Adult Growth Hormone Deficiency Clinical Trial
— GETOfficial title:
A 24-month Prospective, Non-interventional, Observational Study on the Composite Clinical Endpoint (GET-Score) Reflecting Quality of Life, Body Composition and Cholesterol Metabolism in Patients Treated With Norditropin® (Somatropin)
Verified date | April 2015 |
Source | Novo Nordisk A/S |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Federal Institute for Drugs and Medical Devices |
Study type | Observational |
This observational study is conducted in Europe. The aim of this observational study is to investigate the changes in a score (GET-score) which includes quality of life, body composition and cholesterol metabolism in patients on growth hormone treatment. The GET score stands for: Growth hormone deficiency and Efficacy of Treatment, and is a quantitative measurement of the efficacy of the treatment with growth hormone in adults.
Status | Completed |
Enrollment | 121 |
Est. completion date | June 2014 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Severe acquired growth hormone deficiency - No treatment with somatropin in the last 24 months before study participation - Written informed consent Exclusion Criteria: - Contraindications for the treatment with somatropin |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Novo Nordisk A/S |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improvement of an integrated score which consists of Quality of Life (QoL), body composition, lipid metabolism, bone mineral density | at 0, 3, 6, 12, 18 and 24 months after treatment initiation | No | |
Secondary | Health related quality of life (SF-36; EQ-5D) | at 0, 3, 6, 12, 18 and 24 months after treatment initiation | No | |
Secondary | Disease related absences from work | at 0, 3, 6, 12, 18 and 24 months after treatment initiation | No | |
Secondary | Bone mineral density DXA Z-score lumbar | at 0, 3, 6, 12, 18 and 24 months after treatment initiation | No | |
Secondary | Total cholesterol, HDL, LDL | at 0, 3, 6, 12, 18 and 24 months after treatment initiation | No | |
Secondary | Body composition: fat mass, fat-free mass, impedance (BIA) | at 0, 3, 6, 12, 18 and 24 months after treatment initiation | No | |
Secondary | Waist-circumference | at 0, 3, 6, 12, 18 and 24 months after treatment initiation | No | |
Secondary | Blood pressure | at 0, 3, 6, 12, 18 and 24 months after treatment initiation | No | |
Secondary | Adverse Drug Reactions and Severe Adverse Drug Reactions | at 0, 3, 6, 12, 18 and 24 months after treatment initiation | Yes | |
Secondary | Triceps skinfold thickness | at 0, 3, 6, 12, 18 and 24 months after treatment initiation | Yes | |
Secondary | Upper arm circumference | at 0, 3, 6, 12, 18 and 24 months after treatment initiation | Yes | |
Secondary | IGF-I (Insulin-like growth factor 1) | at 0, 3, 6, 12, 18 and 24 months after treatment initiation | No |
Status | Clinical Trial | Phase | |
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