Abstract | PURPOSE: 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.
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Authors | Gary R Strokosch, Andrew J Friedman, Shu-Chen Wu, Marc Kamin |
Journal | The 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 |
PMID | 17116511
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Contraceptives, Oral, Combined
- Ethinyl Estradiol-Norgestrel Combination
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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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