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Zoledronic Acid in Rheumatoid Arthritis (AZAR)

Primary Purpose

Arthritis, Rheumatoid

Status
Terminated
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Zoledronic acid
Sponsored by
Carmen Gómez-Vaquero
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Arthritis, Rheumatoid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Universitari de Bellvitge
  • Hospital de Sant Joan Despí Moisés Broggi
  • Hospital Residència Sant Camil
  • Hospital de Viladecans
  • Hospital Universitario de Cruces
  • Hospital Universitari Son Espases
  • Complexo Hospitalario Universitario A Coruña
  • Hospital Clinic I Provincial de Barcelona
  • Hospital Universitario de La Princesa
  • Hospital Universitario La Paz
  • Hospital Virgen Macarena

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Zoledronic acid

No intervention

Arm Description

Zoledronic acid: 5 mg/year x 2 years

No intervention

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 23, 2014
Last Updated
February 21, 2019
Sponsor
Carmen Gómez-Vaquero
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1. Study Identification

Unique Protocol Identification Number
NCT02123264
Brief Title
Zoledronic Acid in Rheumatoid Arthritis
Acronym
AZAR
Official Title
Randomized Clinical Trial on the Prevention of Radiographic Progression With Zoledronic Acid in Patients With Early Rheumatoid Arthritis and Low Disease Activity
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Study Start Date
May 2014 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Carmen Gómez-Vaquero

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zoledronic acid
Arm Type
Active Comparator
Arm Description
Zoledronic acid: 5 mg/year x 2 years
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Drug
Intervention Name(s)
Zoledronic acid
Other Intervention Name(s)
Aclasta
Intervention Description
Zoledronic acid: 5 mg/year x 2 years
Primary Outcome Measure Information:
Title
Sharp van der Heijde index
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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) 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmen Gómez-Vaquero, MD, PhD
Organizational Affiliation
Hospital Universitari de Bellvitge
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Silvia Pérez-Pujol, PhD
Organizational Affiliation
UCICEC-Hospital Universitari de Bellvitge
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Universitari de Bellvitge
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital de Sant Joan Despí Moisés Broggi
City
Sant Joan Despí
State/Province
Barcelona
ZIP/Postal Code
08970
Country
Spain
Facility Name
Hospital Residència Sant Camil
City
Sant Pere de Ribes
State/Province
Barcelona
ZIP/Postal Code
08810
Country
Spain
Facility Name
Hospital de Viladecans
City
Viladecans
State/Province
Barcelona
ZIP/Postal Code
08840
Country
Spain
Facility Name
Hospital Universitario de Cruces
City
Barakaldo
State/Province
Bilbao
ZIP/Postal Code
48903
Country
Spain
Facility Name
Hospital Universitari Son Espases
City
Palma de Mallorca
State/Province
Mallorca
ZIP/Postal Code
07120
Country
Spain
Facility Name
Complexo Hospitalario Universitario A Coruña
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Clinic I Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario de La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Virgen Macarena
City
Sevilla
ZIP/Postal Code
41071
Country
Spain

12. IPD Sharing Statement

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Zoledronic Acid in Rheumatoid Arthritis

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