Influence of Dermocorticoids on Bone Mineral Density in Patients With Bullous Pemphigoid
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Variation of the bone mineral density (BMD) expressed in g/cm² at the lumbar spine between baseline and the theorical end of the treatment.
研究概览
简要总结
Bullous pemphigoid is the most common type of bullous skin disease and is clinically characterized by clear-tense bullae, which result in post-bullous cutaneous erosions, altering the skin barrier. The treatment of this pathology consists of the application of high doses of topical corticosteroids (clobetasol propionate) for a prolonged period of at least 6 months. The main objective of this study is to demonstrate a change in bone mineral density at 6 months after initiation of treatment, in subjects with bullous pemphigoid and treated with topical corticosteroid.
详细描述
Glucocorticoids have direct effects on bone remodeling by suppressing bone formation (inhibition of osteoblastic differentiation, inhibition of mature osteoblasts function and apoptosis of mature osteoblasts) and by increasing bone resorption (decrease in osteoclast apoptosis and stimulation of osteoclastogenesis). They also have indirect bone effects by decreasing the intestinal absorption of calcium and increasing its urinary excretion, and by inhibiting the somatotropic and gonadotropic axis. This pathophysiology results in excessive bone fragility. Bone loss and increased incidence of fractures occur within 6 months after the introduction of oral corticosteroid therapy, with a partially reversible phenomenon within months of discontinuation. The extent of bone loss depends on the dose and duration of glucocorticoid administration.
The systemic transition of topical corticosteroids depends on several parameters such as excipients, anatomical location, cutaneous state, the dose used and the duration of exposure.
Clobetasol propionate, used for long-term use in bullous pemphigoid, is a Class IV dermocorticoid (highly potent). Patients with bullous pemphigoid will benefit from bone densitometry at the initiation of treatment, at 3 months (theoretical end of the treatment of attack) and at 6 months (theoretical end of the treatment).
Patients will also benefit a blood test of serum calcium, phosphoremia, albumin, 25 OH vitamin D and cortisol at 8 to highlight possible correlations between changes in bone mineral density and phosphocalcic parameters and 8 cortisolemia (braking of the hypothalamic-pituitary-adrenal axis).
Patients will also benefit from standard radiographs of the thoracic and lumbar spine at the initiation of treatment and at 6 months. Follow-up is planned over 6 months, with 2 follow-up visits at 3 months and 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥ 18 years
- •Patients with newly diagnosed bullous pemphigoid (BP), treated according to the national diagnostic and care protocol issued by the French Reference Center for Autoimmune Bullous Diseases in April
- •In patients for whom lumbar spine bone densitometry cannot be interpreted at several vertebral levels from L1 to L4 (severe lumbar osteoarthritis, history of lumbar vertebroplasty, osteosynthesis hardware), the data will be interpreted using the remaining evaluable vertebrae. If the BMD of none of the vertebrae from L1 to L4 is evaluable, only hip BMD will be interpreted.
- •Patients, or their legal representative, who have received written and oral information and have signed an informed consent form.
- •Social Security affiliation.
排除标准
- •Patients receiving anti-osteoporotic maintenance treatment (zoledronic acid, risedronate, alendronate, pamidronate, ibandronate, teriparatide, denosumab, raloxifene).
- •Patients requiring immediate initiation of anti-osteoporotic maintenance treatment (T-score < -3 SD at at least one site or FRAX® score above the therapeutic intervention threshold).
- •Patients presenting with one or more major risk factors for osteoporosis:
- •In men and premenopausal women: newly diagnosed or radiologically confirmed vertebral fracture without an obvious traumatic or tumor-related context; personal history of a peripheral fracture occurring without major trauma; systemic corticosteroid therapy prescribed for at least three consecutive months at a dose ≥ 7.5 mg/day prednisone equivalent; prolonged hypogonadism; untreated active hyperthyroidism; hypercortisolism; primary hyperparathyroidism; and osteogenesis imperfecta.
- •In postmenopausal women: premature menopause < 40 years of age; BMI < 19 kg/m²; parental history of femoral neck fracture without major trauma in a first-degree relative; history of corticosteroid therapy for at least three consecutive months at a dose ≥ 7.5 mg/day prednisone equivalent.
- •Patients who have received topical corticosteroids for more than one week during the two weeks preceding inclusion.
研究组 & 干预措施
Clobetasol propionate treatment
Clobetasol propionate (Dermoval® 0,05% cream), administered for 6 months.
干预措施: Clobetasol propionate (Procedure)
Clobetasol propionate treatment
Clobetasol propionate (Dermoval® 0,05% cream), administered for 6 months.
干预措施: bone densitometry (Procedure)
Clobetasol propionate treatment
Clobetasol propionate (Dermoval® 0,05% cream), administered for 6 months.
干预措施: blood test (Biological)
Clobetasol propionate treatment
Clobetasol propionate (Dermoval® 0,05% cream), administered for 6 months.
干预措施: radiographs of the thoracic and lumbar spine (Procedure)
结局指标
主要结局
Variation of the bone mineral density (BMD) expressed in g/cm² at the lumbar spine between baseline and the theorical end of the treatment.
时间窗: 6 months after beginning of the treatment
Patients with bullous pemphigoid and treated with Clobetasol propionate will benefit from bone densitometry at the initiation of the treatment and at 6 months (theoretical end of the treatment).
次要结局
- frequency of fractures (axial and , or peripheral)(6 months after beginning of the treatment)
- Variation in plasma concentrations of corrected calcemia, phosphoremia, 25 OH vitamin D and cortisolemia between Baseline and the theorical end of the treatment.(6 months after beginning of the treatment)
- Variation of the bone mineral density (BMD) expressed in g/cm² at the hip between baseline and the theorical end of the treatment of attack.(3 months after beginning of the treatment)
- Variation of the bone mineral density (BMD) expressed in g/cm² at the hip between baseline and the theorical end of the treatment.(6 months after beginning of the treatment)
- Variation of the bone mineral density (BMD) expressed in g/cm² at the lumbar spine between baseline and the theorical end of the treatment of attack.(3 months after beginning of the treatment)
- Variation in plasma concentrations of corrected calcemia, phosphoremia, 25 OH vitamin D and cortisolemia between Baseline and the theorical end of the treatment of attack.(3 months after beginning of the treatment)