Should biochemical markers of bone turnover be considered standard practice for safety pharmacology?

Abstract

The success in biomedical sciences such as genomics and proteomics is not paralleled in the medical product development methods. The consequence of this is a lack of translation into improved drug safety and efficacy. Therefore the US Food and Drug Administration (FDA) introduced the Critical Path Initiative in 2004 to modernize drug development and safety pharmacology. Bone is that largest tissue by weight, and is continuously remodelled. Changes in bone turnover lead to complications such as osteoporosis and fracture, that is associated with an increased mortality. Recent findings have identified bone as a possible endocrine organ and the availability of valid biochemical bone markers suggests that assessing bone turnover should also play an important role in general safety pharmacology.

Key words::

• Bone markers
• safety pharmacology
• Critical Path Initiative

Acknowledgements

The authors are grateful for the support of ‘the Danish Research Foundation’, ‘den Danske Forskningsfond’ for the support of the current study.

Declaration of interest

All authors declare that the affiliation indicates full disclosure. Morten A. Karsdal owns stocks in Nordic Bioscience.