A Phase 3 interventional study of Zoledronic acid in Arthritis, Rheumatoid, sponsored by Carmen Gómez-Vaquero. Terminated at 11 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-22.
Sponsored by Carmen Gómez-Vaquero · Phase 3, Interventional, and Prevention
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).
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 28 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →This is the only study on the registry with Carmen Gómez-Vaquero as lead sponsor.
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Exclusion Criteria:
Pretreatment with:
Contraindication to treatment with zoledronic acid:
Zoledronic acid: 5 mg/year x 2 years
Drug: Zoledronic acid
No intervention
Zoledronic acid: 5 mg/year x 2 years
Also known as: Aclasta
Sharp van der Heijde index
To assess the progression of radiographic damage in patients with early RA in current treatment with DMARDs and low disease activity to which treatment with zoledronic acid is added, compared to a no treatment control population, after two years.
Time frame: Two years
This study is terminated, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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