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Study on Growth Hormone Deficiency: Comparing Effects of Continuing vs. Stopping Somatropin Treatment in Pubertal Children with Isolated Growth Hormone Deficiency

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What is this trial about?

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

This clinical trial is focused on studying Growth Hormone Deficiency (GHD), a condition where the body does not produce enough growth hormone, which is important for growth and development. The trial will use a treatment called somatropin, which is a form of human growth hormone made in the laboratory. Several brands of somatropin will be used in this study, including NutropinAq, Saizen, Omnitrope, Humatrope, Norditropin FlexPro, and Genotropin MiniQuick. These are all solutions for injection that help to increase growth hormone levels in the body.

The purpose of the study is to compare the effects of continuing versus stopping growth hormone treatment in children who have reached puberty and have shown a reversal of their growth hormone deficiency. The study will involve children who have already stopped taking growth hormone for at least six weeks and have shown improvement in their condition. Participants will be divided into two groups: one group will continue receiving growth hormone treatment, while the other group will not. The main goal is to see how these different approaches affect the children's final height as they grow into adulthood.

Throughout the study, participants will be monitored to assess their growth and development. This will include measuring their height and comparing it to their expected adult height based on their parents' heights. The study will also look at other factors related to growth, such as bone health and certain blood markers. The trial is expected to continue until early 2026, providing valuable information on the best approach to managing growth hormone deficiency in children during puberty.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment
Upon joining the study, you will be enrolled as a participant. This involves confirming your eligibility based on specific criteria, such as age and health condition. You must have a confirmed reversal of Growth Hormone Deficiency (GHD) and have completed a minimum 6-week period without growth hormone medication.
Step 2
Initial assessment
An initial assessment will be conducted to gather baseline data. This may include measuring your height, weight, and conducting a blood test to check hormone levels. A brain scan result confirming normal findings is also required.
Step 3
Randomization
You will be randomly assigned to one of two groups: one group will continue receiving growth hormone treatment, and the other will not. This is done to compare the effects on final height.
Step 4
Treatment phase
If assigned to the treatment group, you will receive one of the following growth hormone medications: NutropinAq, Saizen, Omnitrope, HUMATROPE, Norditropin FlexPro, or Genotropin. These are administered as injections under the skin. The dosage and frequency will be determined by the study team based on your specific needs.
Step 5
Regular follow-ups
Throughout the trial, regular follow-up visits will be scheduled. During these visits, your growth and development will be monitored. This includes measuring your height and weight, and possibly conducting additional blood tests to assess hormone levels.
Step 6
Final assessment
At the end of the trial, a final assessment will be conducted. This will involve measuring your final height and comparing it to the expected height based on parental heights. Additional tests may be performed to evaluate bone health and other growth-related factors.

Who can join the trial?

6 criteria

Children aged 8-15 years for girls and 9-17 years for boys.
Must have a condition called reversed Isolated Growth Hormone Deficiency (I-GHD) and be in established puberty. For girls, this means being in Tanner stages B2/3, and for boys, having testes size between 6-12 milliliters.
Must have a normal result from a Magnetic Resonance Imaging (MRI) scan of the brain, including a small anterior pituitary gland. An MRI is a type of scan that uses magnets and radio waves to create pictures of the inside of the body.
Must have stopped taking growth hormone medication for at least 6 weeks before a growth hormone re-test.
Must show a reversal of growth hormone deficiency, which means having a peak stimulated growth hormone level of 6.7 micrograms per liter or higher, measured using specific tests like the arginine or insulin tolerance test.
Written informed consent must be obtained, meaning that the child and their guardians agree to participate in the study after understanding all the details.

Who cannot join the trial?

9 criteria

Patients with any other medical condition that might interfere with the study.
Patients who are currently taking medications that could affect growth hormone levels.
Patients who have had previous treatment with growth hormone.
Patients with a history of cancer or tumors.
Patients with uncontrolled diabetes. Diabetes is a condition where the body has trouble controlling blood sugar levels.
Patients with severe liver or kidney disease. Liver and kidney are organs that help filter and clean the blood.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial within the last 30 days.
Patients with known allergies to any of the study medications.

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Verified sites

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Johannes Kepler University
Linz, Austria
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Medical University Of Graz
Graz, Austria
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Medizinische Universitaet Innsbruck
Innsbruck, Austria

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Investigated drugs

Growth Hormone is a medication used in this trial to help children with growth hormone deficiency grow taller. It is a man-made version of the natural hormone that helps the body grow and develop. In this study, researchers are looking at what happens when children continue or stop taking this medication during puberty to see how it affects their final height.

Somatropin

What is already known about the treatment

Growth Hormone – This medication is typically administered through an injection under the skin, often in the evening. It is currently well-established in medical practice and literature for treating Growth Hormone Deficiency (GHD), particularly in children. The main therapeutic use is to help children with GHD grow to a normal height. At the molecular level, it works by stimulating growth and cell reproduction in the body. It is classified as a hormone therapy.

Investigated diseases

Growth Hormone Deficiency (GHD) – Growth Hormone Deficiency is a condition characterized by the inadequate secretion of growth hormone from the pituitary gland. This deficiency leads to slower growth rates in children, resulting in shorter stature compared to peers. As the condition progresses, affected individuals may experience delayed puberty and increased fat around the waist. In adults, GHD can lead to decreased muscle mass, reduced bone density, and increased cardiovascular risk. The progression of the disease can vary, with some individuals experiencing more pronounced symptoms than others. The condition is typically identified in childhood but can also be diagnosed in adults.