跳至主要内容
临床试验/NCT05904353
NCT05904353招募中不适用

Collaboration to Improve Bone Health

University Hospital, Akershus2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
2
主要终点
Number of participants offered treatment after one year

研究概览

简要总结

This is a study to improve the collaboration between primary and secondary health care on the treatment of osteoporosis after a hip fracture. In Akershus University Hospital, patients 75 years or older with a hip fracture, are offered treatment with an infusion of zoledronic acid 5mg, combined with vitamin D and calcium supplements, to prevent new fractures. General practitioners (GPs) are requested to take care of the follow-up on this treatment with annual infusions of zoledronic acid for 3 years.

In the opinion of the investigators, it is expedient, safe, and sensible for parts of the subsequent treatment to be provided by GPs. If hospitals take responsibility for initiating the treatment, the investigators believe that most of the subsequent monitoring and continuance of treatment can be conducted by the primary healthcare service. Despite this, the investigators suspect that many patients do not get their annual infusions of zoledronic acid after discharge from the hospital.

This quality assurance study aims to test a new system where ambulant nurses from the hospital support the GP in treating osteoporosis with the administration of zoledronic acid in the following 3 years after femoral neck fractures. Through the project, the investigators will create procedures for the administration and follow-up of zoledronic acid fitted in the setting of the GP office.

The design is a cluster randomized controlled study (RCT) where the regions are prospectively randomized to either intervention or control regions. Patients ≥ 75 years, which suffer a femoral neck fracture, are identified in our Department of Orthopedic Surgery, where they are provided the first infusion of zoledronic acid 5 mg and proposed participation in the study. Patients from the intervention regions will be followed by the protocol of ambulant nurse-assisted administration of zoledronic acid. Patients from the control regions are offered the usual care. Both patients from the control and intervention regions are asked to fill out a questionnaire after 1 year. The questionnaire will ask if the patient has got zoledronic acid as encouraged in the medical journal after discharge from the hospital. The primary study outcome is if the patients are offered treatment at a one-year follow-up or not.

Sample size calculation estimates a total sample of 130 patients based on a minimal clinically important difference of 20% follow-up between the groups. Because of high mortality, the investigators estimate the need for 200 patients.

The investigators hypothesize that the one-year follow-up is better in the intervention group than in the control group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Care Provider, Investigator)

入排标准

年龄范围
75 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients 75 years or older with a hip fracture

排除标准

  • Refuse treatment
  • Another treatment of osteoporosis is indicated
  • Guest patient, do not live in the admission area

结局指标

主要结局

Number of participants offered treatment after one year

时间窗: One year

The primary study outcome is the number of participants offered treatment with zoledronic acid after one-year.

次要结局

未报告次要终点

研究者

发起方
University Hospital, Akershus
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jakob Vangen Nordbø

Principal Investigator

University Hospital, Akershus

研究点 (2)

Loading locations...

相似试验