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

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ClinicalTrials.gov Identifier: NCT01580605
Recruitment Status : Completed
First Posted : April 19, 2012
Last Update Posted : November 12, 2019
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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 or disease Intervention/treatment
Growth Hormone Disorder Adult Growth Hormone Deficiency Drug: somatropin

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Study Type : Observational
Actual Enrollment : 331 participants
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
Actual Study Start Date : July 17, 2003
Actual Primary Completion Date : November 28, 2011
Actual Study Completion Date : November 28, 2011

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

Primary Outcome Measures :
  1. Weight [ Time Frame: Once a year for 5 years ]
  2. Body composition [ Time Frame: Once a year for 5 years ]
  3. Waist:Hip Ratio [ Time Frame: Once a year for 5 years ]
  4. Body mass index (BMI) [ Time Frame: Once a year for 5 years ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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

Inclusion Criteria:

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

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

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Novo Nordisk Investigational Site
Lyon, France, 69394
Sponsors and Collaborators
Novo Nordisk A/S
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01580605    
Other Study ID Numbers: GHDA-1755
First Posted: April 19, 2012    Key Record Dates
Last Update Posted: November 12, 2019
Last Verified: November 2019
Additional relevant MeSH terms:
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Dwarfism, Pituitary
Endocrine System Diseases
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases