Arthritis, Rheumatoid Clinical Trial
Official title:
Randomized Clinical Trial on the Prevention of Radiographic Progression With Zoledronic Acid in Patients With Early Rheumatoid Arthritis and Low Disease Activity
The progression of structural joint damage is the leading cause of disability and
socioeconomic costs associated with rheumatoid arthritis (RA). Remission and low clinical
activity not always imply absence of progression of structural damage. The main objective of
this study is to evaluate the progression of radiological damage in early RA patients
currently treated with disease modifying anti-rheumatic drugs (DMARDs) and low disease
activity to which treatment with zoledronic acid is added.
The investigators propose a randomized clinical trial in 94 patients with RA of less than 2
years of evolution that, being treated with DMARDs, present criteria of low disease activity
(DAS28 < 3.2).
Patients will be randomized into two branches: zoledronic acid and no treatment. The primary
study endpoint is the progression of radiological damage assessed in a blinded way by the
difference in the Sharp-van der Heijde index (SHI) in radiographs of hands and feet after two
years; the secondary variables: radiographic progression after one year, serum bone
biomarkers (OPG, RANKL, DKK-1 and sclerostin) and adverse effects. In a subgroup of patients,
the investigators shall evaluate the change in the size of hand erosions by multislice
computed tomography and the evolution of periarticular osteoporosis and systemic bone mass by
dual X-ray absorptiometry (DXA).
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