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Clinical Trials/NCT00853502
NCT00853502WithdrawnPhase 2

The Effect of Testosterone Replacement on Bone Mineral Density and Bone Microarchitecture in Teenage Boys and Young Adult Men With Anorexia Nervosa

Massachusetts General Hospital1 site in 1 countryStarted: December 2008Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Withdrawn
Locations
1
Primary Endpoint
bone metabolism

Study Overview

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 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.

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 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
14 Years to 30 Years (Child, Adult)
Sex
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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 Criteria

  • 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

Arms & Interventions

testosterone cypionate

Active Comparator

Intervention: testosterone cypionate (Drug)

Outcomes

Primary Outcomes

bone metabolism

Time Frame: 12 months

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Madhusmita Misra

Chief, Pediatric Endocrinology

Massachusetts General Hospital

Study Sites (1)

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