Changes in Body Composition Under Ustekinumab in PsA

Study Overview
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Brief Summary
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There is not much body composition and bone mineral density data available for patients with psoriatic arthritis (rheumatoid arthritis) compared to control subjects. The evaluation of the total fat mass and in particular of its abdominal distribution (visceral adiposity) is important because an excessive adiposity generates adverse effects on the health (hypertension, dyslipidemia, cardiovascular risk and resistance to the insulin). In addition, data on changes in body composition and bone mineral density were not available under a new psA treatment, namely ustekinumab (anti-IL12 / 23 antibody). It is proposed to conduct a pilot study to evaluate body composition, distribution (visceral adiposity) and bone mineral density in patients with psoriatic arthritis (versus control subjects) and their changes after 6 months of treatment with ustekinumab

Official Title
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Body Composition and Bone Mineral Density in Patients With Psoriatic Arthritis and Changes After 6 Months of Treatment With Ustekinumab

Conditions
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Psoriatic Arthritis

Intervention / Treatment
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* Procedure: Bone mineral density (BMD)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Psoriatic arthritis: Men and women ≥ 18 years Patients with PsA according to CASPAR criteria, Patients who do not have yet started ustekinumab, Patients who signed the informed consent. Healthy volunteers: Men and women ≥ 18 years Patients who signed the informed consent. Exclusion Criteria: Items 1 to 10 are applicable to healthy volunteers and PsA History of fragility fracture AND / OR T-score ≤-3 if ≥50 years AND / OR Z-score ≤-3 if <50 years during the screening phase, Corticosteroids ≥10 mg / day, Diseases or treatments affecting bone metabolism (breast cancer with anti-aromatase, malabsorption, primary hyperparathyroidism, uncontrolled hyperthyroidism ...), History of radiotherapy on the lumbar spine or hip, Patients undergoing hormone replacement therapy (HRT) or patients already on anti-osteoporotic therapy (bisphosphonates, strontium ranelate, teriparatide or denosumab), Chronic kidney disease with creatinine clearance (CKD-EPI) ≤ 30 ml / min, Weight> 160 kg, Patients under restrictive diet or considering a diet of this type during the study period, Patients who have an intense exercise program or plan to benefit from it during the study period, Pregnant or lactating women or having a pregnancy project,

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Psoriatic arthritis<br> | Procedure: Bone mineral density (BMD)<br>* The bone mineral density (BMD) performed by DXA, which will allow the analysis of bone density (mg / cm²) at the lumbar spine (BMD L1 to L4) and the total hip (non-dominant). This examination will also allow an analysis of the body composition at the same time (lean mass, fat mass and bone mass for the whole body).<br>|
| Healthy volunteers<br> | Procedure: Bone mineral density (BMD)<br>* The bone mineral density (BMD) performed by DXA, which will allow the analysis of bone density (mg / cm²) at the lumbar spine (BMD L1 to L4) and the total hip (non-dominant). This examination will also allow an analysis of the body composition at the same time (lean mass, fat mass and bone mass for the whole body).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visceral adiposity (VAT) | Comparison at baseline of visceral adiposity (VAT) in cm² between PsA (n = 30) and healthy volunteers (n = 30) matched on age (± 5 years, ≥ 18 years), sex, menopausal status for women and body mass index (BMI, ± 3 kg / m²). | At baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total lean mass | Comparison at baseline of total lean mass (TLM, kg), between PsA (n = 30) and healthy volunteers (n = 30) matched on age (± 5 years, ≥ 18 years), sex, menopausal status for women and body mass index (BMI, ± 3 kg / m²). | At baseline | 
| Total fat mass | Comparison at baseline of total fat mass (TBF, %) between PsA (n = 30) and healthy volunteers (n = 30) matched on age (± 5 years, ≥ 18 years), sex, menopausal status for women and body mass index (BMI, ± 3 kg / m²). | At baseline | 
| Bone mineral density | Comparison at baseline of bone mineral density (BMD, g/cm²) between PsA (n = 30) and healthy volunteers (n = 30) matched on age (± 5 years, ≥ 18 years), sex, menopausal status for women and body mass index (BMI, ± 3 kg / m²). | At baseline | 
| Change in total fat mass (TBF, %) under ustekinumab in PsA |  | at baseline and at 6 months (± 2 months) | 
| Change in total lean mass (TLM, kg) under ustekinumab in PsA |  | at baseline and at 6 months (± 2 months) | 
| Change in visceral adiposity (cm²) under ustekinumab in PsA |  | at baseline and at 6 months (± 2 months) | 
| Change in bone mineral density (BMD, g/cm²) under ustekinumab in PsA |  | at baseline and at 6 months (± 2 months) | 
| Change in makers of bone remodeling under ustekinumab in PsA | C-telopeptide (Ctx), Procollagen type 1 amino-terminal propeptide (P1NP) | at baseline and at 6 months (± 2 months) | 
| Change in leptin under ustekinumab in PsA |  | at baseline and at 6 months (± 2 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriatic arthritis, ustekinumab, body composition, bone mineral density, adiposity