Study type

Study topic

Human medicinal product
Disease /health condition

Study type

Non-interventional study

Scope of the study

Effectiveness study (incl. comparative)

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Other

Non-interventional study design, other

Case-series, Observational, retrospective
Study drug and medical condition

Name of medicine

OMNITROPE

Medical condition to be studied

Growth hormone deficiency
Population studied

Short description of the study population

Patients with Growth hormone deficiency.

Age groups

  • Paediatric Population (< 18 years)
    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • Adults (18 to < 46 years)

Special population of interest

Other

Special population of interest, other

Patients with Growth hormone deficiency

Estimated number of subjects

30
Study design details

Main study objective

Assess the increase in stature (height, standard deviation (SD) of height), growth rate (GR) and standard deviation of growth rate (SDGR) in GHD children treated with Omnitrope® for a minimum of two years.

Outcomes

HeightStandard deviation (SD) of height,Growth rate (GR)Standard deviation of growth rate (SDGR), Identify the time of pubertal development

Data analysis plan

Absolute frequencies will be reported as a summary (n) and relative frequencies as a percentage (%), 95% confidence intervals (CI) will be also given. The ‘normality’ of quantitative variables will be checked with the Kolmogorov-Smirnov test, normally distributed variables will be then summarised using the mean and standard deviation. In all analyses, a significance level below 0.05 was established (95% confidence).