Forteo Patient Registry: Methods, Challenges, and Progress 8 Years In

When the FDA approved the drug teriparatide for treatment of glucocorticoid-induced osteoporosis, it required a study in the form of a prospective registry as a condition of approval. The FORTEO® Patient Registry (FPR) was established in 2009 to enroll patients treated with teriparatide in the US and follow them prospectively to estimate the incidence of bone cancer. Osteosarcoma was to be identified through linking patient data with state cancer registries.

This study is one of a series of studies RTI Health Solutions has been conducting regarding a possible association between teriparatide and osteosarcoma in humans. The studies started in 2003 after the drug was first approved in the US in 2002. Studies include two retrospective case series studies, (one in the US and one in the Nordic countries) and a study that links US Medicare data with cancer registry data (see links below).

Results to Date

Enrollment in the FPR continues through 2019. Our researchers recently published a paper in Osteoporosis International that describes study methods, challenges, and progress so far. As can be seen from the study website (forteoregistry.rti.org), over 70,000 people have signed up to join the study.   

The paper suggests that “The results of the linkage between the FORTEO® Patient Registry and cancer registry data indicate that it is feasible for many US state cancer registries to perform a data linkage using a standard algorithm to evaluate medication exposure.”

Registry Goal

The initial target was to observe a large enough population to have the power to observe a threefold increase in the risk of osteosarcoma, if one exists. To maximize patient registration, researchers used a novel approach to minimize the patient enrollment burden. Patients received information about the registry in product packaging instead of via recruitment sites. So far, it is anticipated that the completed study will be able to detect a fourfold increase in the risk of osteosarcoma if one exists.

Read the research - The Forteo patient registry linkage to multiple state cancer registries: study design and results from the first 8 years. Gilsenan A, Harding A, Kellier-Steele N, Harris D, Midkiff K, Andrews E. Osteoporos Int. 2018 Oct;29(10):2335-43. doi: 10.1007/s00198-018-4604-8. 

Teriparatide and Osteosarcoma Research Series:

The US postmarketing surveillance study of adult osteosarcoma and teriparatide: study design and findings from the first 7 years.

The European postmarketing adult osteosarcoma surveillance study characteristics of patients: a preliminary report.

Complementary observational studies assessing the incidence of a rare cancer outcome by linking state cancer registry data to large pharmacy claims databases in the United States.