Hormonal Therapy for Teens With Anorexia Nervosa
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 11 - 18 |
| Updated: | 4/14/2017 |
| Start Date: | June 2011 |
| End Date: | December 2016 |
Effect of Adrenal and Gonadal Hormones on Bone Marrow and Appendicular BMD
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.
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.
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.
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.
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
We found this trial at
2
sites
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
Click here to add this to my saved trials
Click here to add this to my saved trials