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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01580605
First Posted: April 19, 2012
Last Update Posted: April 30, 2014
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.
Information provided by (Responsible Party):
Novo Nordisk A/S
  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: 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 ]
  • Body composition [ Time Frame: Once a year for 5 years ]
  • Waist:Hip Ratio [ Time Frame: Once a year for 5 years ]
  • Body mass index (BMI) [ Time Frame: Once a year for 5 years ]

Secondary Outcome Measures:
  • IGF-1 (Insulin-like growth factor 1) concentration [ Time Frame: 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 ]
  • Dose prescribed [ Time Frame: Once a year for 5 years ]

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
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): NCT01580605


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

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01580605     History of Changes
Other Study ID Numbers: GHDA-1755
First Submitted: April 13, 2012
First Posted: April 19, 2012
Last Update Posted: April 30, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Endocrine System Diseases
Dwarfism, Pituitary
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