PsoriasisNCT07112755
Prediction Model for Osteopenia in Patients With Psoriasis
An observational study of Psoriasis, run by Chongli Yu at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 23 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Diagnosis of plaque psoriasis according to established diagnostic criteria
- Age ≥ 18 years
- Willingness to participate in the study and provide written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a Risk Prediction Model for Osteopenia in Patients With Psoriasis: A Cross-Sectional Study
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.
Read the 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.
- Conditions
- Psoriasis
- Keywords
- psoriasis, osteopenia
- Medical subject headings
- Psoriasis, Bone Diseases, Metabolic
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the time of DEXA assessment during enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start1 Aug 2022
- Primary completion23 Dec 2022
- Study completion23 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chongli Yu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chongli Yu, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07112755
- Sponsor's protocol ID
- S2022-196-01-01
- Status last verified
- Aug 2025
- First submitted
- 2 Aug 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32635380Ogdie 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.
PubMed 28093419Sepehri 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.
PubMed 34260133D'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.
PubMed 24990650Ojeda 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.
PubMed 3326187Ding 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.
PubMed 22910173
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Risk Prediction Model for Osteopenia in Patients With Psoriasis: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07112755
- Acronym / sponsor ID
- S2022-196-01-01
- Conditions
- Psoriasis
- Keywords
- psoriasis, osteopenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Chongli YuUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 23 Dec 2022 (actual)
- Study completion
- 23 Dec 2022 (actual)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Diagnosis of plaque psoriasis according to established diagnostic criteria
- Age ≥ 18 years
- Willingness to participate in the study and provide written informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Background: PubMed 32635380Sirufo 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.
- Background: PubMed 28093419Ogdie 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.
- Background: PubMed 34260133Sepehri 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.
- Background: PubMed 24990650D'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.
- Background: PubMed 3326187Ojeda 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.
- Background: PubMed 22910173Ding 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by Chongli Yu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Osteopenia in Patients With Psoriasis (time frame: At the time of DEXA assessment during enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07112755, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.