Research Triangle Park, NC - RTI Health Solutions® (RTI-HS) is implementing a 15-year surveillance study in the US to evaluate a potential association between use of Forteo® (teriparatide), a medication used for osteoporosis, and development of osteosarcoma in adults. The safety study, which was initiated in 2003, is a postmarketing commitment to the FDA. Preclinical studies showed an association between use of teriparatide and development of osteosarcoma.
Interim results, from the first 7 years of this 15-year study have been published in the Journal of Bone and Mineral Density doi: [10.1002/jbmr.1768].
With fewer than three cases per million individuals each year, osteosarcoma is a very rare cancer. To conduct the study, researchers contact patients with osteosarcoma identified in US cancer registries, including state, regional and medical center registries. They obtain information on prior treatment with teriparatide and other risk factors.
A surveillance study, such as this, helps reduce the uncertainties around potential risks to patients.
Full text of the publication is available at the link below:
The US Postmarketing Surveillance Study of Adult Osteosarcoma and Teriparatide: Study Design and Findings From the First 7 Years
A companion study, being conducted in the Nordic countries, was described in a prior publication: von Scheele, B., R.D. Martin, A.W. Gilsenan, J. Ceberg, E.B. Andrews, D. Masica, and T. Alvegard. (2009). "The European postmarketing adult Osteosarcoma Surveillance Study: characteristics of patients A preliminary report." Acta Orthopaedica, 80:67-74.
For more information about the study contact:
Elizabeth Andrews, PhD
Vice President, Pharmacoepidemiology and Risk Management
Phone: (919) 541-5819
About RTI Health Solutions:
RTI Health Solutions provide scientifically rigorous research and consulting services to pharmaceutical, biotechnology and medical device companies.