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Gender Dysphoria in ChildrenNCT04203381

Skeletal Health and Bone Marrow Composition Among Youth

A study testing GnRH Agonist in people with Gender Dysphoria in Children and Puberty, run by Amy DiVasta, MD at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 9 to 14 yearsHealthy volunteers can take part
What is being tested?
GnRH Agonist
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
2 sitesUnited States
Study dates
15 Sep 2020to 30 Mar 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 9 to 14 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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%

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Boston Children's Hospital

    Boston, Massachusetts, 02215

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

Other trials in United States

About this study

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.

Read the 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.

Being tested
GnRH Agonist

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GnRH AgonistDevice

    Also called Histrelin, Lupron, Pubertal Blockade

    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, at 12 months and at 24 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 24 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.

Study groups in NCT04203381
Study groupRoleWhat they receive
Transgender ParticipantOtherTransgender 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
Receives: Device: GnRH Agonist
Cisgender Control ParticipantNo interventionCisgender children Tanner II or early Tanner III between 9 and 14 matched by race, age, and BMI.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Bone marrow adiposity by magnetic resonance imaging (MRI) from baseline compared to 24 months

    Change from bone marrow adiposity measured by MRI (T1 maps) from baseline compared to 24 months

    Measured: Change from baseline compared to 24 months

  2. Change from magnetic resonance spectroscopy (MRS) from baseline compared to 24 months

    Change from T2 corrected fat/(fat+ water) ratios from baseline compared to 24 months

    Measured: Change from baseline compared to 24 months

Secondary outcomes (5)

  1. Change from total body bone mineral density Z-score by Dual-energy X-ray absorptiometry (DXA) from baseline compared to 24 months

    Change from total body BMD Z-score from baseline compared to 24 months

    Measured: Change from baseline compared to 24 months

  2. Change from spine BMD Z-score by DXA from baseline compared to 24 months

    Change from lumbar spine BMD Z-score from baseline compared to 24 months

    Measured: Change from baseline compared to 24 months

  3. Change from hip BMD Z-score by DXA from baseline compared to 24 months

    Change from hip bone mineral density (g/cm2) from baseline compared to 24 months

    Measured: Change from baseline compared to 24 months

  4. Change from volumetric bone mineral density (vBMD) from baseline compared to 24 months

    Change from quantitative computed tomography (pQCT) scans will be obtained at sites 3%, 38%, and 66% of tibial length proximal to the distal growth plate from baseline compared to 24 months

    Measured: Change from baseline compared to 24 months

  5. Change from section modulus (bone bending strength) by quantitative computed tomography (pQCT) from baseline compared to 24 months

    Change from pQCT scans will be obtained at sites 3%, 38%, and 66% of tibial length proximal to the distal growth plate from baseline compared to 24 months

    Measured: Change from baseline compared to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2019
  2. Study start15 Sep 2020
  3. Primary completion30 Mar 2026
  4. Study completion30 Mar 2026

Why it stopped: Funding was terminated.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04203381
Sponsor's protocol ID
P00033841
Status last verified
Mar 2026
First submitted
11 Dec 2019
Last updated
3 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing GnRH Agonist in people with Gender Dysphoria in Children and Puberty, run by Amy DiVasta, MD at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Funding was terminated.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Bone marrow adiposity by magnetic resonance imaging (MRI) from baseline compared to 24 months (time frame: Change from baseline compared to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04203381.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.

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