Real-Life and RCT Participants: Alendronate Users Versus FITs' Trial Eligibility Criterion.
We aimed to characterize incident users of alendronate from Denmark and Spain, and investigate their eligibility for participation in the pivotal Fracture Intervention Trial (FIT). This is an international cross-sectional study, where the data were obtained from the SIDIAP database (Sistema d'Informació per al Desenvolupament de l'Investigació en Atenció Primària) from Catalonia (Spain) and the Danish Health Registries (DHR). This study included patients who were incident users of alendronate, ≥40 years old with no history of Paget's disease. Our measurements were the proportion of incident users of alendronate who were not eligible to participate in FIT. 14,316 and 21,221 subjects initiated alendronate in 2006-2007 (SIDIAP) and 2005-2006 (DHR), respectively. SIDIAP and DHR alendronate user cohorts had 2347 (16.4 %) and 5275 (24.9 %) subjects aged >80 years old, reported 9 (0.1 %) and 91 (0.4 %) diagnoses of myocardial infarction, 423 (3 %) and 368 (1.7 %) of erosive gastro-intestinal disease, 200 (1.4 %) and 1109 (5.2 %) of dyspepsia, and 349 (2.4 %) and 149 (0.7 %) of metabolic bone disease, all of which were exclusion criteria in FIT. Men [3818 (26.7 %) in SIDIAP and 3885 (18.3 %) in DHR] and glucocorticoid users [1229 (8.6 %) in SIDIAP and 4716 (22.2 %) in DHR] were also excluded from the FIT trial. Overall, 3447 (35.4 %) SIDIAP and 6228 (44.5 %) (when not considering men and glucocorticoid users) DHR of incident alendronate users would have been excluded from FIT. One in two real-life users of alendronate exhibited one or more clinical characteristics that would have led to them being excluded from the FIT trial.
GREMPAL Research Group, Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Universitat Autònoma de Barcelona, Gran Via Corts Catalanes 587, 08007, Barcelona, Spain.
Carlen
C
Reyes
Clinical Pharmacology, Department of Public Health, University of Southern Denmark, J.B. Winsløws Vej 9B, 2nd Floor, 5000, Odense C, Denmark.
Anton
A
Pottegård
Department of Endocrinology, Research Centre for Ageing and Osteoporosis, Rigshospitalet-Glostrup Hospital, Nordre Ringvej 69, Glostrup, 2600, Copenhagen, Denmark.
Peter
P
Schwarz
Oxford NIHR Musculoskeletal Biomedical Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Nuffield Orthopaedic Centre, University of oxford, Windmill Road, Oxford, OX3 7LD, UK.|MRC Lifecourse Epidemiology Unit, Southampton General Hospital, University of Southampton, Southampton, SO16 6YD, UK.
M Kassim
MK
Javaid
Health eResearch Centre, Farr Institute for Health Informatics Research, University of Manchester, 1.003 Vaughan House, Portsmouth Road, Manchester, M13 9PL, UK.|Department of Pharmacoepidemiology, Utrecht University, Utrecht, The Netherlands.
Tjeerd P
TP
Van Staa
Oxford NIHR Musculoskeletal Biomedical Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Nuffield Orthopaedic Centre, University of oxford, Windmill Road, Oxford, OX3 7LD, UK.|MRC Lifecourse Epidemiology Unit, Southampton General Hospital, University of Southampton, Southampton, SO16 6YD, UK.|National Institute for Health Research Nutrition Biomedical Research Centre, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton General Hospital, Southampton, SO16 6YD, UK.
Cyrus
C
Cooper
Musculoskeletal Research Unit and RETICEF, IMIM Research Foundation, Parc de Salut Mar and Instituto de Salud Carlos III, Parc de Recerca Biomèdica de Barcelona, Universitat Autònoma de Barcelona, c/Dr. Aiguader 88, 08003, Barcelona, Spain. ADiez@parcdesalutmar.cat.
Adolfo
A
Diez-Perez
Department of Medicine, Holbæk Hospital, Smedelundsgade 60, Holbæk, 4300, Holbæk, Denmark.|OPEN Odense Patient Data Explorative Network, Institute of Clinical Research, Department of Clinical Research, University of Southern Denmark, J.B. Winsløws Vej 9 A, 3. Sal., 5000, Odense C, Denmark.
Bo
B
Abrahamsen
GREMPAL Research Group, Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Universitat Autònoma de Barcelona, Gran Via Corts Catalanes 587, 08007, Barcelona, Spain.|Oxford NIHR Musculoskeletal Biomedical Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Nuffield Orthopaedic Centre, University of oxford, Windmill Road, Oxford, OX3 7LD, UK.|MRC Lifecourse Epidemiology Unit, Southampton General Hospital, University of Southampton, Southampton, SO16 6YD, UK.|Musculoskeletal Research Unit and RETICEF, IMIM Research Foundation, Parc de Salut Mar and Instituto de Salud Carlos III, Parc de Recerca Biomèdica de Barcelona, Universitat Autònoma de Barcelona, c/Dr. Aiguader 88, 08003, Barcelona, Spain.
Daniel
D
Prieto-Alhambra
D000328:Adult; D000369:Aged, 80 and over; D019386:Alendronate / Q000008:administration & dosage / Q000009:adverse effects*; D015992:Body Mass Index; D015331:Cohort Studies; D003430:Cross-Sectional Studies; D005260:Female; D050723:Fractures, Bone / Q000209:etiology*; D005938:Glucocorticoids / Q000008:administration & dosage / Q000009:adverse effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic
D005938:Glucocorticoids; D019386:Alendronate
Alendronate; Observational study; Osteoporosis; Population characteristics; Randomized controlled trial