Chronic Kidney Disease Clinical Trial
Official title:
NordiNet® International Outcome Study-Observational Prospective Study on Patients Treated With Norditropin®
Verified date | October 2017 |
Source | Novo Nordisk A/S |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 21249 |
Est. completion date | December 31, 2016 |
Est. primary completion date | December 31, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Judged by the physician as per the Norditropin® label Exclusion Criteria: - Judged by the physician as per the Norditropin® label |
Country | Name | City | State |
---|---|---|---|
Argentina | Novo Nordisk Investigational Site | Prov. de Buenos Aires | |
Belgium | Novo Nordisk Investigational Site | Brussels | |
Czechia | Novo Nordisk Investigational Site | Prague | |
Denmark | Novo Nordisk Investigational Site | Copenhagen S | |
Finland | Novo Nordisk Investigational Site | Espoo | |
France | Novo Nordisk Investigational Site | Paris La défense cedex | |
Germany | Novo Nordisk Investigational Site | Mainz | |
Hungary | Novo Nordisk Investigational Site | Budapest | |
Ireland | Novo Nordisk Investigational Site | Dublin 2 | |
Israel | Novo Nordisk Investigational Site | Kfar Saba | |
Italy | Novo Nordisk Investigational Site | Rome | |
Lithuania | Novo Nordisk Investigational Site | Vilnius | |
Luxembourg | Novo Nordisk Investigational Site | Luxembourg | |
Netherlands | Novo Nordisk Investigational Site | Alphen a/d Rijn | |
Norway | Novo Nordisk Investigational Site | Rud | |
Russian Federation | Novo Nordisk Investigational Site | Moscow | |
Saudi Arabia | Novo Nordisk Investigational Site | Riyadh | |
Serbia | Novo Nordisk Investigational Site | Belgrade | |
Slovenia | Novo Nordisk Investigational Site | Ljubljana | |
Spain | Novo Nordisk Investigational Site | Madrid | |
Sweden | Novo Nordisk Investigational Site | Malmö | |
Switzerland | Novo Nordisk Investigational Site | Zurich | |
United Kingdom | Novo Nordisk Investigational Site | Crawley |
Lead Sponsor | Collaborator |
---|---|
Novo Nordisk A/S |
Argentina, Belgium, Czechia, Denmark, Finland, France, Germany, Hungary, Ireland, Israel, Italy, Lithuania, Luxembourg, Netherlands, Norway, Russian Federation, Saudi Arabia, Serbia, Slovenia, Spain, Sweden, Switzerland, United Kingdom,
Blankenstein O, Snajderova M, Blair J, Pournara E, Pedersen BT, Petit IO. Real-life GH dosing patterns in children with GHD, TS or born SGA: a report from the NordiNet® International Outcome Study. Eur J Endocrinol. 2017 Aug;177(2):145-155. doi: 10.1530/E — View Citation
Christesen HT, Pedersen BT, Pournara E, Petit IO, Júlíusson PB. Short Stature: Comparison of WHO and National Growth Standards/References for Height. PLoS One. 2016 Jun 9;11(6):e0157277. doi: 10.1371/journal.pone.0157277. eCollection 2016. — View Citation
Höybye C, Sävendahl L, Christesen HT, Lee P, Pedersen BT, Schlumpf M, Germak J, Ross J. The NordiNet® International Outcome Study and NovoNet® ANSWER Program®: rationale, design, and methodology of two international pharmacoepidemiological registry-based — View Citation
Lee PA, Sävendahl L, Oliver I, Tauber M, Blankenstein O, Ross J, Snajderova M, Rakov V, Pedersen BT, Christesen HT. Comparison of response to 2-years' growth hormone treatment in children with isolated growth hormone deficiency, born small for gestational — View Citation
Sävendahl L, Blankenstein O, Oliver I, Christesen HT, Lee P, Pedersen BT, Rakov V, Ross J. Gender influences short-term growth hormone treatment response in children. Horm Res Paediatr. 2012;77(3):188-94. doi: 10.1159/000337570. Epub 2012 Apr 12. — View Citation
Sävendahl L, Pournara E, Pedersen BT, Blankenstein O. Is safety of childhood growth hormone therapy related to dose? Data from a large observational study. Eur J Endocrinol. 2016 May;174(5):681-91. doi: 10.1530/EJE-15-1017. Epub 2016 Feb 22. — View Citation
Weber MM, Biller BM, Pedersen BT, Pournara E, Christiansen JS, Höybye C. The effect of growth hormone (GH) replacement on blood glucose homeostasis in adult nondiabetic patients with GH deficiency: real-life data from the NordiNet(®) International Outcome — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effect of Norditropin® treatment on height gain (change in height) in children | 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. | ||
Primary | Effect of Norditropin® treatment on body weight and body composition in adults | 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 | Effect of Norditropin® treatment body weight, blood biochemistry, bone age, the endocrine system and pubertal development in children | 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 | Effect of Norditropin® treatment on quality of life, blood biochemistry and the endocrine system in adults | 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. |
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