French National Registry of Adults With Growth Hormone Deficiency Treated With Somatropin
Prospective, Longitudinal and National Follow-up Program of Adult Patients With Somatotropic Hormone Deficiency for Whom Substituting Treatment by Norditropin SimpleXx Was Started
1 other identifier
observational
331
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2003
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 17, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 28, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 28, 2011
CompletedFirst Submitted
Initial submission to the registry
April 13, 2012
CompletedFirst Posted
Study publicly available on registry
April 19, 2012
CompletedNovember 12, 2019
November 1, 2019
8.4 years
April 13, 2012
November 8, 2019
Conditions
Outcome Measures
Primary Outcomes (4)
Weight
Once a year for 5 years
Body composition
Once a year for 5 years
Waist:Hip Ratio
Once a year for 5 years
Body mass index (BMI)
Once a year for 5 years
Secondary Outcomes (3)
IGF-1 (Insulin-like growth factor 1) concentration
Once a year for 5 years
Lipids: Total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL) and triglycerides
Once a year for 5 years
Dose prescribed
Once a year for 5 years
Study Arms (1)
Users of somatropin
Interventions
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 Criteria
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
You may qualify if:
- Adult with growth hormone deficiency
- Treated with Norditropin® SimpleXx (somatropin)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Novo Nordisk Investigational Site
Lyon, 69394, France
Related Publications (1)
Borson-Chazot F, Chabre O, Salenave S, Klein M, Brac de la Perriere A, Reznik Y, Kerlan V, Hacques E, Villette B. Adherence to growth hormone therapy guidelines in a real-world French cohort of adult patients with growth hormone deficiency. Ann Endocrinol (Paris). 2021 Feb;82(1):59-68. doi: 10.1016/j.ando.2020.11.007. Epub 2020 Dec 5.
PMID: 33290752DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2012
First Posted
April 19, 2012
Study Start
July 17, 2003
Primary Completion
November 28, 2011
Study Completion
November 28, 2011
Last Updated
November 12, 2019
Record last verified: 2019-11