Skeletal Health and Bone Marrow Composition Among Youth (NCT04203381) | Clinical Trial Compass
TerminatedNot Applicable
Skeletal Health and Bone Marrow Composition Among Youth
Stopped: Funding was terminated.
United States78 participantsStarted 2020-09-15
Plain-language 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.
Who can participate
Age range9 Years – 14 Years
SexALL
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Inclusion criteria
✓. 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%
Exclusion criteria
✕. 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
What they're measuring
1
Change from Bone marrow adiposity by magnetic resonance imaging (MRI) from baseline compared to 24 months
Timeframe: Change from baseline compared to 24 months
2
Change from magnetic resonance spectroscopy (MRS) from baseline compared to 24 months
Timeframe: Change from baseline compared to 24 months