Pilot Study on the Epidemiology, Identification Rate and Treatment Penetration of Vertebral Fractures Due to Osteoporosis in Switzerland (SwOF)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 303
- 试验地点
- 3
- 主要终点
- Prevalence of vertebral fractures in community dwelling Swiss women aged 65-79 years
研究概览
简要总结
In Switzerland, the prevalence of vertebral fractures in community- dwelling women is unknown and the published data from the Swiss hospitals statistics represent only the tip of the iceberg. In addition, the percentages of women correctly identified with vertebral fractures due to osteoporosis and the treatment rate of these women with a drug proven to reduce the risk of further fractures are unknown. Furthermore, it is not known whether the prevalence of vertebral fractures differs between urban and rural areas or between mountain areas and plain country, e.g. due to possible differences in sun exposure (vitamin D production) and/ or in physical activity and/ or dietary habits.
Clinical signs and symptoms leading to the suspicion of vertebral fracture(s) lack either sensitivity (wall-occiput distance) or specificity (rib-pelvis distance). Whether a combination of both would improve sensitivity and specificity is unknown.
The gold standard for the diagnosis of vertebral fracture relies on antero-posterior and lateral X-Rays of the thoracic and lumbar spine. Despite standardization of X-Ray readings, a retrospective study of hospitalized elderly patients has shown that as many as 50% of the radiographic reports failed to note the presence of moderate to severe vertebral fractures. In a primary care setting, fewer than 2% of the women received diagnoses of osteoporosis or vertebral fracture, although expected prevalence is 20% to 30% and appropriate drug treatment was offered to only 36% of the diagnosed patients.
The recent availability of software for vertebral fracture assessment (VFA) coupled to DXA measurements allows for the detection of vertebral deformities, which is critical for management of osteoporosis, as the existence of such deformities substantially increases the risk of subsequent fracture. Recently published results show that VFA allows the diagnosis of a vertebral fracture. The sensitivity of VFA for detection of vertebral fractures compared to expert radiologist reading of X-ray is excellent for grade 2 and 3 fractures, ranging between 90-94%.
详细描述
Examinations
- Community-dwelling women from a random sample (address lists may be chosen from public and/ or private providers)
- Aged 65-79 yrs
- Written informed consent
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 79 Years（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Community-dwelling women from a random sample (address lists may be chosen from public and/ or private providers)
- •Aged 65-79 yrs
- •Written informed consent
排除标准
- •Patients who underwent spine surgery
- •Not willing or not able to sign informed consent
- •In patients not willing or not able to participate, the reason for denial will be recorded for future evaluation.
结局指标
主要结局
Prevalence of vertebral fractures in community dwelling Swiss women aged 65-79 years
时间窗: at the only study visit
次要结局
- Assessment of the differences between these women and those who are either not correctly diagnosed or not correctly treated(at the only study visit)
- Specificity, sensitivity, positive predictive value and negative predictive value for the prediction of underlying vertebral fracture of selected risk factors, clinical signs and vitamin D level, alone or in combination(at the only study visit)
- Assessment of the percentage of women correctly identified with a vertebral fracture and adequately treated for underlying osteoporosis and(at the only study visit)
研究者
Prof. Dr. med. Kurt Lippuner
President
Interessengemeinschaft Osteoporose