Zoledronic Acid in Rheumatoid Arthritis
Information source: Hospital Universitari de Bellvitge
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Arthritis, Rheumatoid
Intervention: Zoledronic acid (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Carmen Gómez-Vaquero Official(s) and/or principal investigator(s): Carmen GĂłmez-Vaquero, MD, PhD, Principal Investigator, Affiliation: Hospital Universitari de Bellvitge Silvia PĂ©rez-Pujol, PhD, Study Director, Affiliation: UCICEC-Hospital Universitari de Bellvitge
Overall contact: Carmen GĂłmez-Vaquero, MD, PhD, Phone: +34932607712, Email: carmen.gomez@bellvitgehospital.cat
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).
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Sharp van der Heijde index
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Carmen GĂłmez-Vaquero, MD, PhD, Phone: +34932607712, Email: carmen.gomez@bellvitgehospital.cat
Complexo Hospitalario Universitario A Coruña, A Coruña 15006, Spain; Recruiting Jenaro Graña, MD, PhD, Phone: 34 98 1176307, Email: genaro.grana.gil@sergas.es Jenaro Graña, MD, PhD, Principal Investigator Javier de Toro, MD, PhD, Sub-Investigator
Hospital Clinic I Provincial de Barcelona, Barcelona 08036, Spain; Recruiting Victoria Hernández-Miguel, MD, PhD, Phone: 34 93 2275400, Ext: 2236, Email: mvhernan@clinic.ub.es Victoria Hernández-Miguel, MD, PhD, Principal Investigator Raimon SanmartĂ, MD, PhD, Sub-Investigator
Hospital Universitario de La Princesa, Madrid 28006, Spain; Recruiting Ana M Ortiz-GarcĂa, MD, Phd, Phone: 34 91 5202200, Ext: 2473, Email: lanult@yahoo.es Ana M Ortiz-GarcĂa, MD, PhD, Principal Investigator
Hospital Universitario La Paz, Madrid 28046, Spain; Recruiting Laura Nuño, MD, PhD, Phone: 34 91 2727108, Email: lauranuno2@hotmail.com Laura Nuño, MD, PhD, Principal Investigator Pilar Aguado, MD, PhD, Sub-Investigator
Hospital Virgen Macarena, Sevilla 41071, Spain; Recruiting Blanca Hernández-Cruz, MD, PhD, Phone: 34 95 5009124, Email: blancahcruz@gmail.com Blanca Hernández-Cruz, MD, PhD, Principal Investigator Paula Cejas, MD, Sub-Investigator
Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona 08907, Spain; Recruiting Carmen GĂłmez-Vaquero, MD, PhD, Phone: +34 93 2607712, Email: carmen.gomez@bellvitgehospital.cat Javier Narváez, MD, PhD, Principal Investigator Joan M Nolla, MD, PhD, Sub-Investigator Jose Antonio Narváez, MD, Sub-Investigator Javier Hernández-Gañan, MD, Sub-Investigator Pedro AlĂa, MD, PhD, Sub-Investigator
Hospital de Sant Joan DespĂ MoisĂ©s Broggi, Sant Joan DespĂ, Barcelona 08970, Spain; Recruiting Daniel Roig-Vilaseca, MD, PhD, Phone: 34 93 5531200, Ext: 8523, Email: 26188drv@comb.cat Daniel Roig-Vilaseca, MD, PhD, Principal Investigator
Hospital Residència Sant Camil, Sant Pere de Ribes, Barcelona 08810, Spain; Recruiting Esther Campoy, MD, PhD, Phone: 34 93 8960025, Ext: 3515, Email: ecampoy@csg.cat Esther Campoy, MD, PhD, Principal Investigator
Hospital de Viladecans, Viladecans, Barcelona 08840, Spain; Recruiting JosĂ© MarĂa Ruiz, MD, Phone: 34 93 6590111, Ext: 251, Email: jmruiz.hv@gencat.cat JosĂ© MarĂa Ruiz, MD, Principal Investigator Sergi Ros, MD, PhD, Sub-Investigator
Hospital Universitario de Cruces, Barakaldo, Bilbao 48903, Spain; Recruiting Joana Atxotegui Saenz de Buruaga, MD, Phone: 34 94 6006470, Email: joana.atxotegisaenzdeburuaga@osakidetza.net Joana Atxotegui Saenz de Buruaga, MD, Principal Investigator Alberto Alonso, MD, PhD, Sub-Investigator Nathalie Rivas, MD, Sub-Investigator
Hospital Universitari Son Espases, Palma de Mallorca, Mallorca 07120, Spain; Recruiting Jordi Fiter, MD, Phone: +34 871205345, Email: jordi.fiter@ssib.es Jordi Fiter, MD, Principal Investigator LluĂs Espadaler, MD, Sub-Investigator
Additional Information
Starting date: May 2014
Last updated: March 23, 2015
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