NCT04473989Unknown2 期
The Effect of Weekly Injection of Teriparatide on the Healing of Distal Radius Fracture in a Double-blind, Randomized Controlled Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 主要终点
- The median time of radiographic healing
研究概览
简要总结
The purpose of this study is to examine the effect of weekly dosing strategy on fracture healing.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Postmenopausal women aged 45-75 (at least 2 years after menopause)
- •With primary osteoporosis
- •Patients with Colles fractures with a fracture time of no more than 7 days
- •conservative treatment after fracture (closed reduction and immobilization)
- •no multiple fractures
- •Informed well and agree to participate in this clinical trial
排除标准
- •Combine other physical diseases, including diabetes, severe hypertension, autoimmune diseases, heart, liver and kidney diseases, malignant tumors, mental illnesses, and other diseases that doctors believe may affect the healing process.
- •In addition to primary osteoporosis, any disease affecting bone metabolism or treatment response, including serum PTH>65pg/ml, 25-hydroxyvitamin D<20ng/ml, alkaline phosphatase>135U/L, history of bone tumor, Paget disease, history of radiotherapy
- •The fracture site has a history of trauma or surgery, affecting the function of the wrist or forearm
- •Those who are allergic to PTH or any excipients
- •Currently receiving anti-osteoporosis treatment or receiving other anti-osteoporosis treatment during the trial
- •Contraindication of teriparatide including hyperparathyroidism, severe renal insufficiency, hypercalcemia, etc.
研究组 & 干预措施
Placebo
Placebo Comparator
Injection product without active teriparatide
干预措施: Placebo (Drug)
PTH 40ug/w
Experimental
Injection product with active teriparatide
干预措施: recombinant teriparatide for injection (Drug)
结局指标
主要结局
The median time of radiographic healing
时间窗: 0-14 weeks
A score of 13 by Modified Radiographic Union Scale for Tibia fractures (mRUST) scoring system would provide a confident assessment of union
次要结局
- Patient-Rated Wrist Evaluation(0, 4, 6, 8, 10, 12, 14 and 16 weeks)
- Grip strength(6, 8, 10, 12, 14, and 16 weeks)
研究者
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