title: The US postmarketing surveillance study of adult osteosarcoma and teriparatide: study design and findings from the first 7 years.
abstract: 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 ≥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.
authors.affiliation: RTI Health Solutions, Research Triangle Park, NC 27709, USA. eandrews@rti.org
authors.forename: Elizabeth B
authors.initials: EB
authors.lastname: Andrews
authors.forename: Alicia W
authors.initials: AW
authors.lastname: Gilsenan
authors.forename: Kirk
authors.initials: K
authors.lastname: Midkiff
authors.forename: Beth
authors.initials: B
authors.lastname: Sherrill
authors.forename: Yun
authors.initials: Y
authors.lastname: Wu
authors.forename: Beth H
authors.initials: BH
authors.lastname: Mann
authors.forename: Daniel
authors.initials: D
authors.lastname: Masica
mesh_terms: D000328:Adult; D000368:Aged; D001859:Bone Neoplasms / Q000139:chemically induced; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010024:Osteoporosis / Q000188:drug therapy; D012516:Osteosarcoma / Q000139:chemically induced* / Q000453:epidemiology; D010281:Parathyroid Hormone / Q000009:adverse effects / Q000627:therapeutic use; D011358:Product Surveillance, Postmarketing; D012042:Registries; D019379:Teriparatide / Q000009:adverse effects* / Q000627:therapeutic use; D014481:United States / Q000453:epidemiology
chemical_list: C470125:PTH protein, human; D010281:Parathyroid Hormone; D019379:Teriparatide