Osteoporosis management: a perspective based on bisphosphonate data from randomised clinical trials and observational databases


  • Disclosures
    Steven Boonen has received research funding from GlaxoSmithKline, Merck, Novartis, Procter and Gamble Pharmaceuticals, Roche, and sanofi-aventis. No funding was received in relation to this study. Richard Kay has received over the past 12 months consultancy fees from Astellas, Ark Therapeutics, Cogentus, Eisai, Genta, Renovo and Servier, and training fees from Astellas and Janssen-Cilag. No funding was received in relation to this study. Cyrus Cooper has received lecture fees and honoraria from Servier, ABBH, MSD, Wyeth, Eli Lilly, Amgen, and Novartis. No funding was received in relation to this study. Patrick Haentjens has no conflicts of interest or disclosures. Dirk Vanderschueren has no conflicts of interest or disclosures. Filip Callewaert has no conflicts of interest or disclosures. Koen Milisen has no conflicts of interest or disclosures. Serge Ferrari has received research funding and/or consulting fees from Procter and Gamble Pharmaceuticals, the Alliance for Better Bone Health, Merck and Co., Amgen, Novartis, and Eli Lilly. No funding was received in relation to this study.

Steven Boonen, Leuven University Center for Metabolic Bone Diseases and Division of Geriatric Medicine, Herestraat 49, B-3000, Leuven, Belgium
Tel.: + 32 1634 2648
Fax: + 32 1634 4402
Email: steven.boonen@uz.kuleuven.ac.be


Aims:  The efficacy of treatments for osteoporosis can be evaluated using a variety of study designs. This article aims to comprehensively review the evidence for bisphosphonate anti-fracture efficacy in postmenopausal women, discussing the strengths and limitations associated with each study method.

Methods:  Literature analysis included English-language publications reporting results of randomised controlled trials (RCTs), post hoc analyses, meta analyses and observational studies evaluating the efficacy of alendronate (ALN), ibandronate (IBN), risedronate (RIS) and zoledronate (ZOL), with an initial sample size ≥ 100 patients, and follow-up data for at least 1 year.

Results:  Primary and secondary analyses of RCT data suggest differences among bisphosphonates with regard to site-specific anti-fracture efficacy and onset of fracture risk reduction. While some observational studies indicate differences in clinical outcomes among these agents, others report similar effectiveness. ALN and RIS data demonstrate sustained fracture protection for up to 10 and 7 years of treatment respectively. The efficacy of IBN and ZOL has been evaluated for up to 3 and 5 years respectively.

Conclusions:  Understanding of the benefits of bisphosphonate treatment can be maximised by evaluating complementary data from RCTs and observational database studies. Fracture risk reduction with bisphosphonates is shown in RCTs and in real-world clinical settings.