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.
Study Type
OBSERVATIONAL
Enrollment
750
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.
Uniklinik Ulm - Dt. Zentrum für Kinder- und Jugendgesundheit (DZKJ)
Ulm, Germany
Near final height (NFH) standard deviation score (SDS) measured in scores
SDS, -3 to +3
Time frame: At the end of the study (up to 10 years)
Change in growth rate (height velocity standard deviation score, HV SDS)
Score, range -10 to +10
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From baseline (month 0) to end of study (up to 10 years)
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