Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-26 @ 9:30 PM
Study NCT ID:
NCT07140666
Status:
COMPLETED
Last Update Posted:
2025-09-02
First Post:
2025-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of Influence Factors on Osteopenia in Different Treatment of Psoriasis
Sponsor:
Chongli Yu
Organization:
Study Overview
Official Title:
Analysis of Influence Factors on Osteopenia in Different Treatment of Psoriasis
Status:
COMPLETED
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
Temporal trends in bone metabolism biomarkers.
Comparison between treatment groups after adjusting for potential confounders (e.g., age, sex, BMI, PASI score, disease duration, inflammatory markers).
Statistical methods such as linear mixed models (LMM), marginal means estimation, and subgroup analysis will be used to evaluate treatment effects. Additional sensitivity analyses including propensity score matching (PSM) and multiple imputation for missing data will be performed to enhance the robustness of findings.
This study is expected to provide clinical evidence on how different biological treatments may influence bone health in psoriatic patients, thus guiding personalized and preventive care strategies for comorbid osteoporosis.
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.
Temporal trends in bone metabolism biomarkers.
Comparison between treatment groups after adjusting for potential confounders (e.g., age, sex, BMI, PASI score, disease duration, inflammatory markers).
Statistical methods such as linear mixed models (LMM), marginal means estimation, and subgroup analysis will be used to evaluate treatment effects. Additional sensitivity analyses including propensity score matching (PSM) and multiple imputation for missing data will be performed to enhance the robustness of findings.
This study is expected to provide clinical evidence on how different biological treatments may influence bone health in psoriatic patients, thus guiding personalized and preventive care strategies for comorbid osteoporosis.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: