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Puberty blockers and bones: new study explores risks for transgender teens

NCT ID NCT04203381

Knowledge-focused Sponsor: Amy DiVasta, MD Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at bone health in transgender youth aged 9-14 who were starting puberty blockers (GnRH agonists). Researchers used MRI and other scans to measure bone marrow and density changes over 24 months, comparing them to healthy peers. The goal was to understand if blocking puberty affects bone development. The study was terminated early, so findings are limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
GnRH agonist (puberty blocker)
What this could lead to
If successful, this could help doctors understand how puberty blockers affect bone development in transgender youth, guiding safer treatment.
What could go wrong
This was a small, terminated observational study with only 78 participants, so results may be limited and not apply to all youth.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

78 people

The number who actually took part.

Started

Sep 2020

Finished

Mar 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

9 to 14 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

bone development disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bone development Gender dysphoria in children Puberty

Contacts and locations

Locations

  • Boston Children's Hospital

    Boston, Massachusetts, 02215, United States

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

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