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1 Drugs for the Treatment and Prevention of Osteoporosis in Postmenopausal Women List of Included Studies (main publications) 1. Adami S, Bruni V, Bianchini D, et al. Prevention of early postmenopausal bone loss with cyclical etidronate. J Endocrinol Invest. 2000;23(5):310-316. 2. Adami S, Passeri M, Ortolani S, et al. Effects of oral alendronate and intranasal salmon calcitonin on bone mass and biochemical markers of bone turnover in postmenopausal women with osteoporosis. Bone. 1995;17(4):383-390. 3. Aki S, Gulbaba RG, Eskiyurt N. Effect of alendronate on bone density and bone markers in postmenopausal osteoporosis. J Back Musculoskelet Rehabil. 2004;17(1):27-31. 4. Akyol Y, Tander B, Alayli G, Durmus D, Bek Y, Canturk F. The comparison of effectiveness of alendronate and risedronate in osteoporosis treatment. Turkiye Fiziksel Tip ve Rehabilitasyon Dergisi. 2006;52(3):110-114. 5. Anastasilakis AD, Polyzos SA, Gkiomisi A, Bisbinas I, Gerou S, Makras P. Comparative effect of zoledronic acid versus denosumab on serum sclerostin and Dickkopf-1 levels of naive postmenopausal women with low bone mass: a randomized, head-to-head clinical trial. J Clin Endocrinol Metab. 2013;98(8):3206-3212. 6. Anastasilakis AD, Polyzos SA, Gkiomisi A, et al. Denosumab versus zoledronic acid in patients previously treated with zoledronic acid. Osteoporos Int. 2015;26:2521-2527. 7. Aro E, Moritz N, Mattila K, Aro HT. A long-lasting bisphosphonate partially protects periprosthetic bone, but does not enhance initial stability of uncemented femoral stems: A randomized placebo- controlled trial of women undergoing total hip arthroplasty. J Biomech. 2018;75:35-45. 8. Aro HT. Denosumab in prevention of periprosthetic bone loss in cementless hip replacement of postmenopausal women. Osteoporos Int. 2018(Supplement 1):S131. 9. Ascott-Evans BH, Guanabens N, Kivinen S, et al. Alendronate prevents loss of bone density associated with discontinuation of hormone replacement therapy: A randomized controlled trial. Arch Intern Med. 2003;163(7):789-794. 10. Atmaca A, Gedik O. Effects of alendronate and risedronate on bone mineral density and bone turnover markers in late postmenopausal women with osteoporosis. Adv Ther. 2006;23(6):842- 853. 11. Bai H, Jing D, Guo A, Yin S. Randomized controlled trial of zoledronic acid for treatment of osteoporosis in women. J Int Med Res. 2013;41(3):697-704. 12. Bala Y, Chapurlat R, Cheung AM, et al. Risedronate slows or partly reverses cortical and trabecular microarchitectural deterioration in postmenopausal women. J Bone Miner Res. 2014;29(2):380-388. 13. Bell NH, Bilezikian JP, Bone HG, Kaur A, Maragoto A, Santora AC. Alendronate increases bone mass and reduces bone markers in postmenopausal African-American women. J Clin Endocrinol Metab. 2002;87(6):2792-2797. 14. Benhamou CL, Seefried L, Agodoa I, et al. Treatment satisfaction in postmenopausal women suboptimally adherent to alendronate who transitioned to denosumab vs risedronate. Osteoporos Int. 2013;24(Suppl 1):S159-S160. 15. Bilek LD, Waltman NL, Lappe JM, et al. Protocol for a randomized controlled trial to compare bone-loading exercises with risedronate for preventing bone loss in osteopenic postmenopausal women. BMC Womens Health. 2016;16:59, 2016. 16. Black DM, Cummings SR, Karpf DB, et al. Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Lancet. 1996;348(9041):1535-1541. 17. 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. 18. Black DM, Greenspan SL, Ensrud KE, et al. The effects of parathyroid hormone and alendronate alone or in combination in postmenopausal osteoporosis. N Engl J Med. 2003;349(13):1207- 1215.

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Page 1: Drugs for the Treatment and Prevention of …Rajatanavin R. Effect of alendronate on bone mineral density and bone turnover in Thai postmenopausal osteoporosis. J Bone Miner Metab

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Drugs for the Treatment and Prevention of Osteoporosis in Postmenopausal Women

List of Included Studies (main publications) 1. Adami S, Bruni V, Bianchini D, et al. Prevention of early postmenopausal bone loss with cyclical

etidronate. J Endocrinol Invest. 2000;23(5):310-316. 2. Adami S, Passeri M, Ortolani S, et al. Effects of oral alendronate and intranasal salmon calcitonin

on bone mass and biochemical markers of bone turnover in postmenopausal women with osteoporosis. Bone. 1995;17(4):383-390.

3. Aki S, Gulbaba RG, Eskiyurt N. Effect of alendronate on bone density and bone markers in postmenopausal osteoporosis. J Back Musculoskelet Rehabil. 2004;17(1):27-31.

4. Akyol Y, Tander B, Alayli G, Durmus D, Bek Y, Canturk F. The comparison of effectiveness of alendronate and risedronate in osteoporosis treatment. Turkiye Fiziksel Tip ve Rehabilitasyon Dergisi. 2006;52(3):110-114.

5. Anastasilakis AD, Polyzos SA, Gkiomisi A, Bisbinas I, Gerou S, Makras P. Comparative effect of zoledronic acid versus denosumab on serum sclerostin and Dickkopf-1 levels of naive postmenopausal women with low bone mass: a randomized, head-to-head clinical trial. J Clin Endocrinol Metab. 2013;98(8):3206-3212.

6. Anastasilakis AD, Polyzos SA, Gkiomisi A, et al. Denosumab versus zoledronic acid in patients previously treated with zoledronic acid. Osteoporos Int. 2015;26:2521-2527.

7. Aro E, Moritz N, Mattila K, Aro HT. A long-lasting bisphosphonate partially protects periprosthetic bone, but does not enhance initial stability of uncemented femoral stems: A randomized placebo-controlled trial of women undergoing total hip arthroplasty. J Biomech. 2018;75:35-45.

8. Aro HT. Denosumab in prevention of periprosthetic bone loss in cementless hip replacement of postmenopausal women. Osteoporos Int. 2018(Supplement 1):S131.

9. Ascott-Evans BH, Guanabens N, Kivinen S, et al. Alendronate prevents loss of bone density associated with discontinuation of hormone replacement therapy: A randomized controlled trial. Arch Intern Med. 2003;163(7):789-794.

10. Atmaca A, Gedik O. Effects of alendronate and risedronate on bone mineral density and bone turnover markers in late postmenopausal women with osteoporosis. Adv Ther. 2006;23(6):842-853.

11. Bai H, Jing D, Guo A, Yin S. Randomized controlled trial of zoledronic acid for treatment of osteoporosis in women. J Int Med Res. 2013;41(3):697-704.

12. Bala Y, Chapurlat R, Cheung AM, et al. Risedronate slows or partly reverses cortical and trabecular microarchitectural deterioration in postmenopausal women. J Bone Miner Res. 2014;29(2):380-388.

13. Bell NH, Bilezikian JP, Bone HG, Kaur A, Maragoto A, Santora AC. Alendronate increases bone mass and reduces bone markers in postmenopausal African-American women. J Clin Endocrinol Metab. 2002;87(6):2792-2797.

14. Benhamou CL, Seefried L, Agodoa I, et al. Treatment satisfaction in postmenopausal women suboptimally adherent to alendronate who transitioned to denosumab vs risedronate. Osteoporos Int. 2013;24(Suppl 1):S159-S160.

15. Bilek LD, Waltman NL, Lappe JM, et al. Protocol for a randomized controlled trial to compare bone-loading exercises with risedronate for preventing bone loss in osteopenic postmenopausal women. BMC Womens Health. 2016;16:59, 2016.

16. Black DM, Cummings SR, Karpf DB, et al. Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Lancet. 1996;348(9041):1535-1541.

17. 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.

18. Black DM, Greenspan SL, Ensrud KE, et al. The effects of parathyroid hormone and alendronate alone or in combination in postmenopausal osteoporosis. N Engl J Med. 2003;349(13):1207-1215.

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19. Black DM, Schwartz AV, Ensrud KE, et al. Effects of continuing or stopping alendronate after 5 years of treatment: The Fracture Intervention Trial long-term extension (FLEX): A randomized trial. JAMA. 2006;296(24):2927-2938.

20. Bone HG, Bolognese M, Yuen CK, et al. Effects of denosumab on bone mineral density and bone turnover in postmenopausal women. J Clin Endocrinol Metab. 2008;93(6):2149-2157.

21. Bone HG, Downs RW, Tucci JR, et al. Dose-response relationships for alendronate treatment in osteoporotic elderly women. Alendronate Elderly Osteoporosis Study Centers. J Clin Endocrinol Metab. 1997;82(1):265-274.

22. Bone HG, Greenspan SL, McKeever C, et al. Alendronate and estrogen effects in postmenopausal women with low bone mineral density. J Clin Endocrinol Metab. 2000;85(2):720-726.

23. Bonnick S, Broy S, Kaiser F, et al. Treatment with alendronate plus calcium, alendronate alone, or calcium alone for postmenopausal low bone mineral density. Curr Med Res Opin. 2007;23(6):1341-1349.

24. Boutsen Y, Jamart J, Vynckier C, Borght TV, Devogelaer JP. Prevention of postmenopausal osteoporosis with two intermittent alendronate regimens: Bone mineral density and bone markers changes after 24 months. J Bone Miner Res. 2012;27(Suppl 1).

25. Boyd SK, Nishiyama KK, Zebaze RM, et al. Denosumab decreases cortical porosity in postmenopausal women with low BMD. Endocr Rev. 2011;32(3):S182.

26. Brown JP, Kendler DL, McClung MR, et al. The efficacy and tolerability of risedronate once a week for the treatment of postmenopausal osteoporosis. Calcif Tissue Int. 2002;71:103-111.

27. Brown JP, Prince RL, Deal C, et al. Comparison of the effect of denosumab and alendronate on BMD and biochemical markers of bone turnover in postmenopausal women with low bone mass: A randomized, blinded, phase 3 trial. J Bone Miner Res. 2009;24(1):153-161.

28. Burghardt AJ, Kazakia GJ, Sode M, e Papp AE, Link TM, Majumdar S. A longitudinal HR-pQCT study of alendronate treatment in postmenopausal women with low bone density: Relations among density, cortical and trabecular microarchitecture, biomechanics, and bone turnover. J Bone Miner Res. 2010;25(12):2558-2571.

29. Catalano A, Morabito N, Atteritano M, Basile G, Cucinotta D, Lasco A. Vitamin D reduces musculoskeletal pain after infusion of zoledronic acid for postmenopausal osteoporosis. Calcif Tissue Int. 2012;90(4):279-285.

30. Catalano A, Morabito N, Basile G, Brancatelli S, Cucinotta D, Lasco A. Zoledronic acid acutely increases sclerostin serum levels in women with postmenopausal osteoporosis. J Clin Endocrinol Metab. 2013;98(5):1911-1915.

31. Cecelja M, Edwards S, Moore A, Fogelman I, Chowienczyk P, Frost M. A pilot study to assess effects of alendronic acid on aortic calcification and stiffness in postmenopausal women. J Hypertens. 2015;33:e347.

32. Chailurkit LO, Jongjaroenprasert W, Rungbunnapun S, Ongphiphadhanakul B, Sae-Tung S, Rajatanavin R. Effect of alendronate on bone mineral density and bone turnover in Thai postmenopausal osteoporosis. J Bone Miner Metab. 2003;21(6):421-427.

33. Chao M, Hua Q, Yingfeng Z, et al. Study on the role of zoledronic acid in treatment of postmenopausal osteoporosis women. Pakistan Journal of Medical Sciences 2013;29(6):1381-1384.

34. Chavez-Valencia V, Arce-Salinas CA, Espinosa-Ortega F. Cost-minimization study comparing annual infusion of zoledronic acid or weekly oral alendronate in women with low bone mineral density. J Clin Densitom. 2014;17(4):484-489.

35. Cheng ZQ, Yin W, Fan JY, Ma TJ. [The efficacy of alendronate in the prevention and treatment of postmenopausal osteoporosis]. Zhongguo Yi Xue Ke Xue Yuan Xue Bao. 2002;24(3):306-309.

36. Chesnut CH, McClung MR, Ensrud KE, et al. Alendronate treatment of the postmenopausal osteoporotic woman: Effect of multiple dosages on bone mass and bone remodeling. Am J Med. 1995;99(2):144-152.

37. Chilibeck PD, Davison KS, Whiting SJ, Suzuki Y, Janzen CL, Peloso P. The effect of strength training combined with bisphosphonate (etidronate) therapy on bone mineral, lean tissue, and fat mass in postmenopausal women. Can J Physiol Pharmacol. 2002;80(10):941-950.

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38. Clemente PA, Cardama F, Armengol R, Goma MT. [ Effect of therapeutical association between hormone replacement therapy and cyclic intermittent therapy with etidronate about bone mineral content in women with postmenopausal osteoporosis. ]. ProgrObstet Ginecol. 1996;39:593-597.

39. Clemmesen B, Ravn P, Zegels B, Taquet AN, Christiansen C, Reginster JY. A 2-year phase II study with 1-year of follow-up of risedronate (NE-58095) in postmenopausal osteoporosis. Osteoporos Int. 1997;7(5):488-495.

40. Cosman F, Eriksen EF, Recknor C, et al. Effects of intravenous zoledronic acid plus subcutaneous teriparatide in postmenopausal osteoporosis. J Bone Miner Res. 2011;26(3):503-511.

41. Cosman F, Gilchrist N, McClung M, et al. A phase 2 study of MK-5442, a calcium-sensing receptor antagonist, in postmenopausal women with osteoporosis after long-term use of oral bisphosphonates. Osteoporos Int. 2016;27(1):377-386.

42. Cosman F, Keaveny TM, Kopperdahl D, et al. Hip and spine strength effects of adding versus switching to teriparatide in postmenopausal women with osteoporosis treated with prior alendronate or raloxifene. J Bone Miner Res. 2013;28(6):1328-1336.

43. Creatsa M, Pliatsika P, Kaparos G, et al. The effect of vitamin D receptor BsmI genotype on the response to osteoporosis treatment in postmenopausal women: a pilot study. J Obstet Gynaecol Res. 2011;37(10):1415-1422.

44. Cummings SR, Black DM, Thompson DE, et al. Effect of alendronate on risk of fracture in women with low bone density but without vertebral fractures. Results from the Fracture Intervention Trial. JAMA. 1998;280(24):2077-2082.

45. Cummings SR, San Martin J, McClung MR, et al. Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N Engl J Med. 2009;361(8):756-765.

46. D'Amelio P, Grimaldi A, Cristofaro MA, et al. Alendronate reduces osteoclast precursors in osteoporosis. Osteoporos Int. 2010;21(10):1741-1750.

47. Davas I, Altintas A, Yoldemir T, Varolan A, Yazgan A, Baksu B. Effect of daily hormone therapy and alendronate use on bone mineral density in postmenopausal women. Fertil Steril. 2003;80(3):536-540.

48. de Villiers T, Benhamou C, Conrad JC, et al. Resolution of effects on bone turnover markers and BMD after discontinuation of long-term bisphosphonate use. Osteoporos Int. 2013;24(Suppl 1):S138.

49. Delmas PD, Benhamou CL, Man Z, et al. Monthly dosing of 75 mg risedronate on 2 consecutive days a month: efficacy and safety results. Osteoporos Int. 2008;19(7):1039-1045.

50. Delmas PD, McClung MR, Zanchetta JR, et al. Efficacy and safety of risedronate 150 mg once a month in the treatment of postmenopausal osteoporosis. Bone. 2008;42(1):36-42.

51. Devogelaer JP, Brown JP, Burckhardt P, et al. Zoledronic acid efficacy and safety over five years in postmenopausal osteoporosis. Osteoporos Int. 2007;18(9):1211-1218.

52. Dobnig H, Hofbauer LC, Viereck V, Obermayer-Pietsch B, Fahrleitner-Pammer A. Changes in the RANK ligand/osteoprotegerin system are correlated to changes in bone mineral density in bisphosphonate-treated osteoporotic patients. Osteoporos Int. 2006;17(5):693-703.

53. Dogan B, Guzel R, Adam M, Sarpel T, Goncu MK. Comparison of different therapeutic regimens in the treatment of patients with post menopausal osteoporosis. Journal of Rheumatology and Medical Rehabilitation. 2001;12(3):143-147.

54. Downs J, Bell NH, Ettinger MP, et al. Comparison of alendronate and intranasal calcitonin for treatment of osteoporosis in postmenopausal women. J Clin Endocrinol Metab. 2000;85(5):1783-1788.

55. Dundar U, Kavuncu V, Ciftci IH, Evcik D, Solak O, Cakir T. The effect of risedronate treatment on serum cytokines in postmenopausal osteoporosis: a 6-month randomized and controlled study. J Bone Miner Metab. 2009;27(4):464-470.

56. Dursun N, Dursun E, Yalcin S. Comparison of alendronate, calcitonin and calcium treatments in postmenopausal osteoporosis. Int J Clin Pract. 2001;55(8):505-509.

57. Eastell R, Nagase S, Ohyama M, et al. Safety and efficacy of the cathepsin K inhibitor ONO-5334 in postmenopausal osteoporosis: The OCEAN study. J Bone Miner Res. 2011;26(6):1303-1312.

58. Evans RA, Somers NM, Dunstan CR, Royle H, Kos S. The effect of low-dose cyclical etidronate and calcium on bone mass in early postmenopausal women. Osteoporos Int. 1993;3(2):71-75.

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59. Felsenberg D, Charpulat R, Cheung AM, et al. Longitudinal in vivo micro-CT assessment in osteopenic women demonstrated that risedronate reduced the deterioration of cortical bone. Bone. 2010:S35.

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63. Frediani B, Allegri A, Bisogno S, Marcolongo R. Effects of combined treatment with calcitriol plus alendronate on bone mass and bone turnover in postmenopausal osteoporosis: Two years of continuous treatment. Clin Drug Investig. 1998;15:235-244.

64. Freemantle N, Satram-Hoang S, Tang ET, et al. Final results of the DAPS (Denosumab Adherence Preference Satisfaction) study: a 24-month, randomized, crossover comparison with alendronate in postmenopausal women. Osteoporos Int. 2012;23(1):317-326.

65. Fukunaga M, Kushida K, Kishimoto H, et al. A Comparison of the Effect of Risedronate and Etidronate on Lumbar Bone Mineral Density in Japanese Patients with Osteoporosis: A Randomized Controlled Trial. Osteoporos Int. 2002;13(12):971–979.

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117. McClung M, Miller P, Recknor C, Mesenbrink P, Bucci-Rechtweg C, Benhamou CL. Zoledronic acid for the prevention of bone loss in postmenopausal women with low bone mass: A randomized controlled trial. Obstet Gynecol. 2009;114:999-1007.

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124. Miller PD, Pannacciulli N, Brown JP, et al. Denosumab treatment is associated with greater transient increases in serum intact parathyroid hormone concentrations compared with zoledronic acid: Results from a study in postmenopausal women with osteoporosis previously treated with oral bisphosphonates. Endocr Rev. 2016.

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137. Pastore R, Bultrini A, Di GP, Cannuccia A, Frontoni S. Sequentialtherapy in severe osteoporosis. Osteoporos Int. 2014:S254.

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139. Pouilles JM, Tremollieres F, Roux C, et al. Effects of cyclical etidronate therapy on bone loss in early postmenopausal women who are not undergoing hormonal replacement therapy. Osteoporos Int. 1997;7:213-218.

140. Recker R, Valter I, Maasalu K, et al. Bone safety of a novel delayed-release risedronate 35 mg once-a-week assessed by bone histology and histomorphometry. J Bone Miner Res. 2011.

141. Reid DM, Hosking D, Kendler D, et al. A comparison of the effect of alendronate and risedronate on bone mineral density in postmenopausal women with osteoporosis: 24-Month results from FACTS-International. Int J Clin Pract. 2008;62:575-584.

142. Reid IR, Bolland M, Wong S, Horne A, Gamble G, Grey A. A randomized controlled trial ofannual low dose zoledronate in postmenopausal women. Osteoporos Int. 2011:S526.

143. Reid IR, Horne AM, Mihov B, et al. Fracture Prevention with Zoledronate in Older Women with Osteopenia. N Engl J Med. 2018;379(25):2407-2416.

144. Robles-Carranza LP, Chavez-Valencia V, Arce-Salinas CA. Comparison of the efficacy of annual zoledronic acid or weekly alendronate. A 3-yr analysis of postmenopausal women with low bone mineral density. Annals of the Rheumatic Disease. 2013.

145. Rossini M, Gatti D, Girardello S, Braga V, James G, Adami S. Effects of two intermittent alendronate regimens in the prevention or treatment of postmenopausal osteoporosis. Bone. 2000;27:119-122.

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148. Saag KG, Benhamou CL, Villiers TD, et al. Resolution of effects on bone turnover markers and bone mineral density after discontinuation of long-term bisphosphonate use. Arthritis Rheum. 2012:S835-S836.

149. Sahota O, Fowler I, Blackwell PJ, et al. A comparison of continuous alendronate, cyclical alendronate and cyclical etidronate with calcitriol in the treatment of postmenopausal vertebral osteoporosis: A randomized controlled trial. Osteoporos Int. 2000;11:959-966.

150. Sambrook PN, Rodriguez JP, Wasnich RD, et al. Alendronate in the prevention of osteoporosis: 7-year follow-up. Osteoporos Int. 2004;15:483-488.

151. Sarioglu M, Tuzun C, Unlu Z, Tikiz C, Taneli F, Uyanik BS. Comparison of the effects of alendronate and risedronate on bone mineral density and bone turnover markers in postmenopausal osteoporosis. Rheumatol Int. 2006;26:195-200.

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154. Seeman E, Delmas PD, Hanley DA, et al. Microarchitectural deterioration of cortical and trabecular bone: differing effects of denosumab and alendronate. J Bone Miner Res. 2010;25:1886-1894.

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160. Suzuki T, Nakamura Y, Tanaka M, et al. Comparison of the effects of denosumab with either active vitamin D or native vitamin D on bone mineral density and bone turnover markers in postmenopausal osteoporosis. Mod Rheumatol. 2018;28(2):376-379.

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175. Yen ML, Yen BL, Jang MH, Hsu SHJ, Cheng WC, Tsai KS. Effects of alendronate on osteopenic postmenopausal Chinese women. Bone. 2000;27(5):681-685.

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179. Zebaze R, Libanati C, Austin M, Bilezikian J, Seeman E. Antiresorptive action is dependent on access to remodeling upon cortical and trabecular surfaces: Comparison of denosumab and alendronate. J Bone Miner Res. 2012.

180. Zebaze RM, Boyd SK, Nishiyama KK, et al. Denosumab decreases cortical porosity in postmenopausal women with low bone mineral density. Osteoporos Int. 2011:S527.

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182. Zhang J, Zhang T, Xu X, Cai Q, Zhao D. Zoledronic acid combined with percutaneous kyphoplasty in the treatment of osteoporotic compression fracture in a single T12 or L1 vertebral body in postmenopausal women. Osteoporos Int. 2019;Apr 11:Epub ahead of print.

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184. Zhang ZL, Liao EY, Xia WB, et al. Alendronate sodium/vitamin D3 combination tablet versus calcitriol for osteoporosis in Chinese postmenopausal women: a 6-month, randomized, open-label, active-comparator-controlled study with a 6-month extension. Osteoporos Int. 2015;26(9):2365-2374.

185. Zhou W, Liu Y, Guo X, Yang H, Xu Y, Geng D. Effects of zoledronic acid on bone mineral density around prostheses and bone metabolism markers after primary total hip arthroplasty in females with postmenopausal osteoporosis. Osteoporos Int. 2019;May 21.

186. Zhu HM, Tang H, Cheng Q, et al. Efficacy and safety of denosumab in Chinese postmenopausal women with osteoporosis at increased risk of fracture: Results from a 12-month, randomized, double-blind, placebo-controlled phase III study. J Bone Miner Res. 2017(Supplement 1):S160.

List of Included Studies (additional publications related to main trial publications)

1. Adachi JD, Adami S, Kulkarni PM, Wong M, Stock JL. Similar proportions of women lose bone mineral density with raloxifene or alendronate treatment. J Clin Densitom. 2005;8(3):273-277.

2. Adachi JD, McClung M, Minisola S, et al. Fracture incidence in postmenopausal women at higher risk of fracture after 3 years of denosumab treatment. Arthritis Rheum. 2009(60 Suppl 10):884.

3. Adachi JD, McClung MR, Cummings S, et al. Effect of denosumab on hip fractures in postmenopausal women: A subanalysis of the FREEDOM study. J Am Geriatr Soc. 2010;58(Suppl 1):S24.

4. Adami S, Baroni MC, Broggini M, et al. Treatment of postmenopausal osteoporosis with continuous daily oral alendronate in comparison with either placebo or intranasal salmon calcitonin. Osteoporos Int. 1993;3(Suppl 3):21-27.

5. Adami S, Gilchrist N, Lyritis G, et al. Effect of denosumab on fracture healing in postmenopausal women with osteoporosis: Results from the FREEDOM trial. Bone. 2010;47(Suppl 1):S63-S64.

6. Adami S, Libanati C, Adachi J, et al. Denosumab administration is not associated with fracture healing complications in postmenopausal women with osteoporosis: Results from the freedom trial. J Bone Miner Res. 2010;25(Suppl 1):S478-S479.

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7. Adami S, Libanati C, Boonen S, et al. Denosumab treatment in postmenopausal women with osteoporosis does not interfere with fracture-healing: results from the FREEDOM trial. Journal of Bone and Joint SurgeryAmerican Volume. 2012;94(23):2113-2119.

8. Adami S, Palacios S, Pavelka K, et al. Freedom trial: Denosumab is not associated with fracture healing complications in postmenopausal women with osteoporosis. Osteoporos Int. 2011;22(Suppl 1):S243-S244.

9. Antoniucci DM, Sellmeyer DE, Bilezikian JP, et al. Elevations in serum and urinary calcium with parathyroid hormone (1-84) with and without alendronate for osteoporosis. J Clin Endocrinol Metab. 2007;92(3):942-947.

10. Antoniucci DM, Vittinghoff E, Palermo L, Black DM, Sellmeyer DE. Vitamin D insufficiency does not affect response of bone mineral density to alendronate. Osteoporos Int. 2009;20(7):1259-1266.

11. Bala Y, Chapurlat R, Felsenberg D, et al. Risedronate slows or partly reverses microarchitecture deterioration depending on whether remodelling is perturbed or in steady state. Osteoporos Int. 2013;1(Suppl 1):S58-S59.

12. Bauer DC, Black DM, Garnero P, et al. Change in bone turnover and hip, non-spine, and vertebral fracture in alendronate-treated women: the fracture intervention trial. J Bone Miner Res. 2004;19(8):1250-1258.

13. Bauer DC, Garnero P, Hochberg MC, et al. Pretreatment levels of bone turnover and the antifracture efficacy of alendronate: the fracture intervention trial. J Bone Miner Res. 2006;21(2):292-299.

14. Beck TJ, Michael LE, Miller PD, et al. Effects of Denosumab on the Geometry of the Proximal Femur in Postmenopausal Women in Comparison with Alendronate. J Clin Densitom. 2008;11(3):351-359.

15. Bettembuk P, Balogh A. The effect of a one-year alendronate therapy on postmenopausal osteoporosis. (Results in Hungarian of an international multicenter clinical study). Orv Hetil. 1999;140(50):2799–2803.

16. Black D, Delmas PD, Eastell R, et al. [Effect of an annual infusion with 5mg zoledronic acid in post-menopausal women with osteoporosis]. Med Klin. 2007;102(4):16.

17. Black D, Reid I, Cauley J, et al. The effect of 6 versus 9 years of zoledronic acid treatment in osteoporosis: A randomized extension to the HORIZON-pivotal fracture trial (PFT). J Bone Miner Res. 2013(28):Conference.

18. Black DM, Bilezikian JP, Ensrud KE, et al. One year of alendronate after one year of parathyroid hormone (1-84) for osteoporosis. The New England Journal of Medicine. 2005;353(6):555-565.

19. Black DM, Eastell R, Cosman F, Man Z, Bucci-Rechtweg C, Mesenbrink P. Effect of once-yearly zoledronic acid 5 mg on a subset of six non-vertebral fractures. J Clin Densitom. 2010;13:132.

20. Black DM, Eastell R, Cosman F, et al. (Premier poster - Award candidate) Effect of once-yearly zoledronic acid 5 mg on 'Super Six' non-vertebral fractures. Osteoporos Int. 2009(20):S281.

21. Black DM, Reid IR, Boonen S, et al. The effect of 3 versus 6 years of zoledronic acid treatment of osteoporosis: a randomized extension to the HORIZON-Pivotal Fracture Trial (PFT). J Bone Miner Res. 2012;27(2):243-254.

22. Black DM, Reid IR, Cauley JA, et al. The effect of 6 versus 9 years of zoledronic acid treatment in osteoporosis: A randomized second extension to the HORIZON-pivotal fracture trial (PFT). J Bone Miner Res. 2015;30(5):934-944.

23. Black DM, Reiss TF, Nevitt MC, Cauley J, Karpf D, Cummings SR. Design of the Fracture Intervention Trial. Osteoporos Int. 1993;3(Suppl 3):29-39.

24. Black DM, Thompson DE, Bauer DC, et al. Fracture risk reduction with alendronate in women with osteoporosis: the Fracture Intervention Trial. FIT Research Group. The Journal of clinical endocrinology and metabolism. 2000;85(11):4118-4124.

25. Blake GM, Herd RJM, Patel R, Fogelman I. The effect of weight change on total body dual-energy X-ray absorptiometry: Results from a clinical trial. Osteoporos Int. 2000;11(10):832-839.

26. Boivin GY, Chavassieux PM, Santora AC, Yates J, Meunier PJ. Alendronate increases bone strength by increasing the mean degree of mineralization of bone tissue in osteoporotic women. Bone. 2000;27(5):687-694.

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27. Bolland M, Wattie D, Horne A, Gamble G, Reid IR, Grey A. Prolonged anti-resorptive activity of zoledronate-A randomized controlled trial. Bone. 2010;47:S56-S57.

28. Bolognese MA, Bone HG, Kendler DL, et al. Transitioning to denosumab leads to further increases in BMD throughout the skeleton in postmenopausal women who received 5 or more years of continuous alendronate therapy. Arthritis Rheum. 2011;63( Suppl 1).

29. Bolognese MA, Roux C, Bianchi G, et al. Relationship of baseline bone turnover marker levels and month 12 bone mineral density change in postmenopausal women transitioned from alendronate to denosumab. Arthritis Rheum. 2009(60 Suppl 10):871.

30. Bolognese MA, Teglbjaerg CS, Zanchetta JR, et al. Denosumab significantly increases DXA BMD at both trabecular and cortical sites: results from the FREEDOM study. J Clin Densitom. 2013;16(2):147-153.

31. Bone H, Brandi ML, Brown J, et al. Ten years of denosumab treatment in postmenopausal women with osteoporosis: Results from the freedom extension trial. J Rheumatol. 2016(6):1209.

32. Bone HG, Chapurlat R, Franchimont N, et al. Six years of denosumab treatment in postmenopausal women with osteoporosis: Results from the first three years of the freedom. Arthritis Rheum. 2011;63(12):4044-4045.

33. Bone HG, Hosking D, Devogelaer JP, et al. Ten Years' Experience with Alendronate for Osteoporosis in Postmenopausal Women. N Engl J Med. 2004;350(12):1189-1199.

34. Bone HG, Kendler DL, Bolognese MA, et al. Transitioning to denosumab further improves BMD in postmenopausal women who received 5 or more years of continuous alendronate therapy. Endocr Rev. 2011;3:Meeting Abstracts.

35. Bone HG, Wagman RB, Brandi ML, et al. 10 years of denosumab treatment in postmenopausal women with osteoporosis: results from the phase 3 randomised FREEDOM trial and open-label extension. Lancet Diabetes Endocrinol. 2017;5(7):513-523.

36. Bonnick S, Rosen C, Mako B, Delucca P, Byrned C, Melton M. Alendronate vs calcium for treatment of osteoporosis in postmenopausal women. Bone. 1998;350:S476.

37. Bonnick S, Saag KG, Kiel DP, et al. Comparison of weekly treatment of postmenopausal osteoporosis with alendronate versus risedronate over two years. J Clin Endocrinol Metab. 2006;91(7):2631-2637.

38. Boonen S, Adachi JD, Man Z, et al. Treatment with denosumab reduces the incidence of new vertebral and hip fractures in postmenopausal women at high risk. J Clin Endocrinol Metab. 2011;96(6):1727-1736.

39. Boonen S, Lippuner K, Adachi JD, et al. Denosumab reduced the incidence of hip and new vertebral fractures in postmenopausal women with higher fracture risk: A subanalysis of the FREEDOM study. Osteoporos Int. 2010;21(Suppl 5):S746-S747.

40. Boonen S, McClung M, Minisola S, et al. Antifracture effects of denosumab in postmenopausal women at higher fracture risk: A subgroup analysis from the freedom trial. Osteoporos Int. 2010;22(Suppl 1):S376-S377.

41. Boonen S, Sellmeyer DE, Lippuner K, et al. Renal safety of annual zoledronic acid infusions in osteoporotic postmenopausal women. Kidney Int. 2008;74(5):641-648.

42. Borah B, Dufresne T, Nurre J, et al. Risedronate reduces intracortical porosity in postmenopausal women with osteoporosis as measured by a new 3D Micro-CT method. Bone. 2010;46:S61.

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Additional records from grey literature

Records from Clinicaltrials.gov trial registry database

Title NCT Number Link

Zoledronic Acid in the Prevention of Bone Loss in Postmenopausal Women With Osteopenia, 45 Years of Age and Older

NCT00132808 https://ClinicalTrials.gov/show/NCT00132808

A Study of Monthly Risedronate for Osteoporosis

NCT00247273 https://ClinicalTrials.gov/show/NCT00247273

Safety/Efficacy of Zoledronic Acid and Alendronate on Bone Metabolism in Postmenopausal Women With Osteoporosis

NCT00404820 https://ClinicalTrials.gov/show/NCT00404820

Alendronate Prevents Microarchitectural Deterioration of Trabecular Bone in Early Postmenopausal Women

NCT00504166 https://ClinicalTrials.gov/show/NCT00504166

Effect of Stopping Risedronate After Long Term Treatment on Bone Turnover

NCT01249261 https://ClinicalTrials.gov/show/NCT01249261

A Randomized, Double-blind, Placebo-controlled, Dose Response Study of AMG 162 (Denosumab) in Japanese Postmenopausal Osteoporotic Subjects

NCT00306189 https://ClinicalTrials.gov/show/NCT00306189

Study of the Effect of Once a Week Risedronate on the Microstructure of Tibia and Radius Using a New Scanning Method

NCT00386360 https://ClinicalTrials.gov/show/NCT00386360

A Phase II Study Evaluating SB-751689 in Post-Menopausal Women With Osteoporosis

NCT00471237 https://ClinicalTrials.gov/show/NCT00471237

Zoledronic Acid for Osteoporosis in the Elderly

NCT00558012 https://ClinicalTrials.gov/show/NCT00558012

Comparison of the Effect of an Ongoing Treatment With Alendronate or a Drug Holiday on the Fracture Risk in Osteoporotic Patients With Bisphosphonate Long Term Therapy

NCT01512446 https://ClinicalTrials.gov/show/NCT01512446

Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis

NCT01631214 https://ClinicalTrials.gov/show/NCT01631214

Denosumab China Phase III Study NCT02014467 https://ClinicalTrials.gov/show/NCT02014467

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A Phase II/III, Double-blind, Parallel Group Comparative Study of Oral Administration of NE-58095 Tablets

NCT02063854 https://ClinicalTrials.gov/show/NCT02063854

A Double-blind Study to Assess the Efficacy and Safety of Denosumab Produced by Two Different Processes in Postmenopausal Women With Osteoporosis

NCT02157948 https://ClinicalTrials.gov/show/NCT02157948

Records from WHO-ICTRP trial registry database

Title Trial ID Link

Association between timing of zoledronic acid infusion and hip fracture healing in elderly patients.

CTRI/2019/04/018681 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=30558

Preventing Osteoporosis in Patients with Spinal Cord Injury (SCI)

ACTRN12618000915257

http://www.anzctr.org.au/ACTRN12618000915257.aspx

Zoledronic acid in patients with low bone mass.

CTRI/2017/05/008696 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=18914

Effect of Teriparatide, Alendronate, Zoledronic Acid, and combined effect of Teriparatide and Alendronate treatment of primary osteoporosis

IRCT201605169014N99 http://en.irct.ir/trial/9537

Osteoporosis patients after total hip replacement prosthesis research for the prevention and control of aseptic loosening

ChiCTR-ICR-15006893 http://www.chictr.org.cn/showproj.aspx?proj=11558

Zoledronate and fracture prevention in early postmenopausal women

ACTRN12612000270819

http://www.anzctr.org.au/ACTRN12612000270819.aspx

The effect of zoledronate on marrow fat in osteoporotic elderly patients who have suffered a minimal trauma fracture.

ACTRN12611000082909

http://www.anzctr.org.au/ACTRN12611000082909.aspx

To study the effects of Zoledronic acid on bone mineral density in Osteoporotic chronic spinal cord injury patients.

CTRI/2007/091/000027 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=25

Low dose zoledronate in postmenopausal women with thin bones

ACTRN12607000576426

https://anzctr.org.au/ACTRN12607000576426.aspx

Efficacy of the anti-RANKL human antibody (Denosumab) versus Bisphosphonate for the treatment of osteoporosis in patients with primary biliary cirrhosis

JPRN-UMIN000012193 https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014251

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Comparative study of efficacy of minodronate, alendronate and risedronate in patients with osteoporosis

JPRN-UMIN000011407 https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013355

A Non-inferiority Comparison of 35mg Delayed-release Risedronate, Administered Once-weekly Either Before or After Breakfast, and 5mg Immediate-release Risedronate, Administered Once-daily Before Breakfast, in the Treatment of Postmenopausal Osteoporosis as Assessed Over 2 Years; a Phase III, Multicenter, Double-Blind, Double-dummy, Randomized, Active-controlled, Parallel-group Study - Fantasia Phase III

EUCTR2007-001521-98-EE

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-001521-98

A non-invasive evaluation of bone microarchitecture modification in osteopenic postmenopausal women by 3D-peripheral quantitative computed tomography: A 24-month, monocenter, double-blind, randomized, parallel group study comparing weekly oral risedronate 35 mg and placebo

EUCTR2005-005598-30-FR

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-005598-30

A Non-invasive Evaluation of Bone Microarchitecture Modification in Osteopenic Postmenopausal Women by 3D Peripheral Quantitative Computed Tomography: A 12 Month, Multicenter, Double-blind, Randomized, Parallel Group Study Comparing Weekly Oral Risedronate 35 mg and Placebo

EUCTR2005-003033-41-GB

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-003033-41

A Phase III, Multicenter, Double-Blind, Randomized, Active-controlled, Parallel Group, Non-inferiority Study Comparing 150 mg Risedronate Monthly with 5 mg Risedronate Daily in the Treatment of Postmenopausal Osteoporosis as Assessed at 12 and 24 Months. MERIT-OP

EUCTR2005-002785-10-HU

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-002785-10

A multicentre, double-blind, randomised, active controlled, parallel group, noninferiority study comparing 75mg risedronate dosed on two consecutive days monthly with 5mg daily risedronate in the treatment of postmenopausal osteoporosis as assessed over 24 months - 2CDM

EUCTR2004-000486-35-GB

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-000486-35

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The effect of Curcumin on Osteoporosis in Post Menopausal Women

IRCT2016030424308N1 http://en.irct.ir/trial/20548

Concise, accurate diagnosis and treatment eveluation of osteoporosis patients using new imaging techniques

ChiCTR-IPR-16009416 http://www.chictr.org.cn/showproj.aspx?proj=15990

Study to evaluate the efficacy and safety of bisphosphonates in long term treatment of osteoporosis

EUCTR2011-000290-31 https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-000290-31

The Relationship between Osteoporosis and Aortic Calcification in Postmenopausal Women

EUCTR2008-001865-28-GB

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-001865-28

A clinical trial to study the effects of denosumab drug in the treatment of postmenopausal osteoporosis

CTRI/2018/07/014908 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=23029

Study in postmenopausal women with osteoporosis

CTRI/2018/05/013924 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=23200

The purpose of this study is to find out more about the efficacy and safety of denosumab produced by two different processes in postmenopausal women with osteoporosis.

EUCTR2013-001279-19-CZ

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-001279-19

A multicenter, international, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy and safety of AMG 785 treatment in postmenopausal women with osteoporosis

per-089-12 https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=089-12