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首页> 外文期刊>Journal of bone and mineral research: the official journal of the American Society for Bone and Mineral Research >The US postmarketing surveillance study of adult osteosarcoma and teriparatide: Study design and findings from the first 7 years
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The US postmarketing surveillance study of adult osteosarcoma and teriparatide: Study design and findings from the first 7 years

机译：美国成人成骨肉瘤和特立帕肽上市后监测研究：前7年的研究设计和发现

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The Osteosarcoma Surveillance Study, an ongoing 15-year surveillance study initiated in 2003, is a postmarketing commitment to the United States (US) Food and Drug Administration to evaluate a potential association between teriparatide, rhPTH(1-34), a recombinant human parathyroid hormone analog (self-injectable medication to treat osteoporosis), and development of osteosarcoma in response to a finding from preclinical (animal) studies. Incident cases of primary osteosarcoma diagnosed in adults (aged ≤yen;40 years) on or after January 1, 2003, are identified through population-based state, regional, and comprehensive cancer center registries in the US. Information on possible prior treatment with teriparatide, on demographics, and on risk factors is ascertained by patient or proxy telephone interview after patient consent. Between June 2004 and September 30, 2011, 1448 cases (diagnosed 2003 to 2009) were identified by participating cancer registries (estimated to be 62% of all adult cases in the US for that time period); 549 patients or proxies were interviewed. Interviewed patients were similar to noninterviewed patients with regard to mean age, sex, race, and geographical distribution and tumor type and site of tumor. Mean age of those interviewed was 61 years, 46% were female, 86% were white, and 77% were alive when the case was reported to the study investigators. Data collected in the study provide descriptive information on a large number of adults with osteosarcoma, an uncommon malignant bone tumor. After 7 years of the study, there were no osteosarcoma patients who had a prior history of teriparatide treatment. Thus, approximately halfway through this 15-year study, the study has not detected a pattern indicative of a causal association between teriparatide treatment and osteosarcoma in humans.
机译：骨肉瘤监测研究是一项始于2003年的持续15年的监测研究，是对美国食品药品监督管理局的上市后承诺，以评估特立帕肽，重组人甲状旁腺素rhPTH（1-34）之间的潜在关联激素类似物（用于治疗骨质疏松症的自我注射药物），以及根据临床前（动物）研究发现的骨肉瘤的发展。 2003年1月1日或之后，在成人（≤日元; 40岁）成年人中诊断出的原发性骨肉瘤病例是通过美国以人群为基础的州，地区和综合癌症中心注册机构确定的。在患者同意后，可通过患者或代理电话采访确定有关特立帕肽可能的先前治疗，人口统计学和风险因素的信息。在2004年6月至2011年9月30日之间，参与的癌症登记处确定了1448例病例（诊断为2003年至2009年）（估计占该时期美国所有成人病例的62％）;采访了549名患者或代理人。就平均年龄，性别，种族，地理分布以及肿瘤类型和部位而言，接受访谈的患者与未经接受访谈的患者相似。当向研究人员报告该病例时，受访者的平均年龄为61岁，女性为46％，白人为86％，还活着为77％。该研究中收集的数据提供了有关大量成年人骨肉瘤（一种罕见的恶性骨肿瘤）的描述性信息。经过7年的研究，没有骨肉瘤患者接受特立帕肽治疗。因此，在这项为期15年的研究中途进行了大约一半，该研究尚未发现任何指示特立帕肽治疗与人骨肉瘤之间因果关系的模式。

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