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...
| Autores: | , , , |
|---|---|
| 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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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 |
| format |
article |
| status_str |
publishedVersion |
| 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 |
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https://creativecommons.org/licenses/by/4.0/ |
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openAccess |
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application/pdf application/pdf |
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BMJ Publishing Group |
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BMJ Publishing Group |
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reponame:Repositorio Digital de la UPF instname:Universitat Pompeu Fabra |
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Universitat Pompeu Fabra |
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Repositorio Digital de la UPF |
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