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Trial record 1 of 1 for:    NCT01009905
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An Observational Study (Registry) Assessing Treatment Outcomes and Safety for Children and Adults Who Are Prescribed Norditropin® (Human Growth Hormone) (ANSWER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01009905
Recruitment Status : Completed
First Posted : November 9, 2009
Last Update Posted : April 12, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Growth Hormone Disorder Pituitary Dwarfism Hypopituitarism Drug: somatropin

Study Design
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Study Type : Observational
Actual Enrollment : 22960 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Registry of Patients Being Treated With Norditropin®, Recombinant Human Growth Hormone
Actual Study Start Date : June 24, 2002
Actual Primary Completion Date : September 30, 2016
Actual Study Completion Date : September 30, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Groups and Cohorts
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Group/Cohort Intervention/treatment
A Drug: somatropin
Safety and effectiveness data collection in connection with the use of Norditropin® (somatropin) in daily clinical practice


Outcome Measures
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Primary Outcome Measures :
  1. 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. [ Time Frame: measurement made by physician at study entry, annually, or more frequently at physician discretion during the study. ]
  2. Change in waist/hip circumference ratio for adult patients [ Time Frame: measurement made by physician at study entry, annually, or more frequently at physician discretion during the study ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: measurement made by physician at study entry, annually, or more frequently at physician discretion during the study. ]
  2. 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 [ Time Frame: measurement made by physician at study entry, annually, or more frequently at physician discretion during the study. ]
  3. Final Height SDS - Target Height SDS, Final height SDS - predicted adult height SDS [ Time Frame: measurement made by physician at study entry, annually, or more frequently at physician discretion during the study. ]
  4. Proportion achieving HSDS of more than -2 at final height [ Time Frame: measurement made by physician at study entry, annually, or more frequently at physician discretion during the study. ]
  5. Weight, waist circumference, and hip circumference for adult patients [ Time Frame: measurement made by physician at study entry, annually, or more frequently at physician discretion during the study ]

Eligibility Criteria
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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients from both general and specialty practice settings, existing and new users of growth hormones, who have been deemed appropriate to receive Norditropin® as part of routine out-patient care by the prescribing physician.
Criteria

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®
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01009905


Locations
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United States, New Jersey
Novo Nordisk Investigational Site
Plainsboro, New Jersey, United States, 08536
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452), MD Novo Nordisk A/S
More Information
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Additional Information:

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01009905    
Obsolete Identifiers: NCT00615953
Other Study ID Numbers: HGH-2149
U1111-1111-1168 ( Other Identifier: WHO )
First Posted: November 9, 2009    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Dwarfism
Dwarfism, Pituitary
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Endocrine System Diseases
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Bone Diseases, Endocrine