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

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

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.

Study Overview

• Status: Completed
• Conditions: Growth Hormone Disorder; Adult Growth Hormone Deficiency
• Intervention / Treatment: Drug: somatropin; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • ANGERS cedex 09, France, 49033
    • Novo Nordisk Investigational Site
  • Boisguillaume, France, 76233
    • Novo Nordisk Investigational Site
  • Brest, France, 29609
    • Novo Nordisk Investigational Site
  • Caen, France, 14033
    • Novo Nordisk Investigational Site
  • Grenoble, France, 38043
    • Novo Nordisk Investigational Site
  • Le Kremlin-bicetre, France, 94275
    • Novo Nordisk Investigational Site
  • Lille, France, 59037
    • Novo Nordisk Investigational Site
  • Lorient, France, 56322
    • Novo Nordisk Investigational Site
  • Lyon, France, 69394
    • Novo Nordisk Investigational Site
  • Lyon, France, 69437
    • Novo Nordisk Investigational Site
  • MARSEILLE Cédex 05, France, 13385
    • Novo Nordisk Investigational Site
  • MONTPELLIER cedex 5, France, 34295
    • Novo Nordisk Investigational Site
  • Nantes, France, 44093
    • Novo Nordisk Investigational Site
  • Nantes, France, 44000
    • Novo Nordisk Investigational Site
  • Nice, France, 06002
    • Novo Nordisk Investigational Site
  • Paris, France, 75015
    • Novo Nordisk Investigational Site
  • Paris, France, 75010
    • Novo Nordisk Investigational Site
  • Paris, France, 75571
    • Novo Nordisk Investigational Site
  • Reims, France, 51092
    • Novo Nordisk Investigational Site
  • Rennes, France, 35056
    • Novo Nordisk Investigational Site
  • Strasbourg, France, 67098
    • Novo Nordisk Investigational Site
  • TOULOUSE cedex, France, 31054
    • Novo Nordisk Investigational Site
  • Tours, France, 37044
    • Novo Nordisk Investigational Site
  • Vandoeuvre Les Nancy, France, 54511
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: placebo; 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.
Experimental: Somatropin	Drug: somatropin; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Left ventricular mass measured with ultrasonography

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Publications and helpful links

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 1998
• Primary Completion (Actual): December 1, 2002
• Study Completion (Actual): December 1, 2002

Study Registration Dates

• First Submitted: March 22, 2012
• First Submitted That Met QC Criteria: March 23, 2012
• First Posted (Estimated): March 26, 2012

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: GHDADULT/F/1/F