In vitro test battery for screening pro- and anti-osteoporotic effects of new drug candidates

Osteoporotic changes in bone tissue cause pain and restricted movement in affected patients, and can even lead to immobility. A current focus of osteoporosis research is to gain a better understanding of bone (patho)physiology. Building on this, applied translational research is focusing on the development of innovative therapies. While the animal models predominantly used in this context reduce the comparability of patho/physiological processes due to species-specific differences between humans and animals and make it difficult to test new targeted therapeutic strategies, in vitro approaches can generally only reproduce aspects of complex bone physiology to a limited extent. Against this background, we aim to develop ‘InViTOP’, a systematic sequence of in vitro alternative methods, an in vitro test battery. This should be able to quantify endpoints of osteoporosis with defined effect sizes. Our first goal is to facilitate the performance of experiments on bone pathophysiology and to test experimental approaches before conducting animal experiments. Our second goal is to ensure that the test battery fully complies with FDAshort forFood and Drug Administration/EMA requirements for the non-clinical evaluation of drugs for the treatment of osteoporosis in animal models. If this is achieved, applied research in the field of efficacyClose dialogefficacyPositive Predictive ValueTo glossary testing will be supported, resulting in a powerful alternative to animal testing. In detail, as part of the project, we will combine a selection of in vitro methods in a multi-stage process using 2D and 3D models in such a way that a standardised and validated procedure with defined effect sizes and reference values and an associated in vitro test battery for the non-clinical evaluation of drugs for the treatment of osteoporosis will be created as a product of this development.