Harris D, Midkiff K, Gilsenan A, Andrews E. Twelve-year study update for a postmarketing case series study of adult osteosarcoma and teriparatide in the U.S. Poster presented at the North American Association of Central Cancer Registries (NAACCR) 2017 Annual Conference; June 21, 2017. Albuquerque, NM.

BACKGROUND: The Osteosarcoma Surveillance Study, a 15-year safety surveillance study, was initiated in 2003 to monitor for a possible association between teriparatide (an osteoporosis treatment) and osteosarcoma, which occurs in the US in adults aged 40 years or older at a background incidence rate of approximately 2.5 cases per million per year. Multiple state, SEER regional, and comprehensive cancer registries are actively participating in this study.

OBJECTIVE: To provide an update for this ongoing study, including descriptive characteristics of osteosarcoma patients aged 40 years or older, and participation by cancer registries.

METHODS: Incident cases of osteosarcoma diagnosed between January 1, 2003, and December 31, 2014, and tumor information are identified through cancer registries. After consent, information including demographics, prior medications, and exposure to possible risk factors is ascertained via telephone interview. Requirements necessary for contacting the patient (patient-access pathways) vary among participating cancer registries, from passive notification to active permission from the patient and/or physician.

RESULTS: As of September 30, 2016, 3,128 incident cases of osteosarcoma in patients aged 40 years or older were identified by 29 cancer registries. After completing individual cancer registry requirements to release contact information, 2,166 were available to be interviewed. Of these, interviews were completed for 1,031 patients (48%). Of those interviewed, two patients reported use of teriparatide prior to diagnosis of osteosarcoma, which is within the expected range assuming no increased risk with treatment.

CONCLUSIONS: Data from this ongoing study continue to contribute to knowledge about the long-term safety of teriparatide. Participation by many cancer registries is essential for drug safety surveillance for rare cancers.

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