Analysis of Influence Factors on Osteopenia in Different Treatment of Psoriasis

NCT07140666 | Completed

• 1 other identifier: S2022-196-01-02
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Keywords

Psoriasis; Biologic Therapy; Bone Mineral Density; Osteopenia

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 6 months, and 12 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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).

You may not qualify if:

• History of other systemic diseases affecting bone metabolism (e.g., primary hyperparathyroidism, severe chronic kidney disease, Cushing's syndrome).
• 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.

Sponsors & Collaborators

• Chongli Yu: lead

Study Sites (1)

Chinese PLA General Hosptial

Beijing, Beijing Municipality, 100853, China

Location

MeSH Terms

Conditions

Psoriasis; Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

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

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: August 25, 2025
• Study Start: August 1, 2022
• Primary Completion: December 28, 2022
• Study Completion: December 28, 2022
• Last Updated: September 2, 2025

Record last verified: 2025-08

Locations

CN (1)