Treatment with neridronate in children and adolescents with osteogenesis imperfecta: Data from open-label, not controlled, three-year Italian study
The present study assessed the long-term efficacy and safety of intravenous (i.v.) neridronate in children and adolescents affected by osteogenesis imperfecta (OI). 55 young patients (mean age 12.6±3.9years) affected by OI were included in the study. Neridronate was administered by i.v. infusion at...
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| Veröffentlicht in: | Bone (New York, N.Y.) N.Y.), 2017-10, Vol.103, p.144-149 |
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| creator | Idolazzi, L. Fassio, A. Viapiana, O. Rossini, M. Adami, G. Bertoldo, F. Antoniazzi, F. Gatti, D. |
| description | The present study assessed the long-term efficacy and safety of intravenous (i.v.) neridronate in children and adolescents affected by osteogenesis imperfecta (OI).
55 young patients (mean age 12.6±3.9years) affected by OI were included in the study. Neridronate was administered by i.v. infusion at a dose of 2mg/kg (maximum dose of 100mg) at intervals of three-months for three years. Dual X-ray absorptiometry of the lumbar spine, hip and ultradistal and proximal radius were evaluated every 6months. Blood calcium, phosphate, albumin, fasting urinary calcium/creatinine ratio were obtained at baseline and every 3months. Serum bone turnover markers total and bone alkaline phosphatase were performed every 12months in a proportion of patients.
Mean lumbar spine and total hip bone mineral density (BMD) and bone mineral content significantly increased from baseline compared to all subsequent time points (p |
| doi_str_mv | 10.1016/j.bone.2017.07.004 |
| format | Article |
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55 young patients (mean age 12.6±3.9years) affected by OI were included in the study. Neridronate was administered by i.v. infusion at a dose of 2mg/kg (maximum dose of 100mg) at intervals of three-months for three years. Dual X-ray absorptiometry of the lumbar spine, hip and ultradistal and proximal radius were evaluated every 6months. Blood calcium, phosphate, albumin, fasting urinary calcium/creatinine ratio were obtained at baseline and every 3months. Serum bone turnover markers total and bone alkaline phosphatase were performed every 12months in a proportion of patients.
Mean lumbar spine and total hip bone mineral density (BMD) and bone mineral content significantly increased from baseline compared to all subsequent time points (p<0.001). Mean ultradistal radius BMD significantly increased from month 18 (p=0.026). Levels of bone turnover markers significantly decreased from baseline to all post-baseline observation time points. There was no statistically significant effect on fracture risk (p=0.185), although a significant reduction was observed in the mean number of fractures occurring during treatment compared to pre-treatment values. The most frequent adverse events were arthralgia, fever, joint sprain. An acute phase reaction was reported in 26 (22.8%) patients. None of the reported serious adverse events was considered as treatment-related.
Long-term i.v. neridronate treatment has positive effects on BMD, bone turnover markers and fracture risk with a good safety profile.
•Neridronate treatment in children and adolescents with O.I is associated with a significant Increase of BMD and BMC at lumbar spine and hip•Neridronate treatment in children and adolescents with O.I seems to have a significant protective effect on fracture risk•Neridronate treatmenthas a favorable safety profile with no serious adverse events related with the administration of the drug</description><identifier>ISSN: 8756-3282</identifier><identifier>EISSN: 1873-2763</identifier><identifier>DOI: 10.1016/j.bone.2017.07.004</identifier><identifier>PMID: 28684193</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Adolescent ; Bone and Bones - drug effects ; Bone Density - drug effects ; Bone Density Conservation Agents - therapeutic use ; Child ; Diphosphonates - therapeutic use ; Female ; Humans ; Italy ; Male ; Neridronate ; Osteogenesis imperfecta ; Osteogenesis Imperfecta - drug therapy ; Safety ; Tolerability</subject><ispartof>Bone (New York, N.Y.), 2017-10, Vol.103, p.144-149</ispartof><rights>2017 Elsevier Inc.</rights><rights>Copyright © 2017 Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c356t-c1f2df1bfa27b3d92148c295e4432661bb179b12e6f043176828210f11eb06fc3</citedby><cites>FETCH-LOGICAL-c356t-c1f2df1bfa27b3d92148c295e4432661bb179b12e6f043176828210f11eb06fc3</cites><orcidid>0000-0002-7254-4686</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S8756328217302302$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27903,27904,65308</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28684193$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Idolazzi, L.</creatorcontrib><creatorcontrib>Fassio, A.</creatorcontrib><creatorcontrib>Viapiana, O.</creatorcontrib><creatorcontrib>Rossini, M.</creatorcontrib><creatorcontrib>Adami, G.</creatorcontrib><creatorcontrib>Bertoldo, F.</creatorcontrib><creatorcontrib>Antoniazzi, F.</creatorcontrib><creatorcontrib>Gatti, D.</creatorcontrib><title>Treatment with neridronate in children and adolescents with osteogenesis imperfecta: Data from open-label, not controlled, three-year Italian study</title><title>Bone (New York, N.Y.)</title><addtitle>Bone</addtitle><description>The present study assessed the long-term efficacy and safety of intravenous (i.v.) neridronate in children and adolescents affected by osteogenesis imperfecta (OI).
55 young patients (mean age 12.6±3.9years) affected by OI were included in the study. Neridronate was administered by i.v. infusion at a dose of 2mg/kg (maximum dose of 100mg) at intervals of three-months for three years. Dual X-ray absorptiometry of the lumbar spine, hip and ultradistal and proximal radius were evaluated every 6months. Blood calcium, phosphate, albumin, fasting urinary calcium/creatinine ratio were obtained at baseline and every 3months. Serum bone turnover markers total and bone alkaline phosphatase were performed every 12months in a proportion of patients.
Mean lumbar spine and total hip bone mineral density (BMD) and bone mineral content significantly increased from baseline compared to all subsequent time points (p<0.001). Mean ultradistal radius BMD significantly increased from month 18 (p=0.026). Levels of bone turnover markers significantly decreased from baseline to all post-baseline observation time points. There was no statistically significant effect on fracture risk (p=0.185), although a significant reduction was observed in the mean number of fractures occurring during treatment compared to pre-treatment values. The most frequent adverse events were arthralgia, fever, joint sprain. An acute phase reaction was reported in 26 (22.8%) patients. None of the reported serious adverse events was considered as treatment-related.
Long-term i.v. neridronate treatment has positive effects on BMD, bone turnover markers and fracture risk with a good safety profile.
•Neridronate treatment in children and adolescents with O.I is associated with a significant Increase of BMD and BMC at lumbar spine and hip•Neridronate treatment in children and adolescents with O.I seems to have a significant protective effect on fracture risk•Neridronate treatmenthas a favorable safety profile with no serious adverse events related with the administration of the drug</description><subject>Adolescent</subject><subject>Bone and Bones - drug effects</subject><subject>Bone Density - drug effects</subject><subject>Bone Density Conservation Agents - therapeutic use</subject><subject>Child</subject><subject>Diphosphonates - therapeutic use</subject><subject>Female</subject><subject>Humans</subject><subject>Italy</subject><subject>Male</subject><subject>Neridronate</subject><subject>Osteogenesis imperfecta</subject><subject>Osteogenesis Imperfecta - drug therapy</subject><subject>Safety</subject><subject>Tolerability</subject><issn>8756-3282</issn><issn>1873-2763</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kc2OEzEQhC0EYkPgBTggHznsBLc9sWcQF7T8rbQSl-Vseew2cTRjB9sB5Tl4YRxl4YjUUl--rlZVEfIS2AYYyDf7zZQibjgDtWFtWP-IrGBQouNKisdkNait7AQf-BV5VsqeMSZGBU_JFR_k0MMoVuT3fUZTF4yV_gp1RyPm4HKKpiINkdpdmF3GSE101Lg0Y7GNLRc4lYrpO0YsodCwHDB7tNW8pR9MNdTntNB0wNjNZsL5msZUqU2x5jTP6K5p3WXE7oQm09tq5mAiLfXoTs_JE2_mgi8e9pp8-_Tx_uZLd_f18-3N-7vOiq2snQXPnYfJG64m4UYO_WD5uMW-F1xKmCZQ4wQcpWe9ACWHlgQwD4ATk96KNXl90T3k9OOIpeolNHvzbCKmY9EwghKSKcEayi-ozamUjF4fclhMPmlg-lyG3utzGfpchmZt2ss1efWgf5wWdP9O_qbfgHcXAJvLnwGzLjZgtOhCbkFql8L_9P8A1xSdfA</recordid><startdate>201710</startdate><enddate>201710</enddate><creator>Idolazzi, L.</creator><creator>Fassio, A.</creator><creator>Viapiana, O.</creator><creator>Rossini, M.</creator><creator>Adami, G.</creator><creator>Bertoldo, F.</creator><creator>Antoniazzi, F.</creator><creator>Gatti, D.</creator><general>Elsevier Inc</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>7X8</scope><orcidid>https://orcid.org/0000-0002-7254-4686</orcidid></search><sort><creationdate>201710</creationdate><title>Treatment with neridronate in children and adolescents with osteogenesis imperfecta: Data from open-label, not controlled, three-year Italian study</title><author>Idolazzi, L. ; Fassio, A. ; Viapiana, O. ; Rossini, M. ; Adami, G. ; Bertoldo, F. ; Antoniazzi, F. ; Gatti, D.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c356t-c1f2df1bfa27b3d92148c295e4432661bb179b12e6f043176828210f11eb06fc3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Adolescent</topic><topic>Bone and Bones - drug effects</topic><topic>Bone Density - drug effects</topic><topic>Bone Density Conservation Agents - therapeutic use</topic><topic>Child</topic><topic>Diphosphonates - therapeutic use</topic><topic>Female</topic><topic>Humans</topic><topic>Italy</topic><topic>Male</topic><topic>Neridronate</topic><topic>Osteogenesis imperfecta</topic><topic>Osteogenesis Imperfecta - drug therapy</topic><topic>Safety</topic><topic>Tolerability</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Idolazzi, L.</creatorcontrib><creatorcontrib>Fassio, A.</creatorcontrib><creatorcontrib>Viapiana, O.</creatorcontrib><creatorcontrib>Rossini, M.</creatorcontrib><creatorcontrib>Adami, G.</creatorcontrib><creatorcontrib>Bertoldo, F.</creatorcontrib><creatorcontrib>Antoniazzi, F.</creatorcontrib><creatorcontrib>Gatti, D.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Bone (New York, N.Y.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Idolazzi, L.</au><au>Fassio, A.</au><au>Viapiana, O.</au><au>Rossini, M.</au><au>Adami, G.</au><au>Bertoldo, F.</au><au>Antoniazzi, F.</au><au>Gatti, D.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Treatment with neridronate in children and adolescents with osteogenesis imperfecta: Data from open-label, not controlled, three-year Italian study</atitle><jtitle>Bone (New York, N.Y.)</jtitle><addtitle>Bone</addtitle><date>2017-10</date><risdate>2017</risdate><volume>103</volume><spage>144</spage><epage>149</epage><pages>144-149</pages><issn>8756-3282</issn><eissn>1873-2763</eissn><abstract>The present study assessed the long-term efficacy and safety of intravenous (i.v.) neridronate in children and adolescents affected by osteogenesis imperfecta (OI).
55 young patients (mean age 12.6±3.9years) affected by OI were included in the study. Neridronate was administered by i.v. infusion at a dose of 2mg/kg (maximum dose of 100mg) at intervals of three-months for three years. Dual X-ray absorptiometry of the lumbar spine, hip and ultradistal and proximal radius were evaluated every 6months. Blood calcium, phosphate, albumin, fasting urinary calcium/creatinine ratio were obtained at baseline and every 3months. Serum bone turnover markers total and bone alkaline phosphatase were performed every 12months in a proportion of patients.
Mean lumbar spine and total hip bone mineral density (BMD) and bone mineral content significantly increased from baseline compared to all subsequent time points (p<0.001). Mean ultradistal radius BMD significantly increased from month 18 (p=0.026). Levels of bone turnover markers significantly decreased from baseline to all post-baseline observation time points. There was no statistically significant effect on fracture risk (p=0.185), although a significant reduction was observed in the mean number of fractures occurring during treatment compared to pre-treatment values. The most frequent adverse events were arthralgia, fever, joint sprain. An acute phase reaction was reported in 26 (22.8%) patients. None of the reported serious adverse events was considered as treatment-related.
Long-term i.v. neridronate treatment has positive effects on BMD, bone turnover markers and fracture risk with a good safety profile.
•Neridronate treatment in children and adolescents with O.I is associated with a significant Increase of BMD and BMC at lumbar spine and hip•Neridronate treatment in children and adolescents with O.I seems to have a significant protective effect on fracture risk•Neridronate treatmenthas a favorable safety profile with no serious adverse events related with the administration of the drug</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>28684193</pmid><doi>10.1016/j.bone.2017.07.004</doi><tpages>6</tpages><orcidid>https://orcid.org/0000-0002-7254-4686</orcidid></addata></record> |
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| subjects | Adolescent Bone and Bones - drug effects Bone Density - drug effects Bone Density Conservation Agents - therapeutic use Child Diphosphonates - therapeutic use Female Humans Italy Male Neridronate Osteogenesis imperfecta Osteogenesis Imperfecta - drug therapy Safety Tolerability |
| title | Treatment with neridronate in children and adolescents with osteogenesis imperfecta: Data from open-label, not controlled, three-year Italian study |
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