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DERMOS study : Influence of dermocorticoids on bone mineral density in patients with bullous pemphigoid.
EU CTIS ID: 2024-515676-12-00
What this study is testing
Assessment of variation in bone mineral density of patients suffering from bullous pemphigoid (BP) following prolonged treatment (6 months) with topical corticosteroids (Dermoval®).
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- - 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.
You likely can't join if
- - 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.