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| ID | Type | Description | Link |
|---|---|---|---|
| NE0501 |
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Both conditions hypogonadism and immobilisation (paraplegia) may contribute or lead to decreased bone mineral density resp osteoporosis. In this study bone mineral density is assessed in hypogonadal paraplegic patients, who are on standard prophylactic therapy for osteoporosis and and on a standard physiotherapy exercise program one group receiving Nebido for testosterone replacement (TRT). The additional effect of TRT on bone mineral density / osteoporosis is assessed (CT scan lumbar spine).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testosterone Undeconate (Nebido-R, BAY86-5037) | Drug | Male patients > 18yrs in medical practices fulfilling all criteria for documentation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bone mineral density (CT lumbar spine) | 12 weeks after 4th injection |
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Inclusion Criteria:
Male patients > 18yrs
Osteoporosis prophylaxis/therapy with
Standardised physiotherapy exercise programme.
No proliferative bone disease.
No history of calcium oxalate stones.
No use of aromatase inhibitors.
No use of 5-alpha reductase inhibitors.
Nebido group:
Exclusion Criteria:
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Male patients > 18yrs in medical practices fulfilling all criteria for documentation.
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Germany |
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| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| D010264 | Paraplegia |
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D043343 | Testosterone Propionate |
| ID | Term |
|---|---|
| D013739 | Testosterone |
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
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| D009422 |
| Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |