An Observational Study (Registry) Assessing Treatment Outcomes and Safety for Children and Adults Who Are Prescribed Norditropin® (Human Growth Hormone)

Growth Hormone Disorder Clinical Trial

— ANSWER  

Official title:

Registry of Patients Being Treated With Norditropin®, Recombinant Human Growth Hormone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01009905
• Other study ID #: HGH-2149
• Secondary ID: U1111-1111-1168
• Status: Completed
• Phase: N/A
• First received: November 5, 2009
• Last updated: April 11, 2017
• Start date: June 24, 2002
• Est. completion date: September 30, 2016

Study information

• Verified date: April 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is conducted in the United States of America (USA). The aim of this observational study is to collect data concerning the treatment outcomes and safety for children and adults who are prescribed Norditropin®. Specific objectives include: 1) developing models defining the relationship of Norditropin dose to changes in insulin-like growth factor (IGF-I) and treatment outcomes, accounting for independent factors such as age, gender and puberty and 2) determining the relative predictive values of peak growth hormone (GH) and IGF-I levels and other factors before treatment to clinical outcomes.

Other known NCT identifiers

• NCT00615953

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22960
• Est. completion date: September 30, 2016
• Est. primary completion date: September 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• Informed consent obtained

• Children or adult patients treated with Norditropin® for an appropriate condition as prescribed by their physician

Exclusion Criteria:

• Patients not being treated with Norditropin®

• 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®

Related Conditions & MeSH terms

• Dwarfism
• Dwarfism, Pituitary
• Growth Hormone Disorder
• Hypopituitarism
• Pituitary Dwarfism

Intervention

Drug:
• somatropin
Safety and effectiveness data collection in connection with the use of Norditropin® (somatropin) in daily clinical practice

Locations

Country	Name	City	State
United States	Novo Nordisk Investigational Site	Plainsboro	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

References & Publications (4)

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

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. Ep — 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in height, measured as the height standard deviation score (HSDS), from the measurement made by the physician at study entry to the most recent clinic observation, end of GH treatment, de-registration, or change of clinic.		measurement made by physician at study entry, annually, or more frequently at physician discretion during the study.
Primary	Change in waist/hip circumference ratio for adult patients		measurement made by physician at study entry, annually, or more frequently at physician discretion during the study
Secondary	Short-term: Height, Height velocity, Height velocity standard deviation score (SDS), predicted adult height, height SDS for bone age, Proportion achieving height SDS > -2 at end of observational duration period		measurement made by physician at study entry, annually, or more frequently at physician discretion during the study.
Secondary	Final Height (or Adult height), Final Height SDS, near-adult height, near-adult height SDS, Final Height - Target Height, Final height - predicted adult height, height age		measurement made by physician at study entry, annually, or more frequently at physician discretion during the study.
Secondary	Final Height SDS - Target Height SDS, Final height SDS - predicted adult height SDS		measurement made by physician at study entry, annually, or more frequently at physician discretion during the study.
Secondary	Proportion achieving HSDS of more than -2 at final height		measurement made by physician at study entry, annually, or more frequently at physician discretion during the study.
Secondary	Weight, waist circumference, and hip circumference for adult patients		measurement made by physician at study entry, annually, or more frequently at physician discretion during the study

External Links

•   Clinical Trials at Novo Nordisk