BACKGROUND: The Osteosarcoma Surveillance Study, an ongoing 15-year drug safety surveillance study, was initiated in 2003 to monitor for a possible association between teriparatide treatment and osteosarcoma in adults aged 40 years or older in the United States (US).
OBJECTIVE: To provide an update on results, including descriptive characteristics of patients aged 40 years and older with osteosarcoma in the US.
METHODS: Incident cases of adult osteosarcoma diagnosed on or after January 1, 2003, are identified through cancer registries in the US. After consent, case information, including demographics, prior treatment with 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 self-reported information.
RESULTS: As of September 30, 2012, 1,729 patients diagnosed between 2003 and 2010 had been identified from the 16 participating cancer registries and 643 had been interviewed. Characteristics were similar for interviewed and noninterviewed patients. Among patients interviewed, mean age was 60 years, 47% were female, and 86% were white. Osteosarcoma, not otherwise specified (NOS) (72%) and chondroblastic osteosarcoma (11%) were the most common morphologic types; leg bones (31%) and pelvis/sacrum (16%) were the most common anatomical tumor sites. Reported prevalence of known risk factors was 20% for history of radiation and 6% for history of Paget’s disease of bone. The prevalence of other possible risk factors included 27% for prior history of cancer and 18% for prior trauma or infection at site of cancer. No patients reported use of teriparatide prior to the diagnosis of osteosarcoma.
CONCLUSIONS: Data from this 15-year surveillance study contribute to knowledge about the long-term safety of teriparatide. After 8 years of data collection, the study has not detected a pattern indicative of a causal association between treatment with teriparatide and osteosarcoma.
