PRediction Of DIverse Glucocorticoids toxIcity OUtcomeS
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- University Hospital, Brest
- Enrollment
- 300
- Locations
- 23
- Primary Endpoint
- Clinically relevant complication of glucocorticoid therapy
Study Overview
Brief Summary
To date, there is no available tool that allows, at individual level, determination of the probability to develop clinically relevant complications of prolonged glucocorticoid therapy. In patients with inflammatory rheumatic disorders requiring prolonged glucocorticoid therapy, such tool could be useful to adapt first-line treatment decisions (in daily practice and in future clinical trials). The main objective of the study is to identify routine clinical, biological and DXA baseline characteristics predictive of the occurrence of clinically relevant complications of glucocorticoid therapy at 1 year, in order to propose a predictive score.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Life expectancy > 1 year.
- •Indication to initiate prolonged glucocorticoid therapy at a dosage ≥ 15 mg/day for the treatment of an inflammatory rheumatic disease.
- •Initial treatment or relapse.
- •Previsional treatment duration > 3 months.
Exclusion Criteria
- •Unable to consent.
- •Previous corticosteroid therapy in the last 3 months at a significant dosage (> 5 mg per day).
Outcomes
Primary Outcomes
Clinically relevant complication of glucocorticoid therapy
Time Frame: 1 year
The occurrence of one or more clinically relevant complication of glucocorticoid therapy during the first year of treatment, according to the Glucocorticoid Toxicity Index (items and specific list).
Secondary Outcomes
- Quality of life assessed through SF-36(1 year)