Observational Study of the Safety and Efficacy of Norditropin® in Adult Patients With Growth Hormone Deficiency
Completed
- Conditions
- Adult Growth Hormone DeficiencyGrowth Hormone Disorder
- Interventions
- Registration Number
- NCT01109017
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 387
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Norditropin® somatropin -
- Primary Outcome Measures
Name Time Method Number and type of suspected serious adverse drug reactions (SADRs) during the study period after 5 years
- Secondary Outcome Measures
Name Time Method 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