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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A |
| ||
| B |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| somatropin | Drug | For s.c. (under the skin) injection. Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Health related quality of life (SF-36; EQ-5D) | at 0, 3, 6, 12, 18 and 24 months after treatment initiation | |
| Disease related absences from work | at 0, 3, 6, 12, 18 and 24 months after treatment initiation |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with acquired growth hormone deficiency who have been deemed appropriate to receive Norditropin® as treatment and as part of routine out-patient care by the prescribing physician.
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mainz | 55127 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29433573 | Derived | Kann PH, Bergmann S, Bidlingmaier M, Dimopoulou C, Pedersen BT, Stalla GK, Weber MM, Meckes-Ferber S. Design of the Growth hormone deficiency and Efficacy of Treatment (GET) score and non-interventional proof of concept study. BMC Endocr Disord. 2018 Feb 13;18(1):10. doi: 10.1186/s12902-018-0237-3. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| ID | Term |
|---|---|
| D004393 | Dwarfism, Pituitary |
| ID | Term |
|---|---|
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D019382 | Human Growth Hormone |
| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
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| No treatment given | Other | Control group not receiving treatment |
|
| Bone mineral density DXA Z-score lumbar | at 0, 3, 6, 12, 18 and 24 months after treatment initiation |
| Total cholesterol, HDL, LDL | at 0, 3, 6, 12, 18 and 24 months after treatment initiation |
| Body composition: fat mass, fat-free mass, impedance (BIA) | at 0, 3, 6, 12, 18 and 24 months after treatment initiation |
| Waist-circumference | at 0, 3, 6, 12, 18 and 24 months after treatment initiation |
| Blood pressure | at 0, 3, 6, 12, 18 and 24 months after treatment initiation |
| Adverse Drug Reactions and Severe Adverse Drug Reactions | at 0, 3, 6, 12, 18 and 24 months after treatment initiation |
| Triceps skinfold thickness | at 0, 3, 6, 12, 18 and 24 months after treatment initiation |
| Upper arm circumference | at 0, 3, 6, 12, 18 and 24 months after treatment initiation |
| IGF-I (Insulin-like growth factor 1) | at 0, 3, 6, 12, 18 and 24 months after treatment initiation |
| D001849 |
| Bone Diseases, Endocrine |
| D007018 | Hypopituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |