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

Adult Growth Hormone Deficiency Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01580605
• Other study ID #: GHDA-1755
• Status: Completed
• Start date: July 17, 2003
• Est. completion date: November 28, 2011

Study information

• Verified date: November 2019
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 331
• Est. completion date: November 28, 2011
• Est. primary completion date: November 28, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Adult with growth hormone deficiency

• Treated with Norditropin® SimpleXx (somatropin)

Related Conditions & MeSH terms

• Adult Growth Hormone Deficiency
• Dwarfism, Pituitary
• Endocrine System Diseases
• Growth Hormone Disorder

Intervention

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

Locations

Country	Name	City	State
France	Novo Nordisk Investigational Site	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight		Once a year for 5 years
Primary	Body composition		Once a year for 5 years
Primary	Waist:Hip Ratio		Once a year for 5 years
Primary	Body mass index (BMI)		Once a year for 5 years
Secondary	IGF-1 (Insulin-like growth factor 1) concentration		Once a year for 5 years
Secondary	Lipids: Total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL) and triglycerides		Once a year for 5 years
Secondary	Dose prescribed		Once a year for 5 years

External Links

•   Clinical Trials at Novo Nordisk