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. © 2012 American Society for Bone and Mineral Research.

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References 19

1. 1.

   Vahle JL, Sato M, Long GG, Young JK, Francis PC, Engelhardt JA, Westmore MS, Linda Y, Nold JB. Skeletal changes in rats given daily subcutaneous injections of recombinant human parathyroid hormone (1–34) for 2 years and relevance to human safety. Toxicol Pathol. 2002;30(3):312-21.

   Not in our library10.1080/01926230252929882

2. 2.

   Vahle JL, Long GG, Sandusky G, Westmore M, Ma YL, Sato M. Bone neoplasms in F344 rats given teriparatide [rhPTH(1–34)] are dependent on duration of treatment and dose. Toxicol Pathol. 2004;32(4):426-38.

   Not in our library10.1080/01926230490462138

3. 3.

   Vahle JL, Zuehlke U, Schmidt A, Westmore M, Chen P, Sato M. Lack of bone neoplasms and persistence of bone efficacy in cynomolgus macaques after long-term treatment with teriparatide [rhPTH(1–34)]. J Bone Miner Res. 2008;23(12):2033-9.

   Not in our library10.1359/jbmr.080807

4. 4.

   Mirabello L, Troisi RJ, Savage SA. International osteosarcoma incidence patterns in children and adolescents. m iddle ages and elderly persons. Int J Cancer. 2009;125(1):229-34.

   Not in our library10.1002/ijc.24320

5. 5.

   Mirabello L, Troisi RJ, Savage SA. Osteosarcoma incidence and survival rates from 1973 to 2004: data from the Surveillance, Epidemiology, and End Results Program. Cancer. 2009;115(7):1531-43.

   Not in our library10.1002/cncr.24121

6. 6.

   Grimer RJ, Cannon SR, Taminiau AM, Bielack S, Kempf-Bielack B, Windhager R, Dominkus M, Saeter G, Bauer H, Meller I, Szendroi M, Folleras G, San-Julian M, van der Eijken J. Osteosarcoma over the age of forty. Eur J Cancer. 2003;39(2):157-63.

   Not in our library10.1016/s0959-8049(02)00478-1

7. 7.

   Unni KK, Dahlin DC. Dahlin's bone tumor: general aspects and data on 11,087 cases. 1996;143-4.

   Not in our library

8. 8.
   Using Epidemiology and Genomics to Understand Osteosarcoma Etiology · 2011

   No notice
9. 9.

   Merletti F, Richiardi L, Bertoni F, Ahrens W, Buemi A, Costa-Santos C, Eriksson M, Guénel P, Kaerlev L, Jöckel KH, Llopis-Gonzalez A, Merler E, Miranda A, Morales-Suárez-Varela MM, Olsson H, Fletcher T, Olsen J. Occupational factors and risk of adult bone sarcomas: a multicentric case-control study in Europe. Int J Cancer. 2006;118(3):721-7.

   Not in our library10.1002/ijc.21388

10. 10.

    Kim FM, Hayes C, Williams PL, Whitford GM, Joshipura KJ, Hoover RN, Douglass CW. National Osteosarcoma Etiology Group. An assessment of bone fluoride and osteosarcoma. J Dent Res. 2011;90(10):1171-6.

    Not in our library10.1177/0022034511418828

11. 11.

    This reference’s wording can’t be shown under the paper’s licence.

    Not in our library

12. 12.

    von Schéele B, Martin RD, Gilsenan AW, Ceberg J, Andrews EB, Masica D, Alvegård T. The European postmarketing adult osteosarcoma surveillance study: characteristics of patients. Acta Orthopaedica. 2009;80(Suppl 334):67-74.

    Not in our library

13. 13.

    This reference’s wording can’t be shown under the paper’s licence.

    Not in our library

14. 14.

    Harper KD, Krege JH, Marcus R, Mitlak BH. Osteosarcoma and teriparatide? J Bone Miner Res. 2007;22(2):334.

    Not in our library10.1359/jbmr.061111

15. 15.

    Lubitz R, Prasad S. Case report: osteosarcoma and teriparatide (abstract). Poster presented at the ASBMR 31st Annual Meeting. J Bone Miner Res. 2009;24(Suppl 1):SU0354.

    Not in our library

16. 16.

    Subbiah V, Madsen VS, Raymond AK, Benjamin RS, Ludwig JA. Of mice and men: divergent risks of teriparatide-induced osteosarcoma. Osteoporos Int. 2010;21(6):1041-5.

    Not in our library10.1007/s00198-009-1004-0

17. 17.

    This reference’s wording can’t be shown under the paper’s licence.

    Not in our library

18. 18.

    Groves RM, Fowler FJ, Couper MP, Lepkowski JM. Nonresponse in sample surveys. Survey methodology. 2009;183-211.

    Not in our library

19. 19.

    Standards for privacy of individually identifiable health information. Final rule. Fed Regist. 2002;67(157):53181-273.

    Not in our library

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• Predictors of teriparatide treatment failure in patients with low bone mass · 2016
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