Analysis of Influence Factors on Osteopenia in Different Treatment of Psoriasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in Bone Mineral Density
研究概览
简要总结
This clinical study aims to evaluate and compare changes in bone mineral density (BMD) and bone metabolism markers in patients with moderate-to-severe psoriasis treated with either Secukinumab or Adalimumab. Psoriasis is a chronic inflammatory disease that may increase the risk of osteoporosis. While biological therapies have shown efficacy in controlling skin lesions, their long-term effects on bone health remain unclear. By assessing lumbar spine and hip BMD and relevant biomarkers over time, this study seeks to clarify the bone-protective or bone-affecting effects of these two commonly used biologic agents. The results may help optimize treatment strategies for psoriatic patients at risk of osteopenia or osteoporosis.
详细描述
Psoriasis is a chronic, immune-mediated inflammatory skin disease associated with increased systemic inflammation, which may contribute to altered bone metabolism and decreased bone mineral density (BMD). Several studies have reported an elevated risk of osteopenia and osteoporosis in patients with moderate-to-severe psoriasis. The pathophysiological mechanisms may involve pro-inflammatory cytokines, such as TNF-α and IL-17, which influence both skin inflammation and bone remodeling.
Biologic therapies targeting these cytokines have demonstrated significant efficacy in managing psoriasis. However, their long-term impact on bone metabolism and density is still under investigation. Secukinumab, an IL-17A inhibitor, and Adalimumab, a TNF-α inhibitor, are both widely used in clinical practice, but their comparative effects on bone health are unclear.
This prospective, observational, real-world study aims to evaluate the longitudinal changes in BMD (lumbar spine and hip) and bone turnover markers (such as osteocalcin, P1NP, CTX, and iPTH) in psoriasis patients undergoing treatment with Secukinumab or Adalimumab over a follow-up period of XX months. Participants will undergo baseline and follow-up assessments, including dual-energy X-ray absorptiometry (DEXA) and laboratory testing for bone biomarkers.
Key endpoints include:
Changes in BMD at lumbar spine and hip from baseline.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in Bone Mineral Density
时间窗: Baseline, 6 months, and 12 months
Bone mineral density will be assessed using dual-energy X-ray absorptiometry (DXA) at the lumbar spine and hip. The primary outcome is the change in BMD compared with baseline, used to evaluate the presence and progression of osteopenia among patients with psoriasis receiving different treatments.
次要结局
未报告次要终点
研究者
Chongli Yu
PhD Candidate
Chinese PLA General Hospital