Thursday, July 26, 2012

Strontium ranelate in Knee Osteoarthritis at the EULAR 2012

Strontium ranelate in knee osteoarthritis has also been advocated at the EULAR 2012 in Berlin. It has been the Cooper/ Reginster study that had been discussed at the IOF-ECCEO12 Congress at Bordeaux earlier this year ( In April this year I've received a Red Hand Letter concerning strontium ranelate (Link to the German text: EMEA and the German Bundesinstitut für Arzneimittel und Medizinprodukte had Servier to inform all physicians in Germany about new risks concerning strontium ranelate. There is a contraindication for patients with acute venous thrombembolism, phlebothrombosis, or pulmonary embolism. Also immobilized patients aren't allowed to take strontium ranelate. Reason for this information is a study that has been published in France. More about risks at:

C. Cooper and colleagues looked at efficacy and safety of strontium ranelate in the treatment of knee osteoarthritis. The text on “objectives” doesn’t give a clue to an endpoint of the study. In “results” we are given characteristics in mean values of the patients that were assigned to the study in 113 centres. No result whatsoever! In “conclusions” we are given wishful thinking instead of conclusions drawn from results.

C. Cooper1, R. Chapurlat2, C. Christiansen3, H. Genant4, N. Bellamy5, W. Bensen6, F. Navarro7, J. Badurski8, E. Nasonov9, X. Chevalier10, P. Sambrook11, T. Spector12, J.-Y. Reginster13. 1MRC Lifecourse Epidemiology Unit, Southampton General Hospital, Southampton, United Kingdom; 2INSERM UMR 1033 and Université de Lyon, Hôpital Edouard Herriot, Lyon, France; 3CCBR Ballerup, Ballerup, Denmark; 4Radiology, Medicine and Orthopaedic Surgery University of California San Francisco, and Synarc, San Francisco, United States; 5University of Queensland, Royal Brisbane and Women's Hospital, Herston, Queensland, Australia; 6McMaster University Hamilton, Ontario, Canada; 7H. Clinico Virgen de la Macarena Servicio de Reumatologia, Sevilla, Spain; 8Centre of Osteoporosis and Osteo– articular Diseases, Bialystock, Poland; 9State Institute of Rheumatology, the Russian Academy of Medical Sciences, Moscow, Russian Federation; 10Hôpital Henri Mondor, Créteil, France; 11Royal North Shore Hospital, St. Leonards NSW, Australia; 12Kings College London, St Thomas' Campus, London, United Kingdom; 13University of Liège, Liège, Belgium
Conclusions: This large randomised placebo-controlled study will establish the long-term efficacyof SrRan on structure and symptoms in patients with knee osteoarthritis.

Strontium ranelate isn’t a goal getter in osteoporosis therapy. It has a very low persistence in patients, link: I don’t think that strontium ranelate will be a goal getter as a drug against knee osteoarthritis. I think Servier is desperately seeking a new indication to sell strontium ranelate.

Addition at 20. February 2013:
There's an editorial in this month's isssue of the Annals of the Rheumatic Diseases (Ann Rheum Dis 2013;72:157-161 doi:10.1136/annrheumdis-2012-202453) by  Floris PJG Lafeber and Jacob M va Laar: "Strontium ranelate: ready for clinical use as a disease-modifying osteoarthritis drug?" In this editorial they also discussed cindunistat and statins, but had to conclude: "Clearly, none of the three drugs presented is ready for use as a DMOAD [Disease Modyfying Osteoarthritis Drug] in clinical practice." 

Another addendum 10.05.2013:
Strontium ranelate (Protelos®; Osseor®) ist in the discussion at the EMA. 2011 a French study showed 199 severe adverse events, 52% cardiovascular events [4.Jonville-Bera AP, et al: Presse Med. 2011: 40(10): e453-e462. as cited by Medscape Germany]. 2012 the Committee for Medicinal Products for Human Use (CHMP) added deep vein thrombosis and pulmonary embolism as contraindications. As there are more safety issues, EMA might further restrict the use of strontium ranelate.
Considering this, one would be well advised not to use strontium ranelate off-label, which would be prescribing the drug in osteoarthritis patients.

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