Randomized head-to-head comparison of minodronic acid and raloxifene for fracture incidence in postmenopausal Japanese women: the Japanese Osteoporosis Intervention Trial (JOINT)-04

References

• McClung M, Harris ST, Miller PD, et al. Bisphosphonate therapy for osteoporosis: benefits, risks, and drug holiday. Am J Med. 2013;126(1):13–20.
   PubMed Web of Science ®Google Scholar
• Khosla S, Bilezikian JP, Dempster DW, et al. Benefits and risks of bisphosphonate therapy for osteoporosis. J Clin Endocrinol Metab. 2012;97(7):2272–2282.
   PubMed Web of Science ®Google Scholar
• Ettinger B, Black DM, Mitlak BH, et al. Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene: results from a 3-year randomized clinical trial. Multiple Outcomes of Raloxifene Evaluation (MORE) Investigators. JAMA. 1999;282(7):637–645.
   PubMed Web of Science ®Google Scholar
• Silverman SL, Christiansen C, Genant HK, et al. Efficacy of bazedoxifene in reducing new vertebral fracture risk in postmenopausal women with osteoporosis: results from a 3-year, randomized, placebo-, and active-controlled clinical trial. J Bone Miner Res. 2008;23(12):1923–1934.
   PubMed Web of Science ®Google Scholar
• Cummings SR, San Martin J, McClung MR, FREEDOM Trial, et al. Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N Engl J Med. 2009;361(8):756–765..
   PubMed Web of Science ®Google Scholar
• McClung MR, Grauer A, Boonen S, et al. Romosozumab in postmenopausal women with low bone mineral density. N Engl J Med. 2014;370(5):412–420.
   PubMed Web of Science ®Google Scholar
• Cranney A, Guyatt G, Griffith L, Osteoporosis Methodology Group and The Osteoporosis Research Advisory Group, et al. Meta-analyses of therapies for postmenopausal osteoporosis. IX: summary of meta-analyses of therapies for postmenopausal osteoporosis. Endocr Rev. 2002;23(4):570–578.
   PubMed Web of Science ®Google Scholar
• Black DM, Delmas PD, Eastell R, et al. Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. N Engl J Med. 2007;356(18):1809–1822.
   PubMed Web of Science ®Google Scholar
• Matsumoto T, Hagino H, Shiraki M, et al. Effect of daily oral minodronate on vertebral fractures in Japanese postmenopausal women with established osteoporosis: a randomized placebo-controlled double-blind study. Osteoporos Int. 2009;20(8):1429–1437.
   PubMed Web of Science ®Google Scholar
• Hagino H, Shiraki M, Fukunaga M, et al. Three years of treatment with minodronate in patients with postmenopausal osteoporosis. J Bone Miner Metab. 2012;30(4):439–446.
   PubMed Web of Science ®Google Scholar
• Marcus R, Wong M, Heath H, 3rd, et al. Antiresorptive treatment of postmenopausal osteoporosis: comparison of study designs and outcomes in large clinical trials with fracture as an endpoint. Endocr Rev. 2002;23(1):16–37.
   PubMed Web of Science ®Google Scholar
• Marshall D, Johnell O, Wedel H. Meta-analysis of how well measures of bone mineral density predict occurrence of osteoporotic fractures. BMJ. 1996;312(7041):1254–1259.
   PubMed Web of Science ®Google Scholar
• Johnell O, Kanis JA, Oden A, et al. Predictive value of BMD for hip and other fractures [published correction appears in J Bone Miner Res. 2007 May;22(5):774]. J Bone Miner Res. 2005;20(7):1185–1194.
   PubMed Web of Science ®Google Scholar
• Cummings SR, Karpf DB, Harris F, et al. Improvement in spine bone density and reduction in risk of vertebral fractures during treatment with antiresorptive drugs. Am J Med. 2002;112(4):281–289.
   PubMed Web of Science ®Google Scholar
• Delmas PD, Seeman E. Changes in bone mineral density explain little of the reduction in vertebral or nonvertebral fracture risk with anti-resorptive therapy. Bone. 2004;34(4):599–604.
   PubMed Web of Science ®Google Scholar
• Delmas PD, Li Z, Cooper C. Relationship between changes in bone mineral density and fracture risk reduction with antiresorptive drugs: some issues with meta-analyses. J Bone Miner Res. 2004;19(2):330–337.
   PubMed Web of Science ®Google Scholar
• Uemura Y, Tanaka S, Miyazaki T, Adequate Treatment of Osteoporosis (A-TOP) research group, et al. Study design of multi-center, open-label randomized controlled, head-to-head trial comparing minodronic acid and raloxifene: Japanese Osteoporosis Intervention Trial (JOINT)-04. J Bone Miner Metab. 2019;37(3):491–495.
   PubMed Web of Science ®Google Scholar
• Committee for Development Guidelines for Prevention and Treatment of Osteoporosis. Japanese 2015 guidelines for prevention and treatment of osteoporosis. Life Science Publishing 2015 (in Japanese).
   Google Scholar
• Okazaki R, Hagino H, Ito M, et al. Efficacy and safety of monthly oral minodronate in patients with involutional osteoporosis. Osteoporos Int. 2012;23(6):1737–1745.
   PubMed Web of Science ®Google Scholar
• Orimo H, Nakamura T, Hosoi T, et al. Japanese 2011 guidelines for prevention and treatment of osteoporosis-executive summary. Arch Osteoporos. 2012;7(1–2):3–20.
   PubMedGoogle Scholar
• Genant HK, Engelke K, Fuerst T, et al. Noninvasive assessment of bone mineral and structure: state of the art. J Bone Miner Res. 1996;11(6):707–730.
   PubMed Web of Science ®Google Scholar
• Orimo H, Nakamura T, Fukunaga M, A-TOP (Adequate Treatment of Osteoporosis) Research Group, et al. Effects of alendronate plus alfacalcidol in osteoporosis patients with a high risk of fracture: the Japanese Osteoporosis Intervention Trial (JOINT) – 02. Curr Med Res Opin. 2011;27(6):1273–1284.
   PubMed Web of Science ®Google Scholar
• Nguyen ND, Center JR, Eisman JA, et al. Bone loss, weight loss, and weight fluctuation predict mortality risk in elderly men and women. J Bone Miner Res. 2007;22(8):1147–1154.
   PubMed Web of Science ®Google Scholar
• Giner M, Rios MJ, Montoya MJ, et al. Alendronate and raloxifene affect the osteoprotegerin/RANKL system in human osteoblast primary cultures from patients with osteoporosis and osteoarthritis. Eur J Pharmacol. 2011;650(2–3):682–687.
   PubMed Web of Science ®Google Scholar
• Delmas PD, Ensrud KE, Adachi JD, Mulitple Outcomes of Raloxifene Evaluation Investigators, et al. Multiple Outcomes of Raloxifene Evaluation Investigators. Efficacy of raloxifene on vertebral fracture risk reduction in postmenopausal women with osteoporosis: four-year results from a randomized clinical trial. J Clin Endocrinol Metab. 2002;87(8):3609–3617.
   PubMed Web of Science ®Google Scholar
• Sarkar S, Mitlak BH, Wong M, et al. Relationships between bone mineral density and incident vertebral fracture risk with raloxifene therapy. J Bone Miner Res. 2002;17(1):1–10.
   PubMed Web of Science ®Google Scholar
• Li Z, Meredith MP, Hoseyni MS. A method to assess the proportion of treatment effect explained by a surrogate endpoint. Stat Med. 2001;20(21):3175–3188.
   PubMed Web of Science ®Google Scholar
• Watts NB, Cooper C, Lindsay R, et al. Relationship between changes in bone mineral density and vertebral fracture risk associated with risedronate: greater increases in bone mineral density do not relate to greater decreases in fracture risk. J Clin Densitom. 2004;7(3):255–261.
   PubMed Web of Science ®Google Scholar
• Jacques RM, Boonen S, Cosman F, et al. Relationship of changes in total hip bone mineral density to vertebral and nonvertebral fracture risk in women with postmenopausal osteoporosis treated with once-yearly zoledronic acid 5 mg: the HORIZON-Pivotal Fracture Trial (PFT). J Bone Miner Res. 2012;27(8):1627–1634.
   PubMed Web of Science ®Google Scholar
• Foster SA, Shi N, Curkendall S, et al. Fractures in women treated with raloxifene or alendronate: a retrospective database analysis. BMC Womens Health. 2013;13–15.
   PubMed Web of Science ®Google Scholar
• Lin T, Yan SG, Cai XZ, et al. Alendronate versus raloxifene for postmenopausal women: A meta-analysis of seven head-to-head randomized controlled trials. Int J Endocrinol. 2014;2014:796510.
   PubMedGoogle Scholar
• Ensrud KE, Black DM, Palermo L, et al. Treatment with alendronate prevents fractures in women at highest risk: results from the Fracture Intervention Trial. Arch Intern Med. 1997;157(22):2617–2624.
   PubMed Web of Science ®Google Scholar
• Boonen S, McClung MR, Eastell R, et al. Safety and efficacy of risedronate in reducing fracture risk in osteoporotic women aged 80 and older: implications for the use of antiresorptive agents in the old and oldest old. J Am Geriatr Soc. 2004;52(11):1832–1839.
   PubMed Web of Science ®Google Scholar
• Masuda T, McCLung MR, Geusens P. Reducing hip fracture risk with risedronate in elderly women with established osteoporosis. Clin Interv Aging. 2009;4:445–559.
   PubMed Web of Science ®Google Scholar
• Vandenbroucke A, Luyten FP, Flamaing J, et al. Pharmacological treatment of osteoporosis in the oldest old. Clin Interv Aging. 2017;12:1065–1077.
   PubMed Web of Science ®Google Scholar
• van Meurs JB, Dhonukshe-Rutten RA, Pluijm SM, et al. Homocysteine levels and the risk of osteoporotic fracture. N Engl J Med. 2004;350(20):2033–2041.
   PubMed Web of Science ®Google Scholar
• Shiraki M, Kuroda T, Tanaka S, et al. Nonenzymatic collagen cross-links induced by glycoxidation (pentosidine) predicts vertebral fractures. J Bone Miner Metab. 2008;26(1):93–100.
   PubMed Web of Science ®Google Scholar
• Tanaka S, Kuroda T, Saito M, et al. Urinary pentosidine improves risk classification using fracture risk assessment tools for postmenopausal women. J Bone Miner Res. 2011;26(11):2778–2784.
   PubMed Web of Science ®Google Scholar
• Saito M, Marumo K. Collagen cross-links as a determinant of bone quality: a possible explanation for bone fragility in aging, osteoporosis, and diabetes mellitus. Osteoporos Int. 2010;21(2):195–214.
   PubMed Web of Science ®Google Scholar
• Yang J, Hu X, Zhang Q, et al. Homocysteine level and risk of fracture: a meta-analysis and systematic review. Bone. 2012;51(3):376–382.
   PubMed Web of Science ®Google Scholar
• Shiraki M, Kuroda T, Shiraki Y, et al. Urinary pentosidine and plasma homocysteine levels at baseline predict future fractures in osteoporosis patients under bisphosphonate treatment. J Bone Miner Metab. 2011;29(1):62–70.
   PubMed Web of Science ®Google Scholar
• Cox DA, Sarkar S, Harper K, et al. Effect of raloxifene on the incidence of elevated low density lipoprotein (LDL) and achievement of LDL target goals in postmenopausal women. Curr Med Res Opin. 2004;20(7):1049–1055.
   PubMed Web of Science ®Google Scholar
• Huang YF, Chang CT, Muo CH, et al. Impact of bisphosphonate-related osteonecrosis of the jaw on osteoporotic patients after dental extraction: a population-based cohort study. PLOS One. 2015;10(4):e0120756.
   PubMed Web of Science ®Google Scholar
• Taguchi A, Uemura Y, Imai T, Adequate Treatment of Osteoporosis (A-TOP) research group, et al. Incidence of osteonecrosis of the jaw in Japanese osteoporosis patients taking minodronic acid. J Bone Miner Metab. 2019;37(5):886–892.
   PubMed Web of Science ®Google Scholar
• Grady D, Ettinger B, Moscarelli E, Multiple Outcomes of Raloxifene Evaluation Investigators, et al. Safety and adverse effects associated with raloxifene: multiple outcomes of raloxifene evaluation. Obstet Gynecol. 2004;104(4):837–844.
   PubMed Web of Science ®Google Scholar
• Montagnana M, Favaloro EJ, Franchini M, et al. The role of ethnicity, age and gender in venous thromboembolism. J Thromb Thrombolysis. 2010;29(4):489–496.
   PubMed Web of Science ®Google Scholar