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

Completed

• Conditions: Growth Hormone Disorder; Adult Growth Hormone Deficiency
• Interventions: Drug: somatropin

• Registration Number: NCT01580605
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-07-17
• Primary Completion: 2011-11-28
• Study Completion: 2011-11-28
• Study First Submitted: 2012-04-13
• Study First Submitted QC: 2012-04-18
• Study First Posted: 2012-04-19
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-08
• Last Update Posted: 2019-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 331

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Users of somatropin	somatropin	-

Primary Outcome Measures

Name	Time	Method
Weight	Once a year for 5 years
Waist:Hip Ratio	Once a year for 5 years
Body composition	Once a year for 5 years
Body mass index (BMI)	Once a year for 5 years

Secondary Outcome Measures

Name	Time	Method
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
IGF-1 (Insulin-like growth factor 1) concentration	Once a year for 5 years

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇫🇷 Lyon, France