Clinical trial NCT01562834: Effect of Somatropin on Left Ventricular Mass in Growth Hormone Deficient Adult Patients
Official title: Randomized Cross Over Double Blind Versus Placebo Trial Followed by an Open Phase Studying Effect of Norditropin® on Left Ventricular Mass of Growth Hormone Deficient Adult Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Growth Hormone Disorder
Adult Growth Hormone Deficiency
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-03-26
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to assess the effect of somatropin (Norditropin®) replacement therapy on the left ventricular mass of adult patients with a growth hormone deficiency.


Eligibility criteria: Inclusion Criteria:

* Childhood or adult onset growth hormone deficiency (GHD)
* GHD evidenced by two stimulation tests
* Duration of GHD at least 5 years
* Other hormone deficiencies associated with growth hormone deficiency

Exclusion Criteria:

* Pregnancy or pregnancy desired during the suggested duration of the study
* Personal history of colonic polyp or family history of colonic polyposis
* Known insulin-dependent or non-insulin-dependent diabetes
* Cardiovascular disease, left ventricular hypertrophy from other aetiology, recent auricular or ventricular arrhythmia, history of vascularisation by aortocoronary bypass significative mitral or aortic valvular disease, preexcitation syndrome, auriculoventricular conduction delay, bradycardia-tachycardia syndrome, left ventricular mass interfering treatment
* BMI (Body Mass Index) at least 30
* Growth hormone treatment during the 24 months prior to inclusion, history of treatment with extractive pituitary growth hormone, allergy or suspected allergy to somatropin therapy
* Patient who has participated in a different clinical study within the past two months
* Any condition which, in the opinion of the Investigator or the Scientific Committee, may interfere with successful implementation of the study
* Notion of breast cancer for the mother or the sister

Primary outcomes:
measure: Left ventricular mass measured with ultrasonography
Secondary outcomes:
measure: Ventricular function indices assessed by cardiac ultrasonography
measure: Bone mineral density and body composition assessed by DEXA (Dual Energy X-Ray Absorptiometry)
measure: Quality of life using EQ5D (European Quality of Life 5 Dimensions) scales
measure: IGF-I (Insulin-Like Growth Factor I) concentration
Other outcomes:
Locations:
city: ANGERS cedex 09
country: France
facility: Novo Nordisk Investigational Site
city: Boisguillaume
country: France
facility: Novo Nordisk Investigational Site
city: Brest
country: France
facility: Novo Nordisk Investigational Site
city: Caen
country: France
facility: Novo Nordisk Investigational Site
city: Grenoble
country: France
facility: Novo Nordisk Investigational Site
city: Le Kremlin-bicetre
country: France
facility: Novo Nordisk Investigational Site
city: Lille
country: France
facility: Novo Nordisk Investigational Site
city: Lorient
country: France
facility: Novo Nordisk Investigational Site
city: Lyon
country: France
facility: Novo Nordisk Investigational Site
city: Lyon
country: France
facility: Novo Nordisk Investigational Site
city: MARSEILLE Cédex 05
country: France
facility: Novo Nordisk Investigational Site
city: MONTPELLIER cedex 5
country: France
facility: Novo Nordisk Investigational Site
city: Nantes
country: France
facility: Novo Nordisk Investigational Site
city: Nantes
country: France
facility: Novo Nordisk Investigational Site
city: Nice
country: France
facility: Novo Nordisk Investigational Site
city: Paris
country: France
facility: Novo Nordisk Investigational Site
city: Paris
country: France
facility: Novo Nordisk Investigational Site
city: Paris
country: France
facility: Novo Nordisk Investigational Site
city: Reims
country: France
facility: Novo Nordisk Investigational Site
city: Rennes
country: France
facility: Novo Nordisk Investigational Site
city: Strasbourg
country: France
facility: Novo Nordisk Investigational Site
city: TOULOUSE cedex
country: France
facility: Novo Nordisk Investigational Site
city: Tours
country: France
facility: Novo Nordisk Investigational Site
city: Vandoeuvre Les Nancy
country: France
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: