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Seminar 08-10-2008 - asbmr 2008

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  • 1. ASBMR 2008 Dr. H.P. Sleeboom Internist HAGA ziekenhuis Den Haag
  • 2. Relatie BMD verandering en fractuurreductie Kanis JA, Burlet N, Cooper C, et al.Osteoporos Int. 2008; 19:399-428 ESCEO/IOF Guidance 2008 [108] Bruyere O. et al. Journal of Clinical Endocrinology & Metabolism 92(8):3076–3081
  • 3. Baseline Extensie 8 jaar Reginster et al. Osteo Int 2008 0 4 5 6 7 81 2 3 9 10 Strontiumranelaat: Fase III Design N = 1649 Leeftijd: 50-96 jaar SOTI PE: wervelfractuur N = 5091 Leeftijd: 70-100 jaar TROPOS PE: perifere fractuur TROPOS 5 jaar Reginster et al. Arthritis & Rheumatism 2008
  • 4. TROPOS 5 jaar: relevantie
  • 5. Tolerantieprofiel 5 jaar Misselijkheid Symptomen (% patienten) Diarree Hoofdpijn Dermatitis Eczeem 7.1 7.0 3.3 2.3 1.8 Protelos placebo 4.6 5.0 2.7 2.0 1.4 Bijwerking Reginster JY, et al. J Clin Endocrinol Metab. 2005;90(5):2816-2822.
  • 6. Patienten (%) RR: - 24% 0 10 20 Placebo Protelos 2g/dag 24.9% 20.8% 5 jaar fractuurreductie vs placebo Reginster JY, et al. Arthritis Rheum 2008; (6) 1687–1695 30 RR = 0.82; 95%CI: [0.65 ; 0.88] N=2183 P<0.001 RR: - 15% 20.9% 18.6% P=0.032 RR = 0.85; 95%CI: [0.73 ; 0.99] N=2714 RR: - 43% 10.2% 7.2% *> 74 & Femoral neck and Lumbar T score ≤ -2.4SD (NHANES) RR = 0.64 95% CI [0.412;0.997] N=1128* P=0.036 Perifeer Wervel Heup
  • 7. Baseline Extensie 8 jaar Reginster et al. Osteo Int 2008 0 4 5 6 7 81 2 3 9 10 Strontiumranelaat: Fase III Design N = 1649 Leeftijd: 50-96 jaar SOTI PE: wervelfractuur N = 5091 Leeftijd: 70-100 jaar TROPOS PE: perifere fractuur TROPOS 5 jaar Reginster et al. Arthritis & Rheumatism 2008 Fractuurincidentie 5-8 vs 0-3 Reginster JY et al., Osteoporosis International 2008
  • 8. 0 2 4 6 8 10 6 7 8 years 0 2 4 6 8 10 1 2 3 yearsData on file Cumulative incidence 0-3 years 14.9% Cumulative incidence 5-8 years * 13.7% Fractures incidence (%)Fractures incidence (%) * First new fractures on the period NS Behoud wervelfractuurreductie over 8 jaar placebo incidence (SOTI) = 32%
  • 9. 0 2 4 6 8 10 6 7 8 years 0 2 4 6 8 10 1 2 3 years Cumulative incidence 0-3 years 11.2% Cumulative incidence 5-8 years * 12% Fractures incidence (%)Fractures incidence (%) NS * First new fractures on the period Behoud perifere fractuurreductie over 8 jaar placebo incidence = 12.9%
  • 10. * P <0.001 0 5 10 15 20 25 30 0 1 2 3 4 5 6 7 8 Mean relative change (%) jaren * * * * * * * * Lumbar BMD 0 3 6 9 12 0 1 2 3 4 5 6 7 8 * * * * * * *Femoral neck BMD jaren Bot SR concentratie plateau na 3 jaar Boivin G. et al, Calcif. Tissue Int. 2006:78 (suppl1) :page S36-S37: abstract OCO42 BMD toename over 8 jaar (onafhankelijk van bot strontium concentratie) Reginster JY et al., Osteoporosis International 2008
  • 11. Pre-osteoclasten RANK RANK-L CaSR Differentiatie tot Osteoclasten OPG Pre-osteoblasten CaSR Differentiatie Tot Osteoblasten Botremodeling in BMU in aanwezigheid SR1-17 Botresorptie Reversal Botformatie SR SR SR SR SR SR SR SR SR SR SR SR SR SR SR SR SR SR SR SR SR SR SR SR SR SR SR Humane osteoblasten en osteoclasten (in vitro) Botresorptie Reversal Botformatie  1.Arlot ME, Jiang Y. et al. JBMR 2008;23:215-22 2.Brennan T, et al. ASBMR. 2008; (F389) 3.Brennan T, et al. ASBMR. 2008; (M007) 4.Bonnelye E. et al. Bone 2008;42:129-38 5.Chattopadhyay N. et al. Bioch Ph 2007;74:438-447 6.Brennan T, et al. JBMR. 2006;21(suppl1):S1-S350 ( SU375) 7.Coulombe J. et al. Biochem Biophys Res Commun 2004;323:1184-90 8.Baron R. et al. E J of Pharmacology 450 (2002); 11-17 9.Marie PJ. et al. Calcif Tissue Int 2001; 69: 121-129 10.Canalis et al. Bone 1996; 18 (6): 517-523 11.Grynpas MD. et al Bone 1996; 18 : 253-259 12.Ammann P. et al JBMR 1995; 10 (1) 358 13.Morohashi T et al. Jpn J Pharm 1995; 68:153-159 14.Marie PJ. et al. JBMR 1993; 8 (5) 607-614 15.Marie PJ. et al Miner Electrolyte Metab 1985; 11 : 5-13 16.Ferraro EF. et al Calcif Tissue Int 1983; 35 : 258-260 17.Marie PJ. et al MP Columbia 1981;193-208
  • 12. Humane Botmarkers en Botbiopten Netto anabool effect (net anabolic window) Botbiopten2,3 Botmarkers1 3 6 12 18 24 30 36 Strontiumranelaat1a + 8.1% bALP (p<0.001 3mnd - p=0.003 36mnd) - 12.2% CTx (p<0.001 3mnd - p=0.006 36mnd) 1a. Meunier PJ. et al. N Eng J Med 2004;350:459-68. 1b. McClung M. et al. Arch Intern Med 2005; 165: 1762-1768. Trabeculair aantal: +14% (p=0.05) Corticale dikte: +18% (p=0.008) Intertrabeculaire ruimte: -16% (p=0.04) 2. Arlot ME, Jiang Y. et al. JBMR 2008;23:215-22 Niet gepaard (36mnd; n=41) Trabeculair dikte: +10% (p<0.05) Trabeculaire interconnectie: +49% (p<0.05) Botvolume (BV/TV): +30% (p<0.05) 3. Busse B. et al. JBMR 2007; 22 (suppl 1): S84. Gepaard (12mnd; n=15) 0 10 20 0 Mean relative change (%) vs placebo -10 -20 -30 -40 -50 -60 -70 -80 Alendronaat1b - 72.0 % NTx (p<0.001 6mnd) - 67.0 % P1NP (p<0.001 6mnd)