A comparison of adverse event and fracture efficacy data for strontium ranelate in regulatory documents and the publication record

BMJ Open

Volumn 4, Issue 10, 2014, Pages

  Bolland, Mark J ^a   Grey, Andrew ^a  

^a UNIVERSITY OF AUCKLAND   (New Zealand)

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO; STRONTIUM RANELATE; BONE DENSITY CONSERVATION AGENT; THIOPHENE DERIVATIVE;

ARTICLE; CARDIOVASCULAR RISK; DISEASE PREDISPOSITION; DRUG EFFICACY; DRUG SURVEILLANCE PROGRAM; FRACTURE; HEART INFARCTION; HUMAN; LUNG EMBOLISM; MEDICAL DOCUMENTATION; MEDICAL LITERATURE; PHASE 3 CLINICAL TRIAL (TOPIC); RANDOMIZED CONTROLLED TRIAL (TOPIC); SYSTEMATIC REVIEW; VENOUS THROMBOEMBOLISM; CHEMICALLY INDUCED; COMPARATIVE STUDY; COMPLICATION; DRUG CONTROL; OSTEOPOROSIS; OSTEOPOROTIC FRACTURES; PUBLICATION; RESEARCH; RISK ASSESSMENT;

BONE DENSITY CONSERVATION AGENTS; DRUG AND NARCOTIC CONTROL; HUMANS; MYOCARDIAL INFARCTION; OSTEOPOROSIS; OSTEOPOROTIC FRACTURES; PERIODICALS AS TOPIC; PULMONARY EMBOLISM; RESEARCH REPORT; RISK ASSESSMENT; THIOPHENES; VENOUS THROMBOEMBOLISM;

EID: 84908119915     PISSN: None     EISSN: 20446055     Source Type: Journal    
DOI: 10.1136/bmjopen-2014-005787     Document Type: Article

References (25)

1. Meunier PJ, Reginster JY. Design and methodology of the phase 3 trials for the clinical development of strontium ranelate in the treatment of women with postmenopausal osteoporosis. Osteoporos Int 2003;14(Suppl 3):S66-76.
2. Kaufman JM, Audran M, Bianchi G, et al. Efficacy and safety of strontium ranelate in the treatment of osteoporosis in men. J Clin Endocrinol Metab 2013;98:592-601.
3. Hernlund E, Svedbom A, Ivergard M, et al. Osteoporosis in the European Union: medical management, epidemiology and economic burden. A report prepared in collaboration with the International Osteoporosis Foundation (IOF) and the European Federation of Pharmaceutical Industry Associations (EFPIA). Arch Osteoporos 2013;8:136.
4. European Medicines Agency. Protelos-H-C-560-PSU-31: EPAR - Assessment Report - Periodic safety update report. 2013. http://www.ema.europa.eu/docs/en-GB/document-library/EPAR---Assessment-Report---Variation/human/000560/WC500147168.pdf
5. European Medicines Agency. Press release: PRAC recommends suspending use of Protelos/Osseor. 2014. http://www.ema.europa.eu/ema/index.jsp?curl=pages/news-and-events/news/2014/01/news-detail-002005.jsp&mid=WC0b01ac58004d5c1
6. European Medicines Agency. Protelos and Osseor Article-20 procedure: CHMP scientific conclusions and PRAC assessment report. 2014. http://www.ema.europa.eu/docs/en-GB/document-library/Referrals-document/Protelos-and-Osseor/Opinion-provided-by-Committee-for-Medicinal-Products-for-Human-Use/WC500162132.pdf
7. European Medicines Agency. Press release: European Medicines Agency recommends that Protelos/Osseor remain available but with further restrictions. 2014. http://www.ema.europa.eu/ema/index.jsp?curl=pages/news-and-events/news/2014/02/news-detail-002031.jsp&mid=WC0b01ac58001d126
8. Topol EJ. Failing the public health - rofecoxib, Merck, and the FDA. N Engl J Med 2004;351:1707-9.
9. Cohen D. Rosiglitazone: what went wrong? BMJ 2010;341:c4848.
10. Healy D. Did regulators fail over selective serotonin reuptake inhibitors? BMJ 2006;333:92-5.
11. Gotzsche PC. Why we need easy access to all data from all clinical trials and how to accomplish it. Trials 2011;12:249.
12. European Medicines Agency. Protelos: EPAR - Scientific Discussion. 2005. http://www.ema.europa.eu/docs/en-GB/document-library/EPAR---Scientific-Discussion/human/000560/WC500045522.pdf
13. European Medicines Agency. Protelos-H-C-560-A20-34: EPAR - Assessment Report - Article 20. 2012. http://www.ema.europa.eu/docs/en-GB/document-library/EPAR---Assessment-Report---Variation/human/000560/WC500131789.pdf
14. European Medicines Agency. Protelos-H-C-560-II-31: EPAR - Assessment Report - Variation. 2012. http://www.ema.europa.eu/docs/en-GB/document-library/EPAR---Assessment-Report---Variation/human/000560/WC500131790.pdf
15. Meunier PJ, Slosman DO, Delmas PD, et al. Strontium ranelate: dose-dependent effects in established postmenopausal vertebral osteoporosis - a 2-year randomized placebo controlled trial. J Clin Endocrinol Metab 2002;87:2060-6.
16. Meunier PJ, Roux C, Seeman E, et al. The effects of strontium ranelate on the risk of vertebral fracture in women with postmenopausal osteoporosis. N Engl J Med 2004;350:459-68.
17. Reginster JY, Seeman E, De Vernejoul MC, et al. Strontium ranelate reduces the risk of nonvertebral fractures in postmenopausal women with osteoporosis: Treatment of Peripheral Osteoporosis (TROPOS) study. J Clin Endocrinol Metab 2005;90:2816-22.
18. Hwang JS, Chen JF, Yang TS, et al . The effects of strontium ranelate in Asian women with postmenopausal osteoporosis. Calcif Tissue Int 2008;83:308-14.
19. Reginster JY, Felsenberg D, Boonen S, et al. Effects of long-term strontium ranelate treatment on the risk of nonvertebral and vertebral fractures in postmenopausal osteoporosis: results of a five-year, randomized, placebo-controlled trial. Arthritis Rheum 2008;58:1687-95.
20. Liu JM, Wai-Chee Kung A, Pheng CS, et al. Efficacy and safety of 2 g/day of strontium ranelate in Asian women with postmenopausal osteoporosis. Bone 2009;45:460-5.
21. Meunier PJ, Roux C, Ortolani S, et al. Effects of long-term strontium ranelate treatment on vertebral fracture risk in postmenopausal women with osteoporosis. Osteoporos Int 2009;20:1663-73.
22. Reginster JY, Badurski J, Bellamy N, et al. Efficacy and safety of strontium ranelate in the treatment of knee osteoarthritis: results of a double-blind, randomised placebo-controlled trial. Ann Rheum Dis 2013;72:179-86.
23. O'Donnell S, Cranney A, Wells GA, et al. Strontium ranelate for preventing and treating postmenopausal osteoporosis. Cochrane Database Syst Rev 2006:CD005326.
24. Bolland MJ, Barber A, Doughty RN, et al. Differences between self-reported and verified adverse cardiovascular events in a randomised clinical trial. BMJ Open 2013;3:e002334.
25. Doshi P, Groves T, Loder E. Clinical trial data: get them while you can. BMJ 2014;348:g63.