drugset / Trial / NCT04115397

Bisphosphonates for the Treatment of Seropositive Musculoskeletal Complaints

NCT04115397

Phase 4 Unknown 80 enrolled Karolinska Institutet
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Seropositive Rheumatoid arthritis (RA) is characterized by autoantibodies that develop prior to clinical onset, allowing identification of individuals at risk for disease development. In a unique program in Stockholm, seropositive individuals presenting with musculoskeletal complains are currently identified and followed-up in a dedicated outpatient clinical program. Despite significant disease burden and increased sick leave among these individuals, we lack today any therapeutic and preventive measures. We aim to (1). establish a nation-wide health program, (2). develop an algorithm for disease risk estimation and (3). test a novel strategy to delay and/or prevent disease onset in seropositive at risk individuals with musculoskeletal complains. We will perform a multicentre randomised study to treat autoantibody-positive individuals at risk for developing RA presenting with pain (Population), by repurposing of bisphosphonates (Intervention) as compared to placebo (Control) to treat pain (primary Outcome) and delay/prevent RA development during 1-year follow-up (secondary Outcome)

Timeline

Start
2020-01
Primary completion
2021-12
Completion
2022-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Zoledronic acid Other / unclassified 5 mg Intravenous

Indications