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Clinical Trials/NCT07112755
NCT07112755CompletedNot Applicable

Development of a Risk Prediction Model for Osteopenia in Patients With Psoriasis: A Cross-Sectional Study

Chongli Yu1 site in 1 country200 target enrollmentStarted: August 1, 2022Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
200
Locations
1
Primary Endpoint
Occurrence of Osteopenia in Patients With Psoriasis

Study Overview

Brief Summary

This study aims to develop a clinical prediction model for osteopenia in patients with psoriasis. By retrospectively analyzing demographic, laboratory, and lifestyle variables, the investigators will identify risk factors associated with decreased bone mineral density (BMD) in this population. The study will facilitate the identification of high-risk individuals and provide evidence for early screening and intervention strategies.

Detailed Description

Psoriasis is a chronic inflammatory skin disease associated with various systemic comorbidities, including an increased risk of bone loss. Recent studies suggest that patients with psoriasis have a significantly higher incidence of osteopenia and osteoporosis than the general population, potentially due to systemic inflammation and shared risk factors. All enrolled patients will undergo dual-energy X-ray absorptiometry (DEXA) scans to assess bone mineral density (BMD). Based on the results, patients will be categorized into normal BMD and osteopenia groups. Demographic data (age, sex, height, weight, BMI), clinical variables (disease duration, CRP, ESR, blood glucose, blood lipids, blood pressure), and lifestyle factors (smoking, alcohol use) will be collected and analyzed. Univariate and multivariate logistic regression analyses will be performed to identify independent risk factors. A prediction model will be constructed and evaluated using ROC curve analysis to assess sensitivity, specificity, and accuracy. The objective of this study is to develop a validated tool to assist clinicians in identifying patients with psoriasis at high risk for osteopenia, thereby enabling early screening and preventive management to reduce future fracture risk.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Diagnosis of plaque psoriasis according to established diagnostic criteria
  • Age ≥ 18 years
  • Willingness to participate in the study and provide written informed consent

Exclusion Criteria

  • Severe hepatic or renal dysfunction
  • Coexisting immune, endocrine, or malignant diseases that may affect bone metabolism
  • Congenital joint deformities, history of joint trauma, or joint replacement surgery
  • Use of systemic corticosteroids, calcium supplements, or bisphosphonates within the past 3 months
  • Psychiatric or psychological disorders

Outcomes

Primary Outcomes

Occurrence of Osteopenia in Patients With Psoriasis

Time Frame: At the time of DEXA assessment during enrollment

Bone mineral density (BMD) will be assessed using dual-energy X-ray absorptiometry (DEXA) at the lumbar spine and/or femoral neck. Osteopenia is defined as a T-score between -1.0 and -2.5 according to WHO criteria. Patients will be categorized accordingly.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Chongli Yu
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Chongli Yu

PhD Candidate

Chinese PLA General Hospital

Study Sites (1)

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