Professional Documents
Culture Documents
Boniva
Boniva
OH
CH2 CH2 C
OH
.H O
2
ONa
OH
BONVIVA BONVIVA
3
3.375 ibandronate monosodium salt monohydrate 3
ibandronate
Ibandronate (hydroxyapatite)
Ibandronate
(bone turnover)
2 6 ibandronate
ibandronate
90
40% 50%ibandronate 20 2000 ng/mL (
ibandronate ) 86%
ibandronate
ibandronate P450 1A22A62C92C192D62E1
3A4
Ibandronate
( 50% 60%)
Ibandronate
3 8
Cmax 10%ibandronate
Ibandronate
2 2 4
ibandronate 4.6 15.3
5 25.5
ibandronate 84 160 /
( 60 /) 50% 60%
<18 ibandronate
Ibandronate
ibandronate
ibandronate
()
Ibandronate
(CLcr)
0.5 ibandronate CLcr 40 70 /
(AUC) CLcr>90 /
55%CLcr<30 / 2
(
ibandronate
ibandronate
Ibandronate P450
Ibandronate ibandronate
Melphalan/Prednisolone
30 tamoxifen 2 ibandronate
X
3
(formation)(resorption)
50
40%
0.5 3
BONVIVA
(cross-linked C-telopeptide of Type I collagen [CTX])
(
[osteocalcin])
BONVIVA 3 3 BONVIVA 2.5
1
36 12 CTX
ITT 6 () CTX
57% (BONVIVA ) 62% (BONVIVA 2.5 )
12
BONVIVA 2,946 55 80
21 (L1-L4)
(T ) 2 5 (SD) 1 4
()
2.5 20
BONVIVA 3 X
20%
4 400
D 500
BONVIVA 3 3
1,358 (L1-L4 BMD T
4
2.5 SD)(DIVA )
BONVIVA 2.5
1 BMD
400
D 500
BONVIVA 2.5
() 3
9.6% BONVIVA 2.5
4.7% (p<0.001) (
1) 9 10
20 BONVIVA ()
(50%) 2.5
3
BONVIVA
*
(%)
n=975
9.6
BONVIVA
2.5
(%)
(%)
95% CI
95% CI
n=977
4.7
0-3
10.4
5.1
0-3
()
0-3
5.3
2.8
4.9
52 **
(2.3, 7.4)
(29, 68)
5.3
52
(2.6, 7.9)
(30, 67)
2.5
49
(0.6, 4.5)
(14, 69)
*(3 )
**p=0.0003
5
3 BONVIVA 2.5
[9.1%(95% CI7.1%11.1%)]
[8.2%(95% CI6.3%10.2%)]
(-)
(BMD)
BONVIVA 2.5
BMD 3
BONVIVA 2.5 BMD
3 6
3 BONVIVA 2.5
BMD 6.4%
1.4% 2 BMD
BONVIVA 2.5
BMD BMD
2
BONVIVA 2.5
BMD
BONVIVA 2.5
1.4
6.4
(n=693)
(n=712)
-0.7
3.1
(n=638)
(n=654)
-0.7
2.6
(n=683)
(n=699)
0.2
5.3
(n=683)
(n=699)
*(3 )
BMD
DIVA ITT
1 BONVIVA 3 3
6
1
BONVIVA 2.5
BONVIVA 3 3
BMD
(95% CI)
10
9
8
7
6
BMD
5
4
(%)
3
2
1
0
2.5
3 3
* 3 3 2.5 p<0.001
16 22 20 34 (iliac
crest) BONVIVA 2.5
3 3 ibandronate
22 (n=30) 2 2 ibandronate 23
(n=27)
ibandronate
Schenk (tibial
metaphyses)ibandronate
5 //()
(0.005 //
) 1000 5000
BONVIVA
ibandronate
3 3
8 4 ([/]
AUC ) BMD
Ibandronate
ibandronate
BONVIVA BMD
(
(BMD 2.5
[ T ])
BONVIVA
(
BONVIVA
(
)
BONVIVA BONVIVA
BONVIVA
BONVIVA
BONVIVA D
D
D
()
1530BONVIVA
BONVIVA
BONVIVA (>200
mol/L [2.3 mg/dL][] <30 /
)
()
()
()
(ONJ)
ONJ
/
()(
)
BONVIVA
BONVIVA
BONVIVA 3
3
BONVIVA 3
D
ibandronate
104 Wistar 37 15 /
/( AUC
3 3 3 1 )
78
NMRI 520 40 //(
AUC 3
3 96 14 )
90
NMRI 520 80 //
/ 80
//( AUC 3 3
10
32 51 )
ibandronate
Salmonella typhimurium Escherichia coli
(Ames ) V79
Ibandronate
14 1.2 //
( AUC 3 3
117 )
28
0.3 //( AUC /
3 3 40 )
C
17 20 0.05
0.15 0.5 //(
AUC / 3 3
2 ) ibandronate
0.15 0.5 //( AUC /
3 3 4 )
0.15 0.5 //( AUC
/ 3 3
18 )
(
)class effect
1 //( AUC
/ 3 3
47 )(RPU)
11
/ 0.1 //(
AUC / 3 3
5 )
0.030.07 0.2 //
0.2 //([/]
3 3 19 )
(
)
(
)
BONVIVA
0.08 / 2 24
ibandronate 8.1 0.4 ng/mL
1.5 BONVIVA
BONVIVA
BONVIVA 3 3 1
(DIVA ) 51% 65
12
3 3,900
BONVIVA 2.5 BONVIVA 2.5
3 2% BONVIVA 2.5
2%
BONVIVA 2.5
%
(n=1134)
BONVIVA 2.5
%
(n=1140)
12.2
6.4
3.4
2.3
1.9
13.5
7.8
4.3
3.5
2.5
9.8
5.0
2.3
2.1
1.9
11.9
6.8
3.5
2.7
2.2
4.2
4.8
13
5.1
3.3
2.7
5.7
3.6
3.2
5.8
2.6
2.5
1.9
6.5
3.7
3.0
2.2
33.2
6.8
4.3
1.5
33.7
10.0
5.9
2.5
4.2
5.5
DIVA
BONVIVA 3 3
BONVIVA 2.5 1
BONVIVA 2.5
8.0% BONVIVA 3 3 7.5%
BONVIVA 2.5
6.7% BONVIVA 3 3
8.5%
>2% 4
4
BONVIVA
(3
3 )
BONVIVA
)
(2.5
2%
BONVIVA
2.5 (
)
%
(n=465)
BONVIVA
3 3 (
)
%
(n=469)
8.0
6.0
4.7
3.4
14
3.4
3.4
3.2
2.8
2.8
1.9
1.5
2.6
2.1
1.1
5.6
4.3
4.3
4.1
2.4
2.2
5.1
3.6
2.1
3.4
2.8
1.9
8.6
7.5
2.4
2.2
0.9
9.6
7.0
1.5
2.8
2.8
2.8
2.6
1.9
3.6
7.1
5.3
2.6
2.2
1.1
1.3
1.1
1.1
4.9
2.8
2.8
2.3
4.3
1.5
15
() BONVIVA
3 3 (<2%8/469)
(<1%1/465)
ibandronate
2.5 ibandronate
BONVIVA 2.5
BONVIVA 3 3
BONVIVA
16
BONVIVA 3
15 30 3 (
)
15 30 BONVIVA
(
)
BONVIVA
BONVIVA (
)
BONVIVA
BONVIVA
BONVIVA
BONVIVA
BONVIVA
BONVIVA
3 BONVIVA
(3 ) 3
D (
30 /
BONVIVA
>200 mol/L (2.3 mg/dL)[] <30 mL/min
(
)
17
3 /3 BONVIVA (ibandronate
sodium)
5 (5 cc) 23 3/4
3 ml
100
024630
US 2006 1
10.06-BON-3A01
18