Registry Questions and Answers
Q1: What is the purpose of the Registry?
Forteo is used in both men and postmenopausal women with osteoporosis who are at high risk for having broken bones (fractures). Forteo is also used in both men and women with osteoporosis due to use of glucocorticoids, such as prednisone, for several months, who are at high risk for having broken bones. The safety of Forteo has been studied for over 15 years. The Forteo Patient Registry will help us learn more about the long-term safety of using this medication, specifically, the potential risk of osteosarcoma, a rare bone cancer.
Q2: How does the Registry work?
When patients sign up for the Registry, we take the information you provide from the registration form and store it in a secure database at RTI. We then send this information to state health cancer registries. These cancer registries are located in every state and are required by law to keep information on every newly diagnosed case of cancer in their state. If you sign up for the Forteo Patient Registry, we will link the information from your registration to participating cancer registries every year until the year 2021. We will use the results from the participating cancer registries to find out whether patients who take Forteo have a higher chance of developing osteosarcoma, a rare bone cancer.
Everyone in the US who takes Forteo is asked to sign up. Remember, joining this Registry does not mean that you have this bone cancer or will get this bone cancer.
Q3: How long will it take me to fill out the study forms?
It takes about 3-5 minutes to fill out the study forms.
Q4: Who is running the Registry?
RTI International (RTI), a nonprofit research organization located in Research Triangle Park, North Carolina, is running the Registry. The Registry is sponsored by Eli Lilly and Company, the makers of Forteo.
Q5: Will my personal information remain private?
Your personal information will not be shared outside of the research team or the participating cancer registries. Information that can identify patients will not be shared with Eli Lilly and Company, the sponsor of this Registry, or with anyone outside of the research team without your permission to do so. All staff working on this Registry have agreed to keep your information confidential. The US Food and Drug Administration may also ask to review some of the Registry records.
RTI will keep your personal information for 3 years after the end of the study. At that time, we will shred and destroy any paper documents with your personal information, and we will erase any computer files with your information. At the end of the Registry, RTI may write a research paper about the Registry results. The results will not identify you personally.
Q6: How do I know if Forteo is working for me?
Your doctor is the best person with whom to discuss whether Forteo is working for you.
Q7: How do I withdraw my name from the Registry?
You can withdraw your name and personal information from the Forteo Patient Registry at any time. If you would like to withdraw from the Registry, please call toll-free at 1-866-382-6813.
Q8: How can I obtain a printed version of the material on the Web site?
The information on the Web site is also included in the registration materials. Once you pre-enroll for the Registry, you will receive a registration packet in the mail. It typically takes 2 weeks to receive these materials.
Q9: Is there a number I can call to receive additional information about Forteo?
For information about Forteo, you can call 1-800-Lilly-Rx (1-800-545-5979).
Q10: Is there a Web site where I can find out more about Forteo?
The company who makes Forteo has a Web site that you may visit, www.Forteo.com.
Q11: How can I find out the results of the study?
We plan to publish the results from the full study in a medical journal after the study closes (some-time after 2022). You may also check the Registry Progress page for updates on the study progress and links to information that has been presented at scientific meetings.