NCT00838838已完成不适用
Nebido® Therapy in Hypogonadal Male Patients With Osteoporosis Associated With Paraplegia Compared With Conventional Osteoporosis - Prophylaxis / Therapy in Hypogonadal and Eugonadal Patients With Osteoporosis Associated With Paraplegia
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 26
- 主要终点
- Bone mineral density (CT lumbar spine)
研究概览
简要总结
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients > 18yrs
- •Osteoporosis prophylaxis/therapy with
- •vitamin D 800 - 1200 mg per day,
- •calcium 800 - 1000 mg per day,
- •Fosamax 70 once a week.
- •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:
- •No contraindications to use of Nebido (known prostate or breast carcinoma or suspicion thereof, no past or present history of liver tumours);
- •No known hypersensitivity to testosterone or excipients of Nebido
排除标准
- •Androgen dependent carcinoma of the prostate or male mammary gland, past or present history of liver tumours, hypersensitivity towards the active pharmaceutical ingredient or other ingredients.
研究组 & 干预措施
Group 1
干预措施: Testosterone Undeconate (Nebido-R, BAY86-5037) (Drug)
结局指标
主要结局
Bone mineral density (CT lumbar spine)
时间窗: 12 weeks after 4th injection
次要结局
未报告次要终点
研究者
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