An Observational Study (Registry) Assessing Treatment Outcomes and Safety for Children and Adults Who Are Prescribed Norditropin® (Human Growth Hormone)
NCT ID: NCT01009905
Last Updated: 2017-04-12
Study Results
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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COMPLETED
22960 participants
OBSERVATIONAL
2002-06-24
2016-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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A
somatropin
Safety and effectiveness data collection in connection with the use of Norditropin® (somatropin) in daily clinical practice
Interventions
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somatropin
Safety and effectiveness data collection in connection with the use of Norditropin® (somatropin) in daily clinical practice
Eligibility Criteria
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Inclusion Criteria
* Children or adult patients treated with Norditropin® for an appropriate condition as prescribed by their physician
Exclusion Criteria
* Patients who have discontinued treatment with Norditropin®
* Known or suspected allergy to Norditropin® or related products
* Contraindications for somatropin treatment consistent with the Prescribing Information for Norditropin®
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452), MD
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Plainsboro, New Jersey, United States
Countries
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References
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Ross JL, Lee PA, Gut R, Germak J. Attaining genetic height potential: Analysis of height outcomes from the ANSWER Program in children treated with growth hormone over 5 years. Growth Horm IGF Res. 2015 Dec;25(6):286-93. doi: 10.1016/j.ghir.2015.08.006. Epub 2015 Aug 22.
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.
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.
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.
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.
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.
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.
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.
Angulo M, Abuzzahab MJ, Pietropoli A, Ostrow V, Kelepouris N, Tauber M. Outcomes in children treated with growth hormone for Prader-Willi syndrome: data from the ANSWER Program(R) and NordiNet(R) International Outcome Study. Int J Pediatr Endocrinol. 2020 Nov 10;2020(1):20. doi: 10.1186/s13633-020-00090-6.
Miller BS, Ross J, Ostrow V. Height outcomes in children with growth hormone deficiency and idiopathic short stature treated concomitantly with growth hormone and aromatase inhibitor therapy: data from the ANSWER program. Int J Pediatr Endocrinol. 2020;2020:19. doi: 10.1186/s13633-020-00089-z. Epub 2020 Oct 6.
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.
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.
Rose SR, Reeves G, Gut R, Germak J. Attention-Deficit/Hyperactivity Disorder Medication Treatment Impact on Response to Growth Hormone Therapy: Results from the ANSWER Program, a Non-Interventional Study. J Pediatr. 2015 Dec;167(6):1389-96. doi: 10.1016/j.jpeds.2015.08.036. Epub 2015 Sep 26.
Lee PA, Ross J, Germak JA, Gut R. Effect of 4 years of growth hormone therapy in children with Noonan syndrome in the American Norditropin Studies: Web-Enabled Research (ANSWER) Program(R) registry. Int J Pediatr Endocrinol. 2012 Jun 8;2012(1):15. doi: 10.1186/1687-9856-2012-15.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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U1111-1111-1168
Identifier Type: OTHER
Identifier Source: secondary_id
HGH-2149
Identifier Type: -
Identifier Source: org_study_id
NCT00615953
Identifier Type: -
Identifier Source: nct_alias
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