Treatment fAIlure in Osteoporosis: Who Will Experience a New fRacture? The TAILOR Study

Fragility fractures represent a major clinical burden in the increasingly older population. Old suffering with femoral fractures will die within a year (15-25%) or become dependent (50%). Costs associated with fractures have been estimated to be 32 billion EUR/year in Europe, 20 billion USD in the United States and 12.5 billion USD in China. The second fracture worsen the patients' health and increases costs, the financial burden imposed by second fractures on the United States healthcare system has been calculated in 2 billion USD/year.

The efficacy of treatment in osteoporosis relies in the reduction of the fracture risk: drugs approved for osteoporosis reduce the risk of fractures between 30-70% for vertebral fractures, 40-50% for hip fractures and 15-20% for non-vertebral fractures (1,2). However, no available treatment reset the fracture risk to zero. Treatment efficacy is assumed by a significant reduction in fracture risk supported by an increase in bone mineral density (BMD) and a decrease in markers of bone turnover. The question if a new fracture or bone loss may be considered a treatment failure is highly debated, recently, a position paper of the International Osteoporosis Foundation described the treatment failure (TF) based on the occurrence of two fractures or one fracture plus lack of variation in BMD, markers of bone turnover or both while on treatment (3).

The study of TF and its prevention is crucial, as the correct and precocious identification of the patients that will not benefit from the first line drugs, will prevent unsuccessful treatment and reduce sanitary costs. Several factors has been suggested to be associated with TF, however, until now, the therapeutic decision relies entirely on physician expertise and not on decisional algorithms.

The aim of this project is to characterize the clinical characteristics foreseeing TF. The identification of a signature for TF will increase the standard care of osteoporotic patients reducing the burden due to a new fracture.

TAILOR will pave the way for the generation of a new algorithm to choose wisely a personalize therapeutical approach for osteoporotic patients, taking into account their clinical characteristics, thus minimizing the risk of TF, improving patients quality and expectancy of life and reducing sanitary costs.