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

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: April 13, 2012
Last updated: April 29, 2014
Last verified: April 2014
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.

Condition Intervention
Growth Hormone Disorder
Adult Growth Hormone Deficiency
Drug: somatropin

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective, Longitudinal and National Follow-up Program of Adult Patients With Somatotropic Hormone Deficiency for Whom Substituting Treatment by Norditropin SimpleXx Was Started

Resource links provided by NLM:

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Weight [ Time Frame: Once a year for 5 years ] [ Designated as safety issue: No ]
  • Body composition [ Time Frame: Once a year for 5 years ] [ Designated as safety issue: No ]
  • Waist:Hip Ratio [ Time Frame: Once a year for 5 years ] [ Designated as safety issue: No ]
  • Body mass index (BMI) [ Time Frame: Once a year for 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • IGF-1 (Insulin-like growth factor 1) concentration [ Time Frame: Once a year for 5 years ] [ Designated as safety issue: No ]
  • Lipids: Total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL) and triglycerides [ Time Frame: Once a year for 5 years ] [ Designated as safety issue: No ]
  • Dose prescribed [ Time Frame: Once a year for 5 years ] [ Designated as safety issue: No ]

Enrollment: 331
Study Start Date: July 2003
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Inclusion Criteria:

  • Adult with growth hormone deficiency
  • Treated with Norditropin® SimpleXx (somatropin)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01580605

Lyon, France, 69394
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT01580605     History of Changes
Other Study ID Numbers: GHDA-1755 
Study First Received: April 13, 2012
Last Updated: April 29, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Dwarfism, Pituitary
Endocrine System Diseases
Bone Diseases
Bone Diseases, Developmental
Bone Diseases, Endocrine
Brain Diseases
Central Nervous System Diseases
Hypothalamic Diseases
Musculoskeletal Diseases
Nervous System Diseases
Pituitary Diseases processed this record on May 25, 2016