Clinical trial Recruiting at 3 sites Interventional Ages 18 and up

Nurse-led program to prevent complications from long-term corticosteroid use

Official title: Evaluation of a Nurse-led Program for the Prevention of Complications of Long-term Corticosteroid Therapy

Run by University Hospital, Brest · NCT04909606 · Data updated 2026-11-12

This study tests a nurse-led program to help adults using long-term corticosteroids avoid complications like osteoporosis and infections.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment191 (estimated)
SponsorUniversity Hospital, Brest
Academic / other
Locations5 sites (Brest and 4 other locations)
StatusRecruiting
StartedApril 26, 2022
Main results expectedOctober 26, 2028
Study endsOctober 26, 2028
Registry record updatedMarch 20, 2026
Trial IDNCT04909606 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 or older who are initiating corticosteroid therapy within 30 days and have a cumulative dosage of at least 2000 mg.

Probably not a fit

Patients who have previously been exposed to long-term corticosteroids or those with severe chronic renal failure or organ transplant history may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates a nurse-led prevention program aimed at reducing complications associated with long-term corticosteroid therapy in adult patients. It employs a Prospective Randomized Open trial with a Blind Evaluation (PROBE) design, where participants will be assessed at baseline and after 52 weeks. The program focuses on preventing adverse effects such as osteoporosis, infections, and adrenal insufficiency through tailored interventions including vaccinations, physical activity promotion, and dietary management. The effectiveness of the program will be measured using clinical evaluations, routine biology tests, and quality of life assessments.

Why it matters

Potential benefit: If successful, this program could significantly reduce the adverse effects of long-term corticosteroid therapy, improving patient quality of life.

How similar studies have gone: While nurse-led prevention programs for other therapies have shown success, this specific approach for long-term corticosteroid therapy is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Patients aged 18 or older
* Initiation of corticosteroids within 30 days prior to inclusion
* Estimated cumulative dosage of corticosteroids ≥ 2000 mg
* Affiliated member of the social security system

Exclusion Criteria:

* Patients unable to give consent or unable to understand the protocol
* A patient who is not 'or is no longer' able to communicate remotely by telephone could not 'or no longer' be included in the study.
* Patients under guardianship
* Previous exposure to long-term corticosteroids
* Prescription of corticosteroids for the management of malignant neoplasms
* Severe chronic renal failure with clearance of creatinine \< 30 ml/min.
* History of organ transplantation
* Pregnant or breastfeeding women

Where it's running

  • CHU Brest
    Brest, France
    Recruiting
  • CH La Rochelle
    La Rochelle, France
    Recruiting
  • CH Le Puy en Velay
    Le Puy-en-Velay, France
    Recruiting
  • CH Le Mans
    Le Mans, France
    Enrolling by invitation
  • CH de Morlaix
    Morlaix, France
    Enrolling by invitation

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.