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Trial record 50 of 236 for:    PRASTERONE

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

Brief Summary:
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 or disease Intervention/treatment Phase
Anorexia Nervosa (AN) Drug: DHEA (Prasterone) + ERT (Aviane) Other: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Adrenal and Gonadal Hormones on Bone Marrow and Appendicular BMD
Study Start Date : June 2011
Actual Primary Completion Date : January 2015
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Prasterone

Arm Intervention/treatment
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)

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

Secondary Outcome Measures :
  1. BMD by DXA (spine, hip, whole body) [ Time Frame: Baseline; M6; M12 ]
  2. Bone biomarkers [ Time Frame: Baseline; M3; M6; M9; M12 ]
  3. BMD by pQCT of tibia [ Time Frame: Baseline; M6; M12 ]
  4. Hormonal panel (serum) [ Time Frame: Baseline; M3; M6; M9; M12 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   11 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01343771

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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
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Principal Investigator: Catherine M Gordon, MD, MSc Boston Children’s Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Catherine M. Gordon, Catherine M. Gordon, MD, MSc, Boston Children’s Hospital Identifier: NCT01343771    
Other Study ID Numbers: 11-01-0634
First Posted: April 28, 2011    Key Record Dates
Last Update Posted: April 13, 2017
Last Verified: April 2017
Keywords provided by Catherine M. Gordon, Boston Children’s Hospital:
Anorexia Nervosa (AN)
bone density
estrogen therapy
eating disorder
Additional relevant MeSH terms:
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Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Adjuvants, Immunologic
Immunologic Factors