Anorexia Nervosa (AN) Clinical Trial
Official title:
Effect of Adrenal and Gonadal Hormones on Bone Marrow and Appendicular BMD
The following randomized controlled trial will examine the effects of one year of dehydroepiandrosterone and estrogen replacement therapy (DHEA +ERT) on bone mineral density (BMD) and bone marrow composition in adolescents with anorexia nervosa (AN). The investigators will use imaging techniques including dual-energy x-ray absorptiometry (DXA), peripheral quantitative computed tomography (pQCT), visual assessments of magnetic resonance imaging (MRI) data, MR relaxometry and magnetic resonance spectroscopy (MRS) to measure bone mineral density and evaluate bone marrow composition. The investigators will also collect serum to measure hormonal mediators of the changes observed in both bone density and bone marrow composition, including adrenal and gonadal steroids, insulin-like growth factors, growth hormone, and ghrelin, adiponectin, and leptin.
This double-blinded randomized controlled trial will include 2 treatment arms of 35
patients. Group 1 will receive micronized oral DHEA in a dose of 50 mg daily + ERT (0.3 mg
Premarin, 1 tablet daily for 3 months, follow by Alesse, 20 mg ethinyl estradiol + 0.1 mg
levonorgestrel for 9 months); and Group 2 will receive placebo.There will be 12 months of
therapy with follow up assessments every 3 months. DXA and pQCT measurements will be
obtained at baseline, 6 months, and 12 months; MRI and MRS will be performed at baseline and
1 year; serum samples will be obtained at baseline and every 3 months throughout the
12-month trial; psychological and nutrition surveys will be carried out at baseline, 6, and
12 months.
The investigators anticipate that this study will enable us to evaluate the efficacy of oral
DHEA + ERT as a treatment strategy to optimize peak bone mass and to prevent development of
osteoporosis in patients with AN.
;