Hormonal Therapy for Teens With Anorexia Nervosa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01343771
Recruitment Status : Completed
First Posted : April 28, 2011
Last Update Posted : April 13, 2017
Information provided by (Responsible Party):
Catherine M. Gordon, Boston Children's Hospital

April 20, 2011
April 28, 2011
April 13, 2017
June 2011
January 2015   (Final data collection date for primary outcome measure)
Bone Marrow Fat by MRI/MRS [ Time Frame: Baseline; M12 ]
Same as current
Complete list of historical versions of study NCT01343771 on Archive Site
  • BMD by DXA (spine, hip, whole body) [ Time Frame: Baseline; M6; M12 ]
  • Bone biomarkers [ Time Frame: Baseline; M3; M6; M9; M12 ]
  • BMD by pQCT of tibia [ Time Frame: Baseline; M6; M12 ]
  • Hormonal panel (serum) [ Time Frame: Baseline; M3; M6; M9; M12 ]
Same as current
Not Provided
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Hormonal Therapy for Teens With Anorexia Nervosa
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.

Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Anorexia Nervosa (AN)
  • Drug: DHEA (Prasterone) + ERT (Aviane)
    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 mcg ethinyl estradiol + 0.1 mg levonorgestrel for 9 months)
    Other Names:
    • Dehydroepiandrosterone (DHEA)
    • Estrogen Replacement Therapy (ERT)
  • Other: Placebo
    A placebo tablet will be developed by the Children's Hospital Pharmacy. Both treatments (DHEA+ERT and placebo) will be administered in a gelatin capsule.
    Other Name: Sugar Pill
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
  • Active Comparator: DHEA + ERT
    Intervention: Drug: DHEA (Prasterone) + ERT (Aviane)

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
December 2016
January 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • age 11-18 years (potential subjects age 11-13 years must have a bone age x-ray (obtained within previous 6 months) that is 13 years or more advanced)
  • diagnosis of AN based on DSM-IV criteria
  • female gender
  • postmenarchal

Exclusion Criteria:

  • concomitant chronic diseases which affect bone health (e.g., cystic fibrosis, celiac disease)
  • use of medications known to affect bone metabolism during the last 3 months
  • use of depot medroxyprogesterone acetate during the last 12 months
  • current pregnancy
Sexes Eligible for Study: Female
11 Years to 18 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Catherine M. Gordon, Boston Children's Hospital
Boston Children’s Hospital
Not Provided
Principal Investigator: Catherine M Gordon, MD, MSc Boston Children’s Hospital
Boston Children’s Hospital
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP