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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04203381
The ClinicalTrials.gov registry entry for NCT04203381 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 88-participant average among 8 other Puberty trials with a reported enrollment target. The listed sponsor is Amy DiVasta, MD, which has 1 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.
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