CLOBETASOL PROPIONATE for Bullous pemphigoid

Inclusion criteria

• {"criterion_text":"- Patients ≥ 18 years old.\n- 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 2016.\n- 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.\n- Patients or their legal representative having received written and oral information and having signed informed consent."}

Exclusion criteria

• {"criterion_text":"- Patients receiving background anti-osteoporotic treatment (zoledronic acid, risedronate, alendronate, pamidronate, ibandronate teriparatide, denosumab, raloxifene).\n- Patients immediately requiring basic anti-osteoporotic treatment (Tscore < -3DS on at least 1 site or FRAX® calculation greater than the therapeutic intervention threshold).\n- 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.\n- 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\n- Patients who received topical corticosteroids for more than a week during the 2 weeks preceding inclusion."}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Change in lumbar spine BMD measured in g/cm² between baseline (M0) and end of treatment (M6)."}

Secondary endpoints

• {"endpoint_text":"- Correlation between total exposure to topical corticosteroids and reduction in BMO","definition_or_measurement_approach":"Assessment of the relationship between cumulative topical corticosteroid exposure per patient and change/reduction in bone mineral density (BMD)."}
• {"endpoint_text":"- Variation in BMO between M0 and M3 at the lumbar spine.","definition_or_measurement_approach":"Change in lumbar spine BMD measured in g/cm² between baseline (M0) and M3."}
• {"endpoint_text":"- Variation in BMO between M0 and M3 and M6 at the hip.","definition_or_measurement_approach":"Change in hip BMD measured in g/cm² at M3 and M6 compared with baseline (M0)."}
• {"endpoint_text":"- Varation in plasma concentrations of corrected serum calcium, phosphorus, 25 OH vitamin D and cortisolemia at 8 a.m. between M0, M3 and M6.","definition_or_measurement_approach":"Measurement of plasma corrected calcium, phosphorus, 25-OH vitamin D and 8 a.m. cortisol at baseline, M3 and M6 and assessment of variation over time."}
• {"endpoint_text":"- Frequency of fractures (axial and/or peripheral) according to exposure to corticosteroids at M6.","definition_or_measurement_approach":"Recording frequency of axial and/or peripheral fractures at M6 and analysis by corticosteroid exposure level."}
• {"endpoint_text":"- Correlation between these different biological parameters and density bone mineral at M0, M3 and M6.","definition_or_measurement_approach":"Correlation analyses between specified biological parameters (calcemia, phosphoremia, 25-OH vitamin D, cortisol) and BMD at M0, M3 and M6."}

France

Earliest CTIS Part Ii Submission Date

19-07-2024

Latest Decision Or Authorization Date

31-07-2024

Processing Time Days

12

Number Of Sites

2

Number Of Participants

50

Primary sponsor

Full Name

Centre Hospitalier Universitaire Amiens Picardie

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France