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Hormonal Therapy for Teens With Anorexia Nervosa

Information source: Children's Hospital Boston
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Anorexia Nervosa (AN)

Intervention: DHEA (Prasterone) + ERT (Aviane) (Drug); Placebo (Other)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Children's Hospital Boston

Official(s) and/or principal investigator(s):
Catherine M Gordon, MD, MSc, Principal Investigator, Affiliation: Children's Hospital Boston

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.

Clinical Details

Official title: Effect of Adrenal and Gonadal Hormones on Bone Marrow and Appendicular BMD

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Bone Marrow Fat by MRI/MRS

Secondary outcome:

BMD by DXA (spine, hip, whole body)

Bone biomarkers

BMD by pQCT of tibia

Hormonal panel (serum)

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

Minimum age: 11 Years. Maximum age: 18 Years. Gender(s): Female.

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

Locations and Contacts

Children's Hospital Boston, Boston, Massachusetts 02115, United States

Rhode Island Hospital, Providence, Rhode Island 02903, United States

Additional Information

Related publications:

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.

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.

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.

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.

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.

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.

Starting date: June 2011
Last updated: June 4, 2015

Page last updated: August 23, 2015

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