1. WHO. ASSESSMENT OF FRACTURE RISK AND ITS APPLICATION TO SCREENING FOR POSTMENOPAUSAL OSTEOPOROSIS. WHO.
https://apps.who.int/iris/bitstream/handle/10665/39142/WHO_TRS_843.pdf?s equence=1. Published 2004. Accessed Aug. 31, 2020.
2. WHO. WHO SCIENTIFIC GROUP ON THE ASSESSMENT OF OSTEOPOROSIS AT PRIMARY HEALTH CARE LEVEL.
https://www.who.int/chp/topics/Osteoporosis.pdf. Published 2004. Accessed Sep 2, 2020.
3. 中華民國骨質疏鬆症學會. <2019 台灣成人骨質疏鬆防治共識.pdf>.
4. Riggs BL. The mechanisms of estrogen regulation of bone resorption.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC381441/. Accessed Sep 2, 2020.
5. Foundation IO. Facts and Statistics. International Osteoporosis Foundation.
https://www.iofbonehealth.org/facts-statistics#Category%2027. Published 2017. Accessed Sep 4, 2020.
6. 衛生福利部國民健康署. 骨質疏鬆症臨床治療指引. 衛生福利部國民健康 署. https://www.hpa.gov.tw/Pages/EBook.aspx?nodeid=1151. Published 2013.
Accessed Sep 3, 2020.
7. Dolores Shoback, Clifford J. Rosen, Dennis M. Black, Angela M. Cheung, M.
Hassan Murad, Eastell R. Pharmacological Management of Osteoporosis in Postmenopausal Women: An Endocrine Society Guideline Update. J Clin
Endocrinol Metab 2020; March 2020, 105(3):587–594
8. Australia O. Osteoporosis prevention, diagnosis and management in postmenopausal women and men over 50 years of age. Royal Australian College of General Practitioners.
https://www.racgp.org.au/clinical-resources/clinical-guidelines/key-racgp-guid
elines/view-all-racgp-guidelines/osteoporosis. Published 2017. Accessed Aug
25, 2020.9. Aliya Khan M, ON H, Michel Fortier, MD QQ. Osteoporosis in Menopause. J
Obstet Gynaecol Can
2014; 36(9):839–840. Available from:https://www.jogc.com/article/S1701-2163(15)30489-8/pdf. Accessed Aug 25, 2020.
10. Amir Qaseem, Mary Ann Forciea, Robert M. McLean, Thomas D. Denberg.
Treatment of Low Bone Density or Osteoporosis to Prevent Fractures in Men and Women: A Clinical Practice Guideline Update From the American College of Physicians. 2017. Available from:
https://www.acpjournals.org/doi/10.7326/M16-1361. Accessed Aug 26, 2020.
11. Group NOG. Clinical guideline for the prevention and treatment of osteoporosis. 2018. Available from:
https://www.sheffield.ac.uk/NOGG/NOGG%20Guideline%202017.pdf.
Accessed Aug 27,2020.
12. 國 家 發 展 委 員 會 . 人 口 推 估 查 詢 系 統 . https://pop-proj.ndc.gov.tw/dataSearch2.aspx?r=1&uid=2104&pid=59.
Accessed July 6, 2020.
13. WHO. ATC/DDD Index WHO. https://www.whocc.no/atc_ddd_index/.
Published 2020. Accessed Aug 28, 2020.
14. 衛生福利部食品藥物管理署. 西藥、醫療器材及化粧品許可證查詢. 衛生 福利部食品藥物管理署. https://info.fda.gov.tw/mlms/H0001.aspx. Published 2020. Accessed 31 Aug, 2020
15. 衛生署福利部中央健康保險署. 全民健康保險藥品給付規定. 衛生署福利
部 中 央 健 康 保 險 署 .
https://www.nhi.gov.tw/Content_List.aspx?n=E70D4F1BD029DC37&topn=3
FC7D09599D25979. Published 2020. Accessed Aug 31, 2020.
16. Health. CAfDaTi. Canadian Drug Expert Committee Recommendation Canadian Agency for Drugs and Technologies in Health. https://www.cadth.ca/.
Published 2020. Accessed Aug 19, 2020.
17. Meeting MP. Public Summary Document - Romosozumab: Injection 105 mg in 1.17 ml single use pre-filled syringe; Evenity® . Australian Government
Department of Health.
https://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/psd/2020
-03/romosozumab-injection-105-mg-in-1-17-ml-single-use-pre-fill. Accessed,
Aug 19, 2020.18. NICE guidance. National Institute for Health and Care Excellence.
https://www.nice.org.uk/guidance. Published 2020. Accessed Aug 19, 2020.
19. Consortium SM. Medicines advice Scottish Medicines Consortium.
https://www.scottishmedicines.org.uk/. Published 2020. Accessed Aug 19, 2020.
20. Lau EMC, Dinavahi R, Woo YC, et al. Romosozumab or alendronate for fracture prevention in East Asian patients: a subanalysis of the phase III, randomized ARCH study. Osteoporos Int 2020; 31(4): 677-685.
21. Kendler DL, Bone HG, Massari F, et al. Bone mineral density gains with a second 12-month course of romosozumab therapy following placebo or denosumab. Osteoporos Int 2019; 30(12): 2437-2448.
22. Saag KG, Petersen J, Brandi ML, et al. Romosozumab or Alendronate for
Fracture Prevention in Women with Osteoporosis. N Engl J Med 2017;
377(15): 1417-1427.
23. Langdahl BL, Libanati C, Crittenden DB, et al. Romosozumab (sclerostin monoclonal antibody) versus teriparatide in postmenopausal women with osteoporosis transitioning from oral bisphosphonate therapy: a randomised, open-label, phase 3 trial. 6 October 2017; 390 September(10102, 30):
1585-1594. DOI: https://doi.org/10.1016/S0140-6736(17)31613-6. Available from:
https://www.sciencedirect.com/science/article/abs/pii/S0140673617316136?vi
a%3Dihub. Accessed Sep 7, 2020.
24. Wen F, Du H, Ding L, et al. Clinical efficacy and safety of drug interventions for primary and secondary prevention of osteoporotic fractures in postmenopausal women: Network meta-analysis followed by factor and cluster analysis. PLoS One 2020; 15(6): e0234123.
25. European Medicines Agency E. Assessment report-Evenity. In: European Medicines Agency, EMA; 2020.
26. Pharmaceutical Benefits Advisory Committee. Romosozumab: Injection 105 mg in 1.17 mL pre-filled pen; Evenity® - November 2018.
https://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/psd/2018
-11/romosozumab-psd-november-2018. Accessed August 31, 2020.
27. Pharmaceutical Benefits Advisory Committee. Romosozumab: Injection 105 mg in 1.17 mL single use pre-filled pen; Evenity® . https://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/psd/2019
-07/romosozumab-injection-105-mg-in-1-17-ml-single-use-pre-fill. Accessed
August 31, 2020.28. Davis S, Simpson E. Denosumab, raloxifene, romosozumab and teriparatide to prevent osteoporotic fragility fractures: a systematic review and economic evaluation. 2020; 24(29): 1-314.
29. 衛 生 福 利 部 國 民 健 康 署 . 2015-2018 年 國 民 營 養 健 康 狀 況 變 遷 調 查 . https://www.hpa.gov.tw/Pages/ashx/File.ashx?FilePath=~/File/Attach/11651/F
ile_13202.pdf. Published 2019. Accessed September 9, 2020.
30. al LLe. Romosozumab (sclerostin monoclonal antibody) versus teriparatide in postmenopausal women with osteoporosis transitioning from oral bisphosphonate therapy: a randomised, open-label, phase 3 trial. 6 October 2017; 390 September(10102, 30): 1585-1594. DOI:
https://doi.org/10.1016/S0140-6736(17)31613-6. Available from:
https://www.sciencedirect.com/science/article/abs/pii/S0140673617316136?vi
a%3Dihub. Accessed Sep 7, 2020.
31. Camacho PM, Petak SM, Binkley N, et al. American Association of Clinical Endocrinologists/American College of Endocrinology Clinical Practice Guidelines for the Diagnosis and Treatment of Postmenopausal Osteoporosis- 2020 Update Executive Summary. Endocrine practice : official journal of the
American College of Endocrinology and the American Association of Clinical Endocrinologists 2020; 26(5): 564-570.
32. Eastell R, Rosen CJ, Black DM, Cheung AM, Murad MH, Shoback D.
Pharmacological Management of Osteoporosis in Postmenopausal Women: An Endocrine Society* Clinical Practice Guideline. The Journal of Clinical
Endocrinology & Metabolism 2019; 104(5): 1595-1622.
33. Tang CH, Chuang PY, Chen CA, Fang YC. Medical Costs of Cardiovascular Diseases in Taiwan. Value in Health 2014; 17(7): A759-A760.
附錄一、療效評估文獻搜尋記錄
資料庫 查詢日期 # 關鍵字 篇數
Cochrane 2020/8/19 1 romosozumab
0
Cochrane review matching
Embase 2020/8/31 1
('amg 785'/exp OR 'amg 785' OR 'cdp 7851'/exp OR 'cdp 7851' OR 'evenity'/exp OR 'evenity' OR 'romosozumab aqqg'/exp OR 'romosozumab aqqg') OR ('romosozumab'/exp OR romosozumab) AND ([controlled clinical trial]/lim OR [randomized controlled trial]/lim)
75
2020/9/1 2
('amg 785'/exp OR 'amg 785' OR 'cdp 7851'/exp OR 'cdp 7851' OR 'evenity'/exp OR 'evenity' OR 'romosozumab aqqg'/exp OR 'romosozumab aqqg') OR ('romosozumab'/exp OR romosozumab) AND ([cochrane review]/lim OR [systematic review]/lim OR [meta analysis]/lim)
40
PubMed 2020/9/2 1
"amg 785"[All Fields] OR "AMG785"[All Fields] OR "amg 785"[All Fields] OR
"evenity"[All Fields] OR
"romosozumab-aqqg"[All Fields] OR
"romosozumab"[Supplementary Concept] OR
"romosozumab"[All Fields] OR "CDP7851"[All Fields] OR "romosozumab"[Supplementary Concept] OR "romosozumab"[All Fields]
235
2 #1 AND
Filters: Meta-Analysis, Systematic Review 12 3 #1 AND Filters: Randomized Controlled Trial 18
附錄二、經濟評估文獻搜尋紀錄
資料庫 查詢日期 # 關鍵字 篇數
PubMed 2020.08.20
1 osteoporosis 89,578
2 romosozumab 232
3 cost OR economic 1,254,895 4 #1 AND #2 AND #3 11
EMBASE 2020.08.20
1 osteoporosis 164,401
2 romosozumab 602
3 cost OR economic 1,213,207 4 #1 AND #2 AND #3 39 Cochrane
Library 2020.08.20
1 osteoporosis 11,349
2 romosozumab 99
3 cost OR economic 83,663 4 #1 AND #2 AND #3 2 CRD 2020.08.20 osteoporosis AND romosozumab 0 INAHTA 2020.08.20 romosozumab 1