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Observational Prospective Study on Patients Treated With Norditropin®

NCT ID: NCT00960128

Last Updated: 2017-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

21249 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-04-01

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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A

Adult cohort

somatropin

Intervention Type DRUG

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

B

Paediatric cohort

somatropin

Intervention Type DRUG

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

Interventions

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somatropin

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

Intervention Type DRUG

somatropin

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Judged by the physician as per the Norditropin® label

Exclusion Criteria

* Judged by the physician as per the Norditropin® label
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Prov. de Buenos Aires, , Argentina

Site Status

Novo Nordisk Investigational Site

Brussels, , Belgium

Site Status

Novo Nordisk Investigational Site

Prague, , Czechia

Site Status

Novo Nordisk Investigational Site

Copenhagen S, , Denmark

Site Status

Novo Nordisk Investigational Site

Espoo, , Finland

Site Status

Novo Nordisk Investigational Site

Paris La Défense Cedex, , France

Site Status

Novo Nordisk Investigational Site

Mainz, , Germany

Site Status

Novo Nordisk Investigational Site

Budapest, , Hungary

Site Status

Novo Nordisk Investigational Site

Dublin, , Ireland

Site Status

Novo Nordisk Investigational Site

Kfar Saba, , Israel

Site Status

Novo Nordisk Investigational Site

Rome, , Italy

Site Status

Novo Nordisk Investigational Site

Vilnius, , Lithuania

Site Status

Novo Nordisk Investigational Site

Luxembourg, , Luxembourg

Site Status

Novo Nordisk Investigational Site

Alphen aan den Rijn, , Netherlands

Site Status

Novo Nordisk Investigational Site

Rud, , Norway

Site Status

Novo Nordisk Investigational Site

Moscow, , Russia

Site Status

Novo Nordisk Investigational Site

Riyadh, , Saudi Arabia

Site Status

Novo Nordisk Investigational Site

Belgrade, , Serbia

Site Status

Novo Nordisk Investigational Site

Ljubljana, , Slovenia

Site Status

Novo Nordisk Investigational Site

Madrid, , Spain

Site Status

Novo Nordisk Investigational Site

Malmo, , Sweden

Site Status

Novo Nordisk Investigational Site

Zurich, , Switzerland

Site Status

Novo Nordisk Investigational Site

Crawley, , United Kingdom

Site Status

Countries

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Brazil Serbia and Montenegro 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

References

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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.

Reference Type RESULT
PMID: 27736009 (View on PubMed)

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.

Reference Type RESULT
PMID: 26903552 (View on PubMed)

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.

Reference Type RESULT
PMID: 22788856 (View on PubMed)

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.

Reference Type RESULT
PMID: 23658497 (View on PubMed)

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.

Reference Type RESULT
PMID: 22508317 (View on PubMed)

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.

Reference Type RESULT
PMID: 28522645 (View on PubMed)

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.

Reference Type RESULT
PMID: 27280591 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40919719 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36947589 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33709288 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33571362 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31972476 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31305924 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2008-001674-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GHLIQUID-3676

Identifier Type: -

Identifier Source: org_study_id