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ZOLEDRONIC ACID VERSUS ALENDRONATE IN THE TREATMENT OF CHILDREN WITH OSTEOGENESIS IMPERFECTA: A 2-YEAR CLINICAL STUDY.
Endocr Pract. 2018 Feb;24(2):179-188
Authors: Lv F, Liu Y, Xu X, Music Y, Li L, Jiang Y, Wang O, Xia W, Xing X
Summary
OBJECTIVE: Bisphosphonates have been demonstrated to extend the bone mineral density (BMD) of osteogenesis imperfecta (OI) sufferers. We aimed to match the efficacy and security of intravenous zoledronic acid and oral alendronate in sufferers with OI.
METHODS: A complete of 161 sufferers with OI starting from 2 to 16 years outdated had been included and randomized at a 2:1 ratio to obtain both weekly oral alendronate (ALN) 70 mg or a once-yearly infusion of zoledronic acid (ZOL) for two years. The first endpoints had been proportion change from baseline in lumbar backbone (LS) BMD and alter in Z-scores of LS BMD.
RESULTS: A complete of 136 sufferers with OI accomplished the 2-year scientific research, 90 of whom had been assigned to obtain ALN, whereas 46 obtained ZOL remedy. The share change in LS BMD was 60.01 ± 7.08% within the ALN group and 62.04 ± 5.9% within the ZOL group ( P = .721). The corresponding BMD Z-score elevated by zero.50 ± zero.05 within the ALN group and zero.71 ± zero.06 within the ZOL group ( P = .013). ZOL was superior to ALN in decreasing the scientific fracture fee (hazard ratio, zero.23; 95% confidence interval, zero.118 to zero.431). There was no distinction within the incidence of extreme negative effects between the 2 teams.
CONCLUSION: A once-yearly 5 mg infusion of ZOL and weekly oral ALN had related results in growing BMD and decreasing bone resorption in kids and adolescents with OI. ZOL was superior to ALN in decreasing the scientific fracture fee.
ABBREVIATIONS: 25OHD = 25-hydroxyvitamin D ALN = alendronate ALP = alkaline phosphatase ?-CTX = cross-linked C-telopeptide of kind I collagen BMD = bone mineral density BP = bisphosphonate FN = femoral neck LS = lumbar backbone OI = osteogenesis imperfecta SAE = extreme antagonistic occasion ZOL = zoledronic acid.
PMID: 29466057 [PubMed – indexed for MEDLINE]