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
  Purpose

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.


Condition Intervention Phase
Anorexia Nervosa (AN)
Drug: DHEA (Prasterone) + ERT (Aviane)
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Adrenal and Gonadal Hormones on Bone Marrow and Appendicular BMD

Resource links provided by NLM:


Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • Bone Marrow Fat by MRI/MRS [ Time Frame: Baseline; M12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 70
Study Start Date: June 2011
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo 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
Active Comparator: DHEA + ERT 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)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   11 Years to 18 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01343771

Contacts
Contact: Jennifer O'Donnell, BA 401-793-8571 ext 3-8571 jodonnell2@lifespan.org

Locations
United States, Massachusetts
Children's Hospital Boston Recruiting
Boston, Massachusetts, United States, 02115
Contact: Jennifer M O'Donnell, BA    401-793-8571 ext 3-8571    jodonnell2@lifespan.org   
Principal Investigator: Catherine M Gordon, MD, MSc         
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Jennifer M O'Donnell, BA    401-793-8571 ext 3-8571    jodonnell2@lifespan.org   
Principal Investigator: Catherine M Gordon, MD, MSc         
Sponsors and Collaborators
Children's Hospital Boston
Investigators
Principal Investigator: Catherine Gordon, MD, MSc Children's Hospital Boston
  More Information

Publications:
Responsible Party: Catherine M. Gordon, Catherine M. Gordon, MD, MSc, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT01343771     History of Changes
Other Study ID Numbers: 11-01-0634
Study First Received: April 20, 2011
Last Updated: September 17, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:
Anorexia Nervosa (AN)
bone density
DHEA
estrogen therapy

Additional relevant MeSH terms:
Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Eating Disorders
Mental Disorders
Dehydroepiandrosterone
Estrogens
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on July 23, 2014