Does sticking to growth hormone treatment help kids grow taller? study aims to find out.
NCT ID NCT03972345
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at children and teenagers with growth hormone deficiency or who were born small for their age. It tracks how closely they follow their prescribed Norditropin® treatment and whether that affects their final height. The study is observational, meaning no new treatment is given—participants just continue their normal care. Up to 750 children in Germany will be followed for up to 10 years.
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.
- Participants
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About 750 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2019
- Expected to finish
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Jun 2031
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Paediatric patients with iGHD or SGA.
- Ages
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0 to 15 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide 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: * Informed consent of parent or legally acceptable representative of subject and child assent, as age-appropriate must be obtained before any study-related activities. 1. The parent or legally acceptable representative of the child must sign and date the Informed Consent Form (according to local requirements) and 2. The child must sign and date the Child Assent Form or provide oral assent (if required according to local requirements). * The decision to initiate treatment with commercially available Norditropin® FlexPro® has been made by the treating physician and the patient's parents/legal guardian before and independently of the decision to include the patient in this study. * Male or female, all age groups equal to or below 15 years with more than 2 years expected remaining treatment time until reaching NFH. Patients who self-inject should be above 8 years of age in order to be able to fill in the questionnaire. * Children being GH naïve at baseline with one of the following confirmed diagnoses 1. Isolated growth hormone deficiency (iGHD) 2. Small for gestational age (SGA) Exclusion Criteria: * Previous participation in this study. Participation is defined as having given informed consent in this study. * Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. * Patients who have an expected future duration of therapy of less than 2 years are not eligible for the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Uniklinik Ulm - Dt. Zentrum für Kinder- und Jugendgesundheit (DZKJ)
Ulm, 89075, Germany
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New growth hormone treatment for short children enters final testing phase
- New growth hormone drug sogroya® tracked in kids for up to 3 years
- Weekly shot could replace daily needles for kids with growth hormone deficiency
- Once-a-Week needle could replace daily pokes for growth hormone deficiency
- Weekly shot may replace daily needle for kids with growth hormone deficiency