Growth Hormone Deficiency in ChildrenNCT03972345
Influence of Adherence to Growth Hormone Therapy (GHT) With Norditropin® on Near Final Height in Patients With Growth Hormone Deficiency (GHD) and Born Small for Gestational Age (SGA)
An observational study of Growth Hormone Deficiency in Children and Born Small for Gestational Age, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
Participants are free to decide if they want to take part in this study or not. The study will be conducted to collect information about the influence of adherence to growth hormone therapy with Norditropin® in children and teenagers in daily practice in Germany. Read more about this study
- Who is it for?
- Ages 0 to 15 years
- Conditions the study is for
- Growth Hormone Deficiency in Children, Born Small for Gestational Age
- What is being tested?
- Norditropin® FlexPro®
- How many people
- 750 participants
- Where
- 1 siteGermany
- Study dates
- 21 Jun 2019to 30 Jun 2031
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Paediatric patients with iGHD or SGA.
Who may be able to join
- Informed consent of parent or legally acceptable representative of subject and child assent, as age-appropriate must be obtained before any study-related activities.
- The parent or legally acceptable representative of the child must sign and date the Informed Consent Form (according to local requirements) and
- 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
- Isolated growth hormone deficiency (iGHD)
- Small for gestational age (SGA)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
Uniklinik Ulm - Dt. Zentrum für Kinder- und Jugendgesundheit (DZKJ)
Ulm, 89075
About this study
Official title: A Non-interventional, Prospective Study in Germany to Investigate the Influence of Adherence to Growth Hormone Therapy (GHT) With Norditropin® on Near Final Height in a Patient Population With Isolated Growth Hormone Deficiency (GHD) and Born Small for Gestational Age (SGA)
Participants are free to decide if they want to take part in this study or not. The study will be conducted to collect information about the influence of adherence to growth hormone therapy with Norditropin® in children and teenagers in daily practice in Germany. This study will look mainly at the difference in near final height between children and teenagers who adhere to their therapy plan with Norditropin® to non-adherent patients. Participants will get Norditropin® as prescribed to them by their doctor. The study will last as long as the therapy with growth hormone is seen necessary by the participants' doctors and the participants, up to a maximum of 10 years. During the visits at the participants' doctors participants will be asked to fill in a questionnaire.
- Being tested
- Norditropin® FlexPro®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Norditropin® FlexPro®Drug
Patients will be treated with commercially available Norditropin® FlexPro® according to routine clinical practice at the discretion of the treating physician. 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.
| Study group | Role | What they receive |
|---|---|---|
| Paediatric patients with iGHD or SGA | Children with one of the following confirmed diagnoses: isolated growth hormone deficiency (iGHD) or small for gestational age (SGA) Receives: Drug: Norditropin® FlexPro® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Near final height (NFH) standard deviation score (SDS) measured in scores
SDS, -3 to +3
Measured: At the end of the study (up to 10 years)
Secondary outcomes (5)
Change in growth rate (height velocity standard deviation score, HV SDS)
Score, range -10 to +10
Measured: From baseline (month 0) to end of study (up to 10 years)
Change in growth rate (HV SDS) between visits (usually patients are seen every 3 to 6 months)
Score, range -10 to +10
Measured: From baseline (month 0) to end of study (up to 10 years)
Adherence response as indicated in question at the bottom of newly developed Patient Reported Outcome (PRO) questionnaire each time questionnaire is filled out (preferably at each visit)
The following adherence levels will be used:
High adherence: above 85.7% of doses administered Medium adherence: 57.1 - 85.7% of doses administered Low adherence: below 57.1% of doses administered
Measured: From baseline (month 0) to end of study (up to 10 years)
Adherence measured as number of medication devices returned versus number of prescribed devices for the period between visits
Count
Measured: From baseline (month 0) to end of study (up to 10 years)
Change of self-rated adherence level throughout the study measured in newly developed PRO questionnaire each time questionnaire is filled out (preferably at each visit)
The following adherence levels will be used:
High adherence: above 85.7% of doses administered Medium adherence: 57.1 - 85.7% of doses administered Low adherence: below 57.1% of doses administered
Measured: From baseline (month 0) to end of study (up to 10 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start21 Jun 2019
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth Hormone Deficiency in ChildrenStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03972345
- Sponsor's protocol ID
- GH-4488
- Other IDs
- U1111-1217-5835
- Status last verified
- Oct 2026
- First submitted
- 31 May 2019
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com