A single infusion of zoledronic acid produces sustained remissions in paget disease: Data to 6.5 years
Two trials have shown that a single 5‐mg infusion of zoledronic acid achieves much higher response rates in Paget disease of bone than risedronate. The duration of this effect is unknown. We have conducted an open follow‐up of responders from the two trials (152 originally treated with zoledronic ac...
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| Veröffentlicht in: | Journal of bone and mineral research 2011-09, Vol.26 (9), p.2261-2270 |
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| container_title | Journal of bone and mineral research |
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| creator | Reid, Ian R Lyles, Kenneth Su, Guoqin Brown, Jacques P Walsh, John P del Pino‐Montes, Javier Miller, Paul D Fraser, William D Cafoncelli, Susan Bucci‐Rechtweg, Christina Hosking, David J |
| description | Two trials have shown that a single 5‐mg infusion of zoledronic acid achieves much higher response rates in Paget disease of bone than risedronate. The duration of this effect is unknown. We have conducted an open follow‐up of responders from the two trials (152 originally treated with zoledronic acid, 115 with risedronate) out to 6.5 years without further intervention. Endpoints were times to relapse (ie, return of serum total alkaline phosphatase activity to within 20% of the pretreatment value) or loss of response (response = normalization of alkaline phosphatase or 75% or greater reduction in its excess). Bone turnover markers were lower in the zoledronic acid group throughout follow‐up, with mean alkaline phosphatase (ALP) remaining within the reference range in these patients, whereas the mean in the risedronate group was above normal from 1 year. Relapse rates were substantially greater in the risedronate group (23 of 115, 20%) than in those treated with zoledronic acid (1 of 152, 0.7%, p |
| doi_str_mv | 10.1002/jbmr.438 |
| format | Article |
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The duration of this effect is unknown. We have conducted an open follow‐up of responders from the two trials (152 originally treated with zoledronic acid, 115 with risedronate) out to 6.5 years without further intervention. Endpoints were times to relapse (ie, return of serum total alkaline phosphatase activity to within 20% of the pretreatment value) or loss of response (response = normalization of alkaline phosphatase or 75% or greater reduction in its excess). Bone turnover markers were lower in the zoledronic acid group throughout follow‐up, with mean alkaline phosphatase (ALP) remaining within the reference range in these patients, whereas the mean in the risedronate group was above normal from 1 year. Relapse rates were substantially greater in the risedronate group (23 of 115, 20%) than in those treated with zoledronic acid (1 of 152, 0.7%, p < .001), and loss of response occurred in 19 (12.5%) zoledronic acid patients compared with 71 (62%) risedronate patients (p < .0001). Risk ratios for relapse and loss of response in zoledronic acid patients were 0.02 [95% confidence interval (CI) 0.00–0.18] and 0.12 (95% CI 0.07–0.19), respectively. Changes from baseline in quality of life, assessed using SF‐36 scores, were more positive in the zoledronic acid group across the follow‐up period (p = .01). Bone markers at 6 months were predictive of response duration. These data demonstrate an unprecedented duration of remission of Paget disease following treatment with zoledronic acid, accompanied by an improved quality of life. © 2011 American Society for Bone and Mineral Research</description><identifier>ISSN: 0884-0431</identifier><identifier>EISSN: 1523-4681</identifier><identifier>DOI: 10.1002/jbmr.438</identifier><identifier>PMID: 21638319</identifier><identifier>CODEN: JBMREJ</identifier><language>eng</language><publisher>Hoboken: Wiley Subscription Services, Inc., A Wiley Company</publisher><subject>Aged ; Alkaline Phosphatase - metabolism ; Biological and medical sciences ; Biomarkers - metabolism ; BISPHOSPHONATES ; Bone and Bones - diagnostic imaging ; Bone and Bones - drug effects ; Bone and Bones - pathology ; Bone and Bones - physiopathology ; Bone Density Conservation Agents - administration & dosage ; Bone Density Conservation Agents - adverse effects ; Bone Density Conservation Agents - pharmacology ; Bone Density Conservation Agents - therapeutic use ; Bone Remodeling - drug effects ; BONE TURNOVER MARKERS ; Diphosphonates - administration & dosage ; Diphosphonates - adverse effects ; Diphosphonates - pharmacology ; Diphosphonates - therapeutic use ; Fundamental and applied biological sciences. Psychology ; Humans ; Imidazoles - administration & dosage ; Imidazoles - adverse effects ; Imidazoles - pharmacology ; Imidazoles - therapeutic use ; Infusions, Intravenous ; Kaplan-Meier Estimate ; Osteitis Deformans - diagnostic imaging ; Osteitis Deformans - drug therapy ; Osteitis Deformans - physiopathology ; PAGET DISEASE ; QUALITY OF LIFE ; Radionuclide Imaging ; Randomized Controlled Trials as Topic ; Recurrence ; Remission Induction ; RISEDRONATE ; Skeleton and joints ; Treatment Outcome ; Vertebrates: osteoarticular system, musculoskeletal system</subject><ispartof>Journal of bone and mineral research, 2011-09, Vol.26 (9), p.2261-2270</ispartof><rights>Copyright © 2011 American Society for Bone and Mineral Research</rights><rights>2015 INIST-CNRS</rights><rights>Copyright © 2011 American Society for Bone and Mineral Research.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4368-84e0831c278745ddd6eba08ccd7ebad65bec291e6787669377ee967da28c639b3</citedby><cites>FETCH-LOGICAL-c4368-84e0831c278745ddd6eba08ccd7ebad65bec291e6787669377ee967da28c639b3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fjbmr.438$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fjbmr.438$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=24469126$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/21638319$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Reid, Ian R</creatorcontrib><creatorcontrib>Lyles, Kenneth</creatorcontrib><creatorcontrib>Su, Guoqin</creatorcontrib><creatorcontrib>Brown, Jacques P</creatorcontrib><creatorcontrib>Walsh, John P</creatorcontrib><creatorcontrib>del Pino‐Montes, Javier</creatorcontrib><creatorcontrib>Miller, Paul D</creatorcontrib><creatorcontrib>Fraser, William D</creatorcontrib><creatorcontrib>Cafoncelli, Susan</creatorcontrib><creatorcontrib>Bucci‐Rechtweg, Christina</creatorcontrib><creatorcontrib>Hosking, David J</creatorcontrib><title>A single infusion of zoledronic acid produces sustained remissions in paget disease: Data to 6.5 years</title><title>Journal of bone and mineral research</title><addtitle>J Bone Miner Res</addtitle><description>Two trials have shown that a single 5‐mg infusion of zoledronic acid achieves much higher response rates in Paget disease of bone than risedronate. The duration of this effect is unknown. We have conducted an open follow‐up of responders from the two trials (152 originally treated with zoledronic acid, 115 with risedronate) out to 6.5 years without further intervention. Endpoints were times to relapse (ie, return of serum total alkaline phosphatase activity to within 20% of the pretreatment value) or loss of response (response = normalization of alkaline phosphatase or 75% or greater reduction in its excess). Bone turnover markers were lower in the zoledronic acid group throughout follow‐up, with mean alkaline phosphatase (ALP) remaining within the reference range in these patients, whereas the mean in the risedronate group was above normal from 1 year. Relapse rates were substantially greater in the risedronate group (23 of 115, 20%) than in those treated with zoledronic acid (1 of 152, 0.7%, p < .001), and loss of response occurred in 19 (12.5%) zoledronic acid patients compared with 71 (62%) risedronate patients (p < .0001). Risk ratios for relapse and loss of response in zoledronic acid patients were 0.02 [95% confidence interval (CI) 0.00–0.18] and 0.12 (95% CI 0.07–0.19), respectively. Changes from baseline in quality of life, assessed using SF‐36 scores, were more positive in the zoledronic acid group across the follow‐up period (p = .01). Bone markers at 6 months were predictive of response duration. These data demonstrate an unprecedented duration of remission of Paget disease following treatment with zoledronic acid, accompanied by an improved quality of life. © 2011 American Society for Bone and Mineral Research</description><subject>Aged</subject><subject>Alkaline Phosphatase - metabolism</subject><subject>Biological and medical sciences</subject><subject>Biomarkers - metabolism</subject><subject>BISPHOSPHONATES</subject><subject>Bone and Bones - diagnostic imaging</subject><subject>Bone and Bones - drug effects</subject><subject>Bone and Bones - pathology</subject><subject>Bone and Bones - physiopathology</subject><subject>Bone Density Conservation Agents - administration & dosage</subject><subject>Bone Density Conservation Agents - adverse effects</subject><subject>Bone Density Conservation Agents - pharmacology</subject><subject>Bone Density Conservation Agents - therapeutic use</subject><subject>Bone Remodeling - drug effects</subject><subject>BONE TURNOVER MARKERS</subject><subject>Diphosphonates - administration & dosage</subject><subject>Diphosphonates - adverse effects</subject><subject>Diphosphonates - pharmacology</subject><subject>Diphosphonates - therapeutic use</subject><subject>Fundamental and applied biological sciences. Psychology</subject><subject>Humans</subject><subject>Imidazoles - administration & dosage</subject><subject>Imidazoles - adverse effects</subject><subject>Imidazoles - pharmacology</subject><subject>Imidazoles - therapeutic use</subject><subject>Infusions, Intravenous</subject><subject>Kaplan-Meier Estimate</subject><subject>Osteitis Deformans - diagnostic imaging</subject><subject>Osteitis Deformans - drug therapy</subject><subject>Osteitis Deformans - physiopathology</subject><subject>PAGET DISEASE</subject><subject>QUALITY OF LIFE</subject><subject>Radionuclide Imaging</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Recurrence</subject><subject>Remission Induction</subject><subject>RISEDRONATE</subject><subject>Skeleton and joints</subject><subject>Treatment Outcome</subject><subject>Vertebrates: osteoarticular system, musculoskeletal system</subject><issn>0884-0431</issn><issn>1523-4681</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp90d9rFDEQB_Agir1Wwb9AAiL1Zc8km50kvtX6m4og-rxkk9mSY2_3mtlFzr_eHD0tCPqUQD6ZmeTL2BMp1lII9XLTbfNa1_YeW8lG1ZUGK--zlbBWV0LX8oSdEm2EENAAPGQnSkJta-lWrL_glMbrAXka-4XSNPKp5z-nAWOexhS4DynyXZ7iEpA4LTT7NGLkGbeJDp7KTb7z1zjzmAg94Sv-xs-ezxOHdcP36DM9Yg96PxA-Pq5n7Pu7t98uP1RXX95_vLy4qoKuwVZWoyhzBWWs0U2MEbDzwoYQTdlEaDoMykmEcg7gamMQHZjolQ1Qu64-Y-e3dcvENwvS3JYpAw6DH3FaqC0fYrXRwhT54r9SWqOsVqBkoc_-optpyWN5R1EAjXKNc3cFQ56IMvbtLqetz_tWivaQUntIqS0pFfr0WHDpthj_wN-xFPD8CDwFP_TZjyHRndManFRQXHXrfqQB9_9s2H56_fnrofEveminow</recordid><startdate>201109</startdate><enddate>201109</enddate><creator>Reid, Ian R</creator><creator>Lyles, Kenneth</creator><creator>Su, Guoqin</creator><creator>Brown, Jacques P</creator><creator>Walsh, John P</creator><creator>del Pino‐Montes, Javier</creator><creator>Miller, Paul D</creator><creator>Fraser, William D</creator><creator>Cafoncelli, Susan</creator><creator>Bucci‐Rechtweg, Christina</creator><creator>Hosking, David J</creator><general>Wiley Subscription Services, Inc., A Wiley Company</general><general>Wiley</general><general>Wiley Subscription Services, Inc</general><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>7TS</scope><scope>K9.</scope><scope>7X8</scope></search><sort><creationdate>201109</creationdate><title>A single infusion of zoledronic acid produces sustained remissions in paget disease: Data to 6.5 years</title><author>Reid, Ian R ; Lyles, Kenneth ; Su, Guoqin ; Brown, Jacques P ; Walsh, John P ; del Pino‐Montes, Javier ; Miller, Paul D ; Fraser, William D ; Cafoncelli, Susan ; Bucci‐Rechtweg, Christina ; Hosking, David J</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4368-84e0831c278745ddd6eba08ccd7ebad65bec291e6787669377ee967da28c639b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>Aged</topic><topic>Alkaline Phosphatase - metabolism</topic><topic>Biological and medical sciences</topic><topic>Biomarkers - metabolism</topic><topic>BISPHOSPHONATES</topic><topic>Bone and Bones - diagnostic imaging</topic><topic>Bone and Bones - drug effects</topic><topic>Bone and Bones - pathology</topic><topic>Bone and Bones - physiopathology</topic><topic>Bone Density Conservation Agents - administration & dosage</topic><topic>Bone Density Conservation Agents - adverse effects</topic><topic>Bone Density Conservation Agents - pharmacology</topic><topic>Bone Density Conservation Agents - therapeutic use</topic><topic>Bone Remodeling - drug effects</topic><topic>BONE TURNOVER MARKERS</topic><topic>Diphosphonates - administration & dosage</topic><topic>Diphosphonates - adverse effects</topic><topic>Diphosphonates - pharmacology</topic><topic>Diphosphonates - therapeutic use</topic><topic>Fundamental and applied biological sciences. Psychology</topic><topic>Humans</topic><topic>Imidazoles - administration & dosage</topic><topic>Imidazoles - adverse effects</topic><topic>Imidazoles - pharmacology</topic><topic>Imidazoles - therapeutic use</topic><topic>Infusions, Intravenous</topic><topic>Kaplan-Meier Estimate</topic><topic>Osteitis Deformans - diagnostic imaging</topic><topic>Osteitis Deformans - drug therapy</topic><topic>Osteitis Deformans - physiopathology</topic><topic>PAGET DISEASE</topic><topic>QUALITY OF LIFE</topic><topic>Radionuclide Imaging</topic><topic>Randomized Controlled Trials as Topic</topic><topic>Recurrence</topic><topic>Remission Induction</topic><topic>RISEDRONATE</topic><topic>Skeleton and joints</topic><topic>Treatment Outcome</topic><topic>Vertebrates: osteoarticular system, musculoskeletal system</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Reid, Ian R</creatorcontrib><creatorcontrib>Lyles, Kenneth</creatorcontrib><creatorcontrib>Su, Guoqin</creatorcontrib><creatorcontrib>Brown, Jacques P</creatorcontrib><creatorcontrib>Walsh, John P</creatorcontrib><creatorcontrib>del Pino‐Montes, Javier</creatorcontrib><creatorcontrib>Miller, Paul D</creatorcontrib><creatorcontrib>Fraser, William D</creatorcontrib><creatorcontrib>Cafoncelli, Susan</creatorcontrib><creatorcontrib>Bucci‐Rechtweg, Christina</creatorcontrib><creatorcontrib>Hosking, David J</creatorcontrib><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 & Calcified Tissue Abstracts</collection><collection>Physical Education Index</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of bone and mineral research</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Reid, Ian R</au><au>Lyles, Kenneth</au><au>Su, Guoqin</au><au>Brown, Jacques P</au><au>Walsh, John P</au><au>del Pino‐Montes, Javier</au><au>Miller, Paul D</au><au>Fraser, William D</au><au>Cafoncelli, Susan</au><au>Bucci‐Rechtweg, Christina</au><au>Hosking, David J</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A single infusion of zoledronic acid produces sustained remissions in paget disease: Data to 6.5 years</atitle><jtitle>Journal of bone and mineral research</jtitle><addtitle>J Bone Miner Res</addtitle><date>2011-09</date><risdate>2011</risdate><volume>26</volume><issue>9</issue><spage>2261</spage><epage>2270</epage><pages>2261-2270</pages><issn>0884-0431</issn><eissn>1523-4681</eissn><coden>JBMREJ</coden><abstract>Two trials have shown that a single 5‐mg infusion of zoledronic acid achieves much higher response rates in Paget disease of bone than risedronate. The duration of this effect is unknown. We have conducted an open follow‐up of responders from the two trials (152 originally treated with zoledronic acid, 115 with risedronate) out to 6.5 years without further intervention. Endpoints were times to relapse (ie, return of serum total alkaline phosphatase activity to within 20% of the pretreatment value) or loss of response (response = normalization of alkaline phosphatase or 75% or greater reduction in its excess). Bone turnover markers were lower in the zoledronic acid group throughout follow‐up, with mean alkaline phosphatase (ALP) remaining within the reference range in these patients, whereas the mean in the risedronate group was above normal from 1 year. Relapse rates were substantially greater in the risedronate group (23 of 115, 20%) than in those treated with zoledronic acid (1 of 152, 0.7%, p < .001), and loss of response occurred in 19 (12.5%) zoledronic acid patients compared with 71 (62%) risedronate patients (p < .0001). Risk ratios for relapse and loss of response in zoledronic acid patients were 0.02 [95% confidence interval (CI) 0.00–0.18] and 0.12 (95% CI 0.07–0.19), respectively. Changes from baseline in quality of life, assessed using SF‐36 scores, were more positive in the zoledronic acid group across the follow‐up period (p = .01). Bone markers at 6 months were predictive of response duration. These data demonstrate an unprecedented duration of remission of Paget disease following treatment with zoledronic acid, accompanied by an improved quality of life. © 2011 American Society for Bone and Mineral Research</abstract><cop>Hoboken</cop><pub>Wiley Subscription Services, Inc., A Wiley Company</pub><pmid>21638319</pmid><doi>10.1002/jbmr.438</doi><tpages>10</tpages></addata></record> |
| fulltext | fulltext |
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| ispartof | Journal of bone and mineral research, 2011-09, Vol.26 (9), p.2261-2270 |
| issn | 0884-0431 1523-4681 |
| language | eng |
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| source | Oxford University Press Journals All Titles (1996-Current); Wiley Online Library - AutoHoldings Journals; MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Alma/SFX Local Collection |
| subjects | Aged Alkaline Phosphatase - metabolism Biological and medical sciences Biomarkers - metabolism BISPHOSPHONATES Bone and Bones - diagnostic imaging Bone and Bones - drug effects Bone and Bones - pathology Bone and Bones - physiopathology Bone Density Conservation Agents - administration & dosage Bone Density Conservation Agents - adverse effects Bone Density Conservation Agents - pharmacology Bone Density Conservation Agents - therapeutic use Bone Remodeling - drug effects BONE TURNOVER MARKERS Diphosphonates - administration & dosage Diphosphonates - adverse effects Diphosphonates - pharmacology Diphosphonates - therapeutic use Fundamental and applied biological sciences. Psychology Humans Imidazoles - administration & dosage Imidazoles - adverse effects Imidazoles - pharmacology Imidazoles - therapeutic use Infusions, Intravenous Kaplan-Meier Estimate Osteitis Deformans - diagnostic imaging Osteitis Deformans - drug therapy Osteitis Deformans - physiopathology PAGET DISEASE QUALITY OF LIFE Radionuclide Imaging Randomized Controlled Trials as Topic Recurrence Remission Induction RISEDRONATE Skeleton and joints Treatment Outcome Vertebrates: osteoarticular system, musculoskeletal system |
| title | A single infusion of zoledronic acid produces sustained remissions in paget disease: Data to 6.5 years |
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