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

NCT ID: NCT00853502

Last Updated: 2021-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2016-10-31

Brief Summary

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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

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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.

Conditions

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Bone Metabolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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testosterone cypionate

Group Type ACTIVE_COMPARATOR

testosterone cypionate

Intervention Type DRUG

dose dependent on pubertal stage, intramuscular injection once every 3 weeks for 12 months

bone monitoring

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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testosterone cypionate

dose dependent on pubertal stage, intramuscular injection once every 3 weeks for 12 months

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Madhusmita Misra

Chief, Pediatric Endocrinology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Madhusmita Misra, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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. doi: 10.1210/jc.2008-0170. Epub 2008 Jun 10.

Reference Type BACKGROUND
PMID: 18544623 (View on PubMed)

Other Identifiers

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2008P-001902

Identifier Type: -

Identifier Source: org_study_id