Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

The Growth Hormone Deficiency Reversal Trial: Effect on final height of discontinuation vs continuation of growth hormone treatment in pubertal children with isolated growth hormone deficiency – A non-inferiority randomised controlled trial

This research is for young people with growth hormone deficiency who are going through puberty. Currently, it's not clear if they benefit from continuing growth hormone treatment until they reach their final adult height, or if they can stop earlier. This study wants to find out if stopping the treatment at puberty has the same results as continuing it, in terms of their final adult height. The study will compare two groups: one that stops treatment and one that continues. Researchers will look at how tall they get, how healthy their bones are, and other health markers to understand the best approach for these young people.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

University College London

Enrolment target

Start

20 Mar 2023

Growth Hormone Deficiency (GHD)

What is this study about?

This study is designed for children who have a condition called Growth Hormone Deficiency (GHD). This means their bodies don't make enough growth hormone, which helps them grow normally. These children usually receive growth hormone treatment to help them reach a healthy adult height. The current research focuses specifically on young people with GHD who are going through puberty.

During puberty, there's a natural growth spurt. Doctors want to understand whether young people in this situation still need to continue their growth hormone treatment. Some experts believe that once puberty and the main growth spurt begin, the benefits of continuing growth hormone might lessen, but we need more clear evidence. This study aims to provide that evidence by comparing two groups: one group will stop their growth hormone treatment during puberty, and the other will continue.

The main goal is to see if stopping treatment has a similar effect on their final adult height as continuing it. The researchers will also look at other important health aspects, like bone health and certain blood test results, to get a complete picture of the impact of each approach. This information will help doctors make better decisions about when it's best for young people with GHD to stop their growth hormone treatment.

Key takeaways

This study compares stopping vs. continuing growth hormone treatment during puberty.
It aims to find out if stopping treatment affects final adult height.
The research involves young people with Growth Hormone Deficiency (GHD).
It will also look at bone health and other health markers.
Information from this study could help future treatment decisions for GHD.

Who may be eligible?

To be considered for this study, you would need to be a young person with Growth Hormone Deficiency (GHD). The study is open to both boys and girls.

There isn't a specific age range given, but because it focuses on young people going through puberty, participants would likely be in their early to mid-teen years. The study will confirm if you meet specific medical criteria for GHD and if you are currently in puberty.

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.

Do you have Growth Hormone Deficiency (GHD)?
Are you currently going through puberty?
Are you currently receiving growth hormone treatment?
Are you able to attend regular clinic visits and assessments?
Are you and your parents/guardians willing to consider stopping or continuing treatment as part of a study?

Answer every question to see your result.

What does participation involve?

If you join this study, you would be randomly placed into one of two groups: one group would stop taking your growth hormone medicine, and the other would continue. The exact growth hormone medicine used could be one of several available brands, like NutropinAq, Saizen, Omnitrope, Humatrope, Norditropin, or Genotropin MiniQuick, depending on what works best for you and your doctor.

You would have regular check-ups and assessments. These would include measurements of your height and weight, and likely blood tests to check hormone levels and other health markers. Bone age X-rays might also be taken to see how mature your bones are. These visits would happen over time, from when you join the study until you reach your final adult height. The total duration of your participation would depend on how long it takes for you to finish growing.

Potential risks and benefits

Participating in research can offer potential benefits, such as contributing valuable information that could help many other young people with growth hormone deficiency in the future. If you are in the group that continues treatment, you would continue to receive your prescribed medication. If you are in the group that stops, you might find out that stopping treatment doesn't negatively affect your height. However, there are potential risks, such as the usual side effects associated with growth hormone treatment for those who continue, or the possibility that stopping treatment might lead to a less optimal final height for those in that group. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

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Unverified
Austria

Common questions

What is Growth Hormone Deficiency (GHD)?

GHD is a condition where your body doesn't produce enough growth hormone, which is important for growth and development.

What is puberty?

Puberty is the time when a child's body begins to change and develop into an adult body. It involves a rapid growth spurt.

What does 'non-inferiority' mean in a study?

It means the study is trying to show that a new treatment approach (stopping growth hormone) is not worse than the standard approach (continuing growth hormone) in terms of its main effect (final height).

Will I still get my growth hormone if I'm in the study?

It depends on which group you are in. Some participants will continue their growth hormone treatment, while others will stop, based on a random assignment.

What is 'final height'?

Final height refers to the height an individual reaches as an adult, once they have stopped growing.