Safety of Oral Bisphosphonates in Moderate-to-Severe Chronic Kidney Disease: A Binational Cohort Analysis

  • Danielle E Robinson
    Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS) University of Oxford Oxford UK
  • M Sanni Ali
    Department of Public Health Saint Paul Hospital Millennium Medical College Addis Ababa Ethiopia
  • Natalia Pallares
    Biostatistics Unit, Bellvitge Biomedical Research Institute (IDIBELL) L'Hospitalet de Llobregat Barcelona Spain
  • Cristian Tebé
    Basic Medical Sciences Department Rovira Virgili University Tarragona Spain
  • Leena Elhussein
    Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS) University of Oxford Oxford UK
  • Bo Abrahamsen
    Holbæk Hospital, Department of Medicine Holbæk Denmark
  • Nigel K Arden
    Sport, Exercise and Arthritis Centre: Versus Arthritis University of Oxford Oxford UK
  • Yoav Ben-Shlomo
    Population Health Sciences Bristol Medical School, University of Bristol Bristol UK
  • Fergus J Caskey
    North Bristol NHS Trust Bristol UK
  • Cyrus Cooper
    MRC Lifecourse Epidemiology Unit University of Southampton Southampton UK
  • Daniel Dedman
    Clinical Practice Research Datalink (CPRD) London UK
  • Antonella Delmestri
    Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS) University of Oxford Oxford UK
  • Andrew Judge
    Musculoskeletal Research Unit Translational Health Sciences, Bristol Medical School, University of Bristol Bristol UK
  • María José Pérez-Sáez
    Department of Nephrology Hospital del Mar Barcelona Spain
  • Julio Pascual
    Department of Nephrology Hospital del Mar Barcelona Spain
  • Xavier Nogues
    Hospital del Mar Institute of Medical Research Autonomous University of Barcelona Research Network on Frailty and Healthy Aging (CIBERFES) Instituto Carlos III Barcelona Spain
  • Adolfo Diez-Perez
    Internal Medicine, IMIM (Hospital del Mar Research Institute), Centro de Investigación Biomédica en Red de Fragilidad y Envejecimiento Saludable (CIBERFES) Barcelona Spain
  • Victoria Y Strauss
    Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS) University of Oxford Oxford UK
  • M Kassim Javaid
    NDORMS, University of Oxford Oxford UK
  • Daniel Prieto-Alhambra
    Grup de Recerca en Malalties Prevalents de l'Aparell Locomotor (GREMPAL) Research Group and CIBERFes, University Institute for Primary Care Research (IDIAP) Jordi Gol, Universitat Autonoma de Barcelona and Instituto de Salud Carlos III Barcelona Spain

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<jats:title>ABSTRACT</jats:title> <jats:p>Bisphosphonates are the first-line treatment for preventing fractures in osteoporosis patients. However, their use is contraindicated or to be used with caution in chronic kidney disease (CKD) patients, primarily because of a lack of information about their safety and effectiveness. We aimed to investigate the safety of oral bisphosphonates in patients with moderate to severe CKD, using primary-care electronic records from two cohorts, CPRD GOLD (1997–2016) and SIDIAP (2007–2015) in the UK and Catalonia, respectively. Both databases were linked to hospital records. SIDIAP was also linked to end-stage renal disease registry data. Patients with CKD stages 3b to 5, based on two or more estimated glomerular filtration rate measurements less than 45 mL/min/1.73 m2, aged 40 years or older were identified. New bisphosphonate users were propensity score–matched with up to five non-users to minimize confounding within this population. Our primary outcome was CKD stage worsening (estimated glomerular filtration rate [eGFR] decline or renal replacement therapy). Secondary outcomes were acute kidney injury, gastrointestinal bleeding/ulcers, and severe hypocalcemia. Hazard ratios (HRs) were estimated using Cox regression and Fine and Gray sub-HRs were calculated for competing risks. We matched 2447 bisphosphonate users with 8931 non-users from CPRD and 1399 users with 6547 non-users from SIDIAP. Bisphosphonate use was associated with greater risk of CKD progression in CPRD (sub-HR [95% CI]: 1.14 [1.04, 1.26]) and SIDIAP (sub-HR: 1.15 [1.04, 1.27]). No risk differences were found for acute kidney injury, gastrointestinal bleeding/ulcers, or hypocalcemia. Hence, we can conclude a modest (15%) increased risk of CKD progression was identified in association with bisphosphonate use. No other safety concerns were identified. Our findings should be considered before prescribing bisphosphonates to patients with moderate to severe CKD. © 2020 The Authors. Journal of Bone and Mineral Research published byWiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).</jats:p>

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