Foot Bone Mineral Density and Inflammation in Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 主要终点
- Foot Function Index
研究概览
简要总结
Significant increase in the levels of serum adiponectin, ADA, and hsCRP was reported in all RA patients compared to controls.
Compared to patients with early RA, the increase in these markers significantly correlated with disease activity (DAS-ESR), lower f-BMD, radiographic scoring, pain, FFI, and functional limitations in patients with established RA.
Adiponectin showed a negative correlation with serum levels of both ADA and hsCRP. By using ROC curve analysis, optimal cut-off values of adiponectin (28.8 µg/ml), ADA (27.3 IU/L), and hsCRP (1.6 mg/L) could be used to estimate early RA in 45 % of the patients. Similarly, using cut-off values of adiponectin (32.8 µg/ml), ADA (26.1 IU/L ml), and hsCRP (2.5 mg/L), established RA could be predicted in 55 % of patients with 98-99% accuracy.
详细描述
The present study attempts to evaluate the efficacy of adiponectin, ADA, and foot bone mineral density (fBMD) as predictors of the disease progression in patients with rheumatoid arthritis. A total of 80 RA patients and eighty age and sex-matched healthy controls were included in this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 35 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients who diagnosed with Rheumatoid arthritis according to American Rheumatology Association criteria and radiographic analysis for at least 10 years previously were randomly involved in this study
- •Not receiving any drugs affecting the data obtained
- •had Normal daily diets
排除标准
- •Subjects with obvious ischemic heart disease (angina, myocardial infarction, and lead electrocardiogram abnormalities),
- •HCV, HBV, chronic liver and kidney diseases, hypothyroidism.
- •Drugs (diuretics; oral contraceptives).
结局指标
主要结局
Foot Function Index
时间窗: 3 months
Foot Function Index (FFI) is pre-validated questionnaire designed efficiently to measure the effects of foot pathologies such as Rheumatoid Arthritis (RA) on foot function in terms of pain, disability and activity restriction. The FFI has three subscales of measurements; pain, disability, and activity limitation with a total of 23 questions and total score of 10. For each patients, record the respective measurements of the FFI three subscales according to the score range (0-10), whereas; patients with no pain (0); mild pain (1-3); moderate pain(4-6), and severe or worse pain (7-10).
Estimation of Foot bone mineral density (f-BMD)
时间窗: 3 months
Foot BMD for all RH patients was performed by Dual Energy X-ray Absorptiometry (DEXA) scan method by using a Lunar DPX densitometer originally used to measure bone mass of small animals and modified to suits the measurements of hand BMD. Foot measurements were applied according to previously reported method
次要结局
- Assessment of serum Adiponectin concentration(3 months)
- Assessment of serum Adenosine deaminase (ADA) activity(3 months)
研究者
Sami Gabr
clinical Professor
King Saud University