Body Composition and Bone Mineral Density in Patients With Psoriatic Arthritis and Changes After 6 Months of Treatment With Ustekinumab
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Visceral adiposity (VAT)
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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,
结局指标
主要结局
Visceral adiposity (VAT)
时间窗: At baseline
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).
次要结局
- Total fat mass(At baseline)
- Total lean mass(At baseline)
- Change in total fat mass (TBF, %) under ustekinumab in PsA(at baseline and at 6 months (± 2 months))
- Bone mineral density(At baseline)
- Change in visceral adiposity (cm²) under ustekinumab in PsA(at baseline and at 6 months (± 2 months))
- Change in makers of bone remodeling under ustekinumab in PsA(at baseline and at 6 months (± 2 months))
- Change in leptin 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 total lean mass (TLM, kg) under ustekinumab in PsA(at baseline and at 6 months (± 2 months))