Filippo Migliorini1, Nicola Maffulli2,3,4, Filippo Spiezia5, Giuseppe Maria Peretti6,7, Markus Tingart8, Riccardo Giorgino7. 1. Department of Orthopaedic Surgery, University Clinic Aachen, RWTH Aachen University Clinic, Pauwelsstraße 30, 52074, Aachen, Germany. migliorini.md@gmail.com. 2. Department of Medicine, Surgery and Dentistry, University of Salerno, Via S. Allende, 84081, Baronissi, SA, Italy. 3. School of Pharmacy and Bioengineering, Keele University Faculty of Medicine, Thornburrow Drive, Stoke on Trent, Newcastle-under-Lyme, England. 4. Queen Mary University of London, Barts and the London School of Medicine and Dentistry, Centre for Sports and Exercise Medicine, Mile End Hospital, 275 Bancroft Road, London, E1 4DG, England. 5. Department of Orthopedics and Trauma Surgery, Ospedale San Carlo di Potenza, Potenza, Italy. 6. Department of Biomedical Sciences for Health, University of Milan, Milan, Italy. 7. Department of Orthopaedic Surgery, IRCCS Istituto Ortopedico Galeazzi, Milan, Italy. 8. Department of Orthopaedic Surgery, University Clinic Aachen, RWTH Aachen University Clinic, Pauwelsstraße 30, 52074, Aachen, Germany.
Abstract
BACKGROUND: Biochemical markers of bone turnover (BTMs), such as the bone alkaline phosphatase (bALP), procollagen type I N propeptide (PINP), serum cross-linked C-telopeptides of type I collagen (bCTx), and urinary cross-linked N-telopeptides of type I collagen (NTx), are used to manage therapy monitoring in osteoporotic patients. This systematic review analyzed the potential of these BMTs in predicting the clinical outcomes in terms of BMD, t-score, rate of fractures, and adverse events during the therapy setting in postmenopausal osteoporosis. METHODS: All randomized clinical trials (RCTs) reporting data on biomarkers for postmenopausal osteoporosis were accessed. Only articles reporting quantitative data on the level of biomarkers at baseline and on the outcomes of interest at the last follow-up were eligible. RESULTS: A total of 36,706 patients were retrieved. Greater values of bALP were associated with a greater rate of vertebral (P = 0.001) and non-vertebral fractures (P = 0.0001). Greater values of NTx at baseline were associated with a greater rate of adverse events at the last follow-up (P = 0.02). Greater values of CTx at baseline were associated with a greater rate of adverse events leading to discontinuation (P = 0.04), gastrointestinal adverse events (P = 0.0001), musculoskeletal adverse events (P = 0.04), and mortality (P = 0.04). Greater values of PINP at baseline were associated with greater rates of gastrointestinal adverse events (P = 0.02) at the last follow-up. CONCLUSION: The present analysis supports the adoption of BMTs during pharmacological therapy setting of patients suffering from osteoporosis. LEVEL OF EVIDENCE: I, systematic review of RCTs.
BACKGROUND: Biochemical markers of bone turnover (BTMs), such as the bone alkaline phosphatase (bALP), procollagen type I N propeptide (PINP), serum cross-linked C-telopeptides of type I collagen (bCTx), and urinary cross-linked N-telopeptides of type I collagen (NTx), are used to manage therapy monitoring in osteoporoticpatients. This systematic review analyzed the potential of these BMTs in predicting the clinical outcomes in terms of BMD, t-score, rate of fractures, and adverse events during the therapy setting in postmenopausal osteoporosis. METHODS: All randomized clinical trials (RCTs) reporting data on biomarkers for postmenopausal osteoporosis were accessed. Only articles reporting quantitative data on the level of biomarkers at baseline and on the outcomes of interest at the last follow-up were eligible. RESULTS: A total of 36,706 patients were retrieved. Greater values of bALP were associated with a greater rate of vertebral (P = 0.001) and non-vertebral fractures (P = 0.0001). Greater values of NTx at baseline were associated with a greater rate of adverse events at the last follow-up (P = 0.02). Greater values of CTx at baseline were associated with a greater rate of adverse events leading to discontinuation (P = 0.04), gastrointestinal adverse events (P = 0.0001), musculoskeletal adverse events (P = 0.04), and mortality (P = 0.04). Greater values of PINP at baseline were associated with greater rates of gastrointestinal adverse events (P = 0.02) at the last follow-up. CONCLUSION: The present analysis supports the adoption of BMTs during pharmacological therapy setting of patients suffering from osteoporosis. LEVEL OF EVIDENCE: I, systematic review of RCTs.
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