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

This study has been withdrawn prior to enrollment.
(No recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00853502
First Posted: March 2, 2009
Last Update Posted: October 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Anne Klibanski, MD, Massachusetts General Hospital
  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 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 Anne Klibanski, MD, Massachusetts General Hospital:

Primary Outcome Measures:
  • bone metabolism [ Time Frame: 12 months ]

Enrollment: 0
Study Start Date: December 2008
Study Completion Date: October 2016
Primary Completion Date: October 2016 (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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 30 Years   (Child, Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, Chief, Neuroendocrine Unit, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00853502     History of Changes
Other Study ID Numbers: 2008P-001902
First Submitted: February 26, 2009
First Posted: March 2, 2009
Last Update Posted: October 28, 2016
Last Verified: October 2016

Keywords provided by Anne Klibanski, MD, Massachusetts General Hospital:
anorexia nervosa
testosterone
disordered eating
hypogonadism
bone

Additional relevant MeSH terms:
Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and 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
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents