NCT01687374Unknown4 期
Phase IV Study of the Effect of Parathyroid Hormone on Fractures of the Humerus
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Changes in constant score
研究概览
简要总结
Hypothesis:
The investigators want to study whether parathyroid hormone improves healing of humerus after a fracture. The investigators will assess healing of the humerus with Constant score.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •proximal humeral fracture eligible for conservative treatment.
- •able to understand the protocol
- •signs an informed consent
排除标准
- •liver disease
- •kidney disease
- •severe osteoporosis
- •malignant disease
- •bone metabolic disease
- •oral treatment with bisphosphonates during the last 3 months.
- •treatment with Denosumab during the last 6 months.
- •intravenous treatment with bisphosphonates during the last 12 months.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Parathyroid hormone
Experimental
干预措施: 1-84 parathyroid hormone (Drug)
结局指标
主要结局
Changes in constant score
时间窗: 5, 8, 11, 23, and 104 weeks.
Constant score summarizes the function of the arm using a questionnaire (activities of daily living - ADL) and functional testing of the arm.
次要结局
- Changes in Oxford Shoulder Score(5, 8, 11, 23, and 104 weeks.)
- Changes in bone formation evaluated by X-ray.(5, 8, 11, 23, and 104 weeks.)
- Changes in biochemical bone markers(0, 5, 25 weeks)
- Changes in regulatory T lymphocytes(0, 8, 24 weeks)
研究者
Ulrich Bang
Principal investigator
Hvidovre University Hospital
研究点 (1)
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