Novel formulations of oral bisphosphonates in the treatment of osteoporosis
Nicholas R. Fuggle, Nasser M. Al‐Daghri, Olivier Bock, Jaime Branco, Olivier Bruyère, E. Casado, Etienne Cavalier, Bernard Cortet, Maarten de Wit, Andrea Giusti, Philippe Halbout, Nicholas C. Harvey, Mickaël Hiligsmann, Jean‐Marc Kaufman, Andreas Kurth, Stefania Maggi, Radmila Matijević, Salvatore Minisola, Santiago Palacios, Régis Radermecker, Friederike Thomasius, Şansın Tüzün, Nicola Veronese, John A Kanis, Jean‐Yves Reginster, René Rizzoli, Cyrus Cooper
Abstract
Oral bisphosphonates are a key intervention in the treatment of osteoporosis and in reducing the risk of fragility fractures. Their use is supported by over 3 decades of evidence; however, patient adherence to oral bisphosphonates remains poor in part due to complex dosing instructions and adverse events, including upper gastrointestinal symptoms. This problem has led to the development of novel oral bisphosphonate formulations. Buffered, effervescent alendronate is dissolved in water and so seeks to reduce upper gastro-intestinal adverse events, and gastro-resistant risedronate aims to reduce the complexity of dosing procedure (e.g. fasting prior to consumption) whilst still maintaining the efficacy of fracture risk reduction. Clinical trials and real-world data have been employed to demonstrate some benefits in terms of reduced upper gastro-intestinal adverse events, adherence, persistence and health economic outcomes. This report describes the result of an ESCEO (European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis) expert working group, which explores where oral bisphosphonates sit in current clinical practice guidelines, review their risk-benefit profile and the consequences of poor adherence before exploring novel oral bisphosphonate formulations and their potential clinical and health economic impact. Further research is required but there are signs that these novel, oral bisphosphonate formulations may lead to improved tolerance of oral bisphosphonates and thus, improved adherence and fracture outcomes.