Study Stopped
No recruitment
The Effect of Testosterone Replacement on Bone Mineral Density in Boys and Men With Anorexia Nervosa
1 other identifier
interventional
N/A
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2008
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 26, 2009
CompletedFirst Posted
Study publicly available on registry
March 2, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedOctober 26, 2021
October 1, 2021
7.8 years
February 26, 2009
October 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
bone metabolism
12 months
Study Arms (2)
testosterone cypionate
ACTIVE COMPARATORbone monitoring
NO INTERVENTIONInterventions
dose dependent on pubertal stage, intramuscular injection once every 3 weeks for 12 months
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Related Publications (1)
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.
PMID: 18544623BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Madhusmita Misra, MD
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief, Pediatric Endocrinology
Study Record Dates
First Submitted
February 26, 2009
First Posted
March 2, 2009
Study Start
December 1, 2008
Primary Completion
October 1, 2016
Study Completion
October 1, 2016
Last Updated
October 26, 2021
Record last verified: 2021-10