Use of the DeFRA Questionnaire as a "Primary Anamnestic Form" Through a Large Scale Screening of the Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 767
- 试验地点
- 1
- 主要终点
- percent risk of a fracture
研究概览
简要总结
The DeFRA questionnaire is a new validated algorithm derived from FRAX. Here we use the DeFRA as a "primary anamnestic from" to identify subjects at risk of osteoporosis in a population never screened before and never treated for this disease.
详细描述
There is an increasing recognition that the management of osteoporosis requires the characterization of fracture risk to be based on absolute risk rather than single measures such as bone mineral density (BMD). However, the threshold for pharmacological intervention for osteoporosis remains controversial.
The aim of the present project is to perform a large scale study to identify subjects at risk of osteoporosis by administering the DeFRA questionnaire in a population never screened or treated before for osteoporosis.
DeFRA questionnaire will be administered before and after DEXA scanning, to further validate the questionnaire and to highlight the predictive value of this protocol as a tool to screen the general population.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •age: 50 to 70 years
- •no overt pathologies
- •never screened before for osteoporosis
- •no prior use of drugs for osteoporosis
- •signed informed consent form
排除标准
- •overt pathologies (cancer, neurodegenerative diseases, renal or hepatic insufficiency)
- •use of the following drugs: cortisones, loop diuretics, antiepileptic drugs, aromatase inhibitors, dicoumarols, thyroxin in suppressive therapy, antiosteoporosis drugs)
- •patients who underwent radiation therapy
- •hypercalcemia or alterations of the phospho-calcic metabolism
- •patients with metabolic diseases of the bone (including hyperparathyroidism or Paget disease)
结局指标
主要结局
percent risk of a fracture
时间窗: day 1
The DeFRA questionnaire is administered within the same day with or without the DeXA measurement, to evaluate statistically significant differences in the percent risk of a fracture
次要结局
未报告次要终点
研究者
Dell'anna Vincenzo
Principal Investigator
Valmontone Hospital