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NCT04203381 · ClinicalTrials.gov registry record · NA
Skeletal Health and Bone Marrow Composition Among Youth
A NA study of Puberty and Bone Development, sponsored by Amy DiVasta, MD.
- Active
- Registry status
- NA
- Development phase
- 80
- Enrollment target
- 2
- Study locations
NCT04203381: Active NA study of Puberty and Bone Development, sponsored by Amy DiVasta, MD.
NCT04203381 is a NA study of Puberty and Bone Development that is active but no longer recruiting, run by Amy DiVasta, MD. The registered enrollment target is 80 participants, roughly in line with the 88-participant average among 8 other Puberty trials with a reported enrollment target. The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04203381, a NA study of Puberty and Bone Development, is active but no longer recruiting, sponsored by Amy DiVasta, MD.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
- 2
- Study locations
Study Summary
Children and adolescents experiencing gender dysphoria feel increased distress with the onset of puberty. Gender clinics treat these young adolescents by "blocking" puberty using gonadotropin-releasing hormone (GnRH) agonist medications. This has the possibility of impacting bone development as sex steroids are important to bone mass development. In this multi-site study, the investigators will examine bone marrow composition (by MRI) in 40 transgender youth and bone density and body composition before/after pubertal blockade compared to healthy participants.
Primary Outcome
Change from bone marrow adiposity measured by MRI (T1 maps) from baseline compared to 24 months
Conditions Studied
Interventions
- DEVICE GnRH Agonist
Study Locations (2)
Massachusetts
- Boston Children's Hospital - Boston
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2020-09-15 |
| Est. Completion | 2025-12-30 |
| Phase | NA |
What the registry record for NCT04203381 still lists
NCT04203381 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, roughly in line with the 88-participant average among 8 other Puberty trials with a reported enrollment target.
The record links to 3 conditions, with Puberty appearing as the primary indexed condition, and to 1 intervention - of which GnRH Agonist is the first listed.
NCT04203381 reports a single indexed study location in Massachusetts, Ohio.
Frequently Asked Questions
What is clinical trial NCT04203381 about?
NCT04203381 is a clinical study titled "Skeletal Health and Bone Marrow Composition Among Youth". Children and adolescents experiencing gender dysphoria feel increased distress with the onset of puberty. Gender clinics treat these young adolescents by "blocking" puberty using gonadotropin-releasing hormone (GnRH) agonist medications. This has the possibility of impacting bone development as sex ...
What is the current status of trial NCT04203381?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 80 participants. The study started on 2020-09-15. Estimated completion is 2025-12-30.
What conditions does trial NCT04203381 study?
This clinical trial studies the following conditions: Puberty, Bone Development, Gender Dysphoria in Children.
What interventions are being tested in trial NCT04203381?
The interventions under investigation include: GnRH Agonist (DEVICE).
Who is sponsoring clinical trial NCT04203381?
This trial is sponsored by Amy DiVasta, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04203381 being conducted?
This trial has 2 study locations across Massachusetts, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Puberty
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04203381's enrollment target sits among peer trials
80 4th of 8 higher than 5 of 8 other Puberty trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Puberty trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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