Overview

This trial is active, not recruiting.

Condition anorexia nervosa (an)
Treatments dhea (prasterone) + ert (aviane), placebo
Phase phase 3
Sponsor Children's Hospital Boston
Start date June 2011
End date January 2015
Trial size 70 participants
Trial identifier NCT01343771, 11-01-0634

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Placebo Comparator)
placebo Sugar Pill
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.
(Active Comparator)
dhea (prasterone) + ert (aviane) Dehydroepiandrosterone (DHEA)
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)

Primary Outcomes

Measure
Bone Marrow Fat by MRI/MRS
time frame: Baseline; M12

Secondary Outcomes

Measure
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

Eligibility Criteria

Female participants from 11 years up to 18 years old.

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

Additional Information

Official title Effect of Adrenal and Gonadal Hormones on Bone Marrow and Appendicular BMD
Principal investigator Catherine M Gordon, MD, MSc
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Children's Hospital Boston.