On the Interpretation of Rat Carcinogenicity Studies for Human PTH(1‐34) and Human PTH(1‐84)
Two drags have been approved for the treatment of osteoporosis that act by stimulating the formation of new bone--often referred to as bone anabolic agents. These drugs are recombinant human PTH(1-34) (teriparatide), approved in the Americas (Forteo) and in Europe (For-steo), and recombinant human P...
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| Veröffentlicht in: | Journal of bone and mineral research 2008-06, Vol.23 (6), p.803-811 |
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| creator | Tashjian, Armen H Goltzman, David |
| description | Two drags have been approved for the treatment of osteoporosis that act by stimulating the formation of new bone--often referred to as bone anabolic agents. These drugs are recombinant human PTH(1-34) (teriparatide), approved in the Americas (Forteo) and in Europe (For-steo), and recombinant human PTH(1-84) [rhPTH(1-84)], approved in Europe (Preotact). Both of these therapeutic agents, which have shown fracture prevention efficacy in clinical trials, have been shown to produce osteosarcomas in long-term carcinogenicity studies in rats. Although the relevance, if any, of the animal findings to patients will not be known with certainty until extensive clinical experience has accrued, it is believed that the risk of osteosarcomas in treated patients is low and that the therapeutic benefits on bone health of these anabolic agents significantly outweigh the theoretical risk of osteosarcoma. |
| doi_str_mv | 10.1359/jbmr.080208 |
| format | Article |
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Although the relevance, if any, of the animal findings to patients will not be known with certainty until extensive clinical experience has accrued, it is believed that the risk of osteosarcomas in treated patients is low and that the therapeutic benefits on bone health of these anabolic agents significantly outweigh the theoretical risk of osteosarcoma.</description><identifier>ISSN: 0884-0431</identifier><identifier>EISSN: 1523-4681</identifier><identifier>DOI: 10.1359/jbmr.080208</identifier><identifier>PMID: 18435577</identifier><identifier>CODEN: JBMREJ</identifier><language>eng</language><publisher>Washington, DC: John Wiley and Sons and The American Society for Bone and Mineral Research (ASBMR)</publisher><subject>Animals ; Biological and medical sciences ; Carcinogenicity Tests ; Dose-Response Relationship, Drug ; Female ; Fundamental and applied biological sciences. 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These drugs are recombinant human PTH(1-34) (teriparatide), approved in the Americas (Forteo) and in Europe (For-steo), and recombinant human PTH(1-84) [rhPTH(1-84)], approved in Europe (Preotact). Both of these therapeutic agents, which have shown fracture prevention efficacy in clinical trials, have been shown to produce osteosarcomas in long-term carcinogenicity studies in rats. Although the relevance, if any, of the animal findings to patients will not be known with certainty until extensive clinical experience has accrued, it is believed that the risk of osteosarcomas in treated patients is low and that the therapeutic benefits on bone health of these anabolic agents significantly outweigh the theoretical risk of osteosarcoma.</description><subject>Animals</subject><subject>Biological and medical sciences</subject><subject>Carcinogenicity Tests</subject><subject>Dose-Response Relationship, Drug</subject><subject>Female</subject><subject>Fundamental and applied biological sciences. Psychology</subject><subject>Humans</subject><subject>Male</subject><subject>Osteosarcoma - chemically induced</subject><subject>Osteosarcoma - diagnostic imaging</subject><subject>Osteosarcoma - pathology</subject><subject>Parathyroid Hormone - pharmacology</subject><subject>Peptide Fragments - pharmacology</subject><subject>Rats</subject><subject>Skeleton and joints</subject><subject>Time Factors</subject><subject>Tomography, X-Ray Computed</subject><subject>Vertebrates: osteoarticular system, musculoskeletal system</subject><issn>0884-0431</issn><issn>1523-4681</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2008</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp90UFLHDEUB_AgLbpqT72XXFoqZexL3iSTHNuldhXFYvU8xiTTRmYyazKD7K0foZ_RT-LILhV68PTg8eP_4P8IecvgkKHQn29vunQICjioLTJjgmNRSsVekRkoVRZQItshuznfAoAUUm6THaZKFKKqZuT6PNLht6fHcfBpmfxghtBH2jf0wgx0bpINsf_lY7BhWNGfw-iCz7TpE12MnYn0x-XiI3v48xfLA2qi-2-ryoN98roxbfZvNnOPXB19u5wvitPz78fzL6eFLbUuC4eIlVNaI0flFFjHEZ1uGgmONRqFV54xkFaYinOuK-adtiiBOemVQNwjH9a5y9TfjT4PdRey9W1rou_HXDOttFCqmuCnNbSpzzn5pl6m0Jm0qhnUT4XWT4XW60In_W4TO9503j3bTYMTeL8BJlvTNslEG_I_xwErrhmfXLV296H1q5du1idfzy6EFMAR5PS9R9IKjSI</recordid><startdate>200806</startdate><enddate>200806</enddate><creator>Tashjian, Armen H</creator><creator>Goltzman, David</creator><general>John Wiley and Sons and The American Society for Bone and Mineral Research (ASBMR)</general><general>American Society for Bone and Mineral Research</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>7U7</scope><scope>C1K</scope></search><sort><creationdate>200806</creationdate><title>On the Interpretation of Rat Carcinogenicity Studies for Human PTH(1‐34) and Human PTH(1‐84)</title><author>Tashjian, Armen H ; Goltzman, David</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4994-d3337d8993238d80cd233d9ff60d1f935e8e1106c5a7222971ed9c3601d6e8533</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2008</creationdate><topic>Animals</topic><topic>Biological and medical sciences</topic><topic>Carcinogenicity Tests</topic><topic>Dose-Response Relationship, Drug</topic><topic>Female</topic><topic>Fundamental and applied biological sciences. Psychology</topic><topic>Humans</topic><topic>Male</topic><topic>Osteosarcoma - chemically induced</topic><topic>Osteosarcoma - diagnostic imaging</topic><topic>Osteosarcoma - pathology</topic><topic>Parathyroid Hormone - pharmacology</topic><topic>Peptide Fragments - pharmacology</topic><topic>Rats</topic><topic>Skeleton and joints</topic><topic>Time Factors</topic><topic>Tomography, X-Ray Computed</topic><topic>Vertebrates: osteoarticular system, musculoskeletal system</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Tashjian, Armen H</creatorcontrib><creatorcontrib>Goltzman, David</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>Toxicology Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><jtitle>Journal of bone and mineral research</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Tashjian, Armen H</au><au>Goltzman, David</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>On the Interpretation of Rat Carcinogenicity Studies for Human PTH(1‐34) and Human PTH(1‐84)</atitle><jtitle>Journal of bone and mineral research</jtitle><addtitle>J Bone Miner Res</addtitle><date>2008-06</date><risdate>2008</risdate><volume>23</volume><issue>6</issue><spage>803</spage><epage>811</epage><pages>803-811</pages><issn>0884-0431</issn><eissn>1523-4681</eissn><coden>JBMREJ</coden><abstract>Two drags have been approved for the treatment of osteoporosis that act by stimulating the formation of new bone--often referred to as bone anabolic agents. 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| source | Oxford University Press Journals All Titles (1996-Current); MEDLINE; Wiley Online Library Journals Frontfile Complete; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Alma/SFX Local Collection |
| subjects | Animals Biological and medical sciences Carcinogenicity Tests Dose-Response Relationship, Drug Female Fundamental and applied biological sciences. Psychology Humans Male Osteosarcoma - chemically induced Osteosarcoma - diagnostic imaging Osteosarcoma - pathology Parathyroid Hormone - pharmacology Peptide Fragments - pharmacology Rats Skeleton and joints Time Factors Tomography, X-Ray Computed Vertebrates: osteoarticular system, musculoskeletal system |
| title | On the Interpretation of Rat Carcinogenicity Studies for Human PTH(1‐34) and Human PTH(1‐84) |
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