Harris D, Midkiff K, Gilsenan A, Kellier-Steele N, McSorley D, Andrews EB. Study update for a postmarketing case series study of adult osteosarcoma and teriparatide in the United States. Poster presented at the 32nd ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 27, 2016. Dublin, Ireland. [abstract] Pharmacoepidemiol Drug Saf. 2016 Aug; 25(Suppl 3):437-8.

BACKGROUND: The Osteosarcoma Surveillance Study, a 15year safety surveillance study, was initiated in 2003 to monitor for a possible association between teriparatide treatment and osteosarcoma, a rare bone cancer occurring at a rate of approximately 2.5 cases per million per year in the US in adults aged 40 years or older.

To provide a study update for this ongoing study, including descriptive characteristics of US osteosarcoma patients aged 40 years and older.

METHODS: Incident cases of osteosarcoma diagnosed on or after January 1, 2003, and tumor information are identified through cancer registries in the US. After consent, information including demographics, prior medications, and exposure to possible risk factors is ascertained via telephone interview. Medical record review is performed for a random sample each year to validate selfreported information.

RESULTS: As of September 30, 2015, 939 patients diagnosed with osteosarcoma between 2003 and 2013 had been interviewed, and one reported use of teriparatide prior to diagnosis. Taking into account the ageand sexadjusted background incidence rate, the estimated personyears at risk following first exposure to teriparatide, and the proportion of osteosarcoma cases that have been interviewed, three cases would be expected to have been reported at this time. Demographic characteristics were similar for interviewed and noninterviewed patients. Mean age of interviewed patients was 61 years, 52% were male, 85% were white, and 10% were African American. Osteosarcoma, NOS (71%) and chondroblastic osteosarcoma (12%) were the most common morphologic types; leg bones (31%), pelvis/sacrum (15%), and skull/face/mandible (15%) were the most common anatomical tumor sites. Reported prevalence of known risk factors was 19% for history of radiation and 5% for history of Paget's disease of bone.

CONCLUSIONS: Data from this ongoing study continue to contribute to knowledge about the longterm safety of teriparatide.

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