跳至主要内容
临床试验/NCT02239523
NCT02239523已完成不适用

Management Strategies by an Orthopedic Department to Improve the Evaluation and Treatment of Osteoporosis.

Shaare Zedek Medical Center2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年2月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
2
主要终点
Percentage of patients with osteoporosis that are appropriately treated

研究概览

简要总结

Patients who present with fragility fractures are consistently under-evaluated and under-treated for underlying osteoporosis. This point of care represents a lost opportunity to prevent future fractures. The medical field treats the fracture as if the fall is the problem, but bone quality is the real problem. Studies have consistently shown that the recommendations of the International Osteoporosis Foundation and World Health Organization are not being followed. Orthopedics treats the patients for their fractures and primary care physicians focus on general health but no one is taking responsibility for bone health. Strategies to convince primary care to assume care have not succeeded. On the other hand, strategies where orthopedics takes some responsibility have shown success. This prospective 2-arm study will evaluate the success of effort by an academic orthopedic department in osteoporosis evaluation and treatment. We hypothesize that with greater effort by the orthopedic department, the better the adherence to standards of care. A cost benefit analysis will be made in parallel.

详细描述

Patients who present to the orthopedic department in a level I trauma center will be prospectively randomized into one of two groups:

Letter Group: At time of discharge, patients will be sent home with a discharge letter that includes standard recommendations for evaluation and treatment. They will be asked to give the letter to their primary care physician.

Intervention Group: There will be 4 interventions. The patient will be given a short pamphlet with explaining osteoporosis and the importance of treatment. The orthopedic department will perform a bone density testing (DEXA). They will be given a letter with a specific medication recommendation based on a protocol determined by our endocrinology department. They will be asked to give both DEXA and medication recommendation to their primary care doctor to initiate treatment. Finally, a research assistant will contact the patient monthly to encourage them to start treatment.

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 (Participant)

入排标准

年龄范围
50 Years 至 120 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients over age 50 with fragility fracture defined as a fall from standing or walking position

排除标准

  • Patients with metastatic cancer
  • Known metabolic bone disease
  • End-of-life care
  • Inability to provide consent
  • Known MRSA carriers
  • Fractures of the trochanter alone, shaft or peri-prosthetic fractures

结局指标

主要结局

Percentage of patients with osteoporosis that are appropriately treated

时间窗: Determination of proper treatment will be made at 4 months after the fracture.

Treatment will be determined based on a pre-determined algorithm by our endocrinology department. This will be based on patient factors and results of DEXA is not part of the algorithm. All patients with a fragility fracture of the hip, regardless of DEXA results will be considered for treatment.

次要结局

  • Percentage of patients who undergo DEXA scan.(Evaluation will be made 4 months after the initial fracture event.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验