PMID- 21365461 OWN - NLM STAT- MEDLINE DCOM- 20120321 LR - 20220321 IS - 1433-2965 (Electronic) IS - 0937-941X (Linking) VI - 23 IP - 1 DP - 2012 Jan TI - Vertebral fracture efficacy during risedronate therapy in patients using proton pump inhibitors. PG - 277-84 LID - 10.1007/s00198-011-1574-5 [doi] AB - Recent evidence suggests that proton pump inhibitor (PPI) use may affect fracture risk, an important issue for patients being concurrently treated for osteoporosis. The results of our post hoc analysis showed that, regardless of PPI concomitant use, risedronate significantly reduced the risk of new vertebral fractures compared with placebo. INTRODUCTION: Recent evidence suggests that PPI use may affect fracture risk, an important issue for patients being concurrently treated for osteoporosis. Moreover, data suggest that concomitant use of PPIs may wane the anti-fracture effect of bisphosphonates. We explored the relationship between concomitant use of PPIs and incident vertebral fractures among patients treated with risedronate or placebo. Bone mineral density (BMD) and upper gastrointestinal (UGI) adverse events (AEs) were also assessed. METHODS: This study is a post hoc analysis of a subset of patients participating in three prospective, randomized, placebo-controlled clinical trials, with durations of up to 3 years, which evaluated the efficacy of risedronate in reducing fracture risk: Vertebral Efficacy with Risedronate Trial-MultiNational (VERT-MN); Vertebral Efficacy with Risedronate Trial-North America (VERT-NA); and the risedronate Hip Intervention Program (HIP). RESULTS: Total enrollment included 2,729 risedronate and 2,725 placebo patients. Concomitant acid-suppressing drugs were used by 8.8% of the total population (n = 482). Regardless of PPI concomitant use, risedronate significantly reduced the risk of new vertebral fractures compared with placebo (risk reduction: PPI users 57%, p = 0.009; PPI non-users 38%, p < 0.001). BMD increased with risedronate, independent of PPI use. PPI users were at a 2.5-fold greater risk of experiencing at least one UGI AE compared with non-users. CONCLUSIONS: Risedronate significantly reduced the risk of new vertebral fractures compared with placebo, regardless of PPI concomitant use. FAU - Roux, C AU - Roux C AD - Department of Rheumatology, AP-HP Cochin Hospital, Paris Descartes University, 27 rue Faubourg Saint Jacques, Paris 75014, France. christian.roux@cch.aphp.fr FAU - Goldstein, J L AU - Goldstein JL FAU - Zhou, X AU - Zhou X FAU - Klemes, A AU - Klemes A FAU - Lindsay, R AU - Lindsay R LA - eng PT - Journal Article PT - Meta-Analysis DEP - 20110302 PL - England TA - Osteoporos Int JT - Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA JID - 9100105 RN - 0 (Bone Density Conservation Agents) RN - 0 (Proton Pump Inhibitors) RN - KM2Z91756Z (Risedronic Acid) RN - M2F465ROXU (Etidronic Acid) SB - IM MH - Aged MH - Aged, 80 and over MH - Bone Density/drug effects MH - Bone Density Conservation Agents/adverse effects/*therapeutic use MH - Etidronic Acid/adverse effects/*analogs & derivatives/therapeutic use MH - Female MH - Femur Neck/physiopathology MH - Gastrointestinal Diseases/chemically induced MH - Humans MH - Lumbar Vertebrae/physiopathology MH - Middle Aged MH - Osteoporosis, Postmenopausal/complications/drug therapy/physiopathology MH - Osteoporotic Fractures/*prevention & control MH - Polypharmacy MH - Proton Pump Inhibitors/*adverse effects/pharmacology MH - Randomized Controlled Trials as Topic MH - Risedronic Acid MH - Spinal Fractures/etiology/*prevention & control MH - Treatment Outcome EDAT- 2011/03/03 06:00 MHDA- 2012/03/22 06:00 CRDT- 2011/03/03 06:00 PHST- 2010/10/12 00:00 [received] PHST- 2011/01/19 00:00 [accepted] PHST- 2011/03/03 06:00 [entrez] PHST- 2011/03/03 06:00 [pubmed] PHST- 2012/03/22 06:00 [medline] AID - 10.1007/s00198-011-1574-5 [doi] PST - ppublish SO - Osteoporos Int. 2012 Jan;23(1):277-84. doi: 10.1007/s00198-011-1574-5. Epub 2011 Mar 2.