Adult Growth Hormone Deficiency, Growth Hormone Disorder
Conditions
Brief summary
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.
Interventions
DRUGsomatropin
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.
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number and type of suspected serious adverse drug reactions (SADRs) during the study period | after 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Number of impaired glucose tolerance events during the study period | evaluated after 3 months, 6 months, 1 year and between 2-5 years |
| Number of other types of adverse events (AEs) during the study period | evaluated after 3 months, 6 months, 1 year and between 2-5 years |
| Effects on body composition (body fat percentage, lean body weight mass, bone density, bone mineral density) | evaluated after 3 months, 6 months, 1 year and between 2-5 years |
| Effects of insulin-like growth factor-1 (IGF-I) levels | evaluated after 3 months, 6 months, 1 year and between 2-5 years |
Countries
Japan
Outcome results
None listed