Clinical trial NCT00960128: Observational Prospective Study on Patients Treated With Norditropin®
Official title: NordiNet® International Outcome Study-Observational Prospective Study on Patients Treated With Norditropin®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Growth Hormone Disorder
Growth Hormone Deficiency in Children
Adult Growth Hormone Deficiency
Genetic Disorder
Turner Syndrome
Foetal Growth Problem
Small for Gestational Age
Chronic Kidney Disease
Chronic Renal Insufficiency
Noonan Syndrome
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2009-08-17
Enrollment: 21249
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of children and adults who are on treatment with Norditropin® in accordance with normal clinical practice

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.


Eligibility criteria: Inclusion Criteria:

* Judged by the physician as per the Norditropin® label

Exclusion Criteria:

* Judged by the physician as per the Norditropin® label

Primary outcomes:
measure: Effect of Norditropin® treatment on height gain (change in height) in children
timeFrame: 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.
measure: Effect of Norditropin® treatment on body weight and body composition in adults
timeFrame: 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:
measure: Effect of Norditropin® treatment body weight, blood biochemistry, bone age, the endocrine system and pubertal development in children
timeFrame: 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.
measure: Effect of Norditropin® treatment on quality of life, blood biochemistry and the endocrine system in adults
timeFrame: 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.
Other outcomes:
Locations:
city: Prov. de Buenos Aires
country: Argentina
facility: Novo Nordisk Investigational Site
city: Brussels
country: Belgium
facility: Novo Nordisk Investigational Site
city: Prague
country: Czechia
facility: Novo Nordisk Investigational Site
city: Copenhagen S
country: Denmark
facility: Novo Nordisk Investigational Site
city: Espoo
country: Finland
facility: Novo Nordisk Investigational Site
city: Paris La défense cedex
country: France
facility: Novo Nordisk Investigational Site
city: Mainz
country: Germany
facility: Novo Nordisk Investigational Site
city: Budapest
country: Hungary
facility: Novo Nordisk Investigational Site
city: Dublin 2
country: Ireland
facility: Novo Nordisk Investigational Site
city: Kfar Saba
country: Israel
facility: Novo Nordisk Investigational Site
city: Rome
country: Italy
facility: Novo Nordisk Investigational Site
city: Vilnius
country: Lithuania
facility: Novo Nordisk Investigational Site
city: Luxembourg
country: Luxembourg
facility: Novo Nordisk Investigational Site
city: Alphen a/d Rijn
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Rud
country: Norway
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Riyadh
country: Saudi Arabia
facility: Novo Nordisk Investigational Site
city: Belgrade
country: Serbia
facility: Novo Nordisk Investigational Site
city: Ljubljana
country: Slovenia
facility: Novo Nordisk Investigational Site
city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
city: Malmö
country: Sweden
facility: Novo Nordisk Investigational Site
city: Zurich
country: Switzerland
facility: Novo Nordisk Investigational Site
city: Crawley
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Weber MM, Biller BM, Pedersen BT, Pournara E, Christiansen JS, Hoybye 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(R) International Outcome Study. Clin Endocrinol (Oxf). 2017 Feb;86(2):192-198. doi: 10.1111/cen.13256. Epub 2016 Nov 21.
citation: Savendahl 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.
citation: Lee PA, Savendahl 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 age, idiopathic short stature, or multiple pituitary hormone deficiency: combined results from two large observational studies. Int J Pediatr Endocrinol. 2012 Jul 12;2012(1):22. doi: 10.1186/1687-9856-2012-22.
citation: Hoybye C, Savendahl L, Christesen HT, Lee P, Pedersen BT, Schlumpf M, Germak J, Ross J. The NordiNet(R) International Outcome Study and NovoNet(R) ANSWER Program(R): rationale, design, and methodology of two international pharmacoepidemiological registry-based studies monitoring long-term clinical and safety outcomes of growth hormone therapy (Norditropin(R)). Clin Epidemiol. 2013 Apr 26;5:119-27. doi: 10.2147/CLEP.S42602. Print 2013.
citation: Savendahl 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.
citation: 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(R) International Outcome Study. Eur J Endocrinol. 2017 Aug;177(2):145-155. doi: 10.1530/EJE-16-1055. Epub 2017 May 18.
citation: Christesen HT, Pedersen BT, Pournara E, Petit IO, Juliusson 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.
citation: Biller BMK, Hoybye C, Carroll P, Gordon MB, Birkegard AC, Kelepouris N, Nedjatian N, Weber MM. Pregnancy outcomes in women receiving growth hormone replacement therapy enrolled in the NordiNet(R) International Outcome Study (IOS) and the American Norditropin(R) Studies: Web-Enabled Research (ANSWER) Program. Pituitary. 2021 Aug;24(4):611-621. doi: 10.1007/s11102-021-01138-3. Epub 2021 Mar 12.
citation: Savendahl L, Polak M, Backeljauw P, Blair JC, Miller BS, Rohrer TR, Hokken-Koelega A, Pietropoli A, Kelepouris N, Ross J. Long-Term Safety of Growth Hormone Treatment in Childhood: Two Large Observational Studies: NordiNet IOS and ANSWER. J Clin Endocrinol Metab. 2021 May 13;106(6):1728-1741. doi: 10.1210/clinem/dgab080.
citation: Weber MM, Gordon MB, Hoybye C, Jorgensen JOL, Puras G, Popovic-Brkic V, Molitch ME, Ostrow V, Holot N, Pietropoli A, Biller BMK. Growth hormone replacement in adults: Real-world data from two large studies in US and Europe. Growth Horm IGF Res. 2020 Feb;50:71-82. doi: 10.1016/j.ghir.2019.09.002. Epub 2019 Oct 26.
citation: Savendahl L, Polak M, Backeljauw P, Blair J, Miller BS, Rohrer TR, Pietropoli A, Ostrow V, Ross J. Treatment of Children With GH in the United States and Europe: Long-Term Follow-Up From NordiNet(R) IOS and ANSWER Program. J Clin Endocrinol Metab. 2019 Oct 1;104(10):4730-4742. doi: 10.1210/jc.2019-00775.