Abstract
We evaluated the efficacy and safety of intramuscular clodronate (CLO) for the treatment of active erosive osteoarthritis of the hand (EOA). Forty outpatients treated with anti-inflammatory (NSAIDs) or analgesic drugs since at least 6 months, for at least 3 days a week, were randomly divided into two groups. Group A: 24 patients treated for 6 months with intramuscular (i.m.) CLO added to usual NSAIDs or analgesic drugs. The attack dose was 200 mg/day i.m. for 10 days followed by a maintenance dose of CLO i.m. 200 mg/day for 6 days after 3 and 6 months. Group B: 16 patients who continued the usual treatment with anti-inflammatory or analgesic drugs. Patients in both groups reported in a diary, day by day, the consumption of symptomatic drugs. In group A, the consumption of anti-inflammatory or analgesic drugs (p < 0.0001), pain (p < 0.0001), number of tender joints (p = 0.0097), number of swollen joints (p = 0.0251), Dreiser score (p = 0.0119), and patient’s and physician’s global assessment of disease activity significantly decreased (both p < 0.001). At 6 months, serum COMP also significantly decreased (p < 0.0029). Strength of right (p = 0.0465) and left hand (+38%, p = ns) significantly increased. In group B, there was no significant change in all parameters considered. Intramuscular CLO in EOA of the hand is effective and safe on pain with a significant reduction in the consumption of anti-inflammatory or analgesic drugs, increasing the functionality of the hands. Serum COMP reduction suggests that CLO could play a role as a disease-modifying drug (EudraCT number 2013–000832-85).
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06 April 2018
One of the author names on this article was incorrectly tagged during the article mark-up; Luca Dalle Carbonare’s name has now been correctly tagged, with first name ‘Luca’ and last name ‘Dalle Carbonare’.
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The authors thank Dr. Laura Comini for the critical revision and editing of the manuscript.
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Recruitment of patients and assessment: Gianantonio Saviola, Lul Abdi-Ali, Maria Rosaria Povino and Luca Dalle Carbonare.
Clinical analysis: Lorella Campostrini and Silvano Sacco.
Statistics: Silvano Sacco.
Protocol development: Gianantonio Saviola.
Manuscript preparation: Gianantonio Saviola, Luca Dalle Carbonare, and Silvano Sacco.
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Saviola, G., Abdi-Ali, L., Povino, M.R. et al. Intramuscular clodronate in erosive osteoarthritis of the hand is effective on pain and reduces serum COMP: a randomized pilot trial—The ER.O.D.E. study (ERosive Osteoarthritis and Disodium-clodronate Evaluation). Clin Rheumatol 36, 2343–2350 (2017). https://doi.org/10.1007/s10067-017-3681-y
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DOI: https://doi.org/10.1007/s10067-017-3681-y