Prevalence and Impact on Quality of Life of Osteoporosis and Fragility Fractures Among SLE Patients. (FRAIL Trial)
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
- 1
- 主要终点
- influence of SLE medication - immunosuppressant
研究概览
简要总结
The trial is designed to evaluate prevalence of fragility fracture, their impact on quality of life of SLE patients and disease or treatment variables such as steroids dosage or use of specific drugs like hydroxychloroquine, DMARDs or belimumab. Patients will perform DXA evaluation, blood tests and PROs questionnaires. Moreover, the investigators want to correlate those variables to bone turnover markers and bone metabolism modulators. A secondary aim is also to assess the fracture risk of those patients as described by FRAX and DEFRA tools.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •SLE fulfilling 2019 ACR/EULAR or 2012 SLICC criteria
- •willing to perform DXA/ x-Ray investigation (common clinical practice)
- •willing to donate blood sample
- •willing to complete questionnaires
- •the patients should be in a stable disease activity.
排除标准
- •Uncontrolled endocrinological disease.
- •metabolic bone disease other than osteoporosis ( e.g. Paget disease).
- •celiac disease, inflammatory bowel disease or pancreatic exocrine deficiency resulting in malabsorption
- •patients lacking medication history information (SLE and bone related medications).
- •Have any other clinically significant abnormal laboratory value in the opinion of the investigator
- •Have any intercurrent significant medical illness that the investigator considers would make the candidate unsuitable for the study.
- •The patients shouldn't be enrolled during a moderate to severe flare of disease requiring an escalation of therapy ( especially glucocorticoid) - no new BILAG A or B in the last 3 months.
- •Pregnant patients or during the first year after child birth.
结局指标
主要结局
influence of SLE medication - immunosuppressant
时间窗: 1 visit - 1 hour
The population will be analyzed grouping by presence or absence of fragility fracture in relation to medications variables such as difference in percentage percentage of immunosuppressant users
influence of SLE medication - biologics
时间窗: 1 visit - 1 hour
The population will be analyzed grouping by presence or absence of fragility fracture in relation to medications variables such as difference in percentage of percentage of biologics ( e.g. belimumab) users.
Prevalence of osteoporosis
时间窗: 1 visit - 1 hour
percentage of patient with osteoporosis defined by WHO definition with T score
FACIT-F
时间窗: 1 visit - 1 hour
scores in fatigue as for questionnaire FACIT-F (Functional Assessment of Chronic Illness Therapy - Fatigue; min 0 - max 52, higher score less fatigue)
CQR5
时间窗: 1 visit - 1 hour
compliance questionnaire in rheumatology 5 items; adherent - not adherent to medication)
PGA
时间窗: 1 visit - 1 hour
Patient global assessment ( VAS scale 0-10) higher score worse health
EQ5D
时间窗: 1 visit - 1 hour
scores at questionnaire on quality of life EQ5D = EuroQol 5 dimension 5 L; (min 1-1-1-1-1, max 5-5-5-5-5 higher score worse + EQ VAS min 0, max 100 higher score better quality of life)
influence of SLE medication - glucocorticoid
时间窗: 1 visit - 1 hour
The population will be analyzed grouping by presence or absence of fragility fracture in relation to medications variables such as difference in cumulative corticosteroid dose (mg)
Prevalence of fragility fractures
时间窗: 1 visit 1 hour
percentage of patients with fragility fractures
SF-36 v2
时间窗: 1 visit - 1 hour
scores on quality of life with SF36 v2 (Short Form 36 version 2 Health Survey; min 0 - max 100, higher score better health)
HADS
时间窗: 1 visit - 1 hour
scores on mood disorder scale HADS (Health Anxiety and Depression Scale; min 0 - Max 42, higher score worse anxiety)
influence of SLE medication - hydroxychloroquine
时间窗: 1 visit - 1 hour
The population will be analyzed grouping by presence or absence of fragility fracture in relation to medications variables such as difference in percentage of hydroxychloroquine users.
次要结局
- serum bone biomarkers - BAP(1 visit - 1 hour)
- serum bone biomarkers - CTX(1 visit - 1 hour)
- serum bone biomarkers - RANKL(1 visit - 1 hour)
- serum bone biomarkers - OPG(1 visit - 1 hour)
- Descriptive statistics of study population - 1(1 visit - 1 hour)
- Descriptive statistics of study population - 2(1 visit - 1 hour)
- serum bone biomarkers - P1NP(1 visit - 1 hour)
- serum bone biomarkers - Dkk1(1 visit - 1 hour)
- Fracture risk calculation by DEFRA tool(1 visit - 1 hour)
- serum bone biomarkers - Sclerostin(1 visit - 1 hour)
- Fracture risk calculation by FRAX tool(1 visit - 1 hour)
- Descriptive statistics of study population - 3(1 visit - 1 hour)
- Descriptive statistics of study population - 4(1 visit - 1 hour)
- serum bone biomarkers - PTH(1 visit - 1 hour)
- serum bone biomarkers - vitamin D(OH)(1 visit - 1 hour)