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This trial is conducted in Europe. The aim of this trial is to assess the effect of somatropin (Norditropin®) replacement therapy on the left ventricular mass of adult patients with a growth hormone deficiency.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Somatropin | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| somatropin | Drug | Initial dosage 0.5 IU/day, injected subcutaneously (s.c., under the skin) once daily. Dosage will be adjusted monthly depending on clinical safety up to a maximum dose of 3 IU/day. Subjects are treated for six months (randomised trial period) followed by an 12-month open-label trial period with somatropin. |
| Measure | Description | Time Frame |
|---|---|---|
| Left ventricular mass measured with ultrasonography |
| Measure | Description | Time Frame |
|---|---|---|
| Ventricular function indices assessed by cardiac ultrasonography | ||
| Bone mineral density and body composition assessed by DEXA (Dual Energy X-Ray Absorptiometry) | ||
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Inclusion Criteria:
Exclusion Criteria:
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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 |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Angers | 49033 | France | |||
| Novo Nordisk Investigational Site |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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|
| placebo | Drug | Initial dosage 0.5 IU/day, injected subcutaneously (s.c., under the skin) once daily. Dosage will be adjusted monthly depending on clinical safety up to a maximum dose of 3 IU/day. Subjects are treated for six months. After treatment in the randomised trial period, placebo will be discontinued. |
|
| Quality of life using EQ5D (European Quality of Life 5 Dimensions) scales |
| IGF-I (Insulin-Like Growth Factor I) concentration |
| Boisguillaume |
| 76233 |
| France |
| Novo Nordisk Investigational Site | Brest | 29609 | France |
| Novo Nordisk Investigational Site | Caen | 14033 | France |
| Novo Nordisk Investigational Site | Grenoble | 38043 | France |
| Novo Nordisk Investigational Site | Le Kremlin-Bicêtre | 94275 | France |
| Novo Nordisk Investigational Site | Lille | 59037 | France |
| Novo Nordisk Investigational Site | Lorient | 56322 | France |
| Novo Nordisk Investigational Site | Lyon | 69394 | France |
| Novo Nordisk Investigational Site | Lyon | 69437 | France |
| Novo Nordisk Investigational Site | Marseille Cédex 05 | 13385 | France |
| Novo Nordisk Investigational Site | Montpellier | 34295 | France |
| Novo Nordisk Investigational Site | Nantes | 44000 | France |
| Novo Nordisk Investigational Site | Nantes | 44093 | France |
| Novo Nordisk Investigational Site | Nice | 06002 | France |
| Novo Nordisk Investigational Site | Paris | 75010 | France |
| Novo Nordisk Investigational Site | Paris | 75015 | France |
| Novo Nordisk Investigational Site | Paris | 75571 | France |
| Novo Nordisk Investigational Site | Reims | 51092 | France |
| Novo Nordisk Investigational Site | Rennes | 35056 | France |
| Novo Nordisk Investigational Site | Strasbourg | 67098 | France |
| Novo Nordisk Investigational Site | Toulouse | 31054 | France |
| Novo Nordisk Investigational Site | Tours | 37044 | France |
| Novo Nordisk Investigational Site | Vandœuvre-lès-Nancy | 54511 | France |
| ID | Term |
|---|---|
| D004393 | Dwarfism, Pituitary |
| ID | Term |
|---|---|
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| 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 |
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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 |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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