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

October 22, 2021 updated by: Madhusmita Misra, Massachusetts General Hospital

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 30 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
bone metabolism
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (ACTUAL)

October 1, 2016

Study Completion (ACTUAL)

October 1, 2016

Study Registration Dates

First Submitted

February 26, 2009

First Submitted That Met QC Criteria

February 26, 2009

First Posted (ESTIMATE)

March 2, 2009

Study Record Updates

Last Update Posted (ACTUAL)

October 26, 2021

Last Update Submitted That Met QC Criteria

October 22, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008P-001902

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bone Metabolism

Clinical Trials on testosterone cypionate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lithuania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe