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Sponsors and Collaborators: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) National Center for Research Resources (NCRR) |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00089843 |
Women with Anorexia Nervosa have been found to have low bone density. The study will determine whether administration of low doses of a natural hormone, testosterone and/or risedronate, a medication to help prevent bone breakdown will improve or prevent bone loss in this condition.
Condition | Intervention | Phase |
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Anorexia Nervosa |
Drug: Testosterone Drug: Risedronate |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Efficacy Study |
Official Title: | IGF-1 and Bone Loss in Women Anorexia Nervosa |
Enrollment: | 76 |
Study Start Date: | June 2003 |
Study Completion Date: | April 2008 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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2: Placebo Comparator
Placebo Actonel and active testosterone patch
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Drug: Testosterone
Testosterone patch 150mcg daily
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3: Active Comparator
Active Actonel and Active Testosterone patch
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Drug: Testosterone
Testosterone patch 150mcg daily
Drug: Risedronate
Risedronate 35mg PO one time weekly
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4: Active Comparator
Active Actonel and Placebo Testosterone
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Drug: Risedronate
Risedronate 35mg PO one time weekly
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1: No Intervention
Placebo testosterone patch and placebo actonel
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II. SPECIFIC AIMS
Severe osteopenia is a prevalent complication of anorexia nervosa (AN), affecting over half of all women with this disease. Loss of 25-50% of total bone mass occurs frequently and is often permanent. Although anorexia nervosa affects from 0.5-1.0% of college age women, no successful therapeutic interventions have been developed for osteoporosis in this population. Bone loss in anorexia nervosa is characterized by reduced bone formation coupled with increased bone resorption. Anorexia nervosa results in a deficiency of testosterone. Testosterone administration reduces bone resorption and data suggest that low-dose testosterone replacement therapy can increase surrogate markers of bone formation. Bisphosphonates are now well established to decrease bone resorption and improve bone density in severely osteopenic postmenopausal women. However, there are few data regarding the use of this antiresorptive therapy in women with severe pre-menopausal bone loss. Our preliminary data demonstrate that administration of a bisphosphonate decreases bone resorption and increases bone mass in women with AN after 6 and 9 months. These are the first data to demonstrate a striking increase in bone density in such women. We will test the hypothesis that a combined strategy to increase bone formation and decrease bone resorption by combining testosterone with a bisphosphonate will increase bone mass in anorexia nervosa.
The following hypotheses will be tested:
Specific Aim 1. Testosterone, a nutritionally dependent bone trophic factor, is a critical determinant of decreased bone formation in anorexia nervosa, and administration of physiologic testosterone will increase bone formation and lean body mass in this disease
We will investigate in women with anorexia nervosa whether:
A. Bone formation is reduced in association with low serum testosterone B. Testosterone deficiency is due to a combination of ovarian and adrenal defects resulting from undernutrition C. Testosterone administration reverses testosterone deficiency leading to an acute and sustained increase in bone formation and a decrease in bone resorption D. Administration of physiologic testosterone replacement stimulates increases in IGF-I levels in women with anorexia nervosa, a mechanism for increased bone formation and bone density E. Administration of physiologic testosterone replacement increases lean body mass, a major determinant of bone density
Specific Aim 2. Long-term (12 months) physiologic testosterone administration combined with a bisphosphonate increases bone density by a dual anabolic and anti-resorptive strategy
We will investigate in women with anorexia nervosa whether:
A. Physiologic testosterone administration increases bone density B. Administration of a bisphosphonate decreases the excessive state of bone resorption and increases bone density C. Co-administration of physiologic testosterone replacement and a bisphosphonate increases bone density to a greater degree than testosterone or a bisphosphonate alone by increasing bone formation and decreasing bone resorption
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 |
Principal Investigator: | Anne Klibanski, M.D. | Massachusetts General Hospital |
Responsible Party: | Massachusetts General Hospital ( Christine Holley-Williams / Senior Grants and Contracts Administrator ) |
Study ID Numbers: | 5 R01 DK052625-07 |
Study First Received: | August 16, 2004 |
Last Updated: | August 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00089843 |
Health Authority: | United States: Food and Drug Administration |
Eating Disorders Osteopenia |
Calcium, Dietary Signs and Symptoms Testosterone Signs and Symptoms, Digestive Mental Disorders Anorexia |
Methyltestosterone Anorexia Nervosa Risedronic acid Eating Disorders Testosterone 17 beta-cypionate |
Antineoplastic Agents, Hormonal Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Calcium Channel Blockers Bone Density Conservation Agents |
Cardiovascular Agents Hormones Pharmacologic Actions Membrane Transport Modulators Anabolic Agents Therapeutic Uses Androgens |