PsoriasisNCT07140666
Analysis of Influence Factors on Osteopenia in Different Treatment of Psoriasis
An observational study of Psoriasis, run by Chongli Yu at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 28 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: This is a retrospective cohort study conducted at the Department of Dermatology, First Medical Center of Chinese PLA General Hospital. The study population consists of adult patients diagnosed with psoriasis, with or without psoriatic arthritis, who received clinical care at the dermatology department. Patients were managed with conventional systemic therapies, adalimumab, or secukinumab, and clinical records were reviewed to assess bone mineral density, bone metabolism markers, and related outcomes.
Who may be able to join
- Adults aged 18 years or older.
- Clinically confirmed diagnosis of psoriasis (with or without psoriatic arthritis).
- Currently receiving one of the following treatments: TNF-α inhibitor (adalimumab), or IL-17A inhibitor (secukinumab).
- Able and willing to undergo bone mineral density (BMD) assessment using dual-energy X-ray absorptiometry (DXA).
- Signed informed consent provided. Exclusion Criteria
- History of other systemic diseases affecting bone metabolism (e.g., primary hyperparathyroidism, severe chronic kidney disease, Cushing's syndrome).
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- Current use of medications known to strongly affect bone metabolism (e.g., long-term corticosteroids, bisphosphonates, denosumab, teriparatide).
- Pregnant or breastfeeding women.
- History of malignancy or other autoimmune diseases requiring systemic immunosuppressive therapy.
- Inability to complete study visits, assessments, or provide informed consent.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Psoriasis
- Keywords
- Psoriasis, Biologic Therapy, Bone Mineral Density, Osteopenia
- Medical subject headings
- Psoriasis, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adalimumab | Participants in this group are patients with psoriasis who receive treatment with adalimumab, a TNF-α inhibitor. Adalimumab is a biologic therapy administered by subcutaneous injection and is widely used for moderate-to-severe plaque psoriasis and psoriatic arthritis. This group will be observed to evaluate changes in bone mineral density (BMD) and bone metabolism markers during treatment. Outcomes from this group will be compared with those from other treatment groups to assess the impact of TNF-α blockade on bone health in patients with psoriasis. | |
| Secukinumab | Participants in this group are patients with psoriasis who receive treatment with secukinumab, an IL-17A inhibitor. Secukinumab is a biologic therapy given by subcutaneous injection, approved for moderate-to-severe plaque psoriasis and psoriatic arthritis. This group will be observed to evaluate changes in bone mineral density (BMD) and bone metabolism markers during treatment. The outcomes will be compared with other treatment groups to assess the influence of IL-17A blockade on bone health in patients with psoriasis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Bone Mineral Density
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.
Measured: Baseline, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2025
- Study start1 Aug 2022
- Primary completion28 Dec 2022
- Study completion28 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 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
- NCT07140666
- Sponsor's protocol ID
- S2022-196-01-02
- Status last verified
- Aug 2025
- First submitted
- 22 Aug 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Influence Factors on Osteopenia in Different Treatment of Psoriasis
- ClinicalTrials.gov ID
- NCT07140666
- Acronym / sponsor ID
- S2022-196-01-02
- Conditions
- Psoriasis
- Keywords
- Psoriasis, Biologic Therapy, Bone Mineral Density, Osteopenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Chongli YuUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 28 Dec 2022 (actual)
- Study completion
- 28 Dec 2022 (actual)
- First posted
- 25 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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adalimumab | – | –Participants in this group are patients with psoriasis who receive treatment with adalimumab, a TNF-α inhibitor. Adalimumab is a biologic therapy administered by subcutaneous injection and is widely used for moderate-to-severe plaque psoriasis and psoriatic arthritis. This group will be observed to evaluate changes in bone mineral density (BMD) and bone metabolism markers during treatment. Outcomes from this group will be compared with those from other treatment groups to assess the impact of TNF-α blockade on bone health in patients with psoriasis. |
| Secukinumab | – | –Participants in this group are patients with psoriasis who receive treatment with secukinumab, an IL-17A inhibitor. Secukinumab is a biologic therapy given by subcutaneous injection, approved for moderate-to-severe plaque psoriasis and psoriatic arthritis. This group will be observed to evaluate changes in bone mineral density (BMD) and bone metabolism markers during treatment. The outcomes will be compared with other treatment groups to assess the influence of IL-17A blockade on bone health in patients with psoriasis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a retrospective cohort study conducted at the Department of Dermatology, First Medical Center of Chinese PLA General Hospital. The study population consists of adult patients diagnosed with psoriasis, with or without psoriatic arthritis, who received clinical care at the dermatology department. Patients were managed with conventional systemic therapies, adalimumab, or secukinumab, and clinical records were reviewed to assess bone mineral density, bone metabolism markers, and related outcomes.
Key inclusion criteria (10 listed)
- Adults aged 18 years or older.
- Clinically confirmed diagnosis of psoriasis (with or without psoriatic arthritis).
- Currently receiving one of the following treatments: TNF-α inhibitor (adalimumab), or IL-17A inhibitor (secukinumab).
- Able and willing to undergo bone mineral density (BMD) assessment using dual-energy X-ray absorptiometry (DXA).
- Signed informed consent provided. Exclusion Criteria
Key exclusion criteria (0 listed)
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
Change in Bone Mineral Density
Time frame: 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.
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 2 Sep 2025.
- 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 10 inclusion and 0 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 2 Sep 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?
Change in Bone Mineral Density (time frame: Baseline, 6 months, and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Sep 2025.