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Observational Prospective Study on Patients Treated With Norditropin®

NordiNet® International Outcome Study-Observational Prospective Study on Patients Treated With Norditropin®

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00960128
Enrollment
21249
Registered
2009-08-17
Start date
2006-04-01
Completion date
2016-12-31
Last updated
2017-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult Growth Hormone Deficiency, Chronic Kidney Disease, Chronic Renal Insufficiency, Foetal Growth Problem, Genetic Disorder, Growth Hormone Deficiency in Children, Growth Hormone Disorder, Noonan Syndrome, Small for Gestational Age, Turner Syndrome

Brief summary

This observational study is conducted globally. The aim of the study is to investigate the effectiveness and safety of real-life treatment with Norditropin®. The study population will consist of children and adults who are on treatment with Norditropin® in accordance with normal clinical practice.

Interventions

DRUGsomatropin

The effectiveness and safety data collection with the use of Norditropin® in daily clinical practice with adults.

Sponsors

Novo Nordisk A/S
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Judged by the physician as per the Norditropin® label

Exclusion criteria

* Judged by the physician as per the Norditropin® label

Design outcomes

Primary

MeasureTime frame
Effect of Norditropin® treatment on height gain (change in height) in childrenStudy outcomes (study endpoints) will be analysed and reported on annual basis. The mean follow up period for study outcomes is expected to be 5 years in accordance with defined duration of the study.
Effect of Norditropin® treatment on body weight and body composition in adultsStudy outcomes (study endpoints) will be analysed and reported on annual basis. The mean follow up period for study outcomes is expected to be 5 years in accordance with defined duration of the study.

Secondary

MeasureTime frame
Effect of Norditropin® treatment body weight, blood biochemistry, bone age, the endocrine system and pubertal development in childrenStudy outcomes (study endpoints) will be analysed and reported on annual basis. The mean follow up period for study outcomes is expected to be 5 years in accordance with defined duration of the study.
Effect of Norditropin® treatment on quality of life, blood biochemistry and the endocrine system in adultsStudy outcomes (study endpoints) will be analysed and reported on annual basis. The mean follow up period for study outcomes is expected to be 5 years in accordance with defined duration of the study.

Countries

Argentina, Belgium, Czechia, Denmark, Finland, France, Germany, Hungary, Ireland, Israel, Italy, Lithuania, Luxembourg, Netherlands, Norway, Russia, Saudi Arabia, Serbia, Slovenia, Spain, Sweden, Switzerland, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026