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This trial is conducted in Africa, Europe and Middle East. This trial investigates the efficacy and safety of three dose levels of Norditropin® (growth hormone) as compared to placebo in the treatment of tibia fractures. The trial will be conducted in two parts: in the first part, the patients will be evaluated with regard to efficacy (fracture healing) and safety at short time intervals until week 24 post-surgery. In the second part, long-term safety and fracture healing up to 12 months post-surgery will be evaluated.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| somatropin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Time from surgery until fracture has healed | During a 12 month period |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator's assessment: fracture healed | ||
| Number of fractures healed |
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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 | Kuopio | 70211 | Finland | |||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17322494 | Result | Raschke M, Rasmussen MH, Govender S, Segal D, Suntum M, Christiansen JS. Effects of growth hormone in patients with tibial fracture: a randomised, double-blind, placebo-controlled clinical trial. Eur J Endocrinol. 2007 Mar;156(3):341-51. doi: 10.1530/EJE-06-0598. | |
| 21963127 | Derived | Krusenstjerna-Hafstrom T, Rasmussen MH, Raschke M, Govender S, Madsen J, Christiansen JS. Biochemical markers of bone turnover in tibia fracture patients randomly assigned to growth hormone (GH) or placebo injections: Implications for detection of GH abuse. Growth Horm IGF Res. 2011 Dec;21(6):331-5. doi: 10.1016/j.ghir.2011.08.003. Epub 2011 Oct 1. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| Oulu |
| 90029 |
| Finland |
| Novo Nordisk Investigational Site | Strasbourg | 67400 | France |
| Novo Nordisk Investigational Site | Augsburg | 86156 | Germany |
| Novo Nordisk Investigational Site | Berlin | 13353 | Germany |
| Novo Nordisk Investigational Site | Braunschweig | 38118 | Germany |
| Novo Nordisk Investigational Site | Hamburg | 20246 | Germany |
| Novo Nordisk Investigational Site | Homburg | 66421 | Germany |
| Novo Nordisk Investigational Site | Ludwigshafen | 67071 | Germany |
| Novo Nordisk Investigational Site | Mainz | 55131 | Germany |
| Novo Nordisk Investigational Site | München | 81366 | Germany |
| Novo Nordisk Investigational Site | Münster | 48149 | Germany |
| Novo Nordisk Investigational Site | Offenbach | 63069 | Germany |
| Novo Nordisk Investigational Site | Würzburg | D-97080 | Germany |
| Novo Nordisk Investigational Site | Budapest | 1076 | Hungary |
| Novo Nordisk Investigational Site | Budapest | H-1043 | Hungary |
| Novo Nordisk Investigational Site | Budapest | H-1081 | Hungary |
| Novo Nordisk Investigational Site | Budapest | H-1125 | Hungary |
| Novo Nordisk Investigational Site | Győr | 9024 | Hungary |
| Novo Nordisk Investigational Site | Miskolc | H-3526 | Hungary |
| Novo Nordisk Investigational Site | Veszprém | H-8200 | Hungary |
| Novo Nordisk Investigational Site | Beersheba | 84101 | Israel |
| Novo Nordisk Investigational Site | Haifa | 31096 | Israel |
| Novo Nordisk Investigational Site | Jerusalem | 91120 | Israel |
| Novo Nordisk Investigational Site | Kfar Save | 44281 | Israel |
| Novo Nordisk Investigational Site | Tel Aviv | 64239 | Israel |
| Novo Nordisk Investigational Site | Lillestrøm | 2004 | Norway |
| Novo Nordisk Investigational Site | Oslo | 0407 | Norway |
| Novo Nordisk Investigational Site | Gorzów | 66-400 | Poland |
| Novo Nordisk Investigational Site | Krakow | 31-826 | Poland |
| Novo Nordisk Investigational Site | Piekary Śląskie | 41-940 | Poland |
| Novo Nordisk Investigational Site | Sosnowiec | 41-200 | Poland |
| Novo Nordisk Investigational Site | Szczecin-Zdunowo | 70-890 | Poland |
| Novo Nordisk Investigational Site | Durban | KwaZulu-Natal | 4001 | South Africa |
| Novo Nordisk Investigational Site | Cape Town | Western Cape | 7505 | South Africa |
| Novo Nordisk Investigational Site | Cape Town | Western Cape | 7925 | South Africa |
| Novo Nordisk Investigational Site | Cape Town | Western Cape | South Africa |
| Novo Nordisk Investigational Site | Worcester | 6850 | South Africa |
| Novo Nordisk Investigational Site | Madrid | 28041 | Spain |
| Novo Nordisk Investigational Site | Valencia | 46026 | Spain |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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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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