- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04203381
Skeletal Health and Bone Marrow Composition Among Youth
August 25, 2023 updated by: Amy DiVasta, MD, Boston Children's Hospital
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Amy M DiVasta, MD
- Phone Number: 617-355-7181
- Email: amy.divasta@childrens.harvard.edu
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Recruiting
- Boston Children's Hospital
-
Contact:
- Danielle DeMaio
- Phone Number: 617-355-8349
- Email: danielle.demaio@childrens.harvard.edu
-
Principal Investigator:
- Amy DiVasta, MD, MMSc
-
-
Ohio
-
Cincinnati, Ohio, United States, 45229
- Recruiting
- Cincinnati Children's Hospital Medical Center
-
Contact:
- Leah Tyzinski
- Phone Number: 513-636-7514
- Email: leah.tyzinski@cchmc.org
-
Principal Investigator:
- Heidi Kalkwarf, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
9 years to 14 years (Child)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
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.
Other Names:
|
No Intervention: Cisgender Control Participant
Cisgender children Tanner II or early Tanner III between 9 and 14 matched by race, age, and BMI.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Change from bone marrow adiposity measured by MRI (T1 maps) from baseline compared to 24 months
|
Change from baseline compared to 24 months
|
Change from magnetic resonance spectroscopy (MRS) from baseline compared to 24 months
Time Frame: Change from baseline compared to 24 months
|
Change from T2 corrected fat/(fat+ water) ratios from baseline compared to 24 months
|
Change from baseline compared to 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Change from total body BMD Z-score from baseline compared to 24 months
|
Change from baseline compared to 24 months
|
Change from spine BMD Z-score by DXA from baseline compared to 24 months
Time Frame: Change from baseline compared to 24 months
|
Change from lumbar spine BMD Z-score from baseline compared to 24 months
|
Change from baseline compared to 24 months
|
Change from hip BMD Z-score by DXA from baseline compared to 24 months
Time Frame: Change from baseline compared to 24 months
|
Change from hip bone mineral density (g/cm2) from baseline compared to 24 months
|
Change from baseline compared to 24 months
|
Change from volumetric bone mineral density (vBMD) from baseline compared to 24 months
Time Frame: Change 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
|
Change from baseline compared to 24 months
|
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
|
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
|
Change from baseline compared to 24 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from health-related quality of life (HRQL) from baseline compared to 24 months
Time Frame: Change from baseline compared to 24 months
|
Change from HRQL will be assessed at initiation of the GnRH agonist, after 12 months and again after 24 months to understand the impact of pubertal blockade on quality of life using the validated survey, Child Health Questionnaire (CHQF)-87 from baseline compared to 24 months
|
Change from baseline compared to 24 months
|
Change from anxiety from baseline compared to 24 months
Time Frame: Change from baseline compared to 24 months
|
Anxiety will be assessed at initiation of the GnRH agonist, after 12 months and again after 24 months to understand the impact of pubertal blockade on feelings of anxiety.
Change from anxiety will be assessed using the validated survey, the SCARED from baseline compared to 24 months.
|
Change from baseline compared to 24 months
|
Change from depression from baseline compared to 24 months
Time Frame: Change from baseline compared to 24 months
|
Change from depression will be assessed at initiation of the GnRH agonist, after 12 months and again after 24 months to understand the impact of pubertal blockade on feelings of depression using the validated survey, the Children's Depression Inventory (CDI-II) from baseline compared to 24 months
|
Change from baseline compared to 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 15, 2020
Primary Completion (Estimated)
March 31, 2025
Study Completion (Estimated)
March 31, 2025
Study Registration Dates
First Submitted
December 11, 2019
First Submitted That Met QC Criteria
December 16, 2019
First Posted (Actual)
December 18, 2019
Study Record Updates
Last Update Posted (Actual)
August 28, 2023
Last Update Submitted That Met QC Criteria
August 25, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P00033841
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Puberty
-
AbbVieCompletedCentral Precocious Puberty (CPP)United States, Puerto Rico
-
Debiopharm International SARecruiting
-
Foresee Pharmaceuticals Co., Ltd.QPS Holdings LLC; Changchun GeneScience Pharmaceutical Co., Ltd.RecruitingPuberty; Precocious, CentralUnited States, China, Taiwan, Puerto Rico
-
IpsenCompleted
-
TakedaCompletedCentral Precocious PubertyChina
-
TakedaCompletedCentral Precocious PubertyChina
-
Debiopharm International SACompletedCentral Precocious PubertyUnited States, Chile, Mexico
-
Ruijin HospitalShanghai Children's Hospital; Shanghai Children's Medical Center; Xin Hua HospitalCompletedCentral Precocious Puberty
-
Daewoong Pharmaceutical Co. LTD.CompletedCentral Precocious PubertyKorea, Republic of
-
University of PisaUnknownCentral Precocious PubertyItaly
Clinical Trials on GnRH Agonist
-
University of AarhusUnknown
-
Rabin Medical CenterFerring PharmaceuticalsUnknownProstate Cancer | Cardiac Event | Hormone Sensitive Prostate CancerIsrael
-
AZ Jan Palfijn GentOnze Lieve Vrouw HospitalCompletedInfertility | PCOSBelgium
-
Istituto Clinico HumanitasCompletedGnRH Trigger and Rescue Protocol
-
Ferring PharmaceuticalsCompleted
-
Nanjing UniversityUnknownInfertile High-risk Patients With Polycystic OvariesChina
-
Tanta UniversityCompletedInfertility | Intracytoplasmic Sperm Injection | Ovarian Reserve | GnRH AgonistEgypt
-
European Organisation for Research and Treatment...Active, not recruitingProstate CancerGermany, Spain, France, Belgium, United Kingdom, Switzerland, Italy, Denmark
-
Janssen Pharmaceutical K.K.Active, not recruiting
-
Tehran University of Medical SciencesCompletedPolycystic Ovary Syndrome | Infertility, FemaleIran, Islamic Republic of