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DERMOS study : Influence of dermocorticoids on bone mineral density in patients with bullous pemphigoid.

Phase 1
Active, not recruiting
Conditions
Bullous pemphigoid
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Registration Number
CTIS2024-515676-12-00
Lead Sponsor
Centre Hospitalier Universitaire Amiens Picardie
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Recruiting
Sex
All
Target Recruitment
50
Inclusion Criteria

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 2016., 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.

Exclusion Criteria

- 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.

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
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