![Sample our Bioscience journals, sign in here to start your access, Latest two full volumes FREE to you for 14 days]({"type":"image" , "src" : "/sda/5925/TOC-Subject-Sample-2021-Bioscience.jpg"})
Abstract
Introduction:
Postmenopausal osteoporosis is a chronic disease requiring treatment that balances long-term fracture efficacy against risk.
Methods:
We reviewed the efficacy and safety of calcium and vitamin D, the selective estrogen receptor modulators (SERMs), the bisphosphonates, denosumab, and strontium ranelate in studies of 3 years or longer.
Results:
Six trials lasted for 5 years, and seven went beyond that. The evidence beyond 5 years is generally weak, mainly due to methodological issues (open-label design, small samples, or absence of placebo control). Although calcium and vitamin D appear to be beneficial, the data are insufficient to evaluate benefits and risk beyond 3 years. The fracture efficacy of SERMs beyond 5 years is not known, though increases in bone mineral density (BMD) appear to be maintained. The SERMs have good long-term safety, including protective effects against breast cancer. The bisphosphonates have established fracture efficacy to 3 years, and 4 or 5 years with alendronate and risedronate. The evidence beyond 5 years indicates sustained increases in BMD. The safety of the bisphosphonates does not appear to be modified with time, with the possible exceptions of atypical subtrochanteric fracture and other events of unknown frequency. Denosumab has been tested up to 5 years, with continued increased in BMD and no reported safety issues. There is evidence for fracture efficacy of strontium ranelate, and sustained increases in BMD over 10 years. Strontium ranelate has good long-term safety.
Conclusion:
Robust long-term studies are relatively rare for the osteoporosis treatments, and generally show maintenance of BMD and, for some agents, an additional reduction in fracture incidence.
Transparency
Declaration of funding
This study was not funded.
Declaration of financial/other interests
C.C. has disclosed receiving 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. J.-Y.R. has disclosed receiving 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. B.C. has disclosed receiving consulting fees, paid advisory boards, lecture fees, and/or grant support from Servier, Novartis, Lilly, Amgen, GlaxoSmithKline, Roche, Nycomed, Merck Sharp and Dohme, Alliance for Better Bone Health, and Medtronic. M.D.-C. has disclosed receiving consulting fees, paid advisory boards, and/or grant support from Amgen, GlaxoSmithKline, Lilly, Merck Sharp and Dohme, Nycomed, Procter&Gamble, Roche, and Servier. R.S.L. has disclosed that he/she has no significant relationships with or financial interests in any commercial companies related to this study or article. J.A.K. has disclosed receiving consulting fees, paid advisory boards, lecture fees, and/or grant support from the majority of companies concerned with skeletal metabolism. R.R. has disclosed receiving fees from advisory boards and lecture fee for Merck Sharp and Dohme, Eli Lilly, Amgen, Wyeth, Novartis, Servier, Nycomed, and Danone.
CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.
Acknowledgments
This paper was derived from a Working Group meeting supported by the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO). Ms Sarah Novack is sincerely acknowledged for her editorial assistance.