Status:
WITHDRAWN
The Effect of Testosterone Replacement on Bone Mineral Density in Boys and Men With Anorexia Nervosa
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Bone Metabolism
Eligibility:
MALE
14-30 years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
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 disr...
Eligibility Criteria
Inclusion
- Anorexia Nervosa
- Teenage boys and young adult men, age 14-30 years
- Hypogonadism indicated by a testosterone level within the lower 25th percentile for pubertal stage or below normal for pubertal stage
Exclusion
- Disease or illness known to affect bone metabolism
- Use of medications known to affect bone metabolism, such as corticosteroids or androgenic steroids, within 3 months of study initiation
- Subjects with a z-score less than -2.5 on DXA secondary to concerns of severely low bone mineral density which may require aggressive monitoring
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00853502
Start Date
December 1 2008
End Date
October 1 2016
Last Update
October 26 2021
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114