Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1217-5835 | Other Identifier | World Health Organization (WHO) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Near final height (NFH) standard deviation score (SDS) measured in scores | SDS, -3 to +3 | At the end of the study (up to 10 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in growth rate (height velocity standard deviation score, HV SDS) | Score, range -10 to +10 | 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) |
Not provided
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.
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
Exclusion Criteria:
Not provided
Not provided
Paediatric patients with iGHD or SGA.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uniklinik Ulm - Dt. Zentrum für Kinder- und Jugendgesundheit (DZKJ) | Ulm | 89075 | Germany |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Score, range -10 to +10
| 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 | 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 | 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 | From baseline (month 0) to end of study (up to 10 years) |