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Definition of Osteoporosis
NORMAL
OSTEOPOROTIC
fracture risk.
World Health Organization (WHO), 1994
742
378
3250
400
1,5 X
2X
1990 2050
1990 2050
(?)
600
Do something
Low cost
ASIAN
5X
1990 2050
www.iofbonehealth.org/health-professionals/about-osteoporosis/epidemiology.html
Sustained
fracture
risk
reduction
Vertebral
and nonvertebral
fracture
prevention
Bone strength
Grade
Individuals at high risk for fracture should continue osteoporosis therapy without a
drug holiday
Bisphosphonates
(As first line therapy)
Ibandronate,Risedronate,
Alendronate,
Zolendronic Acid
formati
on
therap
y
Hormo
ne
Calcit Raloxi therap Teripar
onin
fene
y
atide
(Estro
gen)**
Vertebr
al
Hip
Non
vertebr
+
* For al
postmenopausal women, indicates first line therapies and Grade A recommendation. For men requiring treatment,
alendronate, risedronate, and zoledronic acid can be used as first line therapies for prevention of fractures [Grade D].
+ In clinical trials, non-vertebral fractures are a composite endpoint including hip, femur, pelvis, tibia, humerus, radius, and clavicle.
** Hormone therapy (estrogen) can be used as first line therapy in women with menopausal symptoms.
Bisphosphonate
First line drug of osteoporosis treatment
Bisphosponates oral is poorly absorbed
Associated with Gatroesophagealo reflux
disease
Antiresorptive agent
To inhibit osteoclastic bone resorption
MEKANISME KERJA
Bonviva bekerja dengan cara
Menghambat aktivitas osteoklas
Menghambat pembentukan osteoklas
Menghambat pematangan ( maturation ) osteoklas
BonAdAsia
Pengaruh Bone Marker Feedback (BMF) Terhadap
Kepatuhan Pengobatan Bonviva Sekali Sebulan Untuk
PMO
Hasil
Bonviva menurunkan CTX serum secara signifikan, dengan profil
keamanan yang baik
Pasien merasa lebih nyaman & lebih memiliki kualitas hidup
dengan mengasup IBN sekali sebulan daripada BP mingguan
Pasien patuh tehadap asupan Bonviva tanpa ada kaitannya
dengan BMF
Ibandronate
Complete fracture protection
BONE
VIBE
10
62% RRR
(95% CI: 4175
p=0.0001 vs.
placebo)
8
6
4
2
0
n=975
n=977
Placebo
Ibandronate
2.5mg daily
15
p=NS
10
n=975
n=977
Placebo
Ibandronate
2.5mg daily
Incidence of non-vertebral
fractures at 3 years (%)
Incidence of non-vertebral
fractures at 3 years (%)
20
15
69% RRR
p=0.012
10
n=124
n=123
Placebo
Ibandronate
2.5mg daily
VIBE STUDY
Ibandronate
long term fracture protection
MOBILE LTE
DIVA
MOBILE STUDY
MOBILE ITT analysis; *p<0.05 vs. MOBILE baseline; **95% CI; At 2 years; LTE = long-term extension
Miller PD, et al. J Bone Miner Res 2005;20:13151322
Reginster JY, et al. Ann Rheum Dis 2006;65:654661
Felsenberg D, et al. Osteoporos Int 2009;20(Suppl.1):S15 (Abstract OC32)
10
MOBILE
MOBILE LTE
8
150mg monthly (n=171)
100mg monthly (n=173)
6
4
2
0
3
Years
ITT population
Pooled data; subgroups of patients on the same dose of ibandronate continuously for 5 years
Are taking
multiple oral
medications
Cannot follow
Dosing instructions
e.g. bedridden
Have problems with
adherence to oral
bisphosphonates
i.v. = intravenous
Swallowing
difficulties
Have cognitive
difficulties
Do not respond
to oral therapy
DIVA STUDY
270 (68.0)
37 (9.0)
0
1 (0.7)
Received continuous IV
ibandronate
3mg q3mo
(n=263, %)
1 (0.4)
94%
88%
80
60
40
Ibandronat 6mg
Placebo
20
0
12
24
36
48
60
72
Study duration (weeks)
84
96
Preclinical differences
Effects
Ibandronat
zoledronate
Tissue damage
renal cortex
renal cortex +
outer medulla
Margin of safety
(Ratio between renal
LOEL & LLD)
25
3.3
24 days
150+ days
No
Yes
Inter-study comparison
of renal deterioration
100
80
60
40
20
0
Ibandronat 6mg
12
24
36
48
60
72
Study duration (weeks)
84
96
ONJ
No cases reported with
ibandronate for PMO
in the clinical
development programme;
CCR: 2.9:1.000.000 pts exposed
in Post Marketing Surveillance
Flu-like illness
First-dose related,
transient mild-tomoderate intensity,
most cases resolve
spontaneously.
Monthly oral and quarterly IV ibandronate are generally well tolerated, with
similar tolerability to daily2,4
Miller PD, et al. J Bone Miner Res 2005;20:131522; 2Reginster J-Y, et al. Ann Rheum Dis 2006;65:65461; 3Delmas PD,
et al. Arthritis Rheum 2006;54:183846; 4Eisman JA, et al. J Rheumatol 2007. In press; 5Eisman JA, et al. Osteoporos Int
2006;17(Suppl. 2);S212 (Abstract P316SA); 6Lewiecki M, et al. Bone 2007;40(Suppl. 2):S302 (Abstract 309Th); 7Lewiecki
M, et al. Bone 2007;40(Suppl. 2):S301 (Abstract 307Th);
1
Summary
Osteoporosis is a significant
problem