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Rheumatology Advance Access originally published online on April 30, 2009
Rheumatology 2009 48(7):773-778; doi:10.1093/rheumatology/kep084
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© The Author 2009. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org

Intra-articular clodronate for the treatment of knee osteoarthritis: dose ranging study vs hyaluronic acid

Maurizio Rossini1, Ombretta Viapiana1, Roberta Ramonda2, Gerolamo Bianchi3, Ignazio Olivieri4, Giovanni Lapadula5 and Silvano Adami1

1Rheumatology Unit, University of Verona, Verona, 2Division of Rheumatology, University of Padua, Padua, 3Rheumatology Unity, Ospedale di Arenzano, Genova, 4Division of Rheumatology, Ospedale di Potenza, Potenza and 5Rheumatology Unit, University of Bari, Bari, Italy.

Correspondence to: Silvano Adami, Rheumatology Unit, University of Verona, Ospedale Civile Maggiore Borgo Trento, P.le Stefani 1, 37127 Verona, Italy. E-mail: silvano.adami{at}univr.it


  Abstract

Objective. Bisphosphonates may have a chondroprotective effect in patients with knee OA (KOA), but the results of clinical trials with oral bisphosphonates have been contradictory. In this Phase 2 randomized, partially blind clinical trial, we tested the efficacy of IA clodronate vs HA in patients with primary KOA.

Methods. One hundred and fifty men or women aged 50–75 years suffering from KOA were randomized to one of five IA therapies: (i) clodronate 0.5 mg one IA injection/week for 4 weeks; (ii) clodronate 1 mg one IA injection/week for 4 weeks; (iii) clodronate 2 mg one IA injection/week for 4 weeks; (iv) clodronate 1 mg two IA injections/week for 2 weeks (clodronate 1 + 1 mg); and (v) HA 20 mg one IA injection/week for 4 weeks.

Results. Visual analogue scores (VASs) for different types of pain and the Lequesne index significantly improved in all treatment groups after the first injection and continued to improve even 2–4 weeks after the last injection without significant difference among the groups. A significant (P = 0.03) linear trend for a dose–response (0.5–2 mg clodronate) relationship was found for active movement VAS pain. Both joint extension and mobility scores improved significantly at all time points in all treatment groups without statistical differences among them.

Conclusions. This study indicates that IA clodronate provides symptomatic and functional improvements at least as good as those obtained with HA.

Trial Registration. Osservatorio Nazionale sulla Sperimentazione Clinica dei Medicinali - Agenzia Italiana del Farmaco. Comitato Etico Azienda Ospedaliera Universitaria Senese number CLIO 22/02 http://oss-sper-clin.agenziafarmaco.it

KEY WORDS: Osteoarthritis, Intra-articular treatment, Knee, Clodronate, Hyaluronic acid, Bisphosphonate, Cartilage, Bone, Pain, Mobility

Submitted 10 December 2008; revised version accepted 17 March 2009.
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