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)
- Conditions
- Growth Hormone Deficiency in ChildrenBorn Small for Gestational Age
- Registration Number
- NCT03972345
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Enrolling by invitation
- Sex
- All
- Target Recruitment
- 750
Inclusion Criteria:<br><br> - Informed consent of parent or legally acceptable representative of subject and child<br> assent, as age-appropriate must be obtained before any study-related activities.<br><br> 1. The parent or legally acceptable representative of the child must sign and date<br> the Informed Consent Form (according to local requirements) and<br><br> 2. The child must sign and date the Child Assent Form or provide oral assent (if<br> required according to local requirements).<br><br> - The decision to initiate treatment with commercially available Norditropin® FlexPro®<br> has been made by the treating physician and the patient's parents/legal guardian<br> before and independently of the decision to include the patient in this study.<br><br> - Male or female, all age groups equal to or below 15 years with more than 2 years<br> expected remaining treatment time until reaching NFH. Patients who self-inject<br> should be above 8 years of age in order to be able to fill in the questionnaire.<br><br> - Children being GH naïve at baseline with one of the following confirmed diagnoses<br><br> 1. Isolated growth hormone deficiency (iGHD)<br><br> 2. Small for gestational age (SGA)<br><br>Exclusion Criteria:<br><br> - Previous participation in this study. Participation is defined as having given<br> informed consent in this study.<br><br> - Mental incapacity, unwillingness or language barriers precluding adequate<br> understanding or cooperation.<br><br> - Patients who have an expected future duration of therapy of less than 2 years are<br> not eligible for the study.
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Near final height (NFH) standard deviation score (SDS) measured in scores
- Secondary Outcome Measures
Name Time Method Change in growth rate (height velocity standard deviation score, HV SDS);Change in growth rate (HV SDS) between visits (usually patients are seen every 3 to 6 months);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);Adherence measured as number of medication devices returned versus number of prescribed devices for the period between visits;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)