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Prévention Médicamenteuse Des Fractures Ostéoporotiques

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Prévention Médicamenteuse Des Fractures Ostéoporotiques Prévention médicamenteuse des fractures ostéoporotiques KCE reports 159B Centre fédéral d’expertise des soins de santé Federaal Kenniscentrum voor de Gezondheidszorg 2011 Le Centre fédéral d’expertise des soins de santé Présentation : Le Centre fédéral d’expertise des soins de santé est un parastatal, créé le 24 décembre 2002 par la loi-programme (articles 262 à 266), sous tutelle du Ministre de la Santé publique et des Affaires sociales, qui est chargé de réaliser des études éclairant la décision politique dans le domaine des soins de santé et de l’assurance maladie. Conseil d’administration Membres effectifs : Pierre Gillet (Président), Dirk Cuypers (Vice président), Jo De Cock (Vice président), Frank Van Massenhove (Vice président), Maggie De Block, Jean-Pierre Baeyens, Ri de Ridder, Olivier De Stexhe, Johan Pauwels, Daniel Devos, Jean-Noël Godin, Xavier De Cuyper, Palstermans Paul, Xavier Brenez, Rita Thys, Marc Moens, Marco Schetgen, Patrick Verertbruggen, Michel Foulon, Myriam Hubinon, Michael Callens, Bernard Lange, Jean-Claude Praet. Membres suppléants : Rita Cuypers, Christiaan De Coster, Benoît Collin, Lambert Stamatakis, Karel Vermeyen, Katrien Kesteloot, Bart Ooghe, Frederic Lernoux, Anne Vanderstappen, Greet Musch, Geert Messiaen, Anne Remacle, Roland Lemeye, Annick Poncé, Pierre Smiets, Jan Bertels, Celien Van Moerkerke, Yolande Husden, Ludo Meyers, Olivier Thonon, François Perl. Commissaire du gouvernement: Yves Roger Direction Directeur général Raf Mertens Directeur général adjoint: Jean-Pierre Closon Contact Centre fédéral d’expertise des soins de santé (KCE). Cité Administrative Botanique, Doorbuilding (10ème) Boulevard du Jardin Botanique, 55 B-1000 Bruxelles Belgium Tel: +32 [0]2 287 33 88 Fax: +32 [0]2 287 33 85 Email : [email protected] Web : http://www.kce.fgov.be Prévention médicamenteuse des fractures ostéoporotiques KCE reports 159B DOMINIQUE ROBERFROID, CÉCILE CAMBERLIN, CÉCILE DUBOIS Centre fédéral d’expertise des soins de santé Federaal Kenniscentrum voor de gezondheidszorg 2011 KCE reports 159B Titre: Prévention médicamenteuse des fractures ostéoporotiques Auteurs: Dominique Roberfroid (KCE), Cécile Camberlin (KCE), Cécile Dubois (KCE) Relecture: Chris De Laet (KCE) Experts externes: Steven Boonen (UZLeuven), Jean-Pierre Devogelaer (UCL), Piet Geusens (UHasselt), Michaël Hillingsmann (ULG), Luc Lefebvre (SSMG), Gustaaf Nelis (Mutualités socialistes), Axelle Pintiaux (GGOLFB), Jean-Yves Reginster (ULG), François Sumkay (Mutualités chrétiennes), Carine Van Necke (INAMI) Remerciements: Marc de Falleur (INAMI) Validateurs externes: Jean-Jacques Body (CHU-Brugmann), Jean-Marc Kaufman (UGent), René Rizzoli (UNIGE, Suisse) Conflits d’intérêt: Bourse, honoraire ou fonds en tant que membre d’un staff ou autre forme de compensation pour la conduite d’une recherche : Body Jean-Jacques, Boonen Steven (paiements à UZLeuven), Geusens Piet, Hiligsmann Michaël, Kaufman Jean-Marc, Reginster J.-Y., Rizzoli René. Consultance ou emploi dans une organisation à laquelle les résultats de ce rapport peuvent apporter des gains ou des pertes: Boonen Steven (paiements à UZLeuven), Kaufman Jean-Marc, Reginster J.-Y. Rémunération pour une communication, subside de formation, prise en charge de frais de voyage ou paiement à l’occasion d’une participation à un symposium: Boonen Steven (paiements à UZLeuven), Devogelaer Jean- Pierre, Geusens Piet, Hiligsmann Michaël, Kaufman Jean-Marc, Reginster J.- Y., Rizzoli René. Toute relation directe ou indirecte avec un producteur, un distributeur ou une institution de soins qui pourrait entraîner un conflit d’intérêt : Kaufman Jean-Marc, Rizzoli René. Disclaimer: - Les experts externes ont été consultés sur une version (préliminaire) du rapport scientifique. Leurs remarques ont été discutées au cours des réunions. Ils ne sont pas co-auteurs du rapport scientifique et n’étaient pas nécessairement d’accord avec son contenu. - Une version (finale) a ensuite été soumise aux validateurs. La validation du rapport résulte d’un consensus ou d’un vote majoritaire entre les validateurs. Les validateurs ne sont pas co- auteurs du rapport scientifique et ils n’étaient pas nécessairement tous les trois d’accord avec son contenu. - Finalement, ce rapport a été approuvé à l’unanimité par le Conseil d’administration. - Le KCE reste seul responsable des erreurs ou omissions qui pourraient subsister de même que des recommandations faites aux autorités publiques. Mise en Page: Ine Verhulst Bruxelles, 5 juillet 2011 (2nd print; 1st print: 4 juillet 2011) Etude n° 2009-01 Domaine: Good Clinical Practice (GCP) MeSH: osteoporosis; fractures, bone; mass screening; diphosphonates; primary prevention Classification NLM: WE 250 Langage: français, anglais Format: Adobe® PDF™ (A4) Dépôt légal: D/2011/10.273/33 Ce document est disponible en téléchargement sur le site Web du Centre fédéral d’expertise des soins de santé. Les rapports KCE sont publiés sous Licence Creative Commons « by/nc/nd » (http://creativecommons.org/licenses/by-nc-nd/2.0/be/deed.fr). Comment citer ce rapport? Roberfroid D, Camberlin C, Dubois C. Prévention médicamenteuse des fractures ostéoporotiques. Good Clinical Practice (GCP). Bruxelles: Centre fédéral d’expertise des soins de santé (KCE). 2011. KCE Reports 159B. D/2011/10.273/33 KCE Reports 159B Fractures ostéoporotiques i PRÉFACE L’ostéoporose entraîne chez les femmes âgées un risque accru de se casser le col du fémur. C’est de notoriété générale et presque considéré comme une fatalité. Ce que l’on sait moins, c’est que le risque de fracture d’une vertèbre est encore plus élevé et que la décalcification peut aussi souvent causer des fractures du haut du bras. Une adaptation du style de vie peut réduire ces risques jusqu’à un certain niveau mais il existe aussi des médicaments qui permettent de lutter contre l’ostéoporose. Toute femme âgée doit elle dès lors prendre ces médicaments de manière préventive ? Les hommes sont ils aussi concernés ? Qui y a en fin de compte le plus d’intérêt ? Serait-ce seulement les fabricants de ces pilules comme le laissent entendre certains ? L’enjeu est de taille, y compris pour l’assurance maladie : avec une population vieillissante et ce genre de traitement à long terme, on risque d’atteindre très vite des montants astronomiques. Il y avait donc toutes les raisons d’examiner de près si ce groupe de médicaments a son utilité ou pas. Il en sort une étude passionnante qui a mis a jour une situation pleine de controverses et en constante évolution. Une étude à laquelle nombreux sont ceux qui ont apporté leur pierre. Nous pensons en particulier au panel d’experts et aux validateurs distingués qui nous ont poussé à aller jusqu’au fond de cette matière complexe de façon à la fois critique et constructive. Nous les remercions chaleureusement pour leur appréciable contribution. Jean Pierre CLOSON Raf MERTENS Directeur général adjoint Directeur général ii Fractures ostéoporotiques KCE Reports 159B Résumé INTRODUCTION QU’EST-CE QUE L’OSTÉOPOROSE ? L’ostéoporose est une affection systémique du squelette qui se caractérise par une masse osseuse diminuée et des détériorations de la micro-architecture du tissu osseux. Elle résulte en une fragilité osseuse accrue et un risque augmenté de fractures, principalement au niveau du poignet, de l’humérus, des vertèbres et du col du fémur. L’Organisation Mondiale de la Santé (OMS) a défini l’ostéoporose en termes de densité de masse osseuse (DMO; g/cm2) mesurée par absorptiométrie biphotonique à rayons X (DEXA). Une personne est considérée ostéoporotique lorsque son DMO (au niveau de la colonne vertébrale ou de la hanche) présente un T-score inférieur à -2.5, c’est-à-dire lorsque son DMO est situé à plus de 2.5 déviations standards en-dessous du DMO moyen observé chez les adultes jeunes d’une population de référence. Le terme d’ostéoporose sévère ou établie correspond à un T-score inférieur à -2.5 en présence d’une ou de plusieurs fractures de fragilité. EST-CE IMPORTANT? Les fractures de fragilité constituent un facteur important de morbidité et de mortalité chez les personnes âgées, particulièrement les fractures du col du fémur. De plus, leur prise en charge nécessite des ressources importantes en termes de services de santé, et cette enveloppe budgétaire va probablement augmenter compte tenu du vieillissement de la population. La prévention de ces fractures pourrait dès lors théoriquement constituer une intervention de santé publique qui en vaut la peine. Une telle prévention ne peut pourtant s’appliquer que si les personnes présentant un risque de fractures de fragilité peuvent être identifiées et qu’un traitement efficace peut leur être proposé. OBJECTIFS DU RAPPORT Ce rapport évalue la validité des stratégies de détection des personnes à risque de fractures de fragilité ainsi que l’efficacité des médicaments dont nous disposons pour prévenir ces fractures, dans le but de formuler des recommandations pour la Belgique le cas échéant. Dans ce contexte, préventions secondaire et primaire correspondent à la prévention des fractures chez des personnes ayant déjà souffert, ou non, d’une fracture de fragilité. Bien que la prévention basée sur des interventions non pharmacologiques constitue aussi une stratégie importante, il n’entrait pas dans le cadre de ce rapport d’évaluer une telle stratégie. MÉTHODES Nous avons effectué une revue systématique de la littérature scientifique sur la prévention pharmacologique des fractures de fragilité. Les données administratives collectées par les mutuelles ont servi à établir l’épidémiologie
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