Prospective, Longitudinal and National Follow-up Program of Adult Patients With Somatotropic Hormone Deficiency for Whom Substituting Treatment by Norditropin SimpleXx Was Started

Novo Nordisk A/S1 site in 1 country331 target enrollmentJuly 17, 2003

ConditionsGrowth Hormone Disorder Adult Growth Hormone Deficiency

Interventionssomatropin

Drugssomatropin

Overview

Phase: Not Applicable
Intervention: somatropin
Conditions: Growth Hormone Disorder
Sponsor: Novo Nordisk A/S
Enrollment: 331
Locations: 1
Primary Endpoint: Weight
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 17, 2003

End Date

November 28, 2011

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

Not provided

Arms & Interventions

Users of somatropin

Intervention: somatropin

Outcomes

Primary Outcomes

Weight

Time Frame: Once a year for 5 years

Waist:Hip Ratio

Time Frame: Once a year for 5 years

Body composition

Time Frame: Once a year for 5 years

Body mass index (BMI)

Time Frame: Once a year for 5 years

Secondary Outcomes

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)