NCT00741182撤回2 期
Effect of PTH(1-34) Treatment on Fracture Healing in Vivo
Glostrup University Hospital, Copenhagen1 个研究点 分布在 1 个国家开始时间: 2008年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Radiological evaluation of healing
研究概览
简要总结
The purpose of the study is to investigate, whether PTH(1-34) is able to promote fracture healing in postmenopausal women with fractures of the hip or shoulder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Acute new osteoporotic trochanteric or collum chirurgicum fracture
- •Postmenopause
排除标准
- •Calcium metabolic disease other than osteoporosis
- •Diseases known to affect calcium homeostasis
- •Hypersensitivity to drug or other components of medication
- •pre-existing hypercalcemia
- •Decreased kidney function
- •Increased alkaline phosphatase
- •Prior external radiation therapy or brachytherapy of the skeleton
- •Skeletal malignancies or bone metastases
- •Alcohol and/or drug abuse
- •Systemic treatment with corticosteroids within the last four weeks
- •Non-cooperating patients
- •Patients who do not speak and understand the danish language
研究组 & 干预措施
Femur PTH(1-34)
Experimental
24 participants with trochanteric fractures will be assigned to Forsteo (PTH(1-34)) treatment
干预措施: rhPTH(1-34) (Drug)
Humerus PTH(1-34)
Experimental
24 participants with collum chirurgicum fracture will be assigned to Forsteo (PTH(1-34)) treatment
干预措施: rhPTH(1-34) (Drug)
结局指标
主要结局
Radiological evaluation of healing
时间窗: 0, 4, 8, 12, (16) weeks after fracture
次要结局
- Biochemical bone markers(0, 1, 2, 3, 4, 8, 12, (16) weeks after fracture)
- SF-36 questionnaire(0, 4, 8, 12, (16) weeks after fracture)
研究者
研究点 (1)
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