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Zoledronic Acid in Rheumatoid Arthritis (AZAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02123264
Recruitment Status : Terminated
First Posted : April 25, 2014
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
Carmen Gómez-Vaquero, Hospital Universitari de Bellvitge

Brief 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).


Condition or disease Intervention/treatment Phase
Arthritis, Rheumatoid Drug: Zoledronic acid Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Clinical Trial on the Prevention of Radiographic Progression With Zoledronic Acid in Patients With Early Rheumatoid Arthritis and Low Disease Activity
Actual Study Start Date : May 2014
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Zoledronic acid
Zoledronic acid: 5 mg/year x 2 years
Drug: Zoledronic acid
Zoledronic acid: 5 mg/year x 2 years
Other Name: Aclasta

No Intervention: No intervention
No intervention



Primary Outcome Measures :
  1. Sharp van der Heijde index [ Time Frame: Two years ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age equal or greater than 18 years
  2. Patients with RA of less than 2 years of evolution
  3. DMARD therapy (methotrexate alone or methotrexate, leflunomide or methotrexate within COBRA strategy) on stable dose for at least 6 weeks prior to study entry
  4. Patients not treated with glucocorticoids or under stable dose of prednisone up to 5 mg / day or equivalent dose of another glucocorticoid
  5. Low disease activity (DAS28 <3.2)
  6. In case of premenopausal women, commitment to make contraceptive treatment up to 3 years after the last dose of zoledronic acid
  7. Signed informed consent

Exclusion Criteria:

  1. Previous or current treatment with biological drugs used for the treatment of RA (infliximab, adalimumab, etanercept, certolizumab, golimumab, rituximab, abatacept, tocilizumab)
  2. Pretreatment with:

    1. Bisphosphonates in the 5 years prior to the onset of RA
    2. Calcitonin, raloxifene, bazedoxifene, strontium ranelate, teriparatide and denosumab in the year before the onset of RA
  3. Contraindication to treatment with zoledronic acid:

    1. Hypersensitivity to bisphosphonates
    2. Hypocalcemia
    3. Glomerular filtration rate <35 mL / min
    4. Pregnant (negative pregnancy test) and lactating women
    5. Poor oral hygiene
    6. Pending invasive dental procedure
  4. Serum levels of calcidiol lower than 25 nmol/L (10 ng/mL).
  5. Simultaneous participation in another clinical trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02123264


Locations
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Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Hospital de Sant Joan Despí Moisés Broggi
Sant Joan Despí, Barcelona, Spain, 08970
Hospital Residència Sant Camil
Sant Pere de Ribes, Barcelona, Spain, 08810
Hospital de Viladecans
Viladecans, Barcelona, Spain, 08840
Hospital Universitario de Cruces
Barakaldo, Bilbao, Spain, 48903
Hospital Universitari Son Espases
Palma de Mallorca, Mallorca, Spain, 07120
Complexo Hospitalario Universitario A Coruña
A Coruña, Spain, 15006
Hospital Clinic I Provincial de Barcelona
Barcelona, Spain, 08036
Hospital Universitario de La Princesa
Madrid, Spain, 28006
Hospital Universitario La Paz
Madrid, Spain, 28046
Hospital Virgen Macarena
Sevilla, Spain, 41071
Sponsors and Collaborators
Carmen Gómez-Vaquero
Investigators
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Principal Investigator: Carmen Gómez-Vaquero, MD, PhD Hospital Universitari de Bellvitge
Study Director: Silvia Pérez-Pujol, PhD UCICEC-Hospital Universitari de Bellvitge
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Responsible Party: Carmen Gómez-Vaquero, MD PhD, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier: NCT02123264    
Other Study ID Numbers: CGV222
First Posted: April 25, 2014    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Zoledronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs