Forteo Patient Registry Progress Page

The Registry began in July 2009. As of June 30, 2017, 63,273 people have signed up to join the Forteo Patient Registry. The Registry enrollment progress through June 30, 2017 is shown below.

Yearly and Cumulative Number of New Patients Registered
from 2010 Through the Fourth Quarter of 2017

Yearly and Cumulative Number of New Patients Registered in the Forteo Patient Registry

a Projected number of patients for calendar year 2017 based on actuals through June 30, 2017.

When Will Results be Available?

A summary of the study progress, including the number of patients enrolled in the Registry and the incidence of osteosarcoma (which is based on the latest cancer registry linkage) is submitted to Eli Lilly and Company quarterly. Results are also reviewed by the Osteosarcoma Surveillance Study Advisory Board, consisting of experts in bone cancer and epidemiology, who provide study guidance and interpretation of the study information and results at least once a year. Summary reports are shared with the US Food and Drug Administration (FDA) at least annually. At the conclusion of this long-term study (sometime after 2025), a final report will be prepared and submitted to the FDA and for publication in a peer-reviewed journal. None of these reports provide identifying data on individual patients.

Related Publications

  1. Andrews EB, Gilsenan AW, Midkiff K, Sherrill B, Wu Y, Mann BH, Masica D. The US postmarketing surveillance study of adult osteosarcoma and teriparatide: study design and findings from the first 7 years. J Bone Miner Res. 2012;27(12):2429-37.

Recent Scientific Presentations

Information about the Registry methods and progress is also shared as scientific presentations. A list of recent scientific presentations is provided below. For a copy of any of the presentations, please contact the study investigator, Dr. Alicia Gilsenan at 919-541-8745 to request a copy.

Presentations

  1. Harris D, Gilsenan A, Harding A, Andrews E, Kellier N, Massica D. Long-term cancer surveillance: Five-year update for the Forteo Patient Registry Surveillance Study. Pharmacoepidemiol Drug Saf. 2015 Sep; 24 (S1): 547-8.

  2. Harris DH, Gilsenan AW, Harding AA, DeGuire B, Andrews EB. Long-Term Cancer Surveillance: Five-Year Update for the Forteo Patient Registry Data Linkage Study. Presented at the North American Association of Central Cancer Registries (NAACCR) Annual conference, Charlotte, NC June 2015.

  3. Kellier N, Krohn K, Masica D, Gilsenan AW, Harding AA, Andrews EB. Forteo Voluntary Patient Registry: 4-Year Progress on a Prospective Osteosarcoma Surveillance Study. Presented at the International Osteoporosis Foundation (IOF) ISCD Skeletal Health Annual Meeting, Orlando, Florida February 2014.

  4. Gilsenan AW, Midkiff KD, Andrews EB, von Schéele B, Masica D, Ceberg J, Alvegård T. Multinational Collaboration: A Long-Term Surveillance Program for Osteosarcoma and Potential Exposure to Teriparatide. Presented at the 36th Meeting of the Scandinavian Sarcoma Group, Helsinki, Finland October 2013.

  5. Kellier N, Crohn K, Gilsenan AW, Harris DH, Andrews EB, Masica D. Forteo Voluntary Patient Registry: 3-Year Progress on a Prospective Osteosarcoma Surveillance Study. Presented at the American Society for Bone and Mineral Research Annual meeting, Baltimore, MD October 2013.

  6. Gilsenan AW, Harris DH, Midkiff KD, Andrews EB, Kellier N, Masica D. Approaches to Long-Term Surveillance for Rare Cancer Events. Presented as a poster at the International Society of Pharmacoepidemiology and Therapeutic Risk Management (ISPE) Annual Meeting, Montreal, Canada. Aug 2013 Pharmacoepidemiol Drug Saf 22 (suppl 1): S444.

  7. Gilsenan AW, Harris DH, Midkiff KD, Andrews EB, Masica D. Seeing the Big Picture in Long-Term Surveillance for Rare Events. Presented at the North American Association of Central Cancer Registries (NAACCR) Annual conference, Austin, TX June 2013.

  8. Harris DH, Gilsenan AW, Midkiff KD, Harding A. Navigating the Registry-Specific Approval Process for a Long-Term Drug Safety Surveillance Study. Presented as a poster at the North American Association of Central Cancer Registries (NAACCR) Annual conference, Austin, TX June 2013.

  9. Gilsenan AW. Challenges and Successes in Using Cancer Registry Surveillance Data to Monitor for a Potential Safety Signal. Presented at the SCOPE Summit 2013: Summit for Clinical Ops Executives, Miami, Florida February 2013.

  10. Gilsenan, A.W., Kellier, N. A. , Harris, D. H., Andrews, E. B., Masica, D. N. Linking a Voluntary Patient Registry with US State Cancer Registries for Signal Detection. Presented as a poster at the International Society of Pharmacoepidemiology and Therapeutic Risk Management (ISPE) Annual Meeting. Barcelona, Spain Aug 2012 Pharmacoepidemiol Drug Saf 21(suppl 3): S464.

  11. Harris, D., Gilsenan, A., Wu, Y., Andrews, E.. Using Cancer Surveillance Data to Advance Science: Monitoring for a Potential Safety Signal for Approved Drugs Through Linkage Studies. Presented at the North American Association of Central Cancer Registries (NAACCR) Annual Meeting. Portland, OR Jun 2012.

  12. Gilsenan, A., Harris, D., Midkiff, K., Andrews, E., Wright, J. Linkage with Multiple State Cancer Registries for Safety Surveillance – Is it Feasible? Presented as a poster at the International Society of Pharmacoepidemiology and Therapeutic Risk Management (ISPE) Annual Meeting. Chicago, IL Aug 2011 Pharmacoepidemiol Drug Saf 2011; 20:S1-S382:S167.

  13. Gilsenan, A., Harris, D., Midkiff, K., Andrews, E. Collaboration with Multiple State Cancer Registries for a Data Linkage Drug Safety Surveillance Study – Yes You Can!. Presented as a poster at the North American Association of Central Cancer Registries (NAACCR) Annual Meeting, Louisville, KY Jun 2011.

  14. Gilsenan A, Andrews EB, Midkiff K, Ladner A. Charting a new course in long-term safety: the critical role of cancer registries. Presented as a poster at the ISPE Annual Meeting. Brighton, UK. Aug 2010. Pharmacoepidemiol Drug Saf 2010;19:S1-S347:S116.

  15. Harris D, Midkiff K, Gilsenan A, Andrews E. Public health surveillance collaboration: establishing a linkage algorithm with cancer registries for the Forteo Patient Registry. Presented as a poster at the NAACCR Annual Meeting, Quebec City, Canada. Jun 2010.