2024-515676-12-00招募中4 期
DERMOS study : Influence of dermocorticoids on bone mineral density in patients with bullous pemphigoid.
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Variation in bone mineral density (BMD) expressed in g/cm² at level of the lumbar spine between the initial BMD at M0 and that achieved at the end of theoretical treatment at M6.
研究概览
简要总结
Assessment of variation in bone mineral density of patients suffering from bullous pemphigoid (BP) following prolonged treatment (6 months) with topical corticosteroids (Dermoval®).
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Etude pilote de cohorte prospective, interventionnelle
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Patients ≥ 18 years old.
- •Presenting newly diagnosed bullous pemphigoid treated according to the national diagnosis and care protocol issued by the reference center for autoimmune bullous diseases in April
- •In patients whose lumbar spine bone densitometry cannot be interpreted on several vertebrae from L1 to L4 (significant lumbar osteoarthritis, history of lumbar vertebroplasty, osteosynthesis material), the data will be interpreted on the remaining vertebrae. If the BMD of no vertebra (from L1 to L4) is usable, only the BMD at the hip level will be interpreted.
- •Patients or their legal representative having received written and oral information and having signed informed consent.
排除标准
- •Patients receiving background anti-osteoporotic treatment (zoledronic acid, risedronate, alendronate, pamidronate, ibandronate teriparatide, denosumab, raloxifene).
- •Patients immediately requiring basic anti-osteoporotic treatment (Tscore < -3DS on at least 1 site or FRAX® calculation greater than the therapeutic intervention threshold).
- •Patients with one or more major risk factors for osteoporosis o In men and premenopausal women: discovery or radiological confirmation of a vertebral fracture without obvious traumatic or tumor context, personal history of peripheral fracture occurring without major trauma, systemic corticosteroid therapy prescribed for a duration of at least three consecutive months, at a dose ≥ 7.5 mg/day of prednisone equivalent, prolonged hypogonadism, untreated progressive hyperthyroidism, hyperadrenocorticism, primary hyperparathyroidism and osteogenesis imperfecta.
- •In postmenopausal women: early menopause < 40 years, BMI < 19 kg/m², history of femoral neck injury without major trauma in a firstdegree relative, history of taking corticosteroids for at least three months consecutive, at a dose ≥ 7.5 mg/day prednisone equivalent
- •Patients who received topical corticosteroids for more than a week during the 2 weeks preceding inclusion.
结局指标
主要结局
Variation in bone mineral density (BMD) expressed in g/cm² at level of the lumbar spine between the initial BMD at M0 and that achieved at the end of theoretical treatment at M6.
Variation in bone mineral density (BMD) expressed in g/cm² at level of the lumbar spine between the initial BMD at M0 and that achieved at the end of theoretical treatment at M6.
次要结局
- Correlation between total exposure to topical corticosteroids and reduction in BMO
- Variation in BMO between M0 and M3 and M6 at the hip.
- Variation in BMO between M0 and M3 at the lumbar spine.
- Varation in plasma concentrations of corrected serum calcium, phosphorus, 25 OH vitamin D and cortisolemia at 8 a.m. between M0, M3 and M6.
- Frequency of fractures (axial and/or peripheral) according to exposure to corticosteroids at M6.
- Correlation between these different biological parameters and density bone mineral at M0, M3 and M6.
研究者
Dr BATTEUX Benjamin
Scientific
Centre Hospitalier Universitaire Amiens Picardie
研究点 (2)
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