Observational Prospective Study on Patients Treated With Norditropin®

NCT00960128 | Completed

• 2 other identifiers: GHLIQUID-36762008-001674-32
• Study Type: observational
• Target: 21,249
• Locations: 22 countries
• Sites: 22

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.

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

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (2)

• 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.

• 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.

Study Arms (2)

A

Adult cohort

Drug: somatropin

B

Paediatric cohort

Drug: somatropin

Interventions

somatropin DRUG

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

A

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Judged by the physician as per the Norditropin® label

You may not qualify if:

• Judged by the physician as per the Norditropin® label

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (23)

Novo Nordisk Investigational Site

Prov. de Buenos Aires, B1636DSU, Argentina

Location

Novo Nordisk Investigational Site

Brussels, 1070, Belgium

Location

Novo Nordisk Investigational Site

Prague, 16000, Czechia

Location

Novo Nordisk Investigational Site

Copenhagen S, 2300, Denmark

Location

Novo Nordisk Investigational Site

Espoo, FI-02600, Finland

Location

Novo Nordisk Investigational Site

Paris La Défense Cedex, 92932, France

Location

Novo Nordisk Investigational Site

Mainz, 55127, Germany

Location

Novo Nordisk Investigational Site

Budapest, 1025, Hungary

Location

Novo Nordisk Investigational Site

Dublin, Ireland

Location

Novo Nordisk Investigational Site

Kfar Saba, 44425, Israel

Location

Novo Nordisk Investigational Site

Rome, 00144, Italy

Location

Novo Nordisk Investigational Site

Vilnius, 01112, Lithuania

Location

Novo Nordisk Investigational Site

Luxembourg, Luxembourg

Location

Novo Nordisk Investigational Site

Alphen aan den Rijn, Netherlands

Location

Novo Nordisk Investigational Site

Rud, 1309, Norway

Location

Novo Nordisk Investigational Site

Moscow, 119330, Russia

Location

Novo Nordisk Investigational Site

Riyadh, 3542, Saudi Arabia

Location

Novo Nordisk Investigational Site

Belgrade, 11 070, Serbia

Location

Novo Nordisk Investigational Site

Ljubljana, SI-1000, Slovenia

Location

Novo Nordisk Investigational Site

Madrid, 28033, Spain

Location

Novo Nordisk Investigational Site

Malmo, 202 15, Sweden

Location

Novo Nordisk Investigational Site

Zurich, CH-8050, Switzerland

Location

Novo Nordisk Investigational Site

Crawley, RH11 9RT, United Kingdom

Location

Related Publications (13)

• 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.

  PMID: 27736009 RESULT

• 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.

  PMID: 26903552 RESULT

• 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.

  PMID: 22788856 RESULT

• 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.

  PMID: 23658497 RESULT

• 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.

  PMID: 22508317 RESULT

• 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.

  PMID: 28522645 RESULT

• 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.

  PMID: 27280591 RESULT

• Rohrer TR, Kotnik P, Miller BS, Kelepouris N, Olsen AH, Pietropoli A, Polak M, Blair J. Better growth outcomes in GH-deficient children treated younger than 2 years of age. Endocr Connect. 2025 Sep 23;14(9):e250493. doi: 10.1530/EC-25-0493. Print 2025 Sep 1.

  PMID: 40919719 DERIVED

• Backeljauw P, Blair JC, Ferran JM, Kelepouris N, Miller BS, Pietropoli A, Polak M, Savendahl L, Verlinde F, Rohrer TR. Early GH Treatment Is Effective and Well Tolerated in Children With Turner Syndrome: NordiNet(R) IOS and Answer Program. J Clin Endocrinol Metab. 2023 Sep 18;108(10):2653-2665. doi: 10.1210/clinem/dgad159.

  PMID: 36947589 DERIVED

• 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.

  PMID: 33709288 DERIVED

• 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.

  PMID: 33571362 DERIVED

• 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.

  PMID: 31972476 DERIVED

• 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.

  PMID: 31305924 DERIVED

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Dwarfism, Pituitary; Genetic Diseases, Inborn; Turner Syndrome; Renal Insufficiency, Chronic; Noonan Syndrome

Interventions

Human Growth Hormone

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Gonadal Dysgenesis; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Sex Chromosome Disorders of Sex Development; Male Urogenital Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Sex Chromosome Disorders; Chromosome Disorders; Gonadal Disorders; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Growth Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2009
• First Posted: August 17, 2009
• Study Start: April 1, 2006
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: October 12, 2017

Record last verified: 2017-10

Locations

LI (1); IE (1); SA (1); DK (1); SL (1); CH (1); BE (1); GB (1); FI (1); NL (1); DE (1); SE (1); NO (1); ES (1); AR (1); IT (1); LU (1); RU (1); FR (1); CZ (1); HU (1); IL (1)