Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2021 Apr;32(4):645-651.
doi: 10.1007/s00198-020-05718-0. Epub 2020 Nov 5.

Long-term cancer surveillance: results from the Forteo Patient Registry Surveillance Study

A Gilsenan  1 , D Harris  2 , M Reynolds  2 , D McSorley  2 , K Midkiff  2 , L Jackson  2 , B Muldavin  3 , N Kellier-Steele  4 , E Andrews  2
Affiliations

Long-term cancer surveillance: results from the Forteo Patient Registry Surveillance Study

A Gilsenan et al. Osteoporos Int. 2021 Apr.

Abstract

The Forteo Patient Registry estimated the incidence of osteosarcoma in US patients treated with teriparatide and enrolled in the study between 2009 and 2019. No incident cases of osteosarcoma were identified among patients registered, and the crude incidence rate was 0 (95% confidence interval [CI], 0-10.2) cases per million person-years.

Purpose: The prospective, voluntary Forteo Patient Registry was established to estimate the incidence of osteosarcoma in patients who have received treatment with teriparatide (Forteo).

Methods: Information on US adults prescribed teriparatide and enrolled in the Forteo Patient Registry 2009-2019 was linked with data from participating state cancer registries annually (2010-2019) to identify incident osteosarcoma cases using a standardized linkage algorithm. Teriparatide exposure was ascertained from self-reported data that included teriparatide initiation and demographics necessary to complete linkage. Osteosarcoma cases diagnosed on or after January 1, 2009, were identified by participating state cancer registries. The crude incidence rate (IR) and standardized incidence ratio (SIR) of observed cases to the expected number of cases adjusted to the background rate (3 per million person-years) and corresponding 95% CIs for the occurrence of osteosarcoma were calculated whereby the cumulative amount of person-time observed was adjusted for mortality.

Results: Data for 75,247 enrolled patients (representing 361,763 cumulative person-years) were linked to each of 42 participating state cancer registries (covering 93% of the US population), which included information on 6180 cases of osteosarcoma. No matches with incident cases of osteosarcoma following registry enrollment were found. The crude IR was 0 (95% CI, 0-10.2) cases per million person-years and the SIR was 0 (95% CI, 0-3.0).

Conclusions: The ability to draw conclusions about the incidence of osteosarcoma among patients participating in the registry was limited due to the smaller than expected amount of patient follow-up time and the fact that no cases were identified.

Keywords: Cancer registry; Linkage; Osteosarcoma; Registry; Teriparatide.

PubMed Disclaimer

Conflict of interest statement

This study was performed under a research contract between RTI Health Solutions and Eli Lilly and Company and was funded by Eli Lilly and Company. Elizabeth Andrews, Alicia Gilsenan, David Harris, David McSorley, Kirk Midkiff, and Maria Reynolds are salaried employees of RTI International, a nonprofit research organization that conducts research with multiple pharmaceutical companies and has an independent right to publish the results of this study. Nicole Kellier-Steele is a salaried employee of Eli Lilly and Company.

Figures

Fig. 1
Fig. 1
Age distribution among the general teriparatide population, stratified by sex (prevalent teriparatide users January 2009 through June 2018) (n = 75,247) (Adapted from IMS Health Prescription Data (LRx), January 2009–June 2018 data provided October 2018)
Fig. 2
Fig. 2
Age distribution of registered patients, stratified by sex, as of June 30, 2019. N = 75,246. One patient was missing data for sex and was excluded from counts in this figure
Fig. 3
Fig. 3
Geographic distribution of patients included in the Forteo Patient Registry Linkage File (n = 75,247). (a) Approximately 5% of patients registered in the Forteo Patient Registry lived in one of the nine states where the cancer registry did not participate in the study. Geographic distribution based on state of residence at time of enrollment into the Forteo Patient Registry
See this image and copyright information in PMC

References

    1. Eli Lilly and Company (Revised 2020) Forteo [package insert]. http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021318s012lbl.pdf. Accessed 11 Jun 2020
    1. Vahle JL, Sato M, Long GG, Young JK, Francis PC, Engelhardt JA, Westmore MS, Ma YL, 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;30:312–321. doi: 10.1080/01926230252929882. - DOI - PubMed
    1. Vahle JL, Long GG, Sandusky G, Westmore M, Ma YL, Sato M. Bone neoplasms in F344 rats given teriparatide [rhPTH(134)] are dependent on duration of treatment and dose. Toxicol Pathol. 2004;32:426–438. doi: 10.1080/01926230490462138. - DOI - PubMed
    1. 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;23:2033–2039. doi: 10.1359/jbmr.080807. - DOI - PubMed
    1. Food and Drug Administration (2009) Approval letter: Forteo (teriparatide, rPTH[1-34]) for the treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021318s012.... Accessed 28 Sept 2017