Adrenal and Gonadal Hormone Replacement in Anorexia Nervosa
NCT ID: NCT00310791
Last Updated: 2018-04-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
80 participants
INTERVENTIONAL
2004-04-30
2010-12-31
Brief Summary
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Detailed Description
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In this project, we will test the hypothesis that combined therapy with DHEA and estrogen/progestin will enhance bone mass in patients with AN through anabolic and antiosteolytic mechanisms. We will test the hypothesis that 18 months of DHEA + HRT will increase bone mineral density (BMD) and markers of bone formation, while decreasing bone resorption markers in these patients. The proposed study will examine whether restoring normal levels of DHEA and estrogen in these young women will increase bone mass during a critical period for bone accretion. The study will also examine whether DHEA's anabolic effects on bone are mediated through the skeletal IGF-I regulatory system. Using cross-sectional analyses of dual energy x-ray absorptiometry (DXA) data, we will also measure indices of bone structural geometry to determine if mechanical strength is compromised in these young women, and if strength is restored in response to combined anabolic/antiresorptive therapy.
To gain new information on the mechanisms underlying bone loss and fracture risk in young women with AN, our research goals are:
Specific Aim I: Through a randomized controlled trial, to measure the effects of an 18-month course of DHEA + HRT on bone mass, markers of bone turnover, and serum levels of IGF-I compared to placebo. Specific Aim II: To determine whether combined therapy with adrenal and gonadal steroid replacement changes bone structure to increase strength compared to placebo, as assessed through cross-sectional geometric analysis of DXA data.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Sugar Pill
Placebo (sugar pill); identical to treatment medication capsule
Placebo (Sugar Pill)
Placebo (sugar pill)
DHEA + Hormone replacement therapy (estrogen/progestin)
Combined therapy of dehydroepiandrosterone (DHEA) and hormone replacement therapy (ERT). Patients randomized to the DHEA + HRT arm will receive micronized oral DHEA in a dose of 50 mg daily + HRT (0.3 mg Premarin, 1 tablet daily for 3 months, follow by Alesse (20 mg ethinyl estradiol + 0.1 mg levonorgestrel for 15 months). The estrogen/progestin component of the regimen has been chosen to maximize patient compliance, as patients with AN may experience bloating or nausea if higher estrogen doses (\> 20 g) are initiated too rapidly. The DHEA capsule strength will be 50 mg, the total daily dose to be studied in combination with HRT. The micronized DHEA preparation achieves more constant DHEA and DHEA-S levels. Fifty milligrams appears to be a physiological replacement dose for these young women, determined both from our pilot (10) and longitudinal studies (7).
Hormone replacement therapy (estrogen/progestin)
Hormone replacement therapy (estrogen/progestin). 0.3 mg conjugated estrogens x 3 months, followed by 9 months of oral contraceptive (20 mg ethinyl estradiol + 0.1 mg levonorgestrel)
Dehydroepiandrosterone (DHEA)
50 mg tablet, 1 daily
Interventions
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Hormone replacement therapy (estrogen/progestin)
Hormone replacement therapy (estrogen/progestin). 0.3 mg conjugated estrogens x 3 months, followed by 9 months of oral contraceptive (20 mg ethinyl estradiol + 0.1 mg levonorgestrel)
Placebo (Sugar Pill)
Placebo (sugar pill)
Dehydroepiandrosterone (DHEA)
50 mg tablet, 1 daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Anorexia nervosa by psychiatric criteria
* Amenorrhea for at least 3 months
Exclusion Criteria
* No other chronic medical conditions
15 Years
30 Years
FEMALE
No
Sponsors
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United States Department of Defense
FED
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Boston Children's Hospital
OTHER
Responsible Party
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Catherine M. Gordon
Catherine Gordon, MD, MSc
Principal Investigators
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Catherine M. Gordon, MD
Role: PRINCIPAL_INVESTIGATOR
Boston Children's Hospital
Locations
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Children's Hospital Boston
Boston, Massachusetts, United States
Countries
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References
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Vajapeyam S, Ecklund K, Mulkern RV, Feldman HA, O'Donnell JM, DiVasta AD, Rosen CJ, Gordon CM. Magnetic resonance imaging and spectroscopy evidence of efficacy for adrenal and gonadal hormone replacement therapy in anorexia nervosa. Bone. 2018 May;110:335-342. doi: 10.1016/j.bone.2018.02.021. Epub 2018 Feb 26.
Divasta AD, Feldman HA, Brown JN, Giancaterino C, Holick MF, Gordon CM. Bioavailability of vitamin D in malnourished adolescents with anorexia nervosa. J Clin Endocrinol Metab. 2011 Aug;96(8):2575-80. doi: 10.1210/jc.2011-0243. Epub 2011 Jun 1.
Divasta AD, Feldman HA, Gordon CM. Vertebral fracture assessment in adolescents and young women with anorexia nervosa: a case series. J Clin Densitom. 2014 Jan-Mar;17(1):207-11. doi: 10.1016/j.jocd.2013.02.011. Epub 2013 Apr 3.
DiVasta AD, Feldman HA, Beck TJ, LeBoff MS, Gordon CM. Does hormone replacement normalize bone geometry in adolescents with anorexia nervosa? J Bone Miner Res. 2014 Jan;29(1):151-7. doi: 10.1002/jbmr.2005.
DiVasta AD, Mulkern RV, Gordon CM, Ecklund K. MR Imaging in a case of severe anorexia nervosa: the 'flip-flop' effect. Pediatr Radiol. 2015 Apr;45(4):617-20. doi: 10.1007/s00247-014-3145-3. Epub 2014 Aug 17.
Donaldson AA, Feldman HA, O'Donnell JM, Gopalakrishnan G, Gordon CM. Spinal Bone Texture Assessed by Trabecular Bone Score in Adolescent Girls With Anorexia Nervosa. J Clin Endocrinol Metab. 2015 Sep;100(9):3436-42. doi: 10.1210/jc.2015-2002. Epub 2015 Jun 24.
DiVasta AD, Feldman HA, O'Donnell JM, Long J, Leonard MB, Gordon CM. Effect of Exercise and Antidepressants on Skeletal Outcomes in Adolescent Girls With Anorexia Nervosa. J Adolesc Health. 2017 Feb;60(2):229-232. doi: 10.1016/j.jadohealth.2016.10.003. Epub 2016 Dec 6.
DiVasta AD, Feldman HA, O'Donnell JM, Long J, Leonard MB, Gordon CM. Skeletal outcomes by peripheral quantitative computed tomography and dual-energy X-ray absorptiometry in adolescent girls with anorexia nervosa. Osteoporos Int. 2016 Dec;27(12):3549-3558. doi: 10.1007/s00198-016-3685-5. Epub 2016 Jul 8.
Bialo SR, Gordon CM. Underweight, overweight, and pediatric bone fragility: impact and management. Curr Osteoporos Rep. 2014 Sep;12(3):319-28. doi: 10.1007/s11914-014-0226-z.
Ecklund K, Vajapeyam S, Mulkern RV, Feldman HA, O'Donnell JM, DiVasta AD, Gordon CM. Bone marrow fat content in 70 adolescent girls with anorexia nervosa: Magnetic resonance imaging and magnetic resonance spectroscopy assessment. Pediatr Radiol. 2017 Jul;47(8):952-962. doi: 10.1007/s00247-017-3856-3. Epub 2017 Apr 22.
Other Identifiers
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Anorexia04
Identifier Type: -
Identifier Source: org_study_id
NCT01343771
Identifier Type: -
Identifier Source: nct_alias
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