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OpenTrials
Completed

NCT Number: NCT01562834

Effect of Somatropin on Left Ventricular Mass in 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.

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Key information

Conditions

Growth Hormone Disorder Adult Growth Hormone Deficiency Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Dwarfism Dwarfism, Pituitary Endocrine System Diseases Hypopituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novo Nordisk Investigational Site, Angers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Somatropin

Drug

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

Drug

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.

Primary outcomes

  1. Left ventricular mass measured with ultrasonography

Secondary outcomes

  1. Ventricular function indices assessed by cardiac ultrasonography

  2. Bone mineral density and body composition assessed by DEXA (Dual Energy X-Ray Absorptiometry)

  3. Quality of life using EQ5D (European Quality of Life 5 Dimensions) scales

  4. IGF-I (Insulin-Like Growth Factor I) concentration

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
1998
Primary completion
2002
Study completion
2002
First posted
Mar 26, 2012
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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