RESUMO
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.
Assuntos
Osteoporose/diagnóstico , Osteoporose/terapia , HumanosRESUMO
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.
Assuntos
Anticorpos Monoclonais/uso terapêutico , Osteoporose/tratamento farmacológico , Ligante RANK/antagonistas & inibidores , Anticorpos Monoclonais Humanizados , Denosumab , Previsões , HumanosRESUMO
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.