Secondary Fracture Prevention in Patients Hospitalized for Hip Fracture: Adding the Metabolic Treatment to the Surgical One.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Reduce number of incidents of secondary hip fracture.
研究概览
简要总结
Due to its prevalence worldwide, osteoporosis is considered a serious public health concern. The worldwide annual incidence of Osteoporotic fractures is approximately 2 million in the US only.
Hip fracture is associated with serious disability and excess mortality. Studies have shown that an initial osteoporotic fracture is a major risk factor for a new fracture. An increased risk of 14.8% for a secondary hip fracture has been demonstrated in people that have already sustained a fracture in the past 4 years (In average). These data indicate the major opportunity afforded by secondary fracture prevention strategies.
By responding to the first fracture, we can reduce the incidence of second and subsequent fractures. However, even after longer medical follow-up according to regular standard of care, medical treatment and rehabilitation, the medical system has been unable to translate the eminent risk into an effective preventive treatment.
详细描述
Study Objectives:
- To create a treatment, follow up and rehabilitation protocol for patients who suffered from a hip fracture, in order to prevent a secondary fracture.
- To demonstrate that a combined treatment from the Hip Fractures Clinic as well as the regular standard treatment and rehabilitation suggested by the Bone Health Clinic (both in addition to standard medication prescribed for osteoporosis) will result in a significant reduction of second and subsequent fractures.
Study Protocol:
- The study protocol will begin after the patients, who have been admitted with a primary hip fracture (of osteoporotic nature), were surgically treated (as customary standard of care).
- According to hospitalization standard protocol, the patients will be treated with vitamin D and calcium. For the first month the patient will be given a loading dose of 70,000 units. For the next months the patients will receive 50,000-80,000 units per month.
In addition, the patient will be treated with Calcium Pills (Caltrate TAB 600mg, once a day) 3. In addition to the clinical customary monitoring tests performed during the hospitalization, Biomarkers and safety assessment will be taken:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults over 18 years old
- •Patients diagnosed with low energy osteoporotic hip fracture, and was treated under surgery.
排除标准
- •Patients not diagnosed with osteoporosis.
- •Patients diagnosed with high energy osteoporotic hip fracture.
- •Patients that suffered from Multiple Trauma.
- •Patients diagnosed with Metabolic diseases or Genetic diseases.
- •Pregnant women
结局指标
主要结局
Reduce number of incidents of secondary hip fracture.
时间窗: 1 year and 6 months
次要结局
未报告次要终点
研究者
pninarotman
Depart. of Medicine 'E' Deputy Head
Meir Medical Center