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Completed

NCT Number: NCT01580605

French National Registry of Adults With Growth Hormone Deficiency Treated With Somatropin

This study is conducted in Europe. The aim of this study is to extract data from the French National Registry holding information about patients having initiated growth hormone therapy with the objective to describe patients receiving growth hormone therapy, assess efficacy and safety of somatropin (Norditropin® SimpleXx®) and evaluate treatment compliance.

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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

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Lyon, 69394, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult with growth hormone deficiency
  • Treated with Norditropin® SimpleXx (somatropin)

Treatment and study plan

Somatropin

Drug

Data are extracted from the French National Registry "l'Observatoire National des Prescriptions et Consommations de Médicaments" to where physicians report data about growth hormone treatment

Primary outcomes

  1. Weight

    Time frame: Once a year for 5 years

  2. Body composition

    Time frame: Once a year for 5 years

  3. Waist:Hip Ratio

    Time frame: Once a year for 5 years

  4. Body mass index (BMI)

    Time frame: Once a year for 5 years

Secondary outcomes

  1. IGF-1 (Insulin-like growth factor 1) concentration

    Time frame: Once a year for 5 years

  2. Lipids: Total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL) and triglycerides

    Time frame: Once a year for 5 years

  3. Dose prescribed

    Time frame: Once a year for 5 years

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Prospective, Longitudinal and National Follow-up Program of Adult Patients With Somatotropic Hormone Deficiency for Whom Substituting Treatment by Norditropin SimpleXx Was Started

Important dates

Study start
2003
Primary completion
2011
Study completion
2011
First posted
Apr 19, 2012
Registry last updated
Nov 12, 2019

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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