SLIDE 6 6
OOC
- First line treatment or most patients with
- steoporosis
- Unique mechanism of action
- anti-resorptive with minimal effect on formation
- indirect anabolic agent
- Better efficacy
- Different tolerability and safety profile
- Possible combinations with anabolic agents
What Will Odanacatib Offer?
M McClung. Personal opinion
OOC
- Sclerostin is an osteocyte-derived inhibitor of Wnt
signaling in osteoblasts, resulting in decreased bone formation
- Sclerostin-deficient adults with sclerostiosis or Van
Buchem’s disease present with high bone mass of excellent quality
- Heterozygotes of these conditions normal phenotype
except high bone
- In animals, anti-sclerostin antibodies promote new bone
formation, normalizing bone mass, structure and strength
Anti-sclerostin Therapy
Li et al. J Bone Miner Res. 2009;24.578-88. Ominsky MS et al. J Bone Miner Res 2010;25:948-59. van Lierop AH et al. J Bone Miner Res. 2011;26:2804-11.
OOC
Romosozumab
Phase 2 Study: Bone Mineral Density
Data are LS means and 95% CIs.
Percentage Change From Baseline
–2 2 4 6 8 10 12 3 6 9 12 11.3%
*†ʌ *†ʌ *†ʌ
*P < 0.0001 vs placebo
†P < 0.0001 vs ALN ʌP ≤ 0.0025 vs TPTD
Month Lumbar Spine
–2 –1 1 2 3 4 5 4.1% 3 6 9 12
* *†ʌ *†ʌ
*P < 0.0001 vs placebo
†P < 0.0001 vs ALN ʌP < 0.0001 vs TPTD
Month Total Hip
Placebo ALN TPTD Romosozumab 210 mg QM
McClung et al. NEJM 2014;370:412-420.
OOC P1NP CTX
250 200 150 100 50 –50 –100 250 200 150 100 50 –50 –100 3 6 9 12 3 6 9 12
Percentage Change from Baseline Month Month * * * *
*P < 0.02 vs placebo *P < 0.04 vs placebo
* * * *
Romosozumab Phase 2 Study
Serum P1NP and CTX
Placebo Romosozumab 210 mg QM
Except for Week 1, all values were collected pre-dose Data are medians and IQRs. P values are only shown for the romosozumab 210 mg QM group. Except for Week 1, all values were collected pre-dose
McClung MR et al. New Engl J Med 2014;370:412-420.
