AuthorisedTherapeutic confirmatory (Phase III)Interventional

Efficacy and safety of a 4 year pubertal therapy with growth hormone (Omnitrope) or growth hormone and an aromatase inhibitor (Letrozole) in boys with a short predicted height.

This research study is for boys who are predicted to be shorter than average when they grow up. It will explore whether a 4-year treatment plan can help them reach a taller adult height. We are testing two different treatment approaches: one group will receive a growth hormone medicine called Omnitrope, and another group will receive Omnitrope along with an additional medicine called Letrozole. The main goal is to compare the final adult height of boys in the study with what their height was predicted to be without treatment. This is a Phase III study, which means it’s a big study to confirm if these treatments are effective and safe for this particular group of boys.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Universitair Ziekenhuis Antwerpen

Enrolment target

Start

10 Jan 2025

Short predicted height

What is this study about?

This study is designed for boys who are expected to be shorter as adults than most other people. Doctors can often estimate how tall a child might be when they grow up, and for some boys, this predicted height is quite short. This research aims to understand if giving certain medicines over several years can help these boys grow taller than they would have otherwise.

The study involves two different treatment options. One group of boys would receive a medicine called Omnitrope, which is a type of growth hormone. The other group would receive Omnitrope together with another medicine called Letrozole. Letrozole is a tablet that might help growth hormone work better in some cases. The treatment would last for four years, which covers an important period of growth during puberty.

The main thing the researchers want to find out is whether boys who take part in the study end up being taller as adults compared to their original predicted height. This is a 'Phase III' study, which means it's a very important step to confirm if these treatments are both helpful and safe for achieving a better adult height in boys who are expected to be short.

Key takeaways

Study for boys predicted to be shorter as adults.
Tests growth hormone (Omnitrope) alone or with Letrozole.
Treatment lasts for four years.
Goal is to see if treatments safely increase adult height.
Involves regular clinic visits and monitoring.

Who may be eligible?

This study is specifically looking for boys. There isn't an exact age range mentioned, which means the study team will likely consider boys at any point in their growing years, though typically these studies focus on boys during their pubertal growth phase.

The key requirement is that a boy must have a "short predicted height." This means that based on their current growth, bone age, and family history, doctors believe they will be shorter than average as adults. The study doctors will carefully assess each boy to see if they meet this specific criteria.

More detailed eligibility requirements, such as specific height predictions or other health conditions, would be discussed with you by the research team if you express interest. It's important that all participants are fit enough to take part and can commit to the study's requirements.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is my child a boy?
Has a doctor told us that my child is likely to be shorter than average as an adult?
Are we able to commit to regular clinic visits over several years?
Are we comfortable with the possibility of daily injections or tablets for our child?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, your son would receive either growth hormone (Omnitrope) injections or growth hormone injections plus Letrozole tablets for a period of four years. The exact frequency of injections and tablets would be fully explained by the study team. You would also need to attend regular visits to the clinic so that doctors and nurses can monitor your son's growth, general health, and response to the treatment. These visits would involve measurements of height and weight, and potentially blood tests or X-rays to check bone development.

Throughout the four years, the study team would be collecting information to see how the treatments are working. There would also be follow-up appointments after the four years of treatment to see what your son's final adult height is. The total duration of the study, including follow-up, would be longer than the four-year treatment period.

Potential risks and benefits

Taking part in a study like this could potentially help your son grow taller than he would have without treatment. You would also receive close medical attention and monitoring throughout the study. However, there are potential risks, as with any medicine. Omnitrope (growth hormone) can sometimes cause side effects like headaches, joint or muscle pain, or swelling. Letrozole can also have side effects, which the study team would explain in detail. All participants have the right to withdraw from the study at any time, for any reason, without it affecting their future medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Belgium

Common questions

What is 'short predicted height'?

It means doctors estimate a boy will be shorter than average when he finishes growing, based on various checks like current height, bone age, and family history.

What is Omnitrope?

Omnitrope is a medicine that acts like the body's natural growth hormone, often given as an injection to help children grow taller.

What is Letrozole?

Letrozole is a tablet that might work alongside growth hormone to help promote growth, especially during puberty.

How long will the treatment last?

The active treatment period in this study is for four years.

Will my son definitely grow taller if he takes part?

The study aims to see if these treatments can help boys grow taller, but there's no guarantee. This is precisely what the researchers are trying to find out.