French National Registry of Adults With Growth Hormone Deficiency Treated With Somatropin

November 8, 2019 updated by: Novo Nordisk A/S

Prospective, Longitudinal and National Follow-up Program of Adult Patients With Somatotropic Hormone Deficiency for Whom Substituting Treatment by Norditropin SimpleXx Was Started

This study is conducted in Europe. The aim of this study is to extract data from the French National Registry holding information about patients having initiated growth hormone therapy with the objective to describe patients receiving growth hormone therapy, assess efficacy and safety of somatropin (Norditropin® SimpleXx®) and evaluate treatment compliance.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

331

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

  • France
      • Lyon, France, 69394
        • 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All adult patients with growth hormone deficiency and treated with Norditropin® SimpleXx (somatropin) for whom Norditropin® SimpleXx® has been initiated either before or during the registry inclusion period

Description

Inclusion Criteria:

  • Adult with growth hormone deficiency
  • Treated with Norditropin® SimpleXx (somatropin)

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: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Users of somatropin
Drug: somatropin
Data are extracted from the French National Registry "l'Observatoire National des Prescriptions et Consommations de Médicaments" to where physicians report data about growth hormone treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight
Time Frame: Once a year for 5 years
Once a year for 5 years
Body composition
Time Frame: Once a year for 5 years
Once a year for 5 years
Waist:Hip Ratio
Time Frame: Once a year for 5 years
Once a year for 5 years
Body mass index (BMI)
Time Frame: Once a year for 5 years
Once a year for 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
IGF-1 (Insulin-like growth factor 1) concentration
Time Frame: Once a year for 5 years
Once a year for 5 years
Lipids: Total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL) and triglycerides
Time Frame: Once a year for 5 years
Once a year for 5 years
Dose prescribed
Time Frame: Once a year for 5 years
Once a year for 5 years

Collaborators and Investigators

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

Sponsor

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)

July 17, 2003

Primary Completion (Actual)

November 28, 2011

Study Completion (Actual)

November 28, 2011

Study Registration Dates

First Submitted

April 13, 2012

First Submitted That Met QC Criteria

April 18, 2012

First Posted (Estimate)

April 19, 2012

Study Record Updates

Last Update Posted (Actual)

November 12, 2019

Last Update Submitted That Met QC Criteria

November 8, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GHDA-1755

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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