Not yet recruiting

Study on the Effects of Somatropin and Letrozole in Boys with Short Predicted Height

Verified siteRegistered drug

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on boys with a condition known as short predicted height, which means they are expected to be shorter than average when they grow up. The study is examining the effects of two treatments: Omnitrope, which is a form of growth hormone, and Letrozole, an aromatase inhibitor. Aromatase inhibitors are medications that can help increase height by affecting hormone levels during puberty.

The purpose of the study is to see if boys who receive a combination of both Omnitrope and Letrozole during puberty will grow taller than those who receive only Omnitrope. The study will last for four years, during which participants will receive their assigned treatment. The growth of the boys will be monitored to determine if the combination therapy leads to a greater increase in height compared to the growth hormone alone.

Participants in the study will receive their treatments either as a solution for injection in the case of Omnitrope or as film-coated tablets for Letrozole. The study aims to provide valuable information on the effectiveness and safety of these treatments in helping boys with short predicted height achieve a taller adult height.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initiation of treatment
The treatment begins with the administration of growth hormone (Omnitrope) and possibly an aromatase inhibitor (Letrozole).
Omnitrope is provided as a solution for injection and is administered through a subcutaneous injection. The dosage and frequency are determined by the healthcare provider.
Letrozole is provided in the form of film-coated tablets and is taken orally. The dosage and frequency are determined by the healthcare provider.
Step 2
Treatment duration
The treatment is planned to last for a period of 4 years.
The objective is to evaluate the increase in adult height compared to the predicted height at the start of the treatment.
Step 3
Monitoring and assessments
Regular monitoring and assessments are conducted to evaluate the progress of the treatment.
These assessments may include measuring height, monitoring bone age, and evaluating any side effects of the medications.
Step 4
Completion of treatment
At the end of the 4-year treatment period, a final assessment is conducted to determine the adult height gain.
The final height is compared to the predicted adult height to evaluate the effectiveness of the treatment.

Who can join the trial?

5 criteria

Must be of male gender.
Have a predicted adult height that is below or equal to -2.5 standard deviations, which means less than 164.0 cm, based on a specific growth chart.
Must be in puberty, which is shown by having at least 4 ml of testicular volume.
Have a bone age between 11 and 13 years. Bone age is a way to measure how mature the bones are.
Must have signed informed consent, meaning they agree to participate in the study after understanding what it involves.

Who cannot join the trial?

4 criteria

Only boys can participate in the study. Girls are not eligible.
Participants must be at the beginning of puberty. If puberty has not started or is already advanced, they cannot join the study.
The study is for boys with a short predicted height. If a boy's predicted adult height is not considered short, he cannot participate.
Participants should not belong to any vulnerable population. This means they should not be in a group that needs special protection or care.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
University Of Antwerp
Edegem, Belgium

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Omnitrope
is a growth hormone used in this study to help boys with a short predicted height grow taller. It is given to support their natural growth processes during puberty.
Letrozole
is an aromatase inhibitor used in combination with growth hormone in this study. It works by reducing the levels of estrogen in the body, which can help increase the effectiveness of the growth hormone therapy in promoting height growth.

What is already known about the treatment

Omnitrope
Omnitrope is administered as an injection under the skin. It is currently used in medical practice and literature for treating growth-related conditions. The main therapeutic indication for Omnitrope is to promote growth in children with short predicted height. At the molecular level, it works by stimulating growth and cell reproduction through its action similar to natural growth hormone. It is classified pharmacologically as a growth hormone.
Letrozole
Letrozole is taken orally in tablet form. It is well-documented in medical literature and is primarily used to treat hormone-related conditions. In the context of this trial, Letrozole is used to help increase adult height in boys with short predicted height by inhibiting the enzyme aromatase, which reduces estrogen production and delays bone maturation. It is classified as an aromatase inhibitor.

Investigated diseases

Short Stature – Short stature refers to a condition where an individual's height is significantly below the average for their age and gender. It can be due to genetic factors, hormonal imbalances, or other underlying health issues. In children, it often becomes noticeable when they fall below the growth curve on standard growth charts. The condition may progress as the child continues to grow at a slower rate compared to peers. It is important to monitor growth patterns over time to determine if the short stature is part of a normal variation or indicative of a medical condition.