PRediction Of DIverse Glucocorticoids toxIcity OUtcomeS
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 23
- 主要终点
- Clinically relevant complication of glucocorticoid therapy
研究概览
简要总结
To date, there is no available tool that allows, at individual level, determination of the probability to develop clinically relevant complications of prolonged glucocorticoid therapy. In patients with inflammatory rheumatic disorders requiring prolonged glucocorticoid therapy, such tool could be useful to adapt first-line treatment decisions (in daily practice and in future clinical trials). The main objective of the study is to identify routine clinical, biological and DXA baseline characteristics predictive of the occurrence of clinically relevant complications of glucocorticoid therapy at 1 year, in order to propose a predictive score.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Life expectancy > 1 year.
- •Indication to initiate prolonged glucocorticoid therapy at a dosage ≥ 15 mg/day for the treatment of an inflammatory rheumatic disease.
- •Initial treatment or relapse.
- •Previsional treatment duration > 3 months.
排除标准
- •Unable to consent.
- •Previous corticosteroid therapy in the last 3 months at a significant dosage (> 5 mg per day).
结局指标
主要结局
Clinically relevant complication of glucocorticoid therapy
时间窗: 1 year
The occurrence of one or more clinically relevant complication of glucocorticoid therapy during the first year of treatment, according to the Glucocorticoid Toxicity Index (items and specific list).
次要结局
- Quality of life assessed through SF-36(1 year)