Hormonal Therapy for Teens With Anorexia Nervosa

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Children's Hospital Boston
Sponsor:
Information provided by (Responsible Party):
Catherine M. Gordon, Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01343771
First received: April 20, 2011
Last updated: September 17, 2013
Last verified: September 2013

April 20, 2011
September 17, 2013
June 2011
May 2015   (final data collection date for primary outcome measure)
Bone Marrow Fat by MRI/MRS [ Time Frame: Baseline; M12 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01343771 on ClinicalTrials.gov Archive Site
  • BMD by DXA (spine, hip, whole body) [ Time Frame: Baseline; M6; M12 ] [ Designated as safety issue: No ]
  • Bone biomarkers [ Time Frame: Baseline; M3; M6; M9; M12 ] [ Designated as safety issue: No ]
  • BMD by pQCT of tibia [ Time Frame: Baseline; M6; M12 ] [ Designated as safety issue: No ]
  • Hormonal panel (serum) [ Time Frame: Baseline; M3; M6; M9; M12 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
May 2015
May 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
Female
11 Years to 18 Years
No
Contact: Jennifer O'Donnell, BA 401-793-8571 ext 3-8571 jodonnell2@lifespan.org
United States
 
NCT01343771
11-01-0634
Yes
Catherine M. Gordon, Children's Hospital Boston
Children's Hospital Boston
Not Provided
Principal Investigator: Catherine Gordon, MD, MSc Children's Hospital Boston
Children's Hospital Boston
September 2013

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