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
  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 2

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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • bone metabolism [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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

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.

  Eligibility

Ages Eligible for Study:   14 Years to 30 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00853502

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Anne Klibanski, MD Massachusetts General Hospital
  More Information

Publications:
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

Keywords provided by Massachusetts General Hospital:
anorexia nervosa
testosterone
disordered eating
hypogonadism
bone

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on August 21, 2014