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临床试验/NCT01161680
NCT01161680已完成不适用

A Prospective Baseline Assessment of the Risk of Osteoporosis in Patients With Chronic Obstructive Lung Disease and Outcomes After 2 Years; a Pilot Study

University of British Columbia3 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2010年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
3
主要终点
To determine the prevalence of osteoporosis in the respiratory disease population, as determined by bone density and fragility fracture.

研究概览

简要总结

This project will examine the current diagnosis and treatment of bone health in patients with obstructive airway disease. Patients will be referred to The Osteoporosis Centre of BC (OCBC) by their respirologist to be assessed for osteoporosis including Dual Energy Xray Absorptiometry (DXA) scan. Previous chest xrays and will be accessed and examined for vertebral fractures, diagnostic of osteoporosis. The lung and bone data will be entered into a database. This will allow us to explore the relationship of lung disease parameters to osteoporosis predictors, eventually determining a respirology patient population who are at high risk of fracture. Longitudinal evaluation of bone health and its relationship to respiratory parameters over time will be explored by follow-up evaluations at 12 and 24 months.

详细描述

Research Method:

  1. Selected respirologists' practices will identify patients at risk of osteoporosis (according to Osteoporosis Canada Guidelines):

  2. Who have not had a bone density test in the past 2 years and

  3. Who are not already taking osteoporosis pharmacotherapy.

  4. Other patients not meeting these criteria can also be referred at the discretion of the physician

  5. Patients will be given a choice on whether they wish to be referred to the Osteoporosis Centre of BC (Vancouver) through an expedited simple referral system OR they may have their information sent to their referring/family doctor discussing the need for referral for an evaluation of bone health and follow up

i. Informed consent obtained with an Ethics Committee approved Informed Consent Form. Informed consent will be obtained from all patients who will be followed by the research team. The consent will allow the researchers to use clinical data and imaging for observational research; participation in the research will be optional and will not affect patient ability to obtain information on their bone health at OCBC.

ii. A standard, full evaluation will be undertaken on a single visit (DXA bone densitometry, consultation with endocrinologist or geriatrician). Screening for secondary causes of osteoporosis including Vitamin D status through blood tests will occur at a community laboratory. All information obtained from these tests being reviewed by the physicians and clinical treatment decisions will be made based on standard practice.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • men and women over 65 years of age with obstructive airway disease being seen by a respirologist in their clinical practices

排除标准

  • less than 65 years of age
  • patient has had bone density scan within the last 2 years
  • patient is currently being treated for osteoporosis (alendronate, risedronate, zoledronate, etidronate, clodronate, raloxifene, calcitonin, estrogen)

结局指标

主要结局

To determine the prevalence of osteoporosis in the respiratory disease population, as determined by bone density and fragility fracture.

次要结局

  • To associate osteoporosis with severity of pulmonary disease in respirology disease patients.

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mark Fitzgerald

Principal Investigator

University of British Columbia

研究点 (3)

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