Skeletal Health and Bone Marrow Composition Among Youth

  • STATUS
    Recruiting
  • End date
    Mar 31, 2025
  • participants needed
    80
  • sponsor
    Boston Children's Hospital
Updated on 5 May 2021

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.

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.

Details
Condition Puberty, Bone Development, Gender Dysphoria in Children
Treatment GnRH agonist
Clinical Study IdentifierNCT04203381
SponsorBoston Children's Hospital
Last Modified on5 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 9 yrs and 14 yrs?
Gender: Male or Female
Do you have any of these conditions: Puberty or Gender Dysphoria in Children or Bone Development?
Do you have any of these conditions: Bone Development or Puberty or Gender Dysphoria in Children?
Do you have any of these conditions: Gender Dysphoria in Children or Bone Development or Puberty?
Do you have any of these conditions: Gender Dysphoria in Children or Bone Development or Puberty?
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 BCH Transgender Clinic or CCHMC Transgender Clinic, within six weeks of initiating pubertal blockade treatment (e.g., GnRH agonist- Lupron or Vantas)
Controls are matched on age within 1 year, race/ethnicity, sex assigned at birth and BMI within 20%

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
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