Journal
CALCIFIED TISSUE INTERNATIONAL
Volume 112, Issue 2, Pages 197-217Publisher
SPRINGER
DOI: 10.1007/s00223-022-01054-z
Keywords
Sarcopenia; Biomarkers; Biochemical markers; Recommendations; Clinical trial; Pharmacological drugs
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Biochemical markers in clinical trials provide useful information on drug's mode of action, therapeutic response, and side effect monitoring. Identifying biomarkers for sarcopenia management is urgently needed for future clinical practice. A consensus paper from a working group of the ESCEO proposed a list of biochemical markers for musculoskeletal health and aging in Phase II and III clinical trials for sarcopenia treatment, and suggested classifying them into two series based on their evaluation of musculoskeletal status and causal factors.
In clinical trials, biochemical markers provide useful information on the drug's mode of action, therapeutic response and side effect monitoring and can act as surrogate endpoints. In pharmacological intervention development for sarcopenia management, there is an urgent need to identify biomarkers to measure in clinical trials and that could be used in the future in clinical practice. The objective of the current consensus paper is to provide a clear list of biochemical markers of musculoskeletal health and aging that can be recommended to be measured in Phase II and Phase III clinical trials evaluating new chemical entities for sarcopenia treatment. A working group of the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) proposed classifying biochemical markers into 2 series: biochemical markers evaluating musculoskeletal status and biochemical markers evaluating causal factors. For series 1, the group agreed on 4 biochemical markers that should be assessed in Phase II or Phase III trials (i.e., Myostatin-Follistatin, Brain Derived Neurotrophic Factor, N-terminal Type III Procollagen and Serum Creatinine to Serum Cystatin C Ratio - or the Sarcopenia Index). For series 2, the group agreed on 6 biochemical markers that should be assessed in Phase II trials (i.e., the hormones insulin-like growth factor-1 (IGF-I), dehydroepiandrosterone sulphate, and cortisol, and the inflammatory markers C-reactive protein (CRP), interleukin-6 and tumor necrosis factor-alpha), and 2 in Phase III trials (i.e., IGF-I and CRP). The group also proposed optional biochemical markers that may provide insights into the mode of action of pharmacological therapies. Further research and development of new methods for biochemical marker assays may lead to the evolution of these recommendations.
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