AIMS: The Forteo Patient Registry, an ongoing drug safety surveillance study, was initiated in 2009 to estimate the incidence of osteosarcoma in patients who have been treated with Forteo in the US to complement an ongoing retrospective study that was initiated in 2003. The objective of this presentation is to provide an update on study progress, including descriptive characteristics of patients enrolled in the Forteo Patient Registry.
METHODS: In the US, patients treated with Forteo who volunteer to enroll in the study provide informed consent. Patients are asked to complete a one-time registration, which includes request for Forteo start date and information needed to facilitate linkage to cancer registries. On annual basis data from all registered patients are linked to all participating cancer registries to determine whether there are any diagnosed cases of osteosarcoma among registered patients.
RESULTS: As of September 30, 2015, 51,503 patients treated with Forteo had registered with the Forteo Patient Registry. The sex distribution of patients registered reflects that of Forteo users (89% female, 11% male) and the majority were between the ages of 56-84. The sixth annual linkage was completed as of September 21, 2015; data on 49,754 patients were linked to a total of 3,927 adult cases of osteosarcoma aged 18 years and older diagnosed since January 1, 2009 across 41 cancer registries that cover 92% of the US population. To date, no incident cases of osteosarcoma have been identified among patients registered in the voluntary Forteo Patient Registry.
CONCLUSION: Although no incident cases of osteosarcoma have been identified following treatment with Forteo in this ongoing voluntary Forteo Patient Registry safety study, the ability to draw conclusions based on interim results is limited.
