Hormonal Therapy for Teens With Anorexia Nervosa

Anorexia Nervosa (AN) Clinical Trial

Official title:

Effect of Adrenal and Gonadal Hormones on Bone Marrow and Appendicular BMD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01343771
• Other study ID #: 11-01-0634
• Status: Completed
• Phase: Phase 3
• First received: April 20, 2011
• Last updated: April 12, 2017
• Start date: June 2011
• Est. completion date: December 2016

Study information

• Verified date: April 2017
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2016
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 11 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Anorexia Nervosa (AN)

Intervention

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:
• 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.

Locations

Country	Name	City	State
United States	Children's Hospital Boston	Boston	Massachusetts
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children’s Hospital

Country where clinical trial is conducted

United States, 

References & Publications (6)

DiVasta AD, Beck TJ, Petit MA, Feldman HA, LeBoff MS, Gordon CM. Bone cross-sectional geometry in adolescents and young women with anorexia nervosa: a hip structural analysis study. Osteoporos Int. 2007 Jun;18(6):797-804. Epub 2007 Jan 5. — View Citation

DiVasta AD, Ringelheim J, Bristol SK, Feldman HA, Gordon CM. Skeletal measurements by quantitative ultrasound in adolescents and young women with anorexia nervosa. J Pediatr. 2007 Mar;150(3):286-90, 290.e1. — View Citation

Ecklund K, Vajapeyam S, Feldman HA, Buzney CD, Mulkern RV, Kleinman PK, Rosen CJ, Gordon CM. Bone marrow changes in adolescent girls with anorexia nervosa. J Bone Miner Res. 2010 Feb;25(2):298-304. doi: 10.1359/jbmr.090805. — View Citation

Gordon CM, Goodman E, Emans SJ, Grace E, Becker KA, Rosen CJ, Gundberg CM, Leboff MS. Physiologic regulators of bone turnover in young women with anorexia nervosa. J Pediatr. 2002 Jul;141(1):64-70. — View Citation

Gordon CM, Grace E, Emans SJ, Feldman HA, Goodman E, Becker KA, Rosen CJ, Gundberg CM, LeBoff MS. Effects of oral dehydroepiandrosterone on bone density in young women with anorexia nervosa: a randomized trial. J Clin Endocrinol Metab. 2002 Nov;87(11):4935-41. — View Citation

Shaughnessy BF, Feldman HA, Cleveland R, Sonis A, Brown JN, Gordon CM. Oral health and bone density in adolescents and young women with anorexia nervosa. J Clin Pediatr Dent. 2008 Winter;33(2):87-92. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone Marrow Fat by MRI/MRS		Baseline; M12
Secondary	BMD by DXA (spine, hip, whole body)		Baseline; M6; M12
Secondary	Bone biomarkers		Baseline; M3; M6; M9; M12
Secondary	BMD by pQCT of tibia		Baseline; M6; M12
Secondary	Hormonal panel (serum)		Baseline; M3; M6; M9; M12