Efficacy and Safety of a Once-Yearly Intravenous Zoledronic Acid 5 mg for Fracture Prevention in Elderly Postmenopausal Women with Osteoporosis Aged 75 and Older

OBJECTIVES: To determine the efficacy of once‐yearly intravenous zoledronic acid (ZOL) 5 mg in reducing risk of clinical vertebral, nonvertebral, and any clinical fractures in elderly osteoporotic postmenopausal women. DESIGN: A post hoc subgroup analysis of pooled data from the Health Outcome and R...

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Veröffentlicht in:Journal of the American Geriatrics Society (JAGS) 2010-02, Vol.58 (2), p.292-299
Hauptverfasser: Boonen, Steven, Black, Dennis M., Colón-Emeric, Cathleen S., Eastell, Richard, Magaziner, Jay S., Eriksen, Erik Fink, Mesenbrink, Peter, Haentjens, Patrick, Lyles, Kenneth W.
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container_issue 2
container_start_page 292
container_title Journal of the American Geriatrics Society (JAGS)
container_volume 58
creator Boonen, Steven
Black, Dennis M.
Colón-Emeric, Cathleen S.
Eastell, Richard
Magaziner, Jay S.
Eriksen, Erik Fink
Mesenbrink, Peter
Haentjens, Patrick
Lyles, Kenneth W.
description OBJECTIVES: To determine the efficacy of once‐yearly intravenous zoledronic acid (ZOL) 5 mg in reducing risk of clinical vertebral, nonvertebral, and any clinical fractures in elderly osteoporotic postmenopausal women. DESIGN: A post hoc subgroup analysis of pooled data from the Health Outcome and Reduced Incidence with Zoledronic Acid One Yearly (HORIZON) Pivotal Fracture Trial and the HORIZON Recurrent Fracture Trial. SETTING: Multicenter, randomized, double‐blind, placebo‐controlled trials. PARTICIPANTS: Postmenopausal women (aged ≥75) with documented osteoporosis (T‐score ≤−2.5 at femoral neck or ≥1 prevalent vertebral or hip fracture) or a recent hip fracture. INTERVENTION: Patients were randomized to receive an intravenous infusion of ZOL 5 mg (n=1,961) or placebo (n=1,926) at baseline and 12 and 24 months. MEASUREMENTS: Primary endpoints were incidence of clinical vertebral and nonvertebral and any clinical fracture after treatment. RESULTS: At 3 years, incidence of any clinical, clinical vertebral, and nonvertebral fracture were significantly lower in the ZOL group than in the placebo group (10.8% vs 16.6%, 1.1% vs 3.7%, and 9.9% vs 13.7%, respectively) (hazard ratio (HR)=0.65, 95% confidence interval (CI)=0.54–0.78, P
doi_str_mv 10.1111/j.1532-5415.2009.02673.x
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DESIGN: A post hoc subgroup analysis of pooled data from the Health Outcome and Reduced Incidence with Zoledronic Acid One Yearly (HORIZON) Pivotal Fracture Trial and the HORIZON Recurrent Fracture Trial. SETTING: Multicenter, randomized, double‐blind, placebo‐controlled trials. PARTICIPANTS: Postmenopausal women (aged ≥75) with documented osteoporosis (T‐score ≤−2.5 at femoral neck or ≥1 prevalent vertebral or hip fracture) or a recent hip fracture. INTERVENTION: Patients were randomized to receive an intravenous infusion of ZOL 5 mg (n=1,961) or placebo (n=1,926) at baseline and 12 and 24 months. MEASUREMENTS: Primary endpoints were incidence of clinical vertebral and nonvertebral and any clinical fracture after treatment. RESULTS: At 3 years, incidence of any clinical, clinical vertebral, and nonvertebral fracture were significantly lower in the ZOL group than in the placebo group (10.8% vs 16.6%, 1.1% vs 3.7%, and 9.9% vs 13.7%, respectively) (hazard ratio (HR)=0.65, 95% confidence interval (CI)=0.54–0.78, P&lt;.001; HR=0.34, 95% CI=0.21–0.55, P&lt;.001; and HR=0.73, 95% CI=0.60–0.90, P=.002, respectively). The incidence of hip fracture was lower with ZOL but did not reach statistical significance. The incidence rate of postdose adverse events were higher with ZOL, although the rate of serious adverse events and deaths was comparable between the two groups. CONCLUSION: Once‐yearly intravenous ZOL 5 mg was associated with a significant reduction in the risk of new clinical fractures (vertebral and nonvertebral) in elderly postmenopausal women with osteroporosis.</description><identifier>ISSN: 0002-8614</identifier><identifier>EISSN: 1532-5415</identifier><identifier>DOI: 10.1111/j.1532-5415.2009.02673.x</identifier><identifier>PMID: 20070415</identifier><identifier>CODEN: JAGSAF</identifier><language>eng</language><publisher>Malden, USA: Blackwell Publishing Inc</publisher><subject><![CDATA[Age Factors ; Aged ; Biological and medical sciences ; Bone Density - drug effects ; Bone Density Conservation Agents - administration & dosage ; Bone Density Conservation Agents - adverse effects ; Clinical trials ; Diphosphonates - administration & dosage ; Diphosphonates - adverse effects ; Drug Administration Schedule ; Drug therapy ; Drug-Related Side Effects and Adverse Reactions ; elderly ; Female ; Femoral Neck Fractures - prevention & control ; Fractures ; Fractures, Spontaneous - prevention & control ; General aspects ; Humans ; Imidazoles - administration & dosage ; Imidazoles - adverse effects ; Infusions, Intravenous ; Medical sciences ; Medication Adherence ; Miscellaneous ; Older people ; Osteoporosis ; Osteoporosis - drug therapy ; postmenopausal women with osteoporosis ; Prevention and actions ; Preventive medicine ; Public health. Hygiene ; Public health. Hygiene-occupational medicine ; Randomized Controlled Trials as Topic ; Spinal Fractures - prevention & control ; Women ; zoledronic acid]]></subject><ispartof>Journal of the American Geriatrics Society (JAGS), 2010-02, Vol.58 (2), p.292-299</ispartof><rights>2010, Copyright the Authors. Journal compilation © 2010, The American Geriatrics Society</rights><rights>2015 INIST-CNRS</rights><rights>Journal compilation 2010 The American Geriatrics Society/Wiley Periodicals, Inc.</rights><rights>2010, Copyright the Authors 2010</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c6263-2d1740f3f60a1b5c6386baf72683a8b29ead341f3b585682ec2687e39a41ba423</citedby><cites>FETCH-LOGICAL-c6263-2d1740f3f60a1b5c6386baf72683a8b29ead341f3b585682ec2687e39a41ba423</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fj.1532-5415.2009.02673.x$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fj.1532-5415.2009.02673.x$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>230,315,781,785,886,1418,27929,27930,45579,45580</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&amp;idt=22389114$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20070415$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Boonen, Steven</creatorcontrib><creatorcontrib>Black, Dennis M.</creatorcontrib><creatorcontrib>Colón-Emeric, Cathleen S.</creatorcontrib><creatorcontrib>Eastell, Richard</creatorcontrib><creatorcontrib>Magaziner, Jay S.</creatorcontrib><creatorcontrib>Eriksen, Erik Fink</creatorcontrib><creatorcontrib>Mesenbrink, Peter</creatorcontrib><creatorcontrib>Haentjens, Patrick</creatorcontrib><creatorcontrib>Lyles, Kenneth W.</creatorcontrib><title>Efficacy and Safety of a Once-Yearly Intravenous Zoledronic Acid 5 mg for Fracture Prevention in Elderly Postmenopausal Women with Osteoporosis Aged 75 and Older</title><title>Journal of the American Geriatrics Society (JAGS)</title><addtitle>J Am Geriatr Soc</addtitle><description>OBJECTIVES: To determine the efficacy of once‐yearly intravenous zoledronic acid (ZOL) 5 mg in reducing risk of clinical vertebral, nonvertebral, and any clinical fractures in elderly osteoporotic postmenopausal women. DESIGN: A post hoc subgroup analysis of pooled data from the Health Outcome and Reduced Incidence with Zoledronic Acid One Yearly (HORIZON) Pivotal Fracture Trial and the HORIZON Recurrent Fracture Trial. SETTING: Multicenter, randomized, double‐blind, placebo‐controlled trials. PARTICIPANTS: Postmenopausal women (aged ≥75) with documented osteoporosis (T‐score ≤−2.5 at femoral neck or ≥1 prevalent vertebral or hip fracture) or a recent hip fracture. INTERVENTION: Patients were randomized to receive an intravenous infusion of ZOL 5 mg (n=1,961) or placebo (n=1,926) at baseline and 12 and 24 months. MEASUREMENTS: Primary endpoints were incidence of clinical vertebral and nonvertebral and any clinical fracture after treatment. RESULTS: At 3 years, incidence of any clinical, clinical vertebral, and nonvertebral fracture were significantly lower in the ZOL group than in the placebo group (10.8% vs 16.6%, 1.1% vs 3.7%, and 9.9% vs 13.7%, respectively) (hazard ratio (HR)=0.65, 95% confidence interval (CI)=0.54–0.78, P&lt;.001; HR=0.34, 95% CI=0.21–0.55, P&lt;.001; and HR=0.73, 95% CI=0.60–0.90, P=.002, respectively). The incidence of hip fracture was lower with ZOL but did not reach statistical significance. The incidence rate of postdose adverse events were higher with ZOL, although the rate of serious adverse events and deaths was comparable between the two groups. CONCLUSION: Once‐yearly intravenous ZOL 5 mg was associated with a significant reduction in the risk of new clinical fractures (vertebral and nonvertebral) in elderly postmenopausal women with osteroporosis.</description><subject>Age Factors</subject><subject>Aged</subject><subject>Biological and medical sciences</subject><subject>Bone Density - drug effects</subject><subject>Bone Density Conservation Agents - administration &amp; dosage</subject><subject>Bone Density Conservation Agents - adverse effects</subject><subject>Clinical trials</subject><subject>Diphosphonates - administration &amp; dosage</subject><subject>Diphosphonates - adverse effects</subject><subject>Drug Administration Schedule</subject><subject>Drug therapy</subject><subject>Drug-Related Side Effects and Adverse Reactions</subject><subject>elderly</subject><subject>Female</subject><subject>Femoral Neck Fractures - prevention &amp; control</subject><subject>Fractures</subject><subject>Fractures, Spontaneous - prevention &amp; control</subject><subject>General aspects</subject><subject>Humans</subject><subject>Imidazoles - administration &amp; dosage</subject><subject>Imidazoles - adverse effects</subject><subject>Infusions, Intravenous</subject><subject>Medical sciences</subject><subject>Medication Adherence</subject><subject>Miscellaneous</subject><subject>Older people</subject><subject>Osteoporosis</subject><subject>Osteoporosis - drug therapy</subject><subject>postmenopausal women with osteoporosis</subject><subject>Prevention and actions</subject><subject>Preventive medicine</subject><subject>Public health. Hygiene</subject><subject>Public health. Hygiene-occupational medicine</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Spinal Fractures - prevention &amp; control</subject><subject>Women</subject><subject>zoledronic acid</subject><issn>0002-8614</issn><issn>1532-5415</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkt1u0zAYhiMEYmVwC8hCQhyl-CexnQOQqqkrg4oOFTTBieU4dueSxsVOtvZs0i6FO-NKcNZSfo7wiW19z_vq-0sSgOAQxfNyOUQ5wWmeoXyIISyGEFNGhpt7yeAQuJ8MIIQ45RRlR8mjEJYQIgw5f5gcRQ2DkRkk38fGWCXVFsimAnNpdLsFzgAJZo3S6Wctfb0FZ03r5ZVuXBfAF1fryrvGKjBStgL5j5vb1QIY58Gpl6rtvAbnXke6ta4BtgHjutK9y7kL7SqarGUXZA0uXPyAa9tegllotVs774INYLTQFWD5XUKzXvo4eWBkHfST_X2cfDodfzx5k05nk7OT0TRVFFOS4gqxDBpiKJSozBUlnJbSMEw5kbzEhZYVyZAhZc5zyrFWMcI0KWSGSplhcpy83vmuu3KlK6X7qmux9nYl_VY4acXfkcZeioW7EoTS2E8aDV7sDbz71unQipUNSte1bHRsnWAZxQwzDiP57B9y6TrfxOoERpCwgkAeIb6DVGxM8NocUkFQ9HsglqIft-jHLfo9EHd7IDZR-vTPUg7CX4OPwPM9IIOStfGyUTb85jDhBUJZ5F7tuGtb6-1_JyDeTub9K-rTnd7GEW8Oeum_ihhmubh4PxHzKfzwbjIvBCM_AVwa38g</recordid><startdate>201002</startdate><enddate>201002</enddate><creator>Boonen, Steven</creator><creator>Black, Dennis M.</creator><creator>Colón-Emeric, Cathleen S.</creator><creator>Eastell, Richard</creator><creator>Magaziner, Jay S.</creator><creator>Eriksen, Erik Fink</creator><creator>Mesenbrink, Peter</creator><creator>Haentjens, Patrick</creator><creator>Lyles, Kenneth W.</creator><general>Blackwell Publishing Inc</general><general>Wiley-Blackwell</general><general>Wiley Subscription Services, Inc</general><scope>BSCLL</scope><scope>IQODW</scope><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>7QP</scope><scope>7TK</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>7U1</scope><scope>7U2</scope><scope>C1K</scope><scope>5PM</scope></search><sort><creationdate>201002</creationdate><title>Efficacy and Safety of a Once-Yearly Intravenous Zoledronic Acid 5 mg for Fracture Prevention in Elderly Postmenopausal Women with Osteoporosis Aged 75 and Older</title><author>Boonen, Steven ; Black, Dennis M. ; Colón-Emeric, Cathleen S. ; Eastell, Richard ; Magaziner, Jay S. ; Eriksen, Erik Fink ; Mesenbrink, Peter ; Haentjens, Patrick ; Lyles, Kenneth W.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c6263-2d1740f3f60a1b5c6386baf72683a8b29ead341f3b585682ec2687e39a41ba423</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2010</creationdate><topic>Age Factors</topic><topic>Aged</topic><topic>Biological and medical sciences</topic><topic>Bone Density - drug effects</topic><topic>Bone Density Conservation Agents - administration &amp; dosage</topic><topic>Bone Density Conservation Agents - adverse effects</topic><topic>Clinical trials</topic><topic>Diphosphonates - administration &amp; dosage</topic><topic>Diphosphonates - adverse effects</topic><topic>Drug Administration Schedule</topic><topic>Drug therapy</topic><topic>Drug-Related Side Effects and Adverse Reactions</topic><topic>elderly</topic><topic>Female</topic><topic>Femoral Neck Fractures - prevention &amp; control</topic><topic>Fractures</topic><topic>Fractures, Spontaneous - prevention &amp; control</topic><topic>General aspects</topic><topic>Humans</topic><topic>Imidazoles - administration &amp; dosage</topic><topic>Imidazoles - adverse effects</topic><topic>Infusions, Intravenous</topic><topic>Medical sciences</topic><topic>Medication Adherence</topic><topic>Miscellaneous</topic><topic>Older people</topic><topic>Osteoporosis</topic><topic>Osteoporosis - drug therapy</topic><topic>postmenopausal women with osteoporosis</topic><topic>Prevention and actions</topic><topic>Preventive medicine</topic><topic>Public health. Hygiene</topic><topic>Public health. Hygiene-occupational medicine</topic><topic>Randomized Controlled Trials as Topic</topic><topic>Spinal Fractures - prevention &amp; control</topic><topic>Women</topic><topic>zoledronic acid</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Boonen, Steven</creatorcontrib><creatorcontrib>Black, Dennis M.</creatorcontrib><creatorcontrib>Colón-Emeric, Cathleen S.</creatorcontrib><creatorcontrib>Eastell, Richard</creatorcontrib><creatorcontrib>Magaziner, Jay S.</creatorcontrib><creatorcontrib>Eriksen, Erik Fink</creatorcontrib><creatorcontrib>Mesenbrink, Peter</creatorcontrib><creatorcontrib>Haentjens, Patrick</creatorcontrib><creatorcontrib>Lyles, Kenneth W.</creatorcontrib><collection>Istex</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Calcium &amp; Calcified Tissue Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>ProQuest Health &amp; Medical Complete (Alumni)</collection><collection>Nursing &amp; Allied Health Premium</collection><collection>Risk Abstracts</collection><collection>Safety Science and Risk</collection><collection>Environmental Sciences and Pollution Management</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Journal of the American Geriatrics Society (JAGS)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Boonen, Steven</au><au>Black, Dennis M.</au><au>Colón-Emeric, Cathleen S.</au><au>Eastell, Richard</au><au>Magaziner, Jay S.</au><au>Eriksen, Erik Fink</au><au>Mesenbrink, Peter</au><au>Haentjens, Patrick</au><au>Lyles, Kenneth W.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and Safety of a Once-Yearly Intravenous Zoledronic Acid 5 mg for Fracture Prevention in Elderly Postmenopausal Women with Osteoporosis Aged 75 and Older</atitle><jtitle>Journal of the American Geriatrics Society (JAGS)</jtitle><addtitle>J Am Geriatr Soc</addtitle><date>2010-02</date><risdate>2010</risdate><volume>58</volume><issue>2</issue><spage>292</spage><epage>299</epage><pages>292-299</pages><issn>0002-8614</issn><eissn>1532-5415</eissn><coden>JAGSAF</coden><abstract>OBJECTIVES: To determine the efficacy of once‐yearly intravenous zoledronic acid (ZOL) 5 mg in reducing risk of clinical vertebral, nonvertebral, and any clinical fractures in elderly osteoporotic postmenopausal women. DESIGN: A post hoc subgroup analysis of pooled data from the Health Outcome and Reduced Incidence with Zoledronic Acid One Yearly (HORIZON) Pivotal Fracture Trial and the HORIZON Recurrent Fracture Trial. SETTING: Multicenter, randomized, double‐blind, placebo‐controlled trials. PARTICIPANTS: Postmenopausal women (aged ≥75) with documented osteoporosis (T‐score ≤−2.5 at femoral neck or ≥1 prevalent vertebral or hip fracture) or a recent hip fracture. INTERVENTION: Patients were randomized to receive an intravenous infusion of ZOL 5 mg (n=1,961) or placebo (n=1,926) at baseline and 12 and 24 months. MEASUREMENTS: Primary endpoints were incidence of clinical vertebral and nonvertebral and any clinical fracture after treatment. RESULTS: At 3 years, incidence of any clinical, clinical vertebral, and nonvertebral fracture were significantly lower in the ZOL group than in the placebo group (10.8% vs 16.6%, 1.1% vs 3.7%, and 9.9% vs 13.7%, respectively) (hazard ratio (HR)=0.65, 95% confidence interval (CI)=0.54–0.78, P&lt;.001; HR=0.34, 95% CI=0.21–0.55, P&lt;.001; and HR=0.73, 95% CI=0.60–0.90, P=.002, respectively). The incidence of hip fracture was lower with ZOL but did not reach statistical significance. The incidence rate of postdose adverse events were higher with ZOL, although the rate of serious adverse events and deaths was comparable between the two groups. CONCLUSION: Once‐yearly intravenous ZOL 5 mg was associated with a significant reduction in the risk of new clinical fractures (vertebral and nonvertebral) in elderly postmenopausal women with osteroporosis.</abstract><cop>Malden, USA</cop><pub>Blackwell Publishing Inc</pub><pmid>20070415</pmid><doi>10.1111/j.1532-5415.2009.02673.x</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record>
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subjects Age Factors
Aged
Biological and medical sciences
Bone Density - drug effects
Bone Density Conservation Agents - administration & dosage
Bone Density Conservation Agents - adverse effects
Clinical trials
Diphosphonates - administration & dosage
Diphosphonates - adverse effects
Drug Administration Schedule
Drug therapy
Drug-Related Side Effects and Adverse Reactions
elderly
Female
Femoral Neck Fractures - prevention & control
Fractures
Fractures, Spontaneous - prevention & control
General aspects
Humans
Imidazoles - administration & dosage
Imidazoles - adverse effects
Infusions, Intravenous
Medical sciences
Medication Adherence
Miscellaneous
Older people
Osteoporosis
Osteoporosis - drug therapy
postmenopausal women with osteoporosis
Prevention and actions
Preventive medicine
Public health. Hygiene
Public health. Hygiene-occupational medicine
Randomized Controlled Trials as Topic
Spinal Fractures - prevention & control
Women
zoledronic acid
title Efficacy and Safety of a Once-Yearly Intravenous Zoledronic Acid 5 mg for Fracture Prevention in Elderly Postmenopausal Women with Osteoporosis Aged 75 and Older
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