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Zoledronic Acid in Rheumatoid Arthritis

NCT02123264 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2019-02-22

No results posted yet for this study

Summary

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).

Conditions

  • Arthritis, Rheumatoid

Interventions

DRUG

Zoledronic acid

Zoledronic acid: 5 mg/year x 2 years

Sponsors & Collaborators

  • Carmen Gómez-Vaquero

    lead OTHER

Principal Investigators

  • Carmen Gómez-Vaquero, MD, PhD · Hospital Universitari de Bellvitge

  • Silvia Pérez-Pujol, PhD · UCICEC-Hospital Universitari de Bellvitge

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2018-06-30
Completion
2018-06-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02123264 on ClinicalTrials.gov