External auditory canal and middle ear cholesteatoma and osteonecrosis in bisphosphonate-treated osteoporosis patients: a Danish national register-based cohort study and literature review
Summary Long-term treatment with bisphosphonates against osteoporosis may cause atypical femur fractures and osteonecrosis of the jaw. Eight cases of bisphosphonate-associated osteonecrosis of the external auditory canal area are published. Based on Danish national registers, we report a time- and d...
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| Veröffentlicht in: | Osteoporosis international 2014-07, Vol.25 (7), p.1937-1944 |
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| creator | Thorsteinsson, A.-L. Vestergaard, P. Eiken, P. |
| description | Summary
Long-term treatment with bisphosphonates against osteoporosis may cause atypical femur fractures and osteonecrosis of the jaw. Eight cases of bisphosphonate-associated osteonecrosis of the external auditory canal area are published. Based on Danish national registers, we report a time- and dose-dependent increased risk of cholesteatoma in osteoporosis patients treated with bisphosphonates.
Introduction
In the recent years, there has been a focus on possible rare side effects of bisphosphonates (BPs). Eight cases of BP-associated osteonecrosis of the external auditory canal have been reported in the world literature. Our aim was to describe the incidence of external auditory canal and middle ear diseases in Danish patients exposed to BPs in the treatment of osteoporosis.
Methods
This register-based nationwide cohort study was conducted on the Danish population of approximately 5.6 million individuals. Patients who were prescribed BP for treatment of osteoporosis from 2003 to 2010 (
n
= 131,794) were included in the study and compared with the age- and gender-matched controls, unexposed to BP.
Results
The overall incidence of cholesteatoma in the ear was low. Only 350 events were seen in 527,176 cases and controls over 2,826,120.73 observation years. Totally, 119 events of cholesteatoma in the ear were recorded after initiation of BP therapy, 34 in the external auditory canal and 85 in the middle ear. Cholesteatoma in the external auditory canal was more frequent in the exposed than in the unexposed group (
p
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| doi_str_mv | 10.1007/s00198-014-2684-7 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_1540222883</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>3327237221</sourcerecordid><originalsourceid>FETCH-LOGICAL-c496t-df9cbab30c29b91968f665631100d9e927360d0ff31d0a024a7334d05f54253a3</originalsourceid><addsrcrecordid>eNp1kU-L1TAUxYMoznP0A7iRgBs30fxr2riTcUaFATcK7sptk87L0CY1SUffZ_PLTfr6FBFchHC5v3MPnIPQc0ZfM0rrN4lSphtCmSRcNZLUD9COSSEI16p6iHZUi5poyb6doScp3dKi0bp-jM64VEryutqhX5c_s40eRgyLcTnEA-7hOHqDJ2fMaLGFiPt9GG3KFnKY4LgMZQre9jEkl7DzuHNp3of1eciW5Fhge-LmsGEzZGd9Tm8x4PfgXdrjAruwOkZ74wobSQep6PqwDzHjlBdzOBqOriwhL9EW9M7ZH0_RowHGZJ-d_nP09eryy8VHcv35w6eLd9ekl1plYgbdd9AJ2nPdaaZVMyhVKcFKhkZbzWuhqKHDIJihQLmEWghpaDVUklcCxDl6td2dY_i-lBTayaXejiN4G5bUskpSznnTiIK-_Ae9Dcsa70qJ4sOZZIViG7WGl6Id2jm6CeKhZbRdm223ZtvSbLs229ZF8-J0eekma_4ofldZAL4Bqaz8jY1_Wf_36j2y1LLk</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1533602141</pqid></control><display><type>article</type><title>External auditory canal and middle ear cholesteatoma and osteonecrosis in bisphosphonate-treated osteoporosis patients: a Danish national register-based cohort study and literature review</title><source>MEDLINE</source><source>Springer Nature - Complete Springer Journals</source><creator>Thorsteinsson, A.-L. ; Vestergaard, P. ; Eiken, P.</creator><creatorcontrib>Thorsteinsson, A.-L. ; Vestergaard, P. ; Eiken, P.</creatorcontrib><description>Summary
Long-term treatment with bisphosphonates against osteoporosis may cause atypical femur fractures and osteonecrosis of the jaw. Eight cases of bisphosphonate-associated osteonecrosis of the external auditory canal area are published. Based on Danish national registers, we report a time- and dose-dependent increased risk of cholesteatoma in osteoporosis patients treated with bisphosphonates.
Introduction
In the recent years, there has been a focus on possible rare side effects of bisphosphonates (BPs). Eight cases of BP-associated osteonecrosis of the external auditory canal have been reported in the world literature. Our aim was to describe the incidence of external auditory canal and middle ear diseases in Danish patients exposed to BPs in the treatment of osteoporosis.
Methods
This register-based nationwide cohort study was conducted on the Danish population of approximately 5.6 million individuals. Patients who were prescribed BP for treatment of osteoporosis from 2003 to 2010 (
n
= 131,794) were included in the study and compared with the age- and gender-matched controls, unexposed to BP.
Results
The overall incidence of cholesteatoma in the ear was low. Only 350 events were seen in 527,176 cases and controls over 2,826,120.73 observation years. Totally, 119 events of cholesteatoma in the ear were recorded after initiation of BP therapy, 34 in the external auditory canal and 85 in the middle ear. Cholesteatoma in the external auditory canal was more frequent in the exposed than in the unexposed group (
p
< 0.0001). We found a significant dose-event relationship between incidence of cholesteatoma and dose of alendronate (
p
< 0.0001) and etidronate (
p
< 0.0001). Furthermore, we found an association between duration of treatment with alendronate and etidronate and risk of cholesteatoma in the external auditory ear canal (log rank,
p
= 0.002). No cases of bone destruction were observed during the 7-year observation period in either group.
Conclusion
The use of oral BP is associated with an increased risk of cholesteatoma of the external auditory canal. The risk is small and associated with duration and dosage of BP.</description><identifier>ISSN: 0937-941X</identifier><identifier>EISSN: 1433-2965</identifier><identifier>DOI: 10.1007/s00198-014-2684-7</identifier><identifier>PMID: 24664275</identifier><language>eng</language><publisher>London: Springer London</publisher><subject>Administration, Oral ; Aged ; Aged, 80 and over ; Bisphosphonate-Associated Osteonecrosis of the Jaw - epidemiology ; Bone Density Conservation Agents - administration & dosage ; Bone Density Conservation Agents - adverse effects ; Bone Density Conservation Agents - therapeutic use ; Cholesteatoma - chemically induced ; Cholesteatoma - epidemiology ; Cholesteatoma, Middle Ear - chemically induced ; Cholesteatoma, Middle Ear - epidemiology ; Cohort Studies ; Denmark - epidemiology ; Diphosphonates - administration & dosage ; Diphosphonates - adverse effects ; Diphosphonates - therapeutic use ; Dose-Response Relationship, Drug ; Drug therapy ; Ear Canal ; Ear diseases ; Endocrinology ; Female ; Humans ; Incidence ; Male ; Medicine ; Medicine & Public Health ; Middle Aged ; Original Article ; Orthopedics ; Osteoporosis ; Osteoporosis - drug therapy ; Osteoporosis - epidemiology ; Registries ; Retrospective Studies ; Rheumatology ; Side effects</subject><ispartof>Osteoporosis international, 2014-07, Vol.25 (7), p.1937-1944</ispartof><rights>International Osteoporosis Foundation and National Osteoporosis Foundation 2014</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c496t-df9cbab30c29b91968f665631100d9e927360d0ff31d0a024a7334d05f54253a3</citedby><cites>FETCH-LOGICAL-c496t-df9cbab30c29b91968f665631100d9e927360d0ff31d0a024a7334d05f54253a3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00198-014-2684-7$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00198-014-2684-7$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24664275$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Thorsteinsson, A.-L.</creatorcontrib><creatorcontrib>Vestergaard, P.</creatorcontrib><creatorcontrib>Eiken, P.</creatorcontrib><title>External auditory canal and middle ear cholesteatoma and osteonecrosis in bisphosphonate-treated osteoporosis patients: a Danish national register-based cohort study and literature review</title><title>Osteoporosis international</title><addtitle>Osteoporos Int</addtitle><addtitle>Osteoporos Int</addtitle><description>Summary
Long-term treatment with bisphosphonates against osteoporosis may cause atypical femur fractures and osteonecrosis of the jaw. Eight cases of bisphosphonate-associated osteonecrosis of the external auditory canal area are published. Based on Danish national registers, we report a time- and dose-dependent increased risk of cholesteatoma in osteoporosis patients treated with bisphosphonates.
Introduction
In the recent years, there has been a focus on possible rare side effects of bisphosphonates (BPs). Eight cases of BP-associated osteonecrosis of the external auditory canal have been reported in the world literature. Our aim was to describe the incidence of external auditory canal and middle ear diseases in Danish patients exposed to BPs in the treatment of osteoporosis.
Methods
This register-based nationwide cohort study was conducted on the Danish population of approximately 5.6 million individuals. Patients who were prescribed BP for treatment of osteoporosis from 2003 to 2010 (
n
= 131,794) were included in the study and compared with the age- and gender-matched controls, unexposed to BP.
Results
The overall incidence of cholesteatoma in the ear was low. Only 350 events were seen in 527,176 cases and controls over 2,826,120.73 observation years. Totally, 119 events of cholesteatoma in the ear were recorded after initiation of BP therapy, 34 in the external auditory canal and 85 in the middle ear. Cholesteatoma in the external auditory canal was more frequent in the exposed than in the unexposed group (
p
< 0.0001). We found a significant dose-event relationship between incidence of cholesteatoma and dose of alendronate (
p
< 0.0001) and etidronate (
p
< 0.0001). Furthermore, we found an association between duration of treatment with alendronate and etidronate and risk of cholesteatoma in the external auditory ear canal (log rank,
p
= 0.002). No cases of bone destruction were observed during the 7-year observation period in either group.
Conclusion
The use of oral BP is associated with an increased risk of cholesteatoma of the external auditory canal. The risk is small and associated with duration and dosage of BP.</description><subject>Administration, Oral</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Bisphosphonate-Associated Osteonecrosis of the Jaw - epidemiology</subject><subject>Bone Density Conservation Agents - administration & dosage</subject><subject>Bone Density Conservation Agents - adverse effects</subject><subject>Bone Density Conservation Agents - therapeutic use</subject><subject>Cholesteatoma - chemically induced</subject><subject>Cholesteatoma - epidemiology</subject><subject>Cholesteatoma, Middle Ear - chemically induced</subject><subject>Cholesteatoma, Middle Ear - epidemiology</subject><subject>Cohort Studies</subject><subject>Denmark - epidemiology</subject><subject>Diphosphonates - administration & dosage</subject><subject>Diphosphonates - adverse effects</subject><subject>Diphosphonates - therapeutic use</subject><subject>Dose-Response Relationship, Drug</subject><subject>Drug therapy</subject><subject>Ear Canal</subject><subject>Ear diseases</subject><subject>Endocrinology</subject><subject>Female</subject><subject>Humans</subject><subject>Incidence</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Original Article</subject><subject>Orthopedics</subject><subject>Osteoporosis</subject><subject>Osteoporosis - drug therapy</subject><subject>Osteoporosis - epidemiology</subject><subject>Registries</subject><subject>Retrospective Studies</subject><subject>Rheumatology</subject><subject>Side effects</subject><issn>0937-941X</issn><issn>1433-2965</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNp1kU-L1TAUxYMoznP0A7iRgBs30fxr2riTcUaFATcK7sptk87L0CY1SUffZ_PLTfr6FBFchHC5v3MPnIPQc0ZfM0rrN4lSphtCmSRcNZLUD9COSSEI16p6iHZUi5poyb6doScp3dKi0bp-jM64VEryutqhX5c_s40eRgyLcTnEA-7hOHqDJ2fMaLGFiPt9GG3KFnKY4LgMZQre9jEkl7DzuHNp3of1eciW5Fhge-LmsGEzZGd9Tm8x4PfgXdrjAruwOkZ74wobSQep6PqwDzHjlBdzOBqOriwhL9EW9M7ZH0_RowHGZJ-d_nP09eryy8VHcv35w6eLd9ekl1plYgbdd9AJ2nPdaaZVMyhVKcFKhkZbzWuhqKHDIJihQLmEWghpaDVUklcCxDl6td2dY_i-lBTayaXejiN4G5bUskpSznnTiIK-_Ae9Dcsa70qJ4sOZZIViG7WGl6Id2jm6CeKhZbRdm223ZtvSbLs229ZF8-J0eekma_4ofldZAL4Bqaz8jY1_Wf_36j2y1LLk</recordid><startdate>20140701</startdate><enddate>20140701</enddate><creator>Thorsteinsson, A.-L.</creator><creator>Vestergaard, P.</creator><creator>Eiken, P.</creator><general>Springer London</general><general>Springer Nature B.V</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7QP</scope><scope>7RV</scope><scope>7TS</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PHGZM</scope><scope>PHGZT</scope><scope>PJZUB</scope><scope>PKEHL</scope><scope>PPXIY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope></search><sort><creationdate>20140701</creationdate><title>External auditory canal and middle ear cholesteatoma and osteonecrosis in bisphosphonate-treated osteoporosis patients: a Danish national register-based cohort study and literature review</title><author>Thorsteinsson, A.-L. ; Vestergaard, P. ; Eiken, P.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c496t-df9cbab30c29b91968f665631100d9e927360d0ff31d0a024a7334d05f54253a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Administration, Oral</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Bisphosphonate-Associated Osteonecrosis of the Jaw - epidemiology</topic><topic>Bone Density Conservation Agents - administration & dosage</topic><topic>Bone Density Conservation Agents - adverse effects</topic><topic>Bone Density Conservation Agents - therapeutic use</topic><topic>Cholesteatoma - chemically induced</topic><topic>Cholesteatoma - epidemiology</topic><topic>Cholesteatoma, Middle Ear - chemically induced</topic><topic>Cholesteatoma, Middle Ear - epidemiology</topic><topic>Cohort Studies</topic><topic>Denmark - epidemiology</topic><topic>Diphosphonates - administration & dosage</topic><topic>Diphosphonates - adverse effects</topic><topic>Diphosphonates - therapeutic use</topic><topic>Dose-Response Relationship, Drug</topic><topic>Drug therapy</topic><topic>Ear Canal</topic><topic>Ear diseases</topic><topic>Endocrinology</topic><topic>Female</topic><topic>Humans</topic><topic>Incidence</topic><topic>Male</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Middle Aged</topic><topic>Original Article</topic><topic>Orthopedics</topic><topic>Osteoporosis</topic><topic>Osteoporosis - drug therapy</topic><topic>Osteoporosis - epidemiology</topic><topic>Registries</topic><topic>Retrospective Studies</topic><topic>Rheumatology</topic><topic>Side effects</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Thorsteinsson, A.-L.</creatorcontrib><creatorcontrib>Vestergaard, P.</creatorcontrib><creatorcontrib>Eiken, P.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Nursing & Allied Health Database</collection><collection>Physical Education Index</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest Central (New)</collection><collection>ProQuest One Academic (New)</collection><collection>ProQuest Health & Medical Research Collection</collection><collection>ProQuest One Academic Middle East (New)</collection><collection>ProQuest One Health & Nursing</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><jtitle>Osteoporosis international</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Thorsteinsson, A.-L.</au><au>Vestergaard, P.</au><au>Eiken, P.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>External auditory canal and middle ear cholesteatoma and osteonecrosis in bisphosphonate-treated osteoporosis patients: a Danish national register-based cohort study and literature review</atitle><jtitle>Osteoporosis international</jtitle><stitle>Osteoporos Int</stitle><addtitle>Osteoporos Int</addtitle><date>2014-07-01</date><risdate>2014</risdate><volume>25</volume><issue>7</issue><spage>1937</spage><epage>1944</epage><pages>1937-1944</pages><issn>0937-941X</issn><eissn>1433-2965</eissn><abstract>Summary
Long-term treatment with bisphosphonates against osteoporosis may cause atypical femur fractures and osteonecrosis of the jaw. Eight cases of bisphosphonate-associated osteonecrosis of the external auditory canal area are published. Based on Danish national registers, we report a time- and dose-dependent increased risk of cholesteatoma in osteoporosis patients treated with bisphosphonates.
Introduction
In the recent years, there has been a focus on possible rare side effects of bisphosphonates (BPs). Eight cases of BP-associated osteonecrosis of the external auditory canal have been reported in the world literature. Our aim was to describe the incidence of external auditory canal and middle ear diseases in Danish patients exposed to BPs in the treatment of osteoporosis.
Methods
This register-based nationwide cohort study was conducted on the Danish population of approximately 5.6 million individuals. Patients who were prescribed BP for treatment of osteoporosis from 2003 to 2010 (
n
= 131,794) were included in the study and compared with the age- and gender-matched controls, unexposed to BP.
Results
The overall incidence of cholesteatoma in the ear was low. Only 350 events were seen in 527,176 cases and controls over 2,826,120.73 observation years. Totally, 119 events of cholesteatoma in the ear were recorded after initiation of BP therapy, 34 in the external auditory canal and 85 in the middle ear. Cholesteatoma in the external auditory canal was more frequent in the exposed than in the unexposed group (
p
< 0.0001). We found a significant dose-event relationship between incidence of cholesteatoma and dose of alendronate (
p
< 0.0001) and etidronate (
p
< 0.0001). Furthermore, we found an association between duration of treatment with alendronate and etidronate and risk of cholesteatoma in the external auditory ear canal (log rank,
p
= 0.002). No cases of bone destruction were observed during the 7-year observation period in either group.
Conclusion
The use of oral BP is associated with an increased risk of cholesteatoma of the external auditory canal. The risk is small and associated with duration and dosage of BP.</abstract><cop>London</cop><pub>Springer London</pub><pmid>24664275</pmid><doi>10.1007/s00198-014-2684-7</doi><tpages>8</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0937-941X |
| ispartof | Osteoporosis international, 2014-07, Vol.25 (7), p.1937-1944 |
| issn | 0937-941X 1433-2965 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_1540222883 |
| source | MEDLINE; Springer Nature - Complete Springer Journals |
| subjects | Administration, Oral Aged Aged, 80 and over Bisphosphonate-Associated Osteonecrosis of the Jaw - epidemiology Bone Density Conservation Agents - administration & dosage Bone Density Conservation Agents - adverse effects Bone Density Conservation Agents - therapeutic use Cholesteatoma - chemically induced Cholesteatoma - epidemiology Cholesteatoma, Middle Ear - chemically induced Cholesteatoma, Middle Ear - epidemiology Cohort Studies Denmark - epidemiology Diphosphonates - administration & dosage Diphosphonates - adverse effects Diphosphonates - therapeutic use Dose-Response Relationship, Drug Drug therapy Ear Canal Ear diseases Endocrinology Female Humans Incidence Male Medicine Medicine & Public Health Middle Aged Original Article Orthopedics Osteoporosis Osteoporosis - drug therapy Osteoporosis - epidemiology Registries Retrospective Studies Rheumatology Side effects |
| title | External auditory canal and middle ear cholesteatoma and osteonecrosis in bisphosphonate-treated osteoporosis patients: a Danish national register-based cohort study and literature review |
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