Milena Miljkovic ([email protected])

In initial preclinical studies with teriparatide in rats, increased risk of osteosarcoma incidence was observed, that was dependent on dose and treatment duration. Subsequent studies demonstrated a “no-effect” dose in rats, and no bone tumours in a long-term study of cynomolgus monkeys.

However, the US product label contains a warning to physicians about a potential risk of osteosarcoma and to use the product only in the absence of other risk factors for osteosarcoma (e.g., Paget's disease of bone, prior radiation therapy, or children or young adults with open epiphyses) and to limit exposure to a maximum of 2 years.

Information about the etiology of osteosarcoma in adults is limited, but it has been observed in association with Paget's disease of the bone and after radiation treatment to the bones. In addition, rare inherited disorders (p53 mutation) and retinoblastoma (pRb loss) are associated with increased rates of osteosarcoma, while other potential risk factors include trauma/injury at the tumor site ad occupational exposures.

The exact cellular mechanism of action of teriparatide, as well as possible mechanism by which this medicine can cause osteosarcoma, are not quite clear at the moment.

For additional information, please read articles at the following links:

1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6154045/pdf/198_2018_Article_4604.pdf

2. https://www.annalsofepidemiology.org/article/S1047-2797(16)30274-5/pdf

3. https://onlinelibrary.wiley.com/doi/epdf/10.1002/art.27427

4. https://onlinelibrary.wiley.com/doi/epdf/10.1002/jbmr.1800

5. https://www.jclinepi.com/article/S0895-4356(15)00063-3/pdf

6. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3546381/