Filippo Migliorini1, Nicola Maffulli2,3,4, Filippo Spiezia5, Markus Tingart6, Peretti Giuseppe Maria7,8, Giorgino Riccardo8. 1. Department of Orthopaedics, 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, England. 4. Centre for Sports and Exercise Medicine, Mile End Hospital, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, 275 Bancroft Road, London, E1 4DG, England. 5. Department of Orthopedics and Trauma Surgery, Ospedale San Carlo Potenza, Via Potito Petrone, Potenza, Italy. 6. Department of Orthopaedics, University Clinic Aachen, RWTH Aachen University Clinic, Pauwelsstraße 30, 52074, Aachen, Germany. 7. Department of Biomedical Sciences for Health, University of Milan, Milan, Italy. 8. Orthopedics and Traumatology, University of Milan, IRCCS Istituto Ortopedico Galeazzi, Milan, Italy.
Abstract
BACKGROUND: Biochemical markers of bone turnover (BTMs), such as 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 commonly used for therapy monitoring purposes for osteoporotic patients. The present study evaluated the potential role of BTMs as therapy monitoring. METHODS: All randomized clinical trials (RCTs) comparing two or more pharmacological treatments for postmenopausal osteoporosis were accessed. Only studies that reported the value of bALP, PINP, bCTx, and NTx at last follow-up were included. A multivariate analysis was performed to assess associations between these biomarkers and clinical outcomes and rate of adverse events in patients with postmenopausal osteoporosis. A multiple linear model regression analysis through the Pearson product-moment correlation coefficient was used. RESULTS: A total of 16 RCTs (14,446 patients) were included. The median age was 67 years, and the median BMI 25.4 kg/m2. The median vertebral BMD was 0.82, hip BMD 0.79, and femur BMD 0.64 g/cm2. The ANOVA test found optimal within-group variance concerning mean age, body mass index, and BMD. Greater bALP was associated with lower femoral BMD (P = 0.01). Greater NTx was associated with a greater number of non-vertebral fractures (P = 0.02). Greater NTx was associated with greater rate of therapy discontinuation (P = 0.04). No other statistically significant associations were detected. CONCLUSION: Our analysis supports the adoption of BTMs in therapy monitoring of osteoporotic patients. LEVEL OF EVIDENCE: Level I, systematic review of RCTs.
BACKGROUND: Biochemical markers of bone turnover (BTMs), such as 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 commonly used for therapy monitoring purposes for osteoporoticpatients. The present study evaluated the potential role of BTMs as therapy monitoring. METHODS: All randomized clinical trials (RCTs) comparing two or more pharmacological treatments for postmenopausal osteoporosis were accessed. Only studies that reported the value of bALP, PINP, bCTx, and NTx at last follow-up were included. A multivariate analysis was performed to assess associations between these biomarkers and clinical outcomes and rate of adverse events in patients with postmenopausal osteoporosis. A multiple linear model regression analysis through the Pearson product-moment correlation coefficient was used. RESULTS: A total of 16 RCTs (14,446 patients) were included. The median age was 67 years, and the median BMI 25.4 kg/m2. The median vertebral BMD was 0.82, hipBMD 0.79, and femur BMD 0.64 g/cm2. The ANOVA test found optimal within-group variance concerning mean age, body mass index, and BMD. Greater bALP was associated with lower femoral BMD (P = 0.01). Greater NTx was associated with a greater number of non-vertebral fractures (P = 0.02). Greater NTx was associated with greater rate of therapy discontinuation (P = 0.04). No other statistically significant associations were detected. CONCLUSION: Our analysis supports the adoption of BTMs in therapy monitoring of osteoporoticpatients. LEVEL OF EVIDENCE: Level I, systematic review of RCTs.
Authors: H S Ju; S Leung; B Brown; M A Stringer; S Leigh; C Scherrer; K Shepard; D Jenkins; J Knudsen; R Cannon Journal: Clin Chem Date: 1997-09 Impact factor: 8.327
Authors: S Mora; C Prinster; M C Proverbio; A Bellini; S C de Poli; G Weber; G Abbiati; G Chiumello Journal: Calcif Tissue Int Date: 1998-11 Impact factor: 4.333
Authors: Douglas C Bauer; Patrick Garnero; Stephanie L Harrison; Jane A Cauley; Richard Eastell; Kris E Ensrud; Eric Orwoll Journal: J Bone Miner Res Date: 2009-12 Impact factor: 6.741
Authors: Rinaldo Florencio-Silva; Gisela Rodrigues da Silva Sasso; Estela Sasso-Cerri; Manuel Jesus Simões; Paulo Sérgio Cerri Journal: Biomed Res Int Date: 2015-07-13 Impact factor: 3.411