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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01562834
First received: March 22, 2012
Last updated: June 28, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Growth Hormone Disorder
Adult Growth Hormone Deficiency
Drug: somatropin
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Left ventricular mass measured with ultrasonography [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ventricular function indices assessed by cardiac ultrasonography [ Designated as safety issue: No ]
  • Bone mineral density and body composition assessed by DEXA (Dual Energy X-Ray Absorptiometry) [ Designated as safety issue: No ]
  • Quality of life using EQ5D (European Quality of Life 5 Dimensions) scales [ Designated as safety issue: No ]
  • IGF-I (Insulin-Like Growth Factor I) concentration [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: October 1998
Study Completion Date: December 2002
Primary Completion Date: December 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01562834

Locations
France
Paris, France, 75571
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Catherine Boisson-Lesage, MD Novo Nordisk Pharmaceutique SAS
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01562834     History of Changes
Other Study ID Numbers: GHDADULT/F/1/F
Study First Received: March 22, 2012
Last Updated: June 28, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Dwarfism, Pituitary
Endocrine System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 25, 2014