{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,6]],"date-time":"2025-11-06T20:12:43Z","timestamp":1762459963397,"version":"3.37.3"},"reference-count":22,"publisher":"Wiley","license":[{"start":{"date-parts":[[2021,5,31]],"date-time":"2021-05-31T00:00:00Z","timestamp":1622419200000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100014351","name":"CinnaGen","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100014351","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Journal of Osteoporosis"],"published-print":{"date-parts":[[2021,5,31]]},"abstract":"<jats:p>The safety of teriparatide has been studied in various phase III and phase IV trials. However, a postmarketing study of the biosimilar of teriparatide, CinnoPar\u00ae, has not been conducted on Iranian patients. This was a phase IV study conducted on osteoporotic patients who received an Iranian teriparatide biosimilar with a dose of 20\u2009\u03bcg daily. The primary outcome of this study was to monitor for adverse events (AEs). Effectiveness as the secondary outcome was measured using the EQ-5D quality-of-life questionnaire and back pain Visual Analogue Scale (VAS) score. Among 193 analyzed patients between September 2015 and March 2019, the most common AEs were hypercalcemia (4%), nausea, and pain (3%). No deaths, serious AEs, or other significant AEs occurred in this study. The mean EQ-5D scores decreased after the course of the treatment from 2.3\u2009\u00b1\u20090.66 at the baseline to 2\u2009\u00b1\u20090.66. The mean back pain VAS scores also decreased from 4.9\u2009\u00b1\u20093.6 at baseline to 1.8\u2009\u00b1\u20092.1 at the end of the study. Both changes were statistically significant (<jats:inline-formula>\n                     <a:math xmlns:a=\"http:\/\/www.w3.org\/1998\/Math\/MathML\" id=\"M1\">\n                        <a:mi>p<\/a:mi>\n                        <a:mo>&lt;<\/a:mo>\n                        <a:mn>0.001<\/a:mn>\n                     <\/a:math>\n                  <\/jats:inline-formula>). Consistent with the findings of previous studies and the drug monograph, no new safety concern was observed with this biosimilar teriparatide, and the drug was effective based on the VAS score and EQ-5D in osteoporotic patients.<\/jats:p>","DOI":"10.1155\/2021\/7584308","type":"journal-article","created":{"date-parts":[[2021,6,1]],"date-time":"2021-06-01T03:33:53Z","timestamp":1622518433000},"page":"1-6","source":"Crossref","is-referenced-by-count":3,"title":["A \u2009Phase IV Study of the Safety and Efficacy of CinnoPar\u00ae in Iranian Patients with Osteoporosis"],"prefix":"10.1155","volume":"2021","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0464-8715","authenticated-orcid":true,"given":"Ahmadreza","family":"Jamshidi","sequence":"first","affiliation":[{"name":"Rheumatology Research Center, Tehran University of Medical Sciences, Tehran, Iran"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0324-2609","authenticated-orcid":true,"given":"Farhad","family":"Gharibdoost","sequence":"additional","affiliation":[{"name":"Rheumatology Research Center, Tehran University of Medical Sciences, Tehran, Iran"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0328-0728","authenticated-orcid":true,"given":"Sima","family":"Sedighi","sequence":"additional","affiliation":[{"name":"Bones, Joints, and Connective Tissue Research Center, Golestan University of Medical Sciences, Gorgan, Iran"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7892-7664","authenticated-orcid":true,"given":"Asghar","family":"Hajiabbasi","sequence":"additional","affiliation":[{"name":"Guilan Rheumatology Research Center, Department of Rheumatology, Razi Hospital, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Amir-Hossein","family":"Salari","sequence":"additional","affiliation":[{"name":"Rheumatology Research Center, Tehran University of Medical Sciences, Tehran, Iran"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9482-6967","authenticated-orcid":true,"given":"Alireza","family":"Khabbazi","sequence":"additional","affiliation":[{"name":"Connective Tissue Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9810-4136","authenticated-orcid":true,"given":"Peyman","family":"Mottaghi","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Isfahan University of Medical Sciences, Isfahan, Iran"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5431-4836","authenticated-orcid":true,"given":"Ahmad","family":"Tahammoli Roudsari","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, School of Medicine, Hamadan University of Medical Sciences, Hamadan, Iran"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0143-7306","authenticated-orcid":true,"given":"Mehrdad","family":"Aghaei","sequence":"additional","affiliation":[{"name":"Golestan Rheumatology Research Center, Golestan University of Medical Sciences, Gorgan, Iran"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3967-7022","authenticated-orcid":true,"given":"Irandokht","family":"Shenavar Masooleh","sequence":"additional","affiliation":[{"name":"Guilan Rheumatology Research Center, Department of Rheumatology, Razi Hospital, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Araz","family":"Sabzvari","sequence":"additional","affiliation":[{"name":"CinnaGen Medical Biotechnology Research Center, Alborz University of Medical Sciences, Karaj, Iran"},{"name":"Orchid Pharmed Company, Tehran, Iran"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7247-6743","authenticated-orcid":true,"given":"Nassim","family":"Anjidani","sequence":"additional","affiliation":[{"name":"Medical Department, Orchid Pharmed Company, Tehran, Iran"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","reference":[{"issue":"6","key":"1","first-page":"785","article-title":"NIH consensus development panel on osteoporosis prevention, diagnosis, and therapy. osteoporosis prevention, diagnosis, and therapy","volume":"285","year":"2001","journal-title":"The Journal of the American Medical Association"},{"key":"2","doi-asserted-by":"publisher","DOI":"10.1002\/jbmr.2269"},{"issue":"9","key":"3","first-page":"759","article-title":"Prevalence of osteoporosis in Iran: a meta-analysis","volume":"18","author":"A. D. Irani","year":"2013","journal-title":"Journal of Research in Medical Sciences: The Official Journal of Isfahan University of Medical Sciences"},{"key":"4","doi-asserted-by":"publisher","DOI":"10.1097\/01.blo.0000200248.34876.fe"},{"issue":"2","key":"5","first-page":"92","article-title":"Osteoporosis: a review of treatment options","volume":"43","author":"K. N. Tu","year":"2018","journal-title":"P & T: A Peer-Reviewed Journal for Formulary Management"},{"volume-title":"Drug information. Post TW, ed. UpToDate.","year":"2019","author":"Teriparatide (Recombinant Human Parathyroid Hormone [1-34])","key":"6"},{"year":"2020","author":"U. S. V. Biologics","key":"7"},{"key":"8","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.13586"},{"article-title":"Biosimilars in the EU - information guide for healthcare professionals","year":"2019","author":"European Medicines Agency","key":"9"},{"key":"10","article-title":"Identifying key benefits in European off-patent biologics and biosimilar markets: it is not only about price!","volume":"1","author":"B. Dutta","year":"2019","journal-title":"BioDrugs [Internet]"},{"issue":"9","key":"11","first-page":"1336","article-title":"Efficacy and safety of the biosimilar recombinant human parathyroid hormone Cinnopar\u00ae in postmenopausal osteoporotic women: a randomized double-blind clinical trial","volume":"47","author":"O. Tabatabaei-Malazy","year":"2018","journal-title":"Iranian Journal of Public Health"},{"year":"2020","key":"12"},{"key":"13","doi-asserted-by":"publisher","DOI":"10.1080\/03007995.2017.1354826"},{"key":"14","doi-asserted-by":"publisher","DOI":"10.1056\/nejm200105103441904"},{"issue":"2","key":"15","first-page":"333","volume":"69","author":"E. D. Taniegra","year":"2004","journal-title":"Hyperparathyroidism. Am Fam Physician"},{"key":"16","doi-asserted-by":"publisher","DOI":"10.1007\/s00198-011-1856-y"},{"key":"17","doi-asserted-by":"publisher","DOI":"10.1056\/nejmoa071408"},{"issue":"10","key":"18","doi-asserted-by":"crossref","first-page":"1591","DOI":"10.1359\/jbmr.080506","article-title":"Effects of two years of daily teriparatide treatment on BMD in postmenopausal women with severe osteoporosis with and without prior antiresorptive treatment","volume":"23","author":"B. M. Obermayer\u2010Pietsch","year":"2008","journal-title":"Journal of Bone and Mineral Research"},{"key":"19","doi-asserted-by":"publisher","DOI":"10.1016\/s0140-6736(17)32137-2"},{"key":"20","doi-asserted-by":"publisher","DOI":"10.1007\/s00223-016-0143-5"},{"key":"21","doi-asserted-by":"publisher","DOI":"10.11622\/smedj.2014120"},{"key":"22","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2474-14-251"}],"container-title":["Journal of Osteoporosis"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/downloads.hindawi.com\/journals\/jos\/2021\/7584308.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/downloads.hindawi.com\/journals\/jos\/2021\/7584308.xml","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/downloads.hindawi.com\/journals\/jos\/2021\/7584308.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,6,1]],"date-time":"2021-06-01T03:34:04Z","timestamp":1622518444000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.hindawi.com\/journals\/jos\/2021\/7584308\/"}},"subtitle":[],"editor":[{"given":"Rimesh","family":"Pal","sequence":"additional","affiliation":[],"role":[{"role":"editor","vocabulary":"crossref"}]}],"short-title":[],"issued":{"date-parts":[[2021,5,31]]},"references-count":22,"alternative-id":["7584308","7584308"],"URL":"https:\/\/doi.org\/10.1155\/2021\/7584308","relation":{},"ISSN":["2042-0064","2090-8059"],"issn-type":[{"type":"electronic","value":"2042-0064"},{"type":"print","value":"2090-8059"}],"subject":[],"published":{"date-parts":[[2021,5,31]]}}}