BACKGROUND: In rat toxicology studies, teriparatide, the active ingredient in Forteo, when given for the entire rodent lifespan caused increases in bone mass and a dose-dependent increase in the incidence of osteosarcoma, a rare primary bone cancer. Among adults aged =18 years, the human incidence of osteosarcoma is 2.7 cases per million persons per year. As part of a long-term 12-year surveillance program for a possible signal of osteosarcoma in treated patients, the voluntary Forteo Patient Registry was launched in July 2009 to complement an ongoing retrospective case finding study.
OBJECTIVE: To describe study progress of the Forteo Patient Registry, designed to estimate the incidence of osteosarcoma in patients treated with Forteo, and to enhance healthcare provider awareness of the progress of the Registry after 3 years.
METHODS: Patients who complete a brief pre-enrollment form are sent a registration packet. After completing a one-time registration and consent, patients are considered enrolled. An annual linkage is performed by participating state cancer registries using a standardized linkage algorithm with the Forteo Patient Registry database to identify cases of osteosarcoma potentially associated with Forteo treatment. Linkage variables include name, birth date, sex, address, telephone number, race, ethnicity, and last 4 digits of social security number.
RESULTS: The third annual linkage, performed in September 2012, including a total of 38 state cancer registries covering 86% of the US population linked 26,810 patients from the Forteo Patient Registry with 1,641 adult osteosarcoma cases diagnosed since January 1, 2009. No matches were identified. As of December 2012, of the 30,758 registrants, the distribution by pathway of recruitment was medication packaging (61%), starter kit (26%), study toll-free number (6%), patient brochure (3%), physician tear pad (2%), direct pharmacy mail (2%), and study website (1%).
CONCLUSION: Evaluation of the first 3 years of data, detected no signals of a possible association between Forteo treatment and osteosarcoma. The most frequent pathway for patient recruitment to date is information about the voluntary patient registry in product packaging. Patient respondent burden is kept to a minimum. Healthcare provider encouragement of Forteo treated patients to consider enrolling in the Registry can contribute to the scientific advancement of this surveillance study.
