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临床试验/NCT00679978
NCT00679978已完成不适用

Vertebral Fracture and Osteonecrosis of the Femoral Head Associated With High-dose Glucocorticoid Therapy

Saitama Medical University0 个研究点目标入组 60 人开始时间: 2001年1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
60
主要终点
new vertebral fracture

研究概览

简要总结

Osteoporotic vertebral fracture (VF) and osteonecrosis of the femoral head (OFH) are major concerns in patients with systemic rheumatic diseases treated with high-dose glucocorticoids (GCs). The investigators examined and compared the incidence and risk factors of VF with those of OFH in patients who had recently received high-dose GC therapy to clarify the relationship between these two complications.

详细描述

Patients with rheumatic diseases receiving GCs (≧0.5 mg/kg/day for prednisolone equivalent) within the past 2 months were enrolled in this study, and treated with 200 mg/day of etidronate cyclically. The bone mineral density (BMD) of lumbar spines (L2-4) was examined by QDR2000. OFH was evaluated by magnetic resonance imaging (MRI). ClinicalTrials.gov identifier: NCT00679978.

Forty-four patients completed the 2-year study including annual X-rays and the BMD analysis. MRI evaluation at entry and 2 years was performed in 41 patients. The BMD values with anteroposterior (AP) and lateral views decreased by 6.4% and 9.7% respectively in the first year, but were stable in the second year. Eleven patients developed VF and 9 patients developed OFH. The risk factors for VF included previous VF and a low BMD value (T score < -1.5) of AP view at baseline with odds ratio (OR) 14.9 (95%CI 2.9-76.4), while the risk factor for OFH was the recent maximum GC dosage (>1.2 mg/kg/day versus ≦; OR=7.7, 95%CI 1.3-45.5) and the decrease in BMD value of lateral view (>15% versus ≤; OR=6.7, 95% CI 1.2-36.1) in the first year.

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
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients admitted to our hospital for the treatment of active systemic rheumatic diseases taking at least 0.5 mg/kg/day for PSL equivalent between January 2001 and June 2003 were eligible for this prospective study

排除标准

  • Patients who were not appropriate for this study

结局指标

主要结局

new vertebral fracture

时间窗: 2 years

次要结局

  • osteonecrosis of the femoral head(2 years)

研究者

申办方类型
Other

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