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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 Despí Moisés Broggi, Sant Joan Despí, 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
José María Ruiz, MD, Phone: 34 93 6590111, Ext: 251, Email: jmruiz.hv@gencat.cat
José María 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

Page last updated: August 23, 2015

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