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Completed

NCT Number: NCT01109017

Observational Study of the Safety and Efficacy of Norditropin® in Adult Patients With Growth Hormone Deficiency

This study is conducted in Japan. The aim of this observational study is to collect information about the safety and efficacy of Norditropin® long-term treatment of growth hormone deficiency in adults.

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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

Tokyo, 1000005, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Severe adult growth hormone deficiency

Exclusion criteria

  • Known or suspected allergy to study product(s) or related products
  • Previous participation in the study
  • Diabetes Mellitus
  • Presence of malignant tumor(s)
  • Pregnant or likely to get pregnant

Treatment and study plan

Somatropin

Drug

Norditropin® (somatropin) prescribed at the discretion of the physician according to normal clinical practice. Safety and effectiveness data is recorded by the physician, and a Quality of Life form is completed by the patient, at visits 1 to 5.

Primary outcomes

  1. Number and type of suspected serious adverse drug reactions (SADRs) during the study period

    Time frame: after 5 years

Secondary outcomes

  1. Number of impaired glucose tolerance events during the study period

    Time frame: evaluated after 3 months, 6 months, 1 year and between 2-5 years

  2. Number of other types of adverse events (AEs) during the study period

    Time frame: evaluated after 3 months, 6 months, 1 year and between 2-5 years

  3. Effects on body composition (body fat percentage, lean body weight mass, bone density, bone mineral density)

    Time frame: evaluated after 3 months, 6 months, 1 year and between 2-5 years

  4. Effects of insulin-like growth factor-1 (IGF-I) levels

    Time frame: evaluated after 3 months, 6 months, 1 year and between 2-5 years

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Multicentre, Open Label, Observational, Non-interventional Study to Evaluate the Long-term Safety and Efficacy of Norditropin® Formulation in Patients With AGHD

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Apr 22, 2010
Registry last updated
Jan 8, 2015

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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