Risk of hip, subtrochanteric, and femoral shaft fractures among mid and long term users of alendronate: nationwide cohort and nested case-control study.

OBJECTIVES: To determine the skeletal safety and efficacy of long term (≥10 years) alendronate use in patients with osteoporosis. DESIGN: Open register based cohort study containing two nested case control studies. SETTING: Nationwide study of population of Denmark. PARTICIPANTS: 61 990 men and wome...

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Autores: Abrahamsen, Bo, Eiken, Pia, Prieto-Alhambra, Daniel, Eastell, Richard
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2016
País:España
Institución:Universitat Pompeu Fabra
Repositorio:Repositorio Digital de la UPF
OAI Identifier:oai:repositori.upf.edu:10230/28027
Acceso en línea:http://hdl.handle.net/10230/28027
http://dx.doi.org/10.1136/bmj.i3365
Access Level:acceso abierto
Palabra clave:Articulació coxofemoral -- Fractures
Medicaments -- Efectes secundaris
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spelling Risk of hip, subtrochanteric, and femoral shaft fractures among mid and long term users of alendronate: nationwide cohort and nested case-control study.Abrahamsen, BoEiken, PiaPrieto-Alhambra, DanielEastell, RichardArticulació coxofemoral -- FracturesMedicaments -- Efectes secundarisOBJECTIVES: To determine the skeletal safety and efficacy of long term (≥10 years) alendronate use in patients with osteoporosis. DESIGN: Open register based cohort study containing two nested case control studies. SETTING: Nationwide study of population of Denmark. PARTICIPANTS: 61 990 men and women aged 50-94 at the start of treatment, who had not previously taken alendronate, 1996-2007. INTERVENTIONS: Treatment with alendronate. MAIN OUTCOME MEASURES: Incident fracture of the subtrochanteric femur or femoral shaft (ST/FS) or the hip. Non-fracture controls from the cohort were matched to fracture cases by sex, year of birth, and year of initiation of alendronate treatment. Conditional logistic regression models were fitted to calculate odds ratios with and without adjustment for comorbidity and comedications. Sensitivity analyses investigated subsequent treatment with other drugs for osteoporosis. RESULTS: 1428 participants sustained a ST/FS (incidence rate 3.4/1000 person years, 95% confidence interval 3.2 to 3.6), and 6784 sustained a hip fracture (16.2/1000 person years, 15.8 to 16.6). The risk of ST/FS was lower with high adherence to treatment with alendronate (medication possession ratio (MPR, a proxy for compliance) >80%) compared with poor adherence (MPR <50%; odds ratio 0.88, 0.77 to 0.99; P=0.05). Multivariable adjustment attenuated this association (adjusted odds ratio 0.88, 0.77 to 1.01; P=0.08). The risk was no higher in long term users (≥10 dose years; 0.70, 0.44 to 1.11; P=0.13) or in current compared with past users (0.91, 0.79 to 1.06; P=0.22). Similarly, MPR >80% was associated with a decreased risk of hip fracture (0.73, 0.68 to 0.78; P<0.001) as was longer term cumulative use for 5-10 dose years (0.74, 0.67 to 0.83; P<0.001) or ≥10 dose years (0.74, 0.56 to 0.97; P=0.03). CONCLUSIONS: These findings support an acceptable balance between benefit and risk with treatment with alendronate in terms of fracture outcomes, even for over 10 years of continuous use.BMJ Publishing Group201720172016info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfapplication/pdfhttp://hdl.handle.net/10230/28027http://dx.doi.org/10.1136/bmj.i3365reponame:Repositorio Digital de la UPFinstname:Universitat Pompeu FabraInglésBMJ. 2016 Jun 28;353:i3365This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://crea tivecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.https://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:repositori.upf.edu:10230/280272026-06-12T07:21:37Z
dc.title.none.fl_str_mv Risk of hip, subtrochanteric, and femoral shaft fractures among mid and long term users of alendronate: nationwide cohort and nested case-control study.
title Risk of hip, subtrochanteric, and femoral shaft fractures among mid and long term users of alendronate: nationwide cohort and nested case-control study.
spellingShingle Risk of hip, subtrochanteric, and femoral shaft fractures among mid and long term users of alendronate: nationwide cohort and nested case-control study.
Abrahamsen, Bo
Articulació coxofemoral -- Fractures
Medicaments -- Efectes secundaris
title_short Risk of hip, subtrochanteric, and femoral shaft fractures among mid and long term users of alendronate: nationwide cohort and nested case-control study.
title_full Risk of hip, subtrochanteric, and femoral shaft fractures among mid and long term users of alendronate: nationwide cohort and nested case-control study.
title_fullStr Risk of hip, subtrochanteric, and femoral shaft fractures among mid and long term users of alendronate: nationwide cohort and nested case-control study.
title_full_unstemmed Risk of hip, subtrochanteric, and femoral shaft fractures among mid and long term users of alendronate: nationwide cohort and nested case-control study.
title_sort Risk of hip, subtrochanteric, and femoral shaft fractures among mid and long term users of alendronate: nationwide cohort and nested case-control study.
dc.creator.none.fl_str_mv Abrahamsen, Bo
Eiken, Pia
Prieto-Alhambra, Daniel
Eastell, Richard
author Abrahamsen, Bo
author_facet Abrahamsen, Bo
Eiken, Pia
Prieto-Alhambra, Daniel
Eastell, Richard
author_role author
author2 Eiken, Pia
Prieto-Alhambra, Daniel
Eastell, Richard
author2_role author
author
author
dc.subject.none.fl_str_mv Articulació coxofemoral -- Fractures
Medicaments -- Efectes secundaris
topic Articulació coxofemoral -- Fractures
Medicaments -- Efectes secundaris
description OBJECTIVES: To determine the skeletal safety and efficacy of long term (≥10 years) alendronate use in patients with osteoporosis. DESIGN: Open register based cohort study containing two nested case control studies. SETTING: Nationwide study of population of Denmark. PARTICIPANTS: 61 990 men and women aged 50-94 at the start of treatment, who had not previously taken alendronate, 1996-2007. INTERVENTIONS: Treatment with alendronate. MAIN OUTCOME MEASURES: Incident fracture of the subtrochanteric femur or femoral shaft (ST/FS) or the hip. Non-fracture controls from the cohort were matched to fracture cases by sex, year of birth, and year of initiation of alendronate treatment. Conditional logistic regression models were fitted to calculate odds ratios with and without adjustment for comorbidity and comedications. Sensitivity analyses investigated subsequent treatment with other drugs for osteoporosis. RESULTS: 1428 participants sustained a ST/FS (incidence rate 3.4/1000 person years, 95% confidence interval 3.2 to 3.6), and 6784 sustained a hip fracture (16.2/1000 person years, 15.8 to 16.6). The risk of ST/FS was lower with high adherence to treatment with alendronate (medication possession ratio (MPR, a proxy for compliance) >80%) compared with poor adherence (MPR <50%; odds ratio 0.88, 0.77 to 0.99; P=0.05). Multivariable adjustment attenuated this association (adjusted odds ratio 0.88, 0.77 to 1.01; P=0.08). The risk was no higher in long term users (≥10 dose years; 0.70, 0.44 to 1.11; P=0.13) or in current compared with past users (0.91, 0.79 to 1.06; P=0.22). Similarly, MPR >80% was associated with a decreased risk of hip fracture (0.73, 0.68 to 0.78; P<0.001) as was longer term cumulative use for 5-10 dose years (0.74, 0.67 to 0.83; P<0.001) or ≥10 dose years (0.74, 0.56 to 0.97; P=0.03). CONCLUSIONS: These findings support an acceptable balance between benefit and risk with treatment with alendronate in terms of fracture outcomes, even for over 10 years of continuous use.
publishDate 2016
dc.date.none.fl_str_mv 2016
2017
2017
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
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dc.identifier.none.fl_str_mv http://hdl.handle.net/10230/28027
http://dx.doi.org/10.1136/bmj.i3365
url http://hdl.handle.net/10230/28027
http://dx.doi.org/10.1136/bmj.i3365
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv BMJ. 2016 Jun 28;353:i3365
dc.rights.none.fl_str_mv https://creativecommons.org/licenses/by/4.0/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by/4.0/
eu_rights_str_mv openAccess
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application/pdf
dc.publisher.none.fl_str_mv BMJ Publishing Group
publisher.none.fl_str_mv BMJ Publishing Group
dc.source.none.fl_str_mv reponame:Repositorio Digital de la UPF
instname:Universitat Pompeu Fabra
instname_str Universitat Pompeu Fabra
reponame_str Repositorio Digital de la UPF
collection Repositorio Digital de la UPF
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