Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Hormonal Therapy for Teens With Anorexia Nervosa

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Catherine M. Gordon, Boston Children's Hospital
ClinicalTrials.gov Identifier:
NCT01343771
First received: April 20, 2011
Last updated: April 12, 2017
Last verified: April 2017
  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
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, 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 Boston Children’s Hospital:

Primary Outcome Measures:
  • Bone Marrow Fat by MRI/MRS [ Time Frame: Baseline; M12 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 70
Study Start Date: June 2011
Study Completion Date: December 2016
Primary Completion Date: January 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   (Child, Adult)
Sexes 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

Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Boston Children’s Hospital
Investigators
Principal Investigator: Catherine M Gordon, MD, MSc Boston Children’s Hospital
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Catherine M. Gordon, Catherine M. Gordon, MD, MSc, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT01343771     History of Changes
Other Study ID Numbers: 11-01-0634
Study First Received: April 20, 2011
Last Updated: April 12, 2017

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

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

ClinicalTrials.gov processed this record on April 24, 2017