NCT07112755

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2022

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 8, 2025

Completed
Last Updated

August 13, 2025

Status Verified

August 1, 2025

Enrollment Period

5 months

First QC Date

August 2, 2025

Last Update Submit

August 8, 2025

Conditions

Keywords

psoriasisosteopenia

Outcome Measures

Primary Outcomes (1)

  • Occurrence of Osteopenia in Patients With Psoriasis

    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.

    At the time of DEXA assessment during enrollment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients diagnosed with plaque psoriasis who attended the Department of Dermatology at the First Medical Center of the PLA General Hospital. Eligible participants were aged 18 years or older and underwent bone mineral density assessment by DEXA. Patients with significant comorbidities affecting bone metabolism were excluded.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hosptial

Beijing, Beijing Municipality, 100853, China

Location

Related Publications (6)

  • Sirufo MM, De Pietro F, Bassino EM, Ginaldi L, De Martinis M. Osteoporosis in Skin Diseases. Int J Mol Sci. 2020 Jul 3;21(13):4749. doi: 10.3390/ijms21134749.

    PMID: 32635380BACKGROUND
  • Ogdie A, Harter L, Shin D, Baker J, Takeshita J, Choi HK, Love TJ, Gelfand JM. The risk of fracture among patients with psoriatic arthritis and psoriasis: a population-based study. Ann Rheum Dis. 2017 May;76(5):882-885. doi: 10.1136/annrheumdis-2016-210441. Epub 2017 Jan 16.

    PMID: 28093419BACKGROUND
  • Sepehri NZ, Raeisi T, Razi B, Janmohammadi P, Darand M, Alizadeh S. The association between psoriasis and psoriatic arthritis with the risk of osteoporosis, osteopenia and bone fractures: A systematic review and meta-analysis. Int J Clin Pract. 2021 Nov;75(11):e14630. doi: 10.1111/ijcp.14630. Epub 2021 Jul 22.

    PMID: 34260133BACKGROUND
  • D'Epiro S, Marocco C, Salvi M, Mattozzi C, Luci C, Macaluso L, Giancristoforo S, Campoli M, Scarno M, Migliaccio S, Calvieri S, Richetta A. Psoriasis and bone mineral density: implications for long-term patients. J Dermatol. 2014 Sep;41(9):783-7. doi: 10.1111/1346-8138.12546. Epub 2014 Jul 3.

    PMID: 24990650BACKGROUND
  • Ojeda JL, Ros MA, Garcia-Porrero JA. [Role of the basement membrane in the pathogenesis of polycystic kidney: a new pathogenetic hypothesis based on an experimental model]. Minerva Urol Nefrol. 1987 Jul-Sep;39(3):275-82. No abstract available. Italian.

    PMID: 3326187BACKGROUND
  • Ding X, Wang T, Shen Y, Wang X, Zhou C, Tian S, Liu Y, Peng G, Zhou J, Xue S, Wang R, Tang Y, Meng X, Pei G, Bai Y, Liu Q, Li H, Zhang J. Prevalence of psoriasis in China: a population-based study in six cities. Eur J Dermatol. 2012 Sep-Oct;22(5):663-7. doi: 10.1684/ejd.2012.1802.

    PMID: 22910173BACKGROUND

MeSH Terms

Conditions

PsoriasisBone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

August 2, 2025

First Posted

August 8, 2025

Study Start

August 1, 2022

Primary Completion

December 23, 2022

Study Completion

December 23, 2022

Last Updated

August 13, 2025

Record last verified: 2025-08

Locations