The position of strontium ranelate in today’s management of osteoporosis
- 983 Downloads
Osteoporosis accounts for about 3 % of total European health-care spending. The low proportion of costs for the pharmacological prevention of osteoporotic fracture means that it is highly cost saving, especially in patient with severe osteoporosis or patients who cannot take certain osteoporosis medications due to issues of contraindications or tolerability. Following recent regulatory changes, strontium ranelate is now indicated in patients with severe osteoporosis for whom treatment with other osteoporosis treatments is not possible, and without contraindications including uncontrolled hypertension, established, current or past history of ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease. We review here today’s evidence for the safety and efficacy of strontium ranelate. The efficacy of strontium ranelate in patients complying with the new prescribing information (i.e. severe osteoporosis without contraindications) has been explored in a multivariate analysis of clinical trial data, which concluded that the antifracture efficacy of strontium ranelate is maintained in patients with severe osteoporosis without contraindications and also demonstrated how the new target population mitigates risk. Strontium ranelate is therefore an important alternative in today’s management of osteoporosis, with a positive benefit-risk balance, provided that the revised indication and contraindications are followed and cardiovascular risk is monitored. The bone community should be reassured that there remain viable alternatives in patients in whom treatment with other agents is not possible and protection against the debilitating effects of fracture is still feasible in patients with severe osteoporosis.
KeywordsEfficacy Osteoporosis Safety Strontium ranelate Treatment
Conflict of interest
J.-Y. Reginster received consulting fees, paid advisory boards, lecture fees and/or grant support from Servier, Novartis, Negma, Lilly, Wyeth, Amgen, GlaxoSmithKline, Roche, Merckle, Nycomed, NPS, Theramex, UCB, Merck Sharp and Dohme, Rottapharm, IBSA, Genevrier, Teijin, Teva, Ebewee Pharma, Zodiac, Analis, Novo Nordisk and Bristol Myers Squibb. M.-L. Brandi received consulting fees, paid advisory boards, lecture fees and/or grant support from Amgen, Eli Lilly, Merck Sharp & Dohme, Novartis, Servier, Spa, Stroder and NPS. J. Cannata Andia is a member of international steering committees and scientific advisory boards of Amgen, Abbott, Shire, Roche and Servier. C. Cooper received consulting fees and paid advisory boards for Alliance for Better Bone Health, GlaxoSmithKline, Roche, Merck Sharp and Dohme, Lilly, Amgen, Wyeth, Novartis, Servier and Nycomed. B. Cortet received consultancy or speaker fees from Amgen, Ferring, Lilly, MSD, Medtronic, Novartis, Roche diagnostics, Rottapharm and Servier. J.-M. Feron received paid advisory board and consultant fees for Servier and Lilly. H. Genant is a consultant and/or advisory board for Servier, Amgen, Merck, Lilly, Pfizer, GSK, BMS, Novartis, Roche, Takeda, Janssen, ONO and Radius. S. Palacios is a symposium speaker or advisory board member for Servier, Pfizer, GSK, Abbott, Ferrer, Bioiberica, Shionogi, Amgen Inc. and Novo Nordisk and received research grants and/or consulting fees from Pfizer, Servier, Amgen Inc., MSD, Preglem, Leon Farma, Gynea, Sandoz and Bayer. J.D. Ringe received paid advisory board for Servier and advises to and lectures for various pharmaceutical companies in the field of osteoporosis. R. Rizzoli received paid advisory boards and lecture fees for Merck Sharp and Dohme, Amgen, Servier, Takeda and Danone.
- 2.Hiligsmann M, Bruyere O, Reginster JY (2010) Cost-effectiveness of strontium ranelate versus risedronate in the treatment of postmenopausal osteoporotic women aged over 75 years. Bone 46:440–446Google Scholar
- 5.European Medicines Agency (2014) Strontium ranelate. Summary of product characteristics. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000560/WC500045525.pdf. Accessed 18 July 2014
- 8.European Medicines Agency (2013) Assessment report—periodic safety update report (EPAR - Protelos-H-C-560-PSU31). http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Assessment_Report_-_Variation/human/000560/WC500147168.pdf. Accessed 3 Feb 2014
- 9.Audran M, Jakob FJ, Palacios S et al (2013) A large prospective European cohort study of patients treated with strontium ranelate and followed up over 3 years. Rheumatol Int 33:2231–2239Google Scholar
- 12.Svanström H, Pasternak B, Hviid A (2014) Use of strontium ranelate and risk of acute coronary syndrome: cohort study. Ann Rheum Dis 73:1037–1043Google Scholar
- 15.Kanis JA, Johansson H, Odén A et al. (2014) A meta-analysis of the effect of strontium ranelate on the risk of vertebral and non-vertebral fracture in postmenopausal osteoporosis: the impact of severe osteoporosis and contraindications. Abstract OC25. Presented at the World Congress on Osteoporosis and Osteoarthritis and Musculoskeletal Diseases. WCO-IOF-ESCEO, Seville, SpainGoogle Scholar