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ProtelosLong-Term Antifracture Efficacy
Protelos Vertebral Antifracture Efficacyover 4 years in SOTI
Favors Protelos
RR
P<0.001- 33% All vertebral fractures
P<0.001- 36% Clinical vertebral fractures
0 0.5 1 1.5
Protelos Antifracture Efficacyover 5 years in TROPOS
Favors Protelos
RR
0 0.5 1 1.5
P=0.03- 15% All non vertebral fractures
P=0.03- 18% Major non vertebral fractures
P<0.001- 24% All vertebral fractures
Meunier P.J et al. NEJM.2004 Reginster J.Y et al. JCEM 2005
Relative change from baseline
Protelos Increase in Lumbar Spine BMD
placeboProtelos 2 g/day
Mean change (%)
- 4- 4
00
44
88
1212
1616
00 66 1212 1818 2424 3030 3636
+ 14.4 %+ 14.4 %
SOTI
*
**
**
*
- 4- 4
00
44
88
1212
1616
00 66 1212 1818 2424 3030 3636
Mean change (%)
*
*
*
*
**
+ 14.7 %
TROPOS
*P<0.001
Relative change from baseline
Protelos Increase in Femoral Neck BMD
placeboProtelos 2 g/day
- 4
- 2
0
2
4
6
8
0 6 12 18 24 30 36
Mean change (%)
+ 8.2 %
TROPOS
* ** *
**
- 4
- 2
0
2
4
6
8
0 6 12 18 24 30 36
Mean change (%)
*
*
*
*
*
*
+ 8.3%
SOTI
*P<0.001
Meunier P.J et al. NEJM.2004 Reginster J.Y et al. JCEM 2005
Protelos: BMD Changes Predict Antifracture Efficacy
RR of experiencing a new clinical vertebral fracture after 3 years per 1% increase in hip BMD (after 3 years).
0.90.910.920.930.940.950.960.970.980.99
Total hip Femoral neck
RR95%CI
Bruyere et coll: ECCEO6.
Protelos: BMD Changes Predict Antifracture Efficacy
RR of experiencing a new clinical vertebral fracture after 3 years in patients with or without (0%) increase in total hip or femoral neck BMD (after 3 years)
0
0.2
0.4
0.6
0.8
1
Total hip BMD changes >0% Femoral neck BMD changes>0%
RR95%CI
Bruyere et coll. ECCEO6.
Protelos Normalizes BMD in Osteopenic Patients
0
10
20
30
40
50
60
70
Hip Spine
SR
Placebo
• 1428 subjects from SOTI and TROPOS with osteopenia at the non osteoporotic site.
• SR 2g/day or placebo for 4-5 years
• % of subjects with BMD normalized (T Score>-1) at the end of treatment
• RR (95% CI)
Malaise O. et al. Aging. 2007. in print.
RR=12.38 (5.04-30.45)
RR=4.87 (3.13-7.57)
Pts %
0
5
10
15
20
25
30
35
Protelos
41%
45%
37%
59%
LS
72%
LS/FN
56%
LS/FN LS
Osteoporosis + Fx
Osteopenia + Fx
Osteoporosis - Fx
Osteopenia - Fx
SOTI TROPOS
Placebo
Protelos Broad Range of Efficacy
Non-Vertebral Fx in Elderly Patients
0
5
10
15
20
25
30
Pati
en
ts (
%)
Placebo
29.0%
P = 0.019
RR= 0.73 [0.57-0.95]
N = 1489
24.9%
RR 27%
Vertebral Fracture Risk in Elderly Patients
0
5
10
15
20
25
30
Pati
en
ts (
%)
Placebo
Protelos35.3%
5 years
P = 0.010
RR= 0.69 [0.52-0.92]
N = 896
26.6%
RR 31%35
Protelos
Treatment Effects of Proteloson Vertebral Fracture Risk
Favors Protelos
osteopenic without prevalent F- 72% P=0.045
Over 3 yearsOver 3 years
- 38% P<0.001Clinical VF
- 45% without prevalent VF P<0.001
- 41% with prevalent VF P<0.001
Vertebral F
- 32% P=0.01380 years
Clinical VF P=0.003- 52%
RR After 1 yearAfter 1 year
RELATIVE RISKS AND 95% CI
P<0.001- 49% Vertebral F
0 0.5 1 1.5
Treatment Effects of Protelos on Nonvertebral Fracture Risk
Major nonvertebral fractures: humerus, pelvis-sacrum, ribs-sternum, hip, clavicle, wrist.
Favors Protelos
Over 3 yearsOver 3 years
Nonvert. fractures- 16% P=0.04
Hip fractures, 74 years - 36% P=0.046
Major nonvert. fractures- 19% P=0.031
RR
- 31% Nonvert. fractures, 80 years P=0.011
0 0.5 1 1.5
Long-Term Vertebral and Nonvertebral FractureRisk Reductions with Protelos
Favors Protelos
Vertebral fractures P<0.001- 33%
RR Over 4 yearsOver 4 years
RELATIVE RISKS AND 95% CI
P<0.001- 36% Clinical vertebral fractures
Over 5 yearsOver 5 years
0 0.5 1 1.5
- 24% P<0.001Vertebral fractures
- 15%
P=0.025- 18%
Non vertebral fractures P=0.032
Major non vertebral fractures
P=0.010- 31% Vertebral fractures, 80 years
P=0.018- 27% Non-vertebral fractures, 80 years
Conclusion
Osteoporosis is a global burden
Still many medical unmet needs
Bone is a living tissue
Protelos has a unique dual mode of action
Protelos has the broadest range of antifracture efficacy
