Effect of Somatropin on Left Ventricular Mass in Growth Hormone Deficient Adult Patients

Study Overview
=================
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.

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

Conditions
-----------------
Growth Hormone Disorder, Adult Growth Hormone Deficiency

Intervention / Treatment
-----------------
* Drug: somatropin
* Drug: placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years


Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Somatropin<br> | Drug: somatropin<br>* Initial dosage 0.5 IU/day, injected subcutaneously (s.c., under the skin) once daily. Dosage will be adjusted monthly depending on clinical safety up to a maximum dose of 3 IU/day. Subjects are treated for six months (randomised trial period) followed by an 12-month open-label trial period with somatropin.<br>|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* Initial dosage 0.5 IU/day, injected subcutaneously (s.c., under the skin) once daily. Dosage will be adjusted monthly depending on clinical safety up to a maximum dose of 3 IU/day. Subjects are treated for six months. After treatment in the randomised trial period, placebo will be discontinued.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular mass measured with ultrasonography |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventricular function indices assessed by cardiac ultrasonography |  |  | 
| Bone mineral density and body composition assessed by DEXA (Dual Energy X-Ray Absorptiometry) |  |  | 
| Quality of life using EQ5D (European Quality of Life 5 Dimensions) scales |  |  | 
| IGF-I (Insulin-Like Growth Factor I) concentration |  |  |