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

This study has suspended participant recruitment.
(Slow recruitment)
Sponsor:
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00853502
First received: February 26, 2009
Last updated: July 5, 2011
Last verified: July 2011

February 26, 2009
July 5, 2011
December 2008
July 2011   (final data collection date for primary outcome measure)
bone metabolism [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00853502 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Effect of Testosterone Replacement on Bone Mineral Density in Boys and Men With Anorexia Nervosa
The Effect of Testosterone Replacement on Bone Mineral Density and Bone Microarchitecture in Teenage Boys and Young Adult Men With Anorexia Nervosa

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Bone Metabolism
  • Drug: testosterone cypionate
    dose dependent on pubertal stage, intramuscular injection once every 3 weeks for 12 months
  • Other: Bone monitoring
    bone mineral density and bone microarchitecture will be monitored over time without hormonal intervention
  • Active Comparator: testosterone cypionate
    Intervention: Drug: testosterone cypionate
  • No Intervention: bone monitoring
    Intervention: Other: Bone monitoring
Misra M, Katzman DK, Cord J, Manning SJ, Mendes N, Herzog DB, Miller KK, Klibanski A. Bone metabolism in adolescent boys with anorexia nervosa. J Clin Endocrinol Metab. 2008 Aug;93(8):3029-36. Epub 2008 Jun 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
36
July 2011
July 2011   (final data collection date for primary outcome measure)

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
Male
14 Years to 30 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00853502
2008P-001902
Yes
Anne Klibanski, MD, Massachusetts General Hospital, Neuroendocrine Unit
Massachusetts General Hospital
Not Provided
Principal Investigator: Anne Klibanski, MD Massachusetts General Hospital
Massachusetts General Hospital
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP