Recomendaciones de la Sociedad Española de Reumatología sobre osteoporosis / Recommendations by the Spanish Society of Rheumatology on Osteoporosis

Objetivo: Actualizar las recomendaciones sobre osteoporosis (OP) de la Sociedad Española de Reumatología (SER) basadas en la mejor evidencia posible. Métodos: Se creó un panel formado por nueve reumatólogos expertos en OP previamente seleccionados por la SER mediante una convocatoria abierta. Las fases del trabajo fueron: identificación de las áreas claves para la actualización del consenso anterior, análisis y síntesis de la evidencia científica (utilizando los niveles de evidencia del SIGN) y formulación de recomendaciones a partir de esta evidencia y de técnicas de consenso. Resultados: Esta revisión de las recomendaciones comporta una actualización en la evaluación diagnóstica de la OP y de su tratamiento. Propone unos criterios para considerar alto riesgo de fractura y unas indicaciones para iniciar tratamiento. Las recomendaciones abordan también cuestiones relativas a la seguridad de los tratamientos y al manejo de situaciones especiales como las enfermedades inflamatorias y el tratamiento con glucocorticoides. Conclusiones: Se presenta la actualización de las recomendaciones SER sobre OP

Objective: To update the recommendations on osteoporosis (OP) of the Spanish Society of Rheumatology (SER) based on the best possible evidence. Methods: A panel of nine expert rheumatologists in OP was created, previously selected by the SER through an open call. The phases of the work were: identification of the key areas for updating the previous consensus, analysis and synthesis of the scientific evidence (using the SIGN levels of evidence) and formulation of recommendations based on this evidence and consensus techniques. Results: This revision of the recommendations implies an update in the diagnostic evaluation and treatment of OP. It proposes some criteria to consider the high risk of fracture and some indications to start treatment. The recommendations also address issues related to the safety of treatments and the management of special situations such as inflammatory diseases and treatment with glucocorticoids. Conclusions: We present an update of SER recommendations on OP

Recommendations by the Spanish Society of Rheumatology on Osteoporosis. / Recomendaciones de la Sociedad Española de Reumatología sobre osteoporosis.

OBJECTIVE: To update the recommendations on osteoporosis (OP) of the Spanish Society of Rheumatology (SER) based on the best possible evidence. METHODS: A panel of nine expert rheumatologists in OP was created, previously selected by the SER through an open call. The phases of the work were: identification of the key areas for updating the previous consensus, analysis and synthesis of the scientific evidence (using the SIGN levels of evidence) and formulation of recommendations based on this evidence and consensus techniques. RESULTS: This revision of the recommendations implies an update in the diagnostic evaluation and treatment of OP. It proposes some criteria to consider the high risk of fracture and some indications to start treatment. The recommendations also address issues related to the safety of treatments and the management of special situations such as inflammatory diseases and treatment with glucocorticoids. CONCLUSIONS: We present an update of SER recommendations on OP.

Actualización 2011 del consenso Sociedad Española de Reumatología de osteoporosis / 2011 Up-date of the consensus statement of the Spanish Society of Rheumatology on osteoporosis

Objetivo. Dado el creciente avance en el diagnóstico como evaluación y tratamiento de la osteoporosis, y la incorporación de nuevas herramientas y medicamentos, desde la Sociedad Española de Reumatología (SER) se ha impulsado el desarrollo de recomendaciones basadas en la mejor evidencia posible. Estas deben de servir de referencia para reumatólogos y otros profesionales de la salud implicados en el tratamiento de pacientes con osteoporosis. Métodos. Las recomendaciones se emitieron siguiendo la metodología de grupos nominales. El nivel de evidencia y el grado de recomendación se clasificaron según el modelo del Center for Evidence Based Medicine de Oxford y el grado de acuerdo se extrajo por técnica Delphi. Se utilizó toda la información de consensos previos y guías de práctica clínica disponibles. Resultados. Se realizan recomendaciones sobre el diagnóstico, la evaluación y el tratamiento en pacientes con osteoporosis. Estas recomendaciones incluyen la osteoporosis secundaria a glucocorticoides, la osteoporosis premenopáusica y la del varón. Conclusiones. Se presentan las recomendaciones SER sobre el diagnóstico, la evaluación y el manejo de pacientes con osteoporosis (AU)

Objective. Due to increasing improvement in the diagnosis, evaluation and management of osteoporosis and the development of new tools and drugs, the Spanish Society of Rheumatology (SER) has promoted the development of recommendations based on the best evidence available. These recommendations should be a reference to rheumatologists and other health professionals involved in the treatment of patients with osteoporosis. Methods. Recommendations were developed following a nominal group methodology and based on a systematic review. The level of evidence and degree of recommendation were classified according to the model proposed by the Center for Evidence Based Medicine at Oxford. The level of agreement was established through Delphi technique. Evidence from previous consensus and available clinical guidelines was used. Results. We have produced recommendations on diagnosis, evaluation and management of osteoporosis. These recommendations include the glucocorticoid-induced osteoporosis, premenopausal and male osteoporosis. Conclusions. We present the SER recommendations related to the biologic therapy risk management (AU)

[2011 Up-date of the consensus statement of the Spanish Society of Rheumatology on osteoporosis]. / Actualización 2011 del consenso Sociedad Española de Reumatología de osteoporosis.

OBJECTIVE: Due to increasing improvement in the diagnosis, evaluation and management of osteoporosis and the development of new tools and drugs, the Spanish Society of Rheumatology (SER) has promoted the development of recommendations based on the best evidence available. These recommendations should be a reference to rheumatologists and other health professionals involved in the treatment of patients with osteoporosis. METHODS: Recommendations were developed following a nominal group methodology and based on a systematic review. The level of evidence and degree of recommendation were classified according to the model proposed by the Center for Evidence Based Medicine at Oxford. The level of agreement was established through Delphi technique. Evidence from previous consensus and available clinical guidelines was used. RESULTS: We have produced recommendations on diagnosis, evaluation and management of osteoporosis. These recommendations include the glucocorticoid-induced osteoporosis, premenopausal and male osteoporosis. CONCLUSIONS: We present the SER recommendations related to the biologic therapy risk management.

[Present and future of the treatment of osteoporosis with monoclonal antibodies]. / Presente y futuro de los anticuerpos monoclonales en el tratamiento de la osteoporosis.

An improved knowledge of bone physiopathology has led to new therapeutic targets in osteoporosis, blocking some of them with monoclonal antibodies. The RANK-RANKL-OPG system is considered the final effector pathway of bone resorption regulating factors. Denosumab is a humanized monoclonal antibody (IgG2) with a high affinity for RANKL. Upon binding RANKL it simulates the action of OPG, impedes the interaction between RANK-RANKL, blocks osteoclast activation and inhibits bone resorption. Denosumab has shown, in several phase III trials, to be a rapid, potent and safe antiresorptive agent. When administered subcutaneously every 6 months, it increases bone mineral density and is accompanied by a fast reduction in bone remodeling markers. According to the FREEDOM trial, in postmenopausal women with osteoporosis, treatment with 60 mg/sc of denosumab every 6 months for 3 years is accompanied by a reduction in the relative risk of fracture of 68% (incidence 2,3% in patients treated with denosumab and 7,2% in the placebo group), 20% in the case of non vertebral fractures (incidence 6,5% with denosumab vs. 8% with placebo) and 40% in hip fractures (incidence 0,7% with denosumab vs. 1,2% with placebo). It is a safe drug, with a frequency of adverse events similar to placebo, although an increased risk for skin reactions. Research is being done into blocking the Wnt/ß-catenin pathway with monoclonal antibodies, specifically antisclerostin antibodies and anti-Dkk antibodies. This block of the Wnt/ß-catenin pathway would have an anabolic action on bone remodeling.

Presente y futuro de los anticuerpos monoclonales en el tratamiento de la osteoporosis / Present and future of the treatment of osteoporosis with monoclonal antibodies

El mejor conocimiento de la fisiopatología ósea ha llevado a encontrar nuevas dianas terapéuticas en osteoporosis y se ha conseguido bloquear alguna de ellas con anticuerpos monoclonales. El sistema RANK-RANKL-OPG se considera el elemento efector final de los factores reguladores de la resorción ósea. El denosumab es un anticuerpo monoclonal completamente humanizado (IgG2) con una alta afinidad por el RANKL. Al unirse al RANKL mimetiza la acción de la OPG, impide la interacción RANK-RANKL, bloquea la activación de los osteoclastos e inhibe la resorción ósea. Denosumab ha demostrado en varios ensayos fase III que es un rápido, potente y seguro agente antirresortivo. Administrado por vía subcutánea cada 6 meses, aumenta la densidad mineral ósea y se acompaña de una rápida reducción de los marcadores de resorción ósea. Según los resultados del estudio FREEDOM en mujeres posmenopáusicas con osteoporosis, el tratamiento con 60mg/sc de denosumab cada 6 meses durante 3 años se acompaña de una reducción de riesgo relativo de fractura vertebral del 68% (incidencia del 2,3% en pacientes tratadas con denosumab y del 7,2% en las que recibieron placebo), de fracturas no vertebrales del 20% (incidencia de 6,5% con denosumab frente al 8% con placebo) y de fracturas de cadera del 40% (incidencia de 0,7% con denosumab frente a un 1,2% con placebo). Es un fármaco seguro, con una frecuencia de efectos adversos similares al placebo, aunque parece existir un aumento de efectos adversos cutáneos. Se está investigando el bloqueo mediante anticuerpos monoclonales de antagonistas de la vía de señalización Wnt/β-catenina, y en concreto la utilidad de los anticuerpos antiesclerostina y de los anticuerpos anti-Dkk. Este bloqueo de la vía Wnt/β-catenina tendría una acción anabólica sobre el remodelado óseo (AU)

An improved knowledge of bone physiopathology has led to new therapeutic targets in osteoporosis, blocking some of them with monoclonal antibodies. The RANK-RANKL-OPG system is considered the final effector pathway of bone resorption regulating factors. Denosumab is a humanized monoclonal antibody (IgG2) with a high affinity for RANKL. Upon binding RANKL it simulates the action of OPG, impedes the interaction between RANK-RANKL, blocks osteoclast activation and inhibits bone resorption. Denosumab has shown, in several phase III trials, to be a rapid, potent and safe antiresorptive agent. When administered subcutaneously every 6 months, it increases bone mineral density and is accompanied by a fast reduction in bone remodeling markers. According to the FREEDOM trial, in postmenopausal women with osteoporosis, treatment with 60mg/sc of denosumab every 6 months for 3 years is accompanied by a reduction in the relative risk of fracture of 68% (incidence 2,3% in patients treated with denosumab and 7,2% in the placebo group), 20% in the case of non vertebral fractures (incidence 6,5% with denosumab vs. 8% with placebo) and 40% in hip fractures (incidence 0,7% with denosumab vs. 1,2% with placebo). It is a safe drug, with a frequency of adverse events similar to placebo, although an increased risk for skin reactions. Research is being done into blocking the Wnt/β-catenin pathway with monoclonal antibodies, specifically antisclerostin antibodies and anti-Dkk antibodies. This block of the Wnt/β-catenin pathway would have an anabolic action on bone remodeling (AU)