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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01580605
First received: April 13, 2012
Last updated: November 6, 2012
Last verified: November 2012
History of Changes
  Purpose

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: No treatment given

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:

Drug Information available for: Somatropin
U.S. FDA Resources

Further study details as provided by Novo Nordisk:

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: 333
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: No treatment given
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

  Eligibility

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

Criteria

Inclusion Criteria:

  • Adult with growth hormone deficiency
  • Treated with Norditropin® SimpleXx (somatropin)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01580605

Locations
France
Lyon, France, 69394
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Delphine Jaquet, MD Novo Nordisk France
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01580605     History of Changes
Other Study ID Numbers: GHDA-1755
Study First Received: April 13, 2012
Last Updated: November 6, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Dwarfism, Pituitary
Endocrine System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
 Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013