Zoledronic Acid in Rheumatoid Arthritis (AZAR)
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ClinicalTrials.gov Identifier: NCT02123264 |
Recruitment Status :
Terminated
First Posted : April 25, 2014
Last Update Posted : February 22, 2019
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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 |
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Arthritis, Rheumatoid | Drug: Zoledronic acid | Phase 3 |
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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Zoledronic acid
Zoledronic acid: 5 mg/year x 2 years
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Drug: Zoledronic acid
Zoledronic acid: 5 mg/year x 2 years
Other Name: Aclasta |
No Intervention: No intervention
No intervention
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- 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 |
Inclusion Criteria:
- Age equal or greater than 18 years
- Patients with RA of less than 2 years of evolution
- DMARD therapy (methotrexate alone or methotrexate, leflunomide or methotrexate within COBRA strategy) on stable dose for at least 6 weeks prior to study entry
- Patients not treated with glucocorticoids or under stable dose of prednisone up to 5 mg / day or equivalent dose of another glucocorticoid
- Low disease activity (DAS28 <3.2)
- In case of premenopausal women, commitment to make contraceptive treatment up to 3 years after the last dose of zoledronic acid
- Signed informed consent
Exclusion Criteria:
- Previous or current treatment with biological drugs used for the treatment of RA (infliximab, adalimumab, etanercept, certolizumab, golimumab, rituximab, abatacept, tocilizumab)
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Pretreatment with:
- Bisphosphonates in the 5 years prior to the onset of RA
- Calcitonin, raloxifene, bazedoxifene, strontium ranelate, teriparatide and denosumab in the year before the onset of RA
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Contraindication to treatment with zoledronic acid:
- Hypersensitivity to bisphosphonates
- Hypocalcemia
- Glomerular filtration rate <35 mL / min
- Pregnant (negative pregnancy test) and lactating women
- Poor oral hygiene
- Pending invasive dental procedure
- Serum levels of calcidiol lower than 25 nmol/L (10 ng/mL).
- Simultaneous participation in another clinical trial

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
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 |
Principal Investigator: | Carmen Gómez-Vaquero, MD, PhD | Hospital Universitari de Bellvitge | |
Study Director: | Silvia Pérez-Pujol, PhD | UCICEC-Hospital Universitari de Bellvitge |
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 |
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 |