Skeletal Health and Bone Marrow Composition Among Youth
Stopped early · Not applicable
Conditions studied: Gender Dysphoria in Children, Puberty, Bone Development
In brief
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.
Key facts
- Study ID
- NCT04203381
- Run by
- Amy DiVasta, MD
- People needed
- 78
- Starts
- 2020-09-15
- Expected to finish
- 2026-03-30
- Last updated by the study team
- 2026-04-03
Who can join
Age: 9 and older, up to 14. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Be willing to give informed consent/assent (parent or legal guardian able to provide informed consent)
- Tanner Stage II/III
- Age 9-14 years old for assigned male at birth (AMAB) and 9-13 for assigned female at birth (AFAB)
- Current patient at the Boston Children's Hospital Transgender Clinic or Cincinnati Children's Hospital Medical Center Clinic, within six weeks of initiating pubertal blockade treatment (e.g., GnRH agonist- Lupron or Vantas)
- Controls are matched on age within 2 years, race/ethnicity, sex assigned at birth and BMI within 25%
You may not qualify if…
- The participant must not:
- Have chronic disease known to affect skeletal metabolism (e.g. cystic fibrosis, celiac disease, sickle cell disease, inflammatory bowel disease etc.)
- Receipt of other medications within previous 3 months known to affect skeletal metabolism (e.g., glucocorticoids, anticonvulsants, etc.)
- Have metal implants or hardware in their body that would not allow them to get an MRI
- Have a diagnosis of a developmental disorder or claustrophobia that would prevent them from undergoing an MRI
Where it is running
- Boston Children's Hospital — Boston, Massachusetts, United States
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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