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Sponsors and Collaborators: |
Children's Hospital Boston Department of Defense Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | Children's Hospital Boston |
ClinicalTrials.gov Identifier: | NCT00310791 |
This study seeks to gain new information on why young women with anorexia nervosa are predisposed to early bone loss and osteoporosis. Through a randomized treatment trial in which participants will receive either combined therapy with the adrenal hormone, dehydroepiandrosterone (DHEA) and estrogen replacement therapy or placebo, we will determine the effects of an 18-month treatment course on bone mass, circulating markers of bone turnover, and serum levels of a factor, insulin-like growth factor I (IGF-I). We are also studying if these therapies changes bone structure to increase skeletal strength compared to placebo, as assessed through cross-sectional geometric analysis of our bone density data by dual-energy x-ray absorptiometry (DXA).
Condition | Intervention | Phase |
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Anorexia Nervosa |
Drug: DHEA + Hormone replacement therapy (estrogen/progestin) |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Effects of Adrenal and Gonadal Hormone Replacement in Young Women With Anorexia Nervosa |
Estimated Enrollment: | 80 |
Study Start Date: | April 2004 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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0: Placebo Comparator |
Drug: DHEA + Hormone replacement therapy (estrogen/progestin)
DHEA + Hormone replacement therapy (estrogen/progestin)
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1: Experimental |
Drug: DHEA + Hormone replacement therapy (estrogen/progestin)
DHEA + Hormone replacement therapy (estrogen/progestin)
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Profound osteopenia is a frequent and often irreversible complication of anorexia nervosa (AN). Adolescents with AN often have a reduced peak bone mass and are at increased risk for early osteoporosis and fractures. These young women have subnormal serum levels of gonadal steroids and the adrenal androgen dehydroepiandrosterone (DHEA) that may be associated with their low bone mineral density (BMD). Low DHEA levels are accompanied by decreased levels of insulin-like growth factor I (IGF-I), estrogen, and testosterone. Previous data from our group indicate that oral DHEA therapy in young women with AN: increases lean body mass, serum levels of bone formation markers and IGF-I, and decreases urinary markers of bone resorption. We also found that standard hormonal replacement therapy (HRT) significantly decreased bone resorption markers. Information on the effects of these therapies on bone strength and ultimate fracture risk is lacking. 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 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.
Ages Eligible for Study: | 15 Years to 30 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Children's Hospital Boston | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Catherine M. Gordon, MD | Children's Hospital Boston |
Responsible Party: | Children's Hospital, Boston ( Catherine Gordon, MD, MSc ) |
Study ID Numbers: | Anorexia04, RO1 HD043869 |
Study First Received: | April 3, 2006 |
Last Updated: | July 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00310791 History of Changes |
Health Authority: | United States: Food and Drug Administration |
anorexia nervosa adolescents dual-energy x-ray absorptiometry dehydroepiandrosterone (DHEA) osteoporosis |
Estrogens Signs and Symptoms, Digestive Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Osteoporosis Dehydroepiandrosterone Hormones |
Signs and Symptoms Mental Disorders Progestins Anorexia Anorexia Nervosa Epinephrine Eating Disorders |
Signs and Symptoms Estrogens Signs and Symptoms, Digestive Mental Disorders Progestins Physiological Effects of Drugs |
Hormones, Hormone Substitutes, and Hormone Antagonists Anorexia Anorexia Nervosa Hormones Pharmacologic Actions Eating Disorders |