Effects of an Oral Contraceptive (Norgestimate/Ethinyl Estradiol) on Bone Mineral Density in Adolescent Females with Anorexia Nervosa: A Double-Blind, Placebo-Controlled Study

Eating Disorders Program, Department of Adolescent Medicine, Rush-Presbyterian-St. Luke's Medical Center, Chicago, Illinois, USA.
Journal of Adolescent Health (Impact Factor: 3.61). 01/2007; 39(6):819-27. DOI: 10.1016/j.jadohealth.2006.09.010
Source: PubMed


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).
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.
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.
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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    • "Effective therapies for preventing bone loss in patients with AN have remained elusive. Hormone therapy has yielded disappointing results except in the most severely malnourished patients [4] [5] [6] [7] [8] [9] [10]. As adolescence is a critical period for bone acquisition [11], the identification of strategies to preserve areal BMD (aBMD) in adolescents with AN is paramount. "
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    ABSTRACT: Anorexia nervosa (AN) is characterized by subnormal estrogen and dehydroepiandrosterone (DHEA) levels. We sought to determine whether the combination of DHEA + estrogen/progestin is superior to placebo in preserving skeletal health over 18 months in AN. Females with AN, aged 13 to 27 years, were recruited for participation in this double-blind, placebo-controlled, randomized trial. Ninety-four subjects were randomized, of whom 80 completed baseline assessments and received either study drug (oral micronized DHEA 50 mg + 20 µg ethinyl estradiol/0.1 mg levonorgestrel combined oral contraceptive pill [COC] daily; n = 43) or placebo (n = 37). Serial measurements of areal bone mineral density (aBMD), bone turnover markers, and serum hormone concentrations were obtained. Sixty subjects completed the 18-month trial. Spinal and whole-body aBMD z scores were preserved in the DHEA + COC group, but decreased in the placebo group (comparing trends, P = .008 and P = .001, respectively). Bone turnover markers initially declined in subjects receiving DHEA + COC and then returned to baseline. No differences in body composition, adverse effects of therapy, or alterations in biochemical safety parameters were observed. Combined therapy with DHEA + COC appears to be safe and effective for preventing bone loss in young women with AN, whereas placebo led to decreases in aBMD. Dehydroepiandrosterone + COC may be safely used to preserve bone mass as efforts to reverse the nutritional, psychological, and other hormonal components of AN are implemented.
    Metabolism: clinical and experimental 01/2012; 61(7):1010-20. DOI:10.1016/j.metabol.2011.11.016 · 3.89 Impact Factor
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    • "The remaining 23 studies (22.3%) described their methods in sufficient detail so that specific weight cut-offs could be recalculated for use in the present study. Seven of the 23 studies (Clinton & Norring, 1999; Lee et al. 2001, 2003; Solenberger, 2001; Turner & Bryant-Waugh, 2004; McIntosh et al. 2005; Abbate-Daga et al. 2007) created an absolute BMI cut-off, and another study (Strokosch et al. 2006) described using the 10th percentile BMI for gender and age based on Hebebrand et al. (1996). The other 15 studies (Lee et al. 1993; Gowers et al. 1994; Schork et al. 1994; Fullerton et al. 1995; Carlat et al. 1997; Attia et al. 1998; Schaefer et al. 1998; Mizes et al. 2000, 2004; Kaye et al. 2001; Williamson et al. 2002; Pike et al. 2003; Miller et al. 2005; Levine et al. 2007; Roberto et al., 2008) calculated 85% of EBW based on specific tables of norms, "
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    ABSTRACT: DSM-IV cites <85% of expected body weight (EBW) as a guideline for the diagnosis of anorexia nervosa (AN) but does not require a specific method for calculating EBW. The purpose of the present study was to determine the degree to which weight cut-off calculations vary across studies, and to evaluate whether differential cut-offs lead to discrepancies in the prevalence of individuals who are eligible for the AN diagnosis. Two coders independently recorded the EBW calculation methods from 99 studies that either (a) compared individuals with AN to those with subclinical eating disorders or (b) conducted AN treatment trials. Each weight cut-off was applied to a nationally representative (n=12001) and treatment-seeking (n=189) sample to determine the impact of EBW calculation on the proportion who met the AN weight criterion. Coders identified 10 different EBW methods, each of which produced different weight cut-offs for the diagnosis of AN. Although only 0.23% of the national sample met the lowest cut-off, this number increased 43-fold to 10.10% under the highest cut-off. Similarly, only 48.1% of treatment seekers met the lowest cut-off, whereas 89.4% met the highest. There is considerable variance across studies in the determination of the AN weight cut-off. Discrepancies substantially affect the proportion of individuals who are eligible for diagnosis, treatment and insurance reimbursement. However, differences may not be fully appreciated because the ubiquitous citation of the 85% criterion creates a sense of false consensus.
    Psychological Medicine 09/2008; 39(5):833-43. DOI:10.1017/S0033291708004327 · 5.94 Impact Factor
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    ABSTRACT: Includes bibliographical references.
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