Skip to content

Trial · Interventional

TerminatedNot applicableRegistry data

Skeletal Health and Bone Marrow Composition Among Youth

NCTNCT04203381 (opens ClinicalTrials.gov in a new tab)Other idP00033841
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Terminated
Phase
Not applicable
Enrollment
78 participants (actual)
Sponsor
Amy DiVasta, MD · Other
Design
Not randomized · Open label (no masking)
Countries
1 country

United States

Start
15 Sept 2020
Primary completion
30 Mar 2026
Completion
30 Mar 2026
First posted
18 Dec 2019
Last update posted
3 Apr 2026
Conditions
Gender Dysphoria in Children · Puberty · Bone Development

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2020202220242026
  1. N/A

    Skeletal Health and Bone Marrow Composition Among Youth

    NCT04203381

    15 Sept 2020 to 30 Mar 2026

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • GnRH AgonistDevice

Arms2

  • Other

    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

  • No intervention

    Cisgender Control Participant

    Cisgender children Tanner II or early Tanner III between 9 and 14 matched by race, age, and BMI.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. 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

    Registry description

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

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

    Time frame · Change from baseline compared to 24 months

    Registry description

    Change from T2 corrected fat/(fat+ water) ratios 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

    Time frame · Change from baseline compared to 24 months

    Registry description

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

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

    Time frame · Change from baseline compared to 24 months

    Registry description

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

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

    Time frame · Change from baseline compared to 24 months

    Registry description

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

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

    Time frame · Change from baseline compared to 24 months

    Registry description

    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

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

    Time frame · Change from baseline compared to 24 months

    Registry description

    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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 9 Years up to 14 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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 2 years, race/ethnicity, sex assigned at birth and BMI within 25% 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

PepBank is a research reference. Talk to a doctor before you use any peptide.