4. 1. International Osteoporosis Foundation. Facts and statistics about osteoporosis and its impact. Available at
http://www.iofbonehealth.org/facts-and-statistics.html. Last accessed May 2009
骨質疏鬆症常發生嗎?
平均每3位50歲以上女性，就有
1位會發生骨質疏鬆引起的骨折
4
5. 1. Cole ZA et al. Current Rheumatology Reports 2008;10:92–96. 2. World Health
Organization. WHO Scientific Group on the Assessment of Osteoporosis at Primary Health
Care Level: Summary Meeting Report. 5–7 May, 2004; Brussels, Belgium.
骨鬆引起的嚴重後果-骨折
骨質疏鬆症引起的骨折常發生的
部位1
5
脊椎骨
髖骨
手腕骨
8. Lanham-New SA. Proc Nutr Soc. 2008;67: 163-176; Burger H, et al. Am J Epidemiol 1998;147: 871-879; Recker R, et al. J Bone Miner Res 2000;15:1965-1973; Sambrook P, et al. Baillieres Clin Rheumatol 1993;7:
445-457; Weaver CM, et al. Primer on the Metabolic Bone Diseases and Disorders of Mineral Metabolism. 7th ed. 2008:206-208.
進入更年期停經期*骨量邁向巔峰
骨量
年齡
10 20 40 50 60 70 80300
骨骼成骨作用>
骨骼蝕骨作用
骨量巔峰 骨量減少
* Menopause occurs for approximately one year period during this timeframe
婦女在更年期(停經)過後骨量快速減少!
骨骼蝕骨作用>
骨骼造骨作用
33. Denosumab rapidly decreases active osteoclasts within hours of administration as
measured by bone turnover markers, and increases BMD from as early as month 1
of treatment (P < 0.05)1
類保骨素骨鬆針 Prolia 快速的作用效果
Serum CTX
McClung MR, et al. N Engl J Med. 2006;354:821-31 ; Vasikarin SD. Crit Rev Clin Lab Sci .2008;45:221-258
0 2 4 6 8 10 12
Time (Month)
- 20
- 0
- -40
- -60
- -80
- 0
SeumCTX
Change(%)FromBaselineMeanSE
- 5
- 4
- 3
- 2
- 1
- 0
LumbarSpineBMD
PercentageChangefromBaseline(%)
Lumbar Spine BMD
34. 類保骨素骨鬆針 Prolia治療方式
可以降低骨鬆常發生骨折的各部位骨折風險
1. Cummings SR et al. N Engl J Med 2009;361:756–765.
*All non-vertebral fractures. However, fractures of the skull, face, mandible, metacarpals, fingers, or toes
were excluded because they are not associated with decreased bone mineral density. Pathological
fractures and those associated with severe trauma were also excluded.
根據FREEDOM 研究, 類保骨素骨鬆針可明顯降低可降低脊椎骨折風險
68%, 髖骨骨折風險降低達40%, 非脊椎骨折也減少了20%。
安慰劑 類保骨素骨鬆針
38. 保骼麗 Prolia
耐受性良好，不良反應發生比率與安慰劑相當
PROLIA 常見(>2%)比未用藥(安慰劑)較多的不良反應為皮疹與脹氣
使用PROLIA 不會增加注射部位不良反應、也不會有注射後發燒、全身
痠痛等類流感症狀
不需考量病患的腎功能情況
39
Adverse events, n (%)
Placebo
(n = 3,876)
Denosumab
60 mg Q6M
(n = 3,886)
P
value
All adverse events 3,607 (93.1) 3,605 (92.8) 0.91
Serious adverse events 972 (25.1) 1,004 (25.8) 0.61
Deaths 90 (2.3) 70 (1.8) 0.08
AEs leading to study discontinuation 81 (2.1) 93 (2.4) 0.39
AEs leading to discontinuing the study
drug
202 (5.2) 192 (4.9) 0.55
AEs = adverse events
Adapted from: Cummings SR, et al. N Engl J Med. 2009;361:756-765.
39. 1. Kendler DL. Osteoporos Int 2010;21:837–846.
根據研究結果顯示，77% 的病患偏好6個月皮下注射的方
式勝過口服用藥.
類保骨素藥物不影響腎功能, 腎功能不佳的患者也可以使
用，無需調整用藥
Among patients reporting a preference: n = 1,322. 65% of the Prolia® group and 64% of the alendronate group stated they preferred the
6-monthly injection, giving an average of 64% patients who preferred the 6-monthly injection. 19% of patients in both groups preferred the once-weekly
tablet, meaning that overall 83% of patients expressed a preference. Therefore, of patients who expressed a preference, 77%
(64/83) preferred the 6-monthly injection.
每半年皮下注射
每周一次口服藥物
半年皮下注射治療骨鬆，簡易方便
研究證實是病患較偏好的治療方式
