| The purpose of this study is to assist Research Triangle Institute International (RTI) in conducting a nationwide surveillance study of patients with osteosarcoma. Their goal is to identify at least 40% of adults diagnosed with osteosarcoma and conduct telephone interviews to assess prior exposure to Forteo™ (teriparatide [rDNA origin] injection) as well as other risk factors. RTI is enlisting the University of Texas M. D. Anderson Cancer Center (UTMDACC) to assist with identifying potential patients who meet the eligibility criteria. UTMDACC will be responsible for identifying patients and obtaining consent for the release of patient contact information and tumor information (Appendix F) to RTI, so that RTI can follow-up directly with the patient to conduct the telephone interview. In addition, in the event that a patient has died, MD Anderson will identify the patient's next-of-kin and contact them by mail and telephone regarding participation in the study.
The overall objectives for this surveillance program are:
(1) to systematically monitor for Forteo™ exposures in osteosarcoma patients and
(2) to contribute to the scientific knowledge regarding prevalence of demographic characteristics and some medical factors in adults with this rare cancer.
To meet these objectives the specific aims are:
(1) to identify approximately 40% of newly diagnosed cases of osteosarcoma among men and women 40 years of age and older in the United States (US), starting January 1, 2003 for a duration of at least 10 years;
(2) to determine incident osteosarcoma cases, if any, who have a history of Forteo™ treatment through a telephone interview directly with the patient or the patient's next of kin in the event that the patient has died, and
(3) to systematically collect, for descriptive epidemiology purposes, additional patient information, including demographics and data related to other exposures. |