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Skeletal Health and Bone Marrow Composition Among Youth

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ClinicalTrials.gov Identifier: NCT04203381
Recruitment Status : Recruiting
First Posted : December 18, 2019
Last Update Posted : September 13, 2022
Sponsor:
Collaborator:
Children's Hospital Medical Center, Cincinnati
Information provided by (Responsible Party):
Catherine M. Gordon, MD, MS, Baylor College of Medicine

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Gender Dysphoria in Children Puberty Bone Development Device: GnRH Agonist Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Skeletal Health and Bone Marrow Composition Among Youth
Actual Study Start Date : September 15, 2020
Estimated Primary Completion Date : March 31, 2025
Estimated Study Completion Date : March 31, 2025
Arms and Interventions
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Arm Intervention/treatment
Transgender Participant
Transgender children at Tanner stage II or early Tanner stage III between the ages of 9 and 14. Must be a current patient at a gender patient and within 6 weeks of initiating pubertal blockade treatment
 Device: GnRH Agonist
Forty participants who are transgender and who have been prescribed a gonadotropin-releasing hormone (GnRH) agonist by their physician will undergo magnetic resonance imaging (MRI), magnetic resonance spectroscopy (MRS), dual-energy x-ray absorptiometry (DXA) and peripheral quantitative computed tomography (pQCT) scans at baseline and at 12 months after initiation of the GnRH agonist therapy. This longitudinal observational study of two cohorts seeks to identify significant changes in bone marrow adiposity and bone density over 12 months. The same assessments will be obtained in 40 healthy control subjects matched for age, race/ethnicity and body mass index, all factors that are known to influence skeletal outcomes. The evaluations of bone marrow adiposity will be correlated with bone density measurements and the assessments of mood (validated anxiety and depression scales) and health-related quality of life, before and after pubertal blockade.
Other Names:
  • Histrelin
  • Lupron
  • Pubertal Blockade
No Intervention: Cisgender Control Participant
Cisgender children Tanner II or early Tanner III between 9 and 14 matched by race, age, and BMI.


Outcome Measures
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Primary Outcome Measures :
  1. Bone marrow adiposity by magnetic resonance imaging (MRI) [ Time Frame: Baseline compared to 12 months ]
    Bone marrow adiposity measured by MRI (T1 maps)

  2. Magnetic resonance spectroscopy (MRS) [ Time Frame: Baseline compared to 12 months ]
    T2 corrected fat/(fat+ water) ratios


Secondary Outcome Measures :
  1. Total body bone mineral density Z-score by Dual-energy X-ray absorptiometry (DXA) [ Time Frame: Baseline compared to 12 months ]
    Total body BMD Z-score

  2. Spine BMD Z-score by DXA [ Time Frame: Baseline compared to 12 months ]
    Lumbar spine BMD Z-score

  3. Hip BMD Z-score by DXA [ Time Frame: Baseline compared to 12 months ]
    Hip bone mineral density (g/cm2)

  4. Volumetric bone mineral density (vBMD) [ Time Frame: Baseline compared to 12 months ]
    Quantitative computed tomography (pQCT) scans will be obtained at sites 3%, 38%, and 66% of tibial length proximal to the distal growth plate

  5. Section modulus (bone bending strength) by quantitative computed tomography (pQCT) [ Time Frame: Baseline compared to 12 months ]
    pQCT scans will be obtained at sites 3%, 38%, and 66% of tibial length proximal to the distal growth plate


Other Outcome Measures:
  1. Health-related quality of life (HRQL) [ Time Frame: Baseline compared to 12 months ]
    HRQL will be assessed at initiation of the GnRH agonist and after 12 months to understand the impact of pubertal blockade on quality of life using the validated survey, Child Health Questionnaire (CHQF)-87.

  2. Anxiety [ Time Frame: Baseline compared to 12 months ]
    Anxiety will be assessed at initiation of the GnRH agonist and after 12 months to understand the impact of pubertal blockade on feelings of anxiety. Anxiety will be assessed using the validated survey, the SCARED.

  3. Depression [ Time Frame: Baseline compared to 12 months ]
    Depression will be assessed at initiation of the GnRH agonist and after 12 months to understand the impact of pubertal blockade on feelings of depression using the validated survey, the Children's Depression Inventory (CDI-II)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Participants must identify as transgender or nonbinary to be eligible for the study.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Be willing to give informed consent/assent (parent or legal guardian able to provide informed consent)
  2. Tanner Stage II/III
  3. Age 9-14 years old for assigned male at birth (AMAB) and 9-13 for assigned female at birth (AFAB)
  4. 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)
  5. Controls are matched on age within 1 year, race/ethnicity, sex assigned at birth and BMI within 20%

Exclusion Criteria:

The participant must not:

  1. Have chronic disease known to affect skeletal metabolism (e.g. cystic fibrosis, celiac disease, sickle cell disease, inflammatory bowel disease etc.)
  2. Receipt of other medications within previous 3 months known to affect skeletal metabolism (e.g., glucocorticoids, anticonvulsants, etc.)
  3. Have metal implants or hardware in their body that would not allow them to get an MRI
  4. Have a diagnosis of a developmental disorder or claustrophobia that would prevent them from undergoing an MRI
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04203381


Contacts
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Contact: Catherine M Gordon, MD 713-798-8334 catherine.gordon@childrens.harvard.edu

Locations
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United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02215
Contact: Danielle DeMaio    617-355-8349    danielle.demaio@childrens.harvard.edu   
Principal Investigator: Catherine M Gordon, MD, MSc         
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Leah Tyzinski    513-636-7514    leah.tyzinski@cchmc.org   
Principal Investigator: Heidi Kalkwarf, PhD         
Sponsors and Collaborators
Boston Children's Hospital
Children's Hospital Medical Center, Cincinnati
More Information
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Responsible Party: Catherine M. Gordon, MD, MS, Professor of Pediatrics, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT04203381    
Other Study ID Numbers: P00033841
First Posted: December 18, 2019    Key Record Dates
Last Update Posted: September 13, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gender Dysphoria
Sexual Dysfunctions, Psychological
Mental Disorders