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High Efficacy to
Reduce Fracture
Risk in Osteoporosis
Disclaimer: This scientific information and event supported by PT. Roche Indonesia
Definition
1). Old
definition: a reduced amount of bone that is qualitatively
Osteoporosis
normal. (Albright F. Ann Intern Med. 1947; 27:861)
2). Modern definition: A systemic skeletal disease characterized
by low bone mass and microarchitectural deterioration of
bone tissue, with a consequent increase in bone fragility and
susceptibility to fracture. (1991)
3). Newest definition: Osteoporosis is a skeletal disorder
characterized by compromised bone strength predisposing
to an increased risk of fracture. Bone strength reflects the
integration of two main features: bone density and bone
quality. (2001)
Prevalensi
WHO 200.000.000 orang menderita Osteoporosis di
Osteoporosis
seluruh dunia. Tahun 2050, angka hip fracture
meningkat dua kali lipat pada wanita dan tiga lipat
pada pria.
Di dunia, 1 dari 3 wanita usia 50tahun akan
mengalami fraktur
akibat osteoporosis dan di pria adalah 1 dari 5.
PEROSI (2006) meningkat 23% pada usia 50-80
tahun dan menjadi 53% usia 70-80 tahun
Sistem Informasi Rumah Sakit (SIRS) 2010,
insiden fraktur tulang paha atas sekitar 200/100.000
kasus pada wanita dan pria usia 40 tahun
50% fraktur tulang paha atas: cacat seumur hidup,
Colles'
Hip
Fracture Incidence
per 100,000 Person-Years
Spine
4000
3000
2000
1000
0
35-39
85+
Age
Economic cost of
Osteoporosis
Direct cost: estimated $13.8 billion
(1995) for hospitalization, rehabilitation,
and nursing home care. In 2003 will be
$17 billion
Indirect cost due to loss of productivity
and wages are difficult to measure but it
will very substantial things
By 2025 is expected to be 25 billion
annualy1
NON-VERTEBRAL FRACTURE :
SATU TAHUN SETELAH PATAH TULANG PANGGUL
Tidak dapat melakukan
paling tidak 1 kegiatan
sehari-hari
Pasien (%)
80%
Tidak dapat
berjalan sendiri
Cacat tetap
Meninggal
dalam 1 tahun
40%
30%
20%
Cooper C, Am J Med, 1997;103(2A):12S-17S
Reducing
bone remodelling
Maintaining
structural properties
Bone
strength
Fracture
risk
Ibandronate
Complete fracture protection
BONE
Meta-Analyses
VIBE
Ibandronate
Complete fracture protection
BONE
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
Placebo
Ibandronate
Qualitative histological
analysis of bone biopsies
Ibandronate
Complete fracture protection
Meta-Analyses
Cranney
Lower dose
(ACE* 5.5mg)
Daily oral
2.5mg
Quarterly IV
3mg
Placebo
Bimonthly IV 2mg
NOT LICENSED
Harris
Placebo
*ACE = annual cumulative exposure = dose x doses/year x absorption (e.g. 2.5 x 365 x 0.6% = 5.5mg ACE)
Cranney et al.
Time to non-vertebral fracture is extended with
ibandronate ACE 10.8mg vs. low dose
Daily ibandronate (ACE=5.5mg)
Estimated fracture rate (%)
Time (days)
Adachi JD, et al. ASBMR Annual Meeting, 1619 September 2007; Honolulu, HI. Poster M428.
Cranney A, et. al. Osteoporos Int 2009;20:291297
Harris et al.
10
9
8
7
6
5
4
3
2
1
0
p=0.025 (Log-rank)
50
150
250
350
450
Time (days)
550
650
750
VIBE STUDY
Ibandronate
long term fracture protection
MOBILE LTE
DIVA
Femoral neck
150mg monthly (n=346)
2.5mg daily (n=349)
n=167
n=164
n=156
p<0.05
Total hip
10
9
8
7
6
5
4
3
2
1
0
Year
n=167
p<0.05
Year
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)
n=164
n=156
Are taking
multiple oral
medications
Cannot follow
Dosing instructions
e.g. bedridden
Have problems with
adherence to oral
bisphosphonates
i.v. = intravenous
Have abnormalities
delaying oesophageal
emptying
Have cognitive
difficulties
Do not respond
to oral therapy
8
7
6
5
4
3
2
1
0
Year
PP population; *p<0.001 vs daily ibandronate (2.5mg); At 2 years
Delmas PD, et al. Arthritis Rheum 2006;54:183846
Eisman JA, et al. J Rheumatol 2007. In press
Total hip
PP population
*p<0.05 vs ibandronate daily (2.5mg)
Year
Mean change from
baseline (%)
Year
Femoral neck
Trochanter
Year
6.6
6.3
Lumbar spine
Total hip
5
4.2
3.1
3
2
1
0
n=289
n=289
n=333
n=333
Follow-up
2 years
3 years
12 months
15 days
24 months
BMD and BTM assessment
36 months
BMD
Lumbar
Spine
Serum
CTX
33
BMD
Total
Hip
Biochemical
Bone
Turnover
Marker
DIVA STUDY
Ibandronate Injection 3 mg quaterly
showed impressive BMD increases
from baseline1
Significant BMD
increases delivered
in as few as 2
years and
consistenly
maintained over 5
years.2,3
Monthly oral and quarterly IV ibandronate are generally well tolerated, with
similar tolerability to daily2,4
Ibandronats superior renal safety profile enables to be given as IV Bolus
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