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
Gender Dysphoria in Children, Puberty, Bone Development
Recruitment Status
Recruiting
Detailed Description
The investigators propose to identify the effects of pubertal blockade on bone density and size in pediatric transgender individuals. Information is limited regarding bone health and metabolism for this group, and especially for children who are transgender. Further, the team's expertise in magnetic resonance imaging (MRI), magnetic resonance spectroscopy (MRS), dual-energy x-ray absorptiometry (DXA), and peripheral quantitative computed tomography (pQCT), examining the natal female skeleton in previous NIH funded studies, and extensive clinical expertise, provide an ideal foundation to apply this protocol to examine transgender female and transgender male skeleton. Findings from this study will allow us to identify potential preventative strategies to counter the long-term effects of puberty blockade such as osteoporosis and raise awareness of this medical consequence to medical care providers of transgender patients. The proposed project seeks to answer the clinically relevant question of how bone marrow composition relates to body composition, and its relation to both bone density and skeletal strength, in transgender patients who are undergoing puberty blockade, the first phase of therapy preceding gender-affirming hormone therapy.
Eligibility Criteria
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:
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
Intervention
Intervention Type
Intervention Name
Device
GnRH Agonist
Phase
Not Applicable
Gender
All
Min Age
9 Years
Max Age
14 Years
Download Date
August 28, 2023
Principal Investigator
Amy DiVasta, MD
Primary Contact Information
For more information on this trial, visit clinicaltrials.gov.
Contact
For more information and to contact the study team: