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| Sponsor: | Massachusetts General Hospital |
|---|---|
| Information provided by: | Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00853502 |
Purpose
Decreased bone strength is a common and serious medical problem present in many people with anorexia nervosa. Men with anorexia nervosa have lower levels of gonadal steroids such as testosterone. Low testosterone levels have been shown to result in low bone density.
We are investigating whether bone mineral density and bone microarchitecture are abnormal in males with anorexia nervosa and whether supplementation with testosterone would improve both bone mineral density and bone microarchitecture.
| Condition | Intervention | Phase |
|---|---|---|
|
Bone Metabolism |
Drug: testosterone cypionate Other: Bone monitoring |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Effect of Testosterone Replacement on Bone Mineral Density and Bone Microarchitecture in Teenage Boys and Young Adult Men With Anorexia Nervosa |
| Estimated Enrollment: | 36 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | July 2011 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: testosterone cypionate |
Drug: testosterone cypionate
dose dependent on pubertal stage, intramuscular injection once every 3 weeks for 12 months
|
| No Intervention: bone monitoring |
Other: Bone monitoring
bone mineral density and bone microarchitecture will be monitored over time without hormonal intervention
|
Low bone mineral density is a co-morbidity associated with anorexia nervosa that has been shown to persist even after weight gain. Peak bone mass accrual occurs during the adolescent years, and a disruption in this critical process increases the risk for developing persistent deficits in bone density, and possibly increased fracture risk. Multiple variables contribute to the bone mass accrual process in puberty including adequate levels of sex hormones and puberty specific changes in levels of these hormones. Teenage boys with anorexia nervosa have lower bone density than normal weight boys of comparable maturity, and also have decreased levels of testosterone, as well as estradiol, when compared with healthy controls. Although testosterone is an important predictor of bone density in males with anorexia nervosa, the effect of testosterone replacement on bone mass accrual and bone microarchitecture in hypogonadal teenage boys and young adult men with anorexia nervosa is unknown. We hypothesize both bone mass and bone microarchitecture are abnormal in anorexia nervosa and that testosterone replacement in adolescent males with anorexia nervosa will improve both bone mass and microarchitecture.
Eligibility| Ages Eligible for Study: | 14 Years to 30 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Principal Investigator: | Anne Klibanski, MD | Massachusetts General Hospital |
More Information
| Responsible Party: | Anne Klibanski, MD, Massachusetts General Hospital, Neuroendocrine Unit |
| ClinicalTrials.gov Identifier: | NCT00853502 History of Changes |
| Other Study ID Numbers: | 2008P-001902 |
| Study First Received: | February 26, 2009 |
| Last Updated: | July 5, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
anorexia nervosa testosterone disordered eating hypogonadism bone |
|
Anorexia Anorexia Nervosa Signs and Symptoms, Digestive Signs and Symptoms Eating Disorders Mental Disorders Testosterone Testosterone enanthate Testosterone undecanoate Testosterone 17 beta-cypionate |
Methyltestosterone Androgens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Anabolic Agents |