Background Zoledronic acid (ZA) is approved to prevent or treat osteoporosis in women after menopause (PO), men, secondary osteoporosis, especially glicocorticoid-inducted one (GC). Causes of osteoporosis in patients with connective tissue diseases (CTD) are much more complicated than in patients with postmenopausal osteoporosis.
Objectives The aim of this study was to evaluate the safety and efficacy of ZA in the treatment of glicocorticoid-inducted osteoporosis in the course of connective tissue disease (GC/CTD) in comparison with postmenopausal osteoporosis (PO).
Methods This study included a total of 196 patients in a period of 5 years (2010-2014). Among this group was 75 patients with GC osteoporosis in the course of CTD and 103 with PO. They had been treated with ZA at a dose of 5 mg given iv. once a year with adequate calcium and vitamin D supplementation. All patients included into the study fulfilled the osteoporosis densitometric criteria according to WHO and had contraindications to the use of oral bisphosphonates. The primary endpoint was the number of complications observed in GC patients after ZA administration compared to those noted in patients with PO. The second endpoint was the number of new fractures during 5-year treatment of ZA.
Results In both groups there were no statistically significant differences in terms of the mean age, T-score result before the first administration and during the tratment of zoledronic acid and mean number of osteoporotic fractures. The number of complications in patients with GC/CPD was distinctly higher (12% - 9 in 75 patients) than in patients with postmenopausal osteoporosis (3,88% - 4 in 103 patients). Furthermore in patients with PO the only side effect observed were flu-like symptoms (fever, myalgia, arthralgia) whereas in patients with GC/CPD disease more severe complications were noted such as renal function deterioration-4 cases, trombocytopaenia-1 or osteonecrosis of the jaw-1. No significant difference between a number of bone fractures was noted in the course of observation:8% - 6 fractures in GC/CPD and 7,77% - 8 fractures in PO group.
Conclusions The analysis suggests that the treatment of ZA in 5-years observation in PO is as effective as in GS/CPD subjects. The number of complications was significantly higher and they were more severe in patients who had glicocorticosteroid-inducted osteoporosis associated to CTD as compared to subjects with postmenopausal osteoporosis. The safety and efficacy of a annual dose 5 mg intravenous infusion of zoledronic acid should be further investigated.
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The effect of 3 versus 6 years of zoledronic acid treatment of osteoporosis: a randomized extension to the HORIZON-Pivotal Fracture Trial (PFT). Black DM, Reid IR, at al. J Bone Miner Res. 2012,27:243-54.
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Acknowledgements No declared
Disclosure of Interest None declared
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