Oral ibandronate is as active as intravenous zoledronic acid for reducing bone turnover markers in women with breast cancer and bone metastases
Background: Phase III study comparing the effect of oral ibandronate and intravenous zoledronic acid on bone markers. Patients and methods: Breast cancer patients with bone metastases received ibandronate 50 mg/day (n = 137) or zoledronic acid 4 mg every 4 weeks (n = 138) for 12 weeks. The primary e...
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| Veröffentlicht in: | Annals of oncology 2007-07, Vol.18 (7), p.1165-1171 |
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| creator | Body, J-J Lichinitser, M Tjulandin, S Garnero, P Bergström, B |
| description | Background: Phase III study comparing the effect of oral ibandronate and intravenous zoledronic acid on bone markers. Patients and methods: Breast cancer patients with bone metastases received ibandronate 50 mg/day (n = 137) or zoledronic acid 4 mg every 4 weeks (n = 138) for 12 weeks. The primary end point was mean percentage change in serum levels of cross-linked C-terminal telopeptide of type I collagen (S-CTX) at week 12. Urinary CTX (U-CTX), bone alkaline phosphatase (ALP), amino-terminal procollagen propeptide of type I collagen (PINP) and osteocalcin (OC) were also measured and bone pain and safety assessed. Results: Both bisphosphonates significantly reduced S-CTX (mean ibandronate 76% ± 29 (SD) versus mean zoledronic acid 73% ± 47; P < 0.001 for both versus baseline) and U-CTX (ibandronate 78% ± 50 versus zoledronic acid 86% ± 17; P < 0.001). The difference in S-CTX between treatments was 0.6% (confidence interval −1.7% to 3.0%), which was within the prespecified noninferiority margin. Bone ALP, PINP and OC decreased by 26%–47% compared with baseline with both bisphosphonates. Compared with zoledronic acid, ibandronate patients reported fewer adverse events overall (65.0% versus 75.9%), and on days 1–3 (8.0% versus 47.5%), including less pyrexia (overall incidence 0% versus 16.8%) and bone pain (5.8% versus 12.4%). Conclusions: Oral ibandronate was well tolerated and statistically noninferior to zoledronic acid for percentage change in the bone resorption marker, S-CTX. |
| doi_str_mv | 10.1093/annonc/mdm119 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_20303038</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><oup_id>10.1093/annonc/mdm119</oup_id><sourcerecordid>20303038</sourcerecordid><originalsourceid>FETCH-LOGICAL-c489t-13110ba2f7ae9320dc1742a71ee440f5b0ea3207de298164fd3cd0d12cb6fe643</originalsourceid><addsrcrecordid>eNqFkU1rFTEUhoMo9ra6dCtBUNyMzdfM3CylqFUu1IKKdBMyyRlNnUmuSeZW_RP-ZTPMYMGNJCQhPOfjPS9Cjyh5QYnkp9r74M3paEdK5R20oXUjqy0R9C7aEMl41dZcHKHjlK4JIY1k8j46oq0QrKnlBv2-iHrArtPexuB1BuwS1mWb7A4wv5zPUR_AhynhX2GAmXOmAM7iPkQcwU7G-S-4Cx5wnqIPB4h41PEbxDkc34QRyunyV9xF0Cljo70pTCm6RI2Qy7dOkB6ge70eEjxc7xP08fWrD2fn1e7izduzl7vKiK3MFeWUkk6zvtUgOSPWFElMtxRACNLXHQFdvlsLTG5pI3rLjSWWMtM1PTSCn6BnS959DN8nSFmNLhkYBu2hKFWM8HltC_jkH_A6FI2lN0Vl04i6DLJA1QKZGFKK0Kt9dGUCPxUlarZJLTapxabCP16TTt0I9pZefSnA0xXQyeihj2VgLt1yklDeslnG84UL0_6_NdceXcrw4y9cbFJNy9tanX--UrtPV-8v37VCXfI_pc-8gA</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>196645426</pqid></control><display><type>article</type><title>Oral ibandronate is as active as intravenous zoledronic acid for reducing bone turnover markers in women with breast cancer and bone metastases</title><source>MEDLINE</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>Alma/SFX Local Collection</source><creator>Body, J-J ; Lichinitser, M ; Tjulandin, S ; Garnero, P ; Bergström, B</creator><creatorcontrib>Body, J-J ; Lichinitser, M ; Tjulandin, S ; Garnero, P ; Bergström, B</creatorcontrib><description>Background: Phase III study comparing the effect of oral ibandronate and intravenous zoledronic acid on bone markers. Patients and methods: Breast cancer patients with bone metastases received ibandronate 50 mg/day (n = 137) or zoledronic acid 4 mg every 4 weeks (n = 138) for 12 weeks. The primary end point was mean percentage change in serum levels of cross-linked C-terminal telopeptide of type I collagen (S-CTX) at week 12. Urinary CTX (U-CTX), bone alkaline phosphatase (ALP), amino-terminal procollagen propeptide of type I collagen (PINP) and osteocalcin (OC) were also measured and bone pain and safety assessed. Results: Both bisphosphonates significantly reduced S-CTX (mean ibandronate 76% ± 29 (SD) versus mean zoledronic acid 73% ± 47; P < 0.001 for both versus baseline) and U-CTX (ibandronate 78% ± 50 versus zoledronic acid 86% ± 17; P < 0.001). The difference in S-CTX between treatments was 0.6% (confidence interval −1.7% to 3.0%), which was within the prespecified noninferiority margin. Bone ALP, PINP and OC decreased by 26%–47% compared with baseline with both bisphosphonates. Compared with zoledronic acid, ibandronate patients reported fewer adverse events overall (65.0% versus 75.9%), and on days 1–3 (8.0% versus 47.5%), including less pyrexia (overall incidence 0% versus 16.8%) and bone pain (5.8% versus 12.4%). Conclusions: Oral ibandronate was well tolerated and statistically noninferior to zoledronic acid for percentage change in the bone resorption marker, S-CTX.</description><identifier>ISSN: 0923-7534</identifier><identifier>EISSN: 1569-8041</identifier><identifier>DOI: 10.1093/annonc/mdm119</identifier><identifier>PMID: 17442659</identifier><language>eng</language><publisher>Oxford: Oxford University Press</publisher><subject>Administration, Oral ; Adult ; Aged ; Aged, 80 and over ; Alkaline Phosphatase - drug effects ; Alkaline Phosphatase - urine ; bisphosphonates ; Bone and Bones - drug effects ; Bone Density Conservation Agents - administration & dosage ; Bone Density Conservation Agents - adverse effects ; bone markers ; bone metastases ; Bone Neoplasms - drug therapy ; Bone Neoplasms - secondary ; Bone Remodeling - drug effects ; Breast Neoplasms - drug therapy ; Breast Neoplasms - pathology ; Collagen Type I - analysis ; Collagen Type I - drug effects ; Diphosphonates - administration & dosage ; Diphosphonates - adverse effects ; Female ; Humans ; ibandronate ; Ibandronic Acid ; Imidazoles - administration & dosage ; Imidazoles - adverse effects ; Infusions, Intravenous ; Middle Aged ; Osteocalcin - drug effects ; Osteocalcin - urine ; Peptide Fragments - drug effects ; Peptide Fragments - urine ; Peptides - analysis ; Peptides - drug effects ; Procollagen - drug effects ; Procollagen - urine ; Zoledronic Acid</subject><ispartof>Annals of oncology, 2007-07, Vol.18 (7), p.1165-1171</ispartof><rights>2007 European Society for Medical Oncology 2007</rights><rights>2007 INIST-CNRS</rights><rights>2007 European Society for Medical Oncology</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c489t-13110ba2f7ae9320dc1742a71ee440f5b0ea3207de298164fd3cd0d12cb6fe643</citedby><cites>FETCH-LOGICAL-c489t-13110ba2f7ae9320dc1742a71ee440f5b0ea3207de298164fd3cd0d12cb6fe643</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=19013724$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/17442659$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Body, J-J</creatorcontrib><creatorcontrib>Lichinitser, M</creatorcontrib><creatorcontrib>Tjulandin, S</creatorcontrib><creatorcontrib>Garnero, P</creatorcontrib><creatorcontrib>Bergström, B</creatorcontrib><title>Oral ibandronate is as active as intravenous zoledronic acid for reducing bone turnover markers in women with breast cancer and bone metastases</title><title>Annals of oncology</title><addtitle>Ann Oncol</addtitle><description>Background: Phase III study comparing the effect of oral ibandronate and intravenous zoledronic acid on bone markers. Patients and methods: Breast cancer patients with bone metastases received ibandronate 50 mg/day (n = 137) or zoledronic acid 4 mg every 4 weeks (n = 138) for 12 weeks. The primary end point was mean percentage change in serum levels of cross-linked C-terminal telopeptide of type I collagen (S-CTX) at week 12. Urinary CTX (U-CTX), bone alkaline phosphatase (ALP), amino-terminal procollagen propeptide of type I collagen (PINP) and osteocalcin (OC) were also measured and bone pain and safety assessed. Results: Both bisphosphonates significantly reduced S-CTX (mean ibandronate 76% ± 29 (SD) versus mean zoledronic acid 73% ± 47; P < 0.001 for both versus baseline) and U-CTX (ibandronate 78% ± 50 versus zoledronic acid 86% ± 17; P < 0.001). The difference in S-CTX between treatments was 0.6% (confidence interval −1.7% to 3.0%), which was within the prespecified noninferiority margin. Bone ALP, PINP and OC decreased by 26%–47% compared with baseline with both bisphosphonates. Compared with zoledronic acid, ibandronate patients reported fewer adverse events overall (65.0% versus 75.9%), and on days 1–3 (8.0% versus 47.5%), including less pyrexia (overall incidence 0% versus 16.8%) and bone pain (5.8% versus 12.4%). Conclusions: Oral ibandronate was well tolerated and statistically noninferior to zoledronic acid for percentage change in the bone resorption marker, S-CTX.</description><subject>Administration, Oral</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Alkaline Phosphatase - drug effects</subject><subject>Alkaline Phosphatase - urine</subject><subject>bisphosphonates</subject><subject>Bone and Bones - drug effects</subject><subject>Bone Density Conservation Agents - administration & dosage</subject><subject>Bone Density Conservation Agents - adverse effects</subject><subject>bone markers</subject><subject>bone metastases</subject><subject>Bone Neoplasms - drug therapy</subject><subject>Bone Neoplasms - secondary</subject><subject>Bone Remodeling - drug effects</subject><subject>Breast Neoplasms - drug therapy</subject><subject>Breast Neoplasms - pathology</subject><subject>Collagen Type I - analysis</subject><subject>Collagen Type I - drug effects</subject><subject>Diphosphonates - administration & dosage</subject><subject>Diphosphonates - adverse effects</subject><subject>Female</subject><subject>Humans</subject><subject>ibandronate</subject><subject>Ibandronic Acid</subject><subject>Imidazoles - administration & dosage</subject><subject>Imidazoles - adverse effects</subject><subject>Infusions, Intravenous</subject><subject>Middle Aged</subject><subject>Osteocalcin - drug effects</subject><subject>Osteocalcin - urine</subject><subject>Peptide Fragments - drug effects</subject><subject>Peptide Fragments - urine</subject><subject>Peptides - analysis</subject><subject>Peptides - drug effects</subject><subject>Procollagen - drug effects</subject><subject>Procollagen - urine</subject><subject>Zoledronic Acid</subject><issn>0923-7534</issn><issn>1569-8041</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2007</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkU1rFTEUhoMo9ra6dCtBUNyMzdfM3CylqFUu1IKKdBMyyRlNnUmuSeZW_RP-ZTPMYMGNJCQhPOfjPS9Cjyh5QYnkp9r74M3paEdK5R20oXUjqy0R9C7aEMl41dZcHKHjlK4JIY1k8j46oq0QrKnlBv2-iHrArtPexuB1BuwS1mWb7A4wv5zPUR_AhynhX2GAmXOmAM7iPkQcwU7G-S-4Cx5wnqIPB4h41PEbxDkc34QRyunyV9xF0Cljo70pTCm6RI2Qy7dOkB6ge70eEjxc7xP08fWrD2fn1e7izduzl7vKiK3MFeWUkk6zvtUgOSPWFElMtxRACNLXHQFdvlsLTG5pI3rLjSWWMtM1PTSCn6BnS959DN8nSFmNLhkYBu2hKFWM8HltC_jkH_A6FI2lN0Vl04i6DLJA1QKZGFKK0Kt9dGUCPxUlarZJLTapxabCP16TTt0I9pZefSnA0xXQyeihj2VgLt1yklDeslnG84UL0_6_NdceXcrw4y9cbFJNy9tanX--UrtPV-8v37VCXfI_pc-8gA</recordid><startdate>20070701</startdate><enddate>20070701</enddate><creator>Body, J-J</creator><creator>Lichinitser, M</creator><creator>Tjulandin, S</creator><creator>Garnero, P</creator><creator>Bergström, B</creator><general>Oxford University Press</general><general>Oxford Publishing Limited (England)</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>7T5</scope><scope>7TM</scope><scope>7TO</scope><scope>H94</scope><scope>K9.</scope><scope>7QP</scope></search><sort><creationdate>20070701</creationdate><title>Oral ibandronate is as active as intravenous zoledronic acid for reducing bone turnover markers in women with breast cancer and bone metastases</title><author>Body, J-J ; Lichinitser, M ; Tjulandin, S ; Garnero, P ; Bergström, B</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c489t-13110ba2f7ae9320dc1742a71ee440f5b0ea3207de298164fd3cd0d12cb6fe643</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2007</creationdate><topic>Administration, Oral</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Alkaline Phosphatase - drug effects</topic><topic>Alkaline Phosphatase - urine</topic><topic>bisphosphonates</topic><topic>Bone and Bones - drug effects</topic><topic>Bone Density Conservation Agents - administration & dosage</topic><topic>Bone Density Conservation Agents - adverse effects</topic><topic>bone markers</topic><topic>bone metastases</topic><topic>Bone Neoplasms - drug therapy</topic><topic>Bone Neoplasms - secondary</topic><topic>Bone Remodeling - drug effects</topic><topic>Breast Neoplasms - drug therapy</topic><topic>Breast Neoplasms - pathology</topic><topic>Collagen Type I - analysis</topic><topic>Collagen Type I - drug effects</topic><topic>Diphosphonates - administration & dosage</topic><topic>Diphosphonates - adverse effects</topic><topic>Female</topic><topic>Humans</topic><topic>ibandronate</topic><topic>Ibandronic Acid</topic><topic>Imidazoles - administration & dosage</topic><topic>Imidazoles - adverse effects</topic><topic>Infusions, Intravenous</topic><topic>Middle Aged</topic><topic>Osteocalcin - drug effects</topic><topic>Osteocalcin - urine</topic><topic>Peptide Fragments - drug effects</topic><topic>Peptide Fragments - urine</topic><topic>Peptides - analysis</topic><topic>Peptides - drug effects</topic><topic>Procollagen - drug effects</topic><topic>Procollagen - urine</topic><topic>Zoledronic Acid</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Body, J-J</creatorcontrib><creatorcontrib>Lichinitser, M</creatorcontrib><creatorcontrib>Tjulandin, S</creatorcontrib><creatorcontrib>Garnero, P</creatorcontrib><creatorcontrib>Bergström, B</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>Immunology Abstracts</collection><collection>Nucleic Acids Abstracts</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Calcium & Calcified Tissue Abstracts</collection><jtitle>Annals of oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Body, J-J</au><au>Lichinitser, M</au><au>Tjulandin, S</au><au>Garnero, P</au><au>Bergström, B</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Oral ibandronate is as active as intravenous zoledronic acid for reducing bone turnover markers in women with breast cancer and bone metastases</atitle><jtitle>Annals of oncology</jtitle><addtitle>Ann Oncol</addtitle><date>2007-07-01</date><risdate>2007</risdate><volume>18</volume><issue>7</issue><spage>1165</spage><epage>1171</epage><pages>1165-1171</pages><issn>0923-7534</issn><eissn>1569-8041</eissn><abstract>Background: Phase III study comparing the effect of oral ibandronate and intravenous zoledronic acid on bone markers. Patients and methods: Breast cancer patients with bone metastases received ibandronate 50 mg/day (n = 137) or zoledronic acid 4 mg every 4 weeks (n = 138) for 12 weeks. The primary end point was mean percentage change in serum levels of cross-linked C-terminal telopeptide of type I collagen (S-CTX) at week 12. Urinary CTX (U-CTX), bone alkaline phosphatase (ALP), amino-terminal procollagen propeptide of type I collagen (PINP) and osteocalcin (OC) were also measured and bone pain and safety assessed. Results: Both bisphosphonates significantly reduced S-CTX (mean ibandronate 76% ± 29 (SD) versus mean zoledronic acid 73% ± 47; P < 0.001 for both versus baseline) and U-CTX (ibandronate 78% ± 50 versus zoledronic acid 86% ± 17; P < 0.001). The difference in S-CTX between treatments was 0.6% (confidence interval −1.7% to 3.0%), which was within the prespecified noninferiority margin. Bone ALP, PINP and OC decreased by 26%–47% compared with baseline with both bisphosphonates. Compared with zoledronic acid, ibandronate patients reported fewer adverse events overall (65.0% versus 75.9%), and on days 1–3 (8.0% versus 47.5%), including less pyrexia (overall incidence 0% versus 16.8%) and bone pain (5.8% versus 12.4%). Conclusions: Oral ibandronate was well tolerated and statistically noninferior to zoledronic acid for percentage change in the bone resorption marker, S-CTX.</abstract><cop>Oxford</cop><pub>Oxford University Press</pub><pmid>17442659</pmid><doi>10.1093/annonc/mdm119</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Administration, Oral Adult Aged Aged, 80 and over Alkaline Phosphatase - drug effects Alkaline Phosphatase - urine bisphosphonates Bone and Bones - drug effects Bone Density Conservation Agents - administration & dosage Bone Density Conservation Agents - adverse effects bone markers bone metastases Bone Neoplasms - drug therapy Bone Neoplasms - secondary Bone Remodeling - drug effects Breast Neoplasms - drug therapy Breast Neoplasms - pathology Collagen Type I - analysis Collagen Type I - drug effects Diphosphonates - administration & dosage Diphosphonates - adverse effects Female Humans ibandronate Ibandronic Acid Imidazoles - administration & dosage Imidazoles - adverse effects Infusions, Intravenous Middle Aged Osteocalcin - drug effects Osteocalcin - urine Peptide Fragments - drug effects Peptide Fragments - urine Peptides - analysis Peptides - drug effects Procollagen - drug effects Procollagen - urine Zoledronic Acid |
| title | Oral ibandronate is as active as intravenous zoledronic acid for reducing bone turnover markers in women with breast cancer and bone metastases |
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