Påskyndar PTH läkningen av Konservativt Behandlade Humerusfrakturer?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Callus formation and fracture healing at 7 weeks judged by a blinded assessor who will guess the treatment
研究概览
简要总结
40 postmenopausal women, with a non-operated proximal humeral fracture, will be randomized to standard treatment (physiotherapy) or standard treatment + Forsteo (rhPTH 1-34) during 4 weeks. Follow-up will be at 7 weeks and 3 months including x-ray and DASH score (The Disabilities of the Arm, Shoulder and Hand) measuring physical function, and pain on a visual analoge scale (VAS).
Two doctors, blinded to the treatment, will judge the callus formation and healing on the x-rays and guess the treatment. The DASH score and the pain score will be compared between the treatment groups.
The investigators hypotheses are that callus formation and healing will be more pronounced and that patients have less pain and better function in the rhPTH 1-34 group.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •proximal humeral fracture
- •postmenopausal woman 50 years or older
- •non-surgical treatment
排除标准
- •dementia or psychiatric disorder
- •known malignancy < 5 years prior to fracture
- •calcium above reference value
- •signs of liver disease
- •creatinine over ref. value
- •inflammatory joint disease
- •alcohol or drug abuse
- •oral corticosteroid medication
- •long-term NSAID-treatment (=> 3 months prior to fracture)
研究组 & 干预措施
Proximal humeral fracture - intervention
20 patients will be randomized to 20 micrograms daily of Teriparatide (Forsteo)
干预措施: Teriparatide (Drug)
结局指标
主要结局
Callus formation and fracture healing at 7 weeks judged by a blinded assessor who will guess the treatment
时间窗: 7 weeks
次要结局
- Function(7 weeks and 3 months)
- Pain(7 weeks and 3 months)
研究者
Torsten Johansson
MD, PhD
University Hospital, Linkoeping