolescent Medicine (J Adolesc Health) Vol. 39 Issue 6 Pg. 819-27 (Dec 2006) ISSN: 1879-1972 [Electronic] United States
PMID17116511 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Contraceptives, Oral, Combined
  • Ethinyl Estradiol-Norgestrel Combination
Topics
  • Adolescent
  • Anorexia Nervosa (complications)
  • Bone Density (drug effects)
  • Contraceptives, Oral, Combined (pharmacology)
  • Double-Blind Method
  • Ethinyl Estradiol-Norgestrel Combination (pharmacology)
  • Feeding and Eating Disorders (etiology, prevention & control)
  • Female
  • Humans

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