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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire Amiens Picardie

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Decision date (initial)

2024-07-31

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

GIRCI : Appel à Emergence Nord 2018

External identifiers

EU CT number

2024-515676-12-00

EudraCT number

2018-003953-46

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety

Assessment of variation in bone mineral density of patients suffering from bullous pemphigoid (BP) following prolonged treatment (6 months) with topical corticosteroids (Dermoval®).

Secondary objectives 4

1. • Study the correlation between total exposure to topical corticosteroids per patient and the variation in BMO.
2. Study variations in phosphocalcic biological parameters (corrected serum calcium, serum phosphorus, 25 OH vitamin D) associated with prolonged use of topical corticosteroids.
3. To study the variations in cortisolemia at 8 A.M. associated with prolonged use of topical corticosteroids.
4. Evaluate the association between exposure to topical corticosteroids and fractures (axial and/or peripheral).

Conditions and MedDRA coding

Bullous pemphigoid

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. - Patients ≥ 18 years old.
2. 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.
3. 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.
4. Patients or their legal representative having received written and oral information and having signed informed consent.

Exclusion criteria 5

1. - Patients receiving background anti-osteoporotic treatment (zoledronic acid, risedronate, alendronate, pamidronate, ibandronate teriparatide, denosumab, raloxifene).
2. Patients immediately requiring basic anti-osteoporotic treatment (Tscore < -3DS on at least 1 site or FRAX® calculation greater than the therapeutic intervention threshold).
3. 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.
4. 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
5. Patients who received topical corticosteroids for more than a week during the 2 weeks preceding inclusion.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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.

Secondary endpoints 6

1. Correlation between total exposure to topical corticosteroids and reduction in BMO
2. Variation in BMO between M0 and M3 at the lumbar spine.
3. Variation in BMO between M0 and M3 and M6 at the hip.
4. Varation in plasma concentrations of corrected serum calcium, phosphorus, 25 OH vitamin D and cortisolemia at 8 a.m. between M0, M3 and M6.
5. Frequency of fractures (axial and/or peripheral) according to exposure to corticosteroids at M6.
6. Correlation between these different biological parameters and density bone mineral at M0, M3 and M6.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire Amiens Picardie

Sponsor organisation

Centre Hospitalier Universitaire Amiens Picardie

Address

1 Rond Point Du Pr Christian Cabrol

City

Amiens Cedex 1

Postcode

80054

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire Amiens Picardie

Contact name

Dr BATTEUX Benjamin

Public contact point

Organisation

Centre Hospitalier Universitaire Amiens Picardie

Contact name

Ghania BOULARIAS

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications