Real-Life and RCT Participants: Alendronate Users Versus FITs' Trial Eligibility Criterion

Carlen Reyes, Anton Pottegård, Peter Schwarz, M Kassim Javaid, Tjeerd P Van Staa, Cyrus Cooper, Adolfo Diez-Perez, Bo Abrahamsen, Daniel Prieto-Alhambra

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Resumé

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.

OriginalsprogEngelsk
TidsskriftCalcified Tissue International
Vol/bind99
Udgave nummer3
Sider (fra-til)243-9
Antal sider7
ISSN0171-967X
DOI
StatusUdgivet - sep. 2016

Fingeraftryk

Alendronate
Registries
Health
Glucocorticoids
Intestinal Diseases
Dyspepsia
Denmark
Cross-Sectional Studies
Databases

Citer dette

Reyes, C., Pottegård, A., Schwarz, P., Javaid, M. K., Van Staa, T. P., Cooper, C., ... Prieto-Alhambra, D. (2016). Real-Life and RCT Participants: Alendronate Users Versus FITs' Trial Eligibility Criterion. Calcified Tissue International, 99(3), 243-9. https://doi.org/10.1007/s00223-016-0141-7
Reyes, Carlen ; Pottegård, Anton ; Schwarz, Peter ; Javaid, M Kassim ; Van Staa, Tjeerd P ; Cooper, Cyrus ; Diez-Perez, Adolfo ; Abrahamsen, Bo ; Prieto-Alhambra, Daniel. / Real-Life and RCT Participants : Alendronate Users Versus FITs' Trial Eligibility Criterion. I: Calcified Tissue International. 2016 ; Bind 99, Nr. 3. s. 243-9.
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title = "Real-Life and RCT Participants: Alendronate Users Versus FITs' Trial Eligibility Criterion",
abstract = "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'Informaci{\'o} per al Desenvolupament de l'Investigaci{\'o} en Atenci{\'o} Prim{\`a}ria) 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.",
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Reyes, C, Pottegård, A, Schwarz, P, Javaid, MK, Van Staa, TP, Cooper, C, Diez-Perez, A, Abrahamsen, B & Prieto-Alhambra, D 2016, 'Real-Life and RCT Participants: Alendronate Users Versus FITs' Trial Eligibility Criterion', Calcified Tissue International, bind 99, nr. 3, s. 243-9. https://doi.org/10.1007/s00223-016-0141-7

Real-Life and RCT Participants : Alendronate Users Versus FITs' Trial Eligibility Criterion. / Reyes, Carlen; Pottegård, Anton; Schwarz, Peter; Javaid, M Kassim; Van Staa, Tjeerd P; Cooper, Cyrus; Diez-Perez, Adolfo; Abrahamsen, Bo; Prieto-Alhambra, Daniel.

I: Calcified Tissue International, Bind 99, Nr. 3, 09.2016, s. 243-9.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

TY - JOUR

T1 - Real-Life and RCT Participants

T2 - Alendronate Users Versus FITs' Trial Eligibility Criterion

AU - Reyes, Carlen

AU - Pottegård, Anton

AU - Schwarz, Peter

AU - Javaid, M Kassim

AU - Van Staa, Tjeerd P

AU - Cooper, Cyrus

AU - Diez-Perez, Adolfo

AU - Abrahamsen, Bo

AU - Prieto-Alhambra, Daniel

PY - 2016/9

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N2 - 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.

AB - 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.

KW - Journal Article

U2 - 10.1007/s00223-016-0141-7

DO - 10.1007/s00223-016-0141-7

M3 - Journal article

C2 - 27099132

VL - 99

SP - 243

EP - 249

JO - Calcified Tissue International

JF - Calcified Tissue International

SN - 0171-967X

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ER -