An Observational Study Validating a Score That Quantifies the Therapeutic Response to Treatment With Norditropin®
Information source: Novo Nordisk A/S
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Growth Hormone Disorder; Adult Growth Hormone Deficiency
Intervention: somatropin (Drug); No treatment given (Other)
Phase: N/A
Status: Completed
Sponsored by: Novo Nordisk A/S Official(s) and/or principal investigator(s): Global Clinical Registry (GCR, 1452), Study Director, Affiliation: Novo Nordisk A/S
Summary
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.
Clinical Details
Official 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)
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Improvement of an integrated score which consists of Quality of Life (QoL), body composition, lipid metabolism, bone mineral density
Secondary outcome: Health related quality of life (SF-36; EQ-5D)Disease related absences from work Bone mineral density DXA Z-score lumbar Total cholesterol, HDL, LDL Body composition: fat mass, fat-free mass, impedance (BIA) Waist-circumference Blood pressure Adverse Drug Reactions and Severe Adverse Drug Reactions Triceps skinfold thickness Upper arm circumference IGF-I (Insulin-like growth factor 1)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Mainz 55127, Germany
Additional Information
Clinical Trials at Novo Nordisk
Starting date: July 2009
Last updated: April 28, 2015
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