French National Registry of Adults With Growth Hormone Deficiency Treated With Somatropin
Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT01580605
Collaborator
(none)
331
1
100.4
3.3
Study Details
Study Description
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 | Phase |
|---|---|---|
Study Design
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
:
Jul 17, 2003
Actual Primary Completion Date
:
Nov 28, 2011
Actual Study Completion Date
:
Nov 28, 2011
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Adult with growth hormone deficiency
-
Treated with Norditropin® SimpleXx (somatropin)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novo Nordisk Investigational Site | Lyon | France | 69394 |
Sponsors and Collaborators
- Novo Nordisk A/S
Investigators
- Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01580605
Other Study ID Numbers:
- GHDA-1755
First Posted:
Apr 19, 2012
Last Update Posted:
Nov 12, 2019
Last Verified:
Nov 1, 2019