An observational study in Growth Hormone Disorder, Pituitary Dwarfism and Hypopituitarism, sponsored by Novo Nordisk A/S. Completed at 1 site in United States. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2017-04-12.
Sponsored by Novo Nordisk A/S · Observational
This study is conducted in the United States of America (USA). The aim of this observational study is to collect data concerning the treatment outcomes and safety for children and adults who are prescribed Norditropin®. Specific objectives include: 1) developing models defining the relationship of Norditropin dose to changes in insulin-like growth factor (IGF-I) and treatment outcomes, accounting for independent factors such as age, gender and puberty and 2) determining the relative predictive values of peak growth hormone (GH) and IGF-I levels and other factors before treatment to clinical outcomes.
252 studies on the registry are indexed under Dwarfism, Pituitary; 30 are open to participants now.
This study's enrollment of 22,960 is above the median of 70 across 73 observational studies indexed under Dwarfism, Pituitary.
Browse Dwarfism, Pituitary studies →Novo Nordisk A/S is the lead sponsor of 1,404 studies on the registry; 101 are open to participants now.
Of its 205 completed or terminated interventional studies of FDA-regulated products, 100 (49%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients from both general and specialty practice settings, existing and new users of growth hormones, who have been deemed appropriate to receive Norditropin® as part of routine out-patient care by the prescribing physician.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: somatropin
Safety and effectiveness data collection in connection with the use of Norditropin® (somatropin) in daily clinical practice
Change in height, measured as the height standard deviation score (HSDS), from the measurement made by the physician at study entry to the most recent clinic observation, end of GH treatment, de-registration, or change of clinic.
Time frame: measurement made by physician at study entry, annually, or more frequently at physician discretion during the study.
Change in waist/hip circumference ratio for adult patients
Time frame: measurement made by physician at study entry, annually, or more frequently at physician discretion during the study
Short-term: Height, Height velocity, Height velocity standard deviation score (SDS), predicted adult height, height SDS for bone age, Proportion achieving height SDS > -2 at end of observational duration period
Time frame: measurement made by physician at study entry, annually, or more frequently at physician discretion during the study.
Final Height (or Adult height), Final Height SDS, near-adult height, near-adult height SDS, Final Height - Target Height, Final height - predicted adult height, height age
Time frame: measurement made by physician at study entry, annually, or more frequently at physician discretion during the study.
Final Height SDS - Target Height SDS, Final height SDS - predicted adult height SDS
Time frame: measurement made by physician at study entry, annually, or more frequently at physician discretion during the study.
Proportion achieving HSDS of more than -2 at final height
Time frame: measurement made by physician at study entry, annually, or more frequently at physician discretion during the study.
Weight, waist circumference, and hip circumference for adult patients
Time frame: measurement made by physician at study entry, annually, or more frequently at physician discretion during the study
Ran from Jun 2002 to primary completion in Sep 2016, 171 months.
Of 30 observational studies under Dwarfism, Pituitary, half reached primary completion within 85 months of starting (the median), counting those still running; a quarter within 54 and three quarters within 102. This study's 171 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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