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

April 11, 2017 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

22960

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Plainsboro, New Jersey, United States, 08536
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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®

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
measurement made by physician at study entry, annually, or more frequently at physician discretion during the study.
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
measurement made by physician at study entry, annually, or more frequently at physician discretion during the study

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
measurement made by physician at study entry, annually, or more frequently at physician discretion during the study.
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.
measurement made by physician at study entry, annually, or more frequently at physician discretion during the study.
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.
measurement made by physician at study entry, annually, or more frequently at physician discretion during the study.
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.
measurement made by physician at study entry, annually, or more frequently at physician discretion during the study.
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
measurement made by physician at study entry, annually, or more frequently at physician discretion during the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Global Clinical Registry (GCR, 1452), MD, Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 24, 2002

Primary Completion (Actual)

September 30, 2016

Study Completion (Actual)

September 30, 2016

Study Registration Dates

First Submitted

November 5, 2009

First Submitted That Met QC Criteria

November 6, 2009

First Posted (Estimate)

November 9, 2009

Study Record Updates

Last Update Posted (Actual)

April 12, 2017

Last Update Submitted That Met QC Criteria

April 11, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HGH-2149
  • U1111-1111-1168 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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