Observational Prospective Study on Patients Treated With Norditropin®

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.

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Key information

Conditions

Growth Hormone Disorder Adult Growth Hormone Deficiency Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Cardiovascular Abnormalities Cardiovascular Diseases Central Nervous System Diseases Chromosome Disorders Chronic Disease Chronic Kidney Disease Chronic Renal Insufficiency Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Craniofacial Abnormalities Disease Attributes Disorders of Sex Development Dwarfism Dwarfism, Pituitary Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Foetal Growth Problem Genetic Diseases, Inborn Genetic Disorder Gonadal Disorders Gonadal Dysgenesis Growth Hormone Deficiency in Children Heart Defects, Congenital Heart Diseases Hypopituitarism Hypothalamic Diseases Kidney Diseases Male Urogenital Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Nervous System Diseases Noonan Syndrome Pathologic Processes Pathological Conditions, Signs and Symptoms Pituitary Diseases Renal Insufficiency Renal Insufficiency, Chronic Sex Chromosome Disorders Sex Chromosome Disorders of Sex Development Skin and Connective Tissue Diseases Small for Gestational Age Turner Syndrome Urogenital Abnormalities Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site, Prov. de Buenos Aires, Argentina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Judged by the physician as per the Norditropin® label

Exclusion criteria

Judged by the physician as per the Norditropin® label

Treatment and study plan

Somatropin

Drug

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

Primary outcomes

Effect of Norditropin® treatment on height gain (change in height) in children

Time frame: Study 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 adults

Time frame: Study 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 outcomes

Effect of Norditropin® treatment body weight, blood biochemistry, bone age, the endocrine system and pubertal development in children

Time frame: Study 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 adults

Time frame: Study 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.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start: 2006
Primary completion: 2016
Study completion: 2016
First posted: Aug 17, 2009
Registry last updated: Oct 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed