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2.
Actual. osteol ; 17(3): 85-94, 2021. ilus
Article in Spanish | LILACS, BINACIS, UNISALUD | ID: biblio-1395300

ABSTRACT

La osteoporosis de la posmenopausia es una enfermedad crónica y progresiva asociada con un bajo pico de masa ósea o una rápida y persistente pérdida de masa ósea como con-secuencia del déficit de estrógenos endógenos y del envejecimiento. A pesar de que en la actualidad la oferta de medicamentos para su tratamiento en distintas etapas de la vida es muy importante, sigue siendo una enfermedad subdiagnosticada y subtratada a nivel global. La edad, las comorbilidades existentes, los tratamientos concomitantes, el riesgo de caídas, y los antecedentes familiares o personales de fracturas recientes o pasadas tanto como la densidad mineral ósea son factores que deben ser considerados en la evaluación de cada paciente para determinar el grado de riesgo de fractura En aquellos considerados con alto riesgo o riesgo inminente de fractura se recomienda iniciar un tratamiento con algún agente anabólico seguido por un anticatabólico para lograr una rápida reducción del riesgo de fractura. Por último, una adecuada adherencia en el tiempo al tratamiento es clave para alcanzar la mayor eficacia terapéutica dirigida a la reducción de la ocurrencia de fracturas por fragilidad ósea. (AU)


Postmenopausal osteoporosis is a chronic and progressive disease associated with low peak bone mass or a fast and persistent loss of bone mass as a consequence of endogenous estrogen deficiency and aging, and it is an underdiagnosed and undertreated disease worldwide. At present, there is a wide range of drugs available for the treatment of postmenopausal osteoporosis, with appropriate treatments for each phase of this stage of a woman's life. All factors that may increase the risk of bone fragility fracture should be considered at the time of patient assessment. These include age, existing comorbidities, concomitant treatments, risk of falling, family history of fractures or recent or past personal history of fractures, and the results of bone mineral density assessment. In those patients at high risk or imminent risk of fracture, it is recommended to start treatment with an anabolic agent followed by an anticatabolic agent, in order to achieve an immediate reduction of fracture risk. Finally, an adequate adherence to treatment over time will allow achieving the greatest effectiveness of the proposed therapy, which is the reduction of bone fragility fracture events. (AU)


Subject(s)
Humans , Female , Adult , Middle Aged , Aged , Aged, 80 and over , Osteoporosis, Postmenopausal/drug therapy , Treatment Outcome , Fractures, Bone/prevention & control , Medication Adherence , Bone Density , Risk Factors , Teriparatide/therapeutic use , Risk Reduction Behavior , Diphosphonates/therapeutic use , Antibodies, Monoclonal, Humanized/therapeutic use , Healthy Lifestyle
3.
Article in Chinese | WPRIM | ID: wpr-921722

ABSTRACT

The editorial group of the clinical practice guideline for postmenopausal osteoporosis(PMOP) with traditional Chinese medicine(TCM)(hereinafter referred to as "guideline") is composed of experts specialized in TCM orthopedics, TCM gynecology, clinical epidemiology, etc. The guideline was formulated through registration, collection and selection of clinical issues/outcome indicators, evidence retrieval and screening, preparation of systematic reviews, evaluation of evidence quality, formation of recommendations, drafting, and peer review. The syndromes and treatment of PMOP are elaborated in detail. Specifically, Liuwei Dihuang Pills and Zuogui Pills are recommended for PMOP with Yin deficiency in the liver and kidney, Qing'e Pills for PMOP with kidney deficiency and blood stasis, Yougui Pills and Jingui Shenqi Pills for PMOP with Yang deficiency in the spleen and kidney, and Er'xian Decoction for PMOP with Yin and Yang deficiency in the kidney. In addition, Duhuo Jisheng Decoction can be used to relieve pain. The commonly used Chinese patent medicines include Xianling Gubao Capsules, Qianggu Capsules, Jintiange Capsules, Gushukang Capsules, Hugu Capsules, Jinwu Gutong Capsules, and Guyuling Capsules. Acupuncture and moxibustion are also effective approaches for PMOP. The rehabilitation and daily management were carried out by exercise therapies such as Baduanjin(eight-section brocade), Wuqinxi(five-animal exercises), and Taijiquan(Tai Chi), Chinese medicine diet, health education, and fall prevention. The promotion and application of this guideline will facilitate the implementation of TCM prevention and treatment of PMOP, ensure the quality of life of PMOP patients, provide effective and safe TCM treatment measures for PMOP, and reduce the risk of fracture complications.


Subject(s)
Animals , Drugs, Chinese Herbal/therapeutic use , Female , Humans , Medicine, Chinese Traditional , Osteoporosis, Postmenopausal/drug therapy , Quality of Life , Systematic Reviews as Topic , Yin Deficiency
4.
Article in Chinese | WPRIM | ID: wpr-888090

ABSTRACT

This study evaluated the outcome indicators of the randomized controlled trials(RCTs) of traditional Chinese medicine(TCM) in the treatment of postmenopausal osteoporosis(PMOP) to provide a reference for the related research. Four Chinese databa-ses(CNKI, VIP, Wanfang and CBM) and three English databases(Cochrane Library, EMbase and PubMed) were searched syste-matically to screen RCTs of TCM in the treatment of PMOP according to the pre-set criteria, and the quality of the included trials was evaluated by the Cochrane risk-of-bias tool. A total of 29 627 articles were initially retrieved, and finally, 43 articles were included, including 34 in Chinese and 9 in English. As revealed by the results, the outcome indicators of 43 RCTs were mainly divided into six categories, with biochemical indicators accounting for 54.59%, bone mineral density(BMD) for 26.57%, quality of life for 6.28%, fracture for 1.94%, safety for 5.31%(including adverse reactions or events) and others for 5.31%. Biochemical indicators showed the maximum occurrence, followed by BMD. Many problems were found in the selection of outcome indicators of the TCM RCTs in the treatment of PMOP, such as the confusion of primary and secondary outcome indicators, the lack of endpoint criteria and vital clinical outcome indicators substituted by intermediate indicators, inconsistent evaluation standard of syndrome curative efficacy and neglected blinding in the measurement of subjective outcome indicators. The problems also included importance given to the efficacy indicators instead of the adverse outcome indicators, unnormalized indicator name, large quantitative range of the indicators, unconventional application of TCM efficacy criteria, seldom used confidence interval, relative effect indicator and absolute effect indicator.


Subject(s)
Bone Density , Drugs, Chinese Herbal/therapeutic use , Female , Humans , Medicine, Chinese Traditional , Osteoporosis, Postmenopausal/drug therapy , Quality of Life , Treatment Outcome
5.
s.l; RedARETS; ago. 2019. tab.
Non-conventional in Spanish | LILACS, BRISA | ID: biblio-1095359

ABSTRACT

CONTEXTO: La osteoporosis es un trastorno esquelético caracterizado por resistencia óssea comprometida, predisposición pacientes a un mayor riesgo de fractura. La prevalência aumenta del 6% de las mujeres de edad 50 a 59 años a más del 40% de las mujeres de edad 80 años y mayores.1 Consecuencias de mantener una fractura puede ser grave e incluir un aumento riesgo de fracturas posteriores, hospitalización o institucionalización, disminución de la calidad de vida, y mortalidad prematura, con una carga relacionada com el sistema de salud. DESCRIPCIÓN DE LA TECNOLOGÍA: El denosumab es un anticuerpo monoclonal que inhibe la resorción ósea producida por los osteoclastos. Fue comercializado en 2010 para el tratamiento de la osteoporosis. En estos años se han identificado varios efectos adversos potencialmente graves: predisposición a infecciones, cáncer, reacciones de hipersensibilidad, transtornos autoinmunes, e incremento de la incidencia de múltiples fracturas vertebrales espontáneas al suspender el tratamiento. En este número revisamos estas novedades. TECNOLOGÍAS ALTERNATIVAS: Los agentes antirresortivos como los bifosfonatos orales son el estándar tratamiento para la osteoporosis posmenopáusica, en conjunto con medidas no farmacológicas y sobre todo el énfasis en la prevención de las caídas. Otras opciones de tratamiento incluyen un bisfosfonatos intravenoso (ácido zoledrónico), un agente formador de hueso (teriparatida) y un modulador selectivo del receptor de estrógeno (raloxifeno). MÉTODOS: Se realizó una búsqueda bibliográfica utilizando las siguientes bases de datos bibliográficas: MEDLINE, EMBASE, The Cochrane Library, y PubMed. Aplicaron filtros metodológicos para evaluaciones de tecnología sanitaria, estudios económicos, revisiones sistemáticas, metanálisis, y ensayos controlados aleatorios (ECA). La búsqueda también se limitó a Idioma en Inglés y humanos. Se excluyeron los resúmenes de congresos en los resultados de búsqueda. Se identificó la literatura gris (literatura que no se publica comercialmente) fue identificado mediante la búsqueda de secciones relevantes de la Lista de verificación de Grey Matters (http://www.cadth.ca/en/resources/grey-matters). Google y otros motores de búsqueda de internet fueron se utiliza para buscar en la web adicional materiales Estas búsquedas se complementaron con revisar las bibliografías de documentos clave y a través de contactos con expertos apropiados. ESTRATEGIA DE BÚSQUEDA: Se realizó una búsqueda con última fecha 26/08/2019 en diversas bases de datos, incluidas PubMed y Embase, así como la biblioteca Cochrane, ClinicalTrials.gov y bases de datos de revisiones sistematicas Epistemonikos. La búsqueda sólo incluyó documentos escrito en ingles y espanol. RESULTADOS: Denosumab comparado con placebo para pacientes con osteoporosis. El riesgo en el grupo de intervención (y su intervalo de confianza del 95%) se basa en el riesgo asumido en el grupo de comparación y en el efecto relativo de la intervención (y su intervalo de confianza del 95%). Eficacia frente a bifosfonatos: comparaciones directas. Se evalúa el perfil de evidencia GRADE donde se evidencia el metaanálisis entre cuatro ECA 5-8 que comprendieron 2071 participantes con un rango de seguimiento de 12 a 24 meses y compararon el uso de Denosumab con bifosfonatos orales (Alendronato,Etidronato). Existe incertidumbre en el efecto de denosumab sobre el riesgo de fracturas en comparación con bifosfonatos. La certeza em la evidencia va desde BAJA A MUY BAJA considerando la presencia de imprecisión muy seria y el potencial riesgo de sesgo de publicación. Eficacia frente a bifosfonatos: comparaciones indirectas. No se han encontrado en la literatura comparaciones directas entre Denosumab y otros fármacos distintos. Esta recomendación de cobertura otorga más peso a la incertidumbre en la eficacia comparada con bifosfonatos, al potencial impacto presupuestario de su uso y la potencial reducción de la equidad; que a la preferencia de los pacientes respecto de la forma de administración de las drogas para osteoporosis.


Subject(s)
Humans , Female , Osteoporosis, Postmenopausal/drug therapy , Teriparatide/therapeutic use , Raloxifene Hydrochloride/therapeutic use , Diphosphonates/therapeutic use , Osteoporotic Fractures/drug therapy , Denosumab/therapeutic use , Zoledronic Acid/therapeutic use , Technology Assessment, Biomedical , Cost-Benefit Analysis/economics
6.
Arch. endocrinol. metab. (Online) ; 62(4): 431-437, July-Aug. 2018. tab, graf
Article in English | LILACS | ID: biblio-950078

ABSTRACT

ABSTRACT Objective: To verify which component of body composition (BC) has greater influence on postmenopausal women bone mineral density (BMD). Subjects and methods: Four hundred and thirty women undergoing treatment for osteoporosis and 513 untreated women, except for calcium and vitamin D. Multiple linear regression analysis was performed in order to correlated BMD at lumbar spine (LS), total femur (FT), femoral neck (FN) with body mass (BM), total lean mass (LM) and total fat mass (FM), all determined by DXA. Results: BM significantly correlated with all bone sites in untreated and treated women (r = 0.420 vs 0.277 at LS; r = 0.490 vs 0.418 at FN, r = 0.496 vs 0.414 at FT, respectively). In untreated women, the LM correlated better than FM with all sites, explaining 179% of LS; 32.3% of FN and 30.2% of FT; whereas FM explained 13.2% of LS; 277% of FN, 23.4% of FT In treated women, correlations with BC were less relevant, with the LM explaining 6.7% of BMD at LS; 15.2% of FN, 16% of FT, whereas the FM explained 8.1% of LS; 179% of FN and 176% of FT. Conclusion: LM in untreated women was better predictor of BMD than FM, especialy for distal femur, where it explained more than 30% of the BMD, suggesting that maintaining a healthy muscle mass may contribute to decrease osteoporosis risk. Treatment with anti-osteoporotic drugs seems to mask these relationships. Arch Endocrinol Metab. 2018;62(4):431-7


Subject(s)
Humans , Female , Adult , Middle Aged , Aged , Aged, 80 and over , Thinness/physiopathology , Body Composition/physiology , Bone Density/physiology , Osteoporosis, Postmenopausal/physiopathology , Femur/diagnostic imaging , Body Weight/physiology , Absorptiometry, Photon , Osteoporosis, Postmenopausal/drug therapy , Osteoporosis, Postmenopausal/diagnostic imaging , Adipose Tissue/physiology , Cross-Sectional Studies , Risk Factors , Lumbar Vertebrae/physiology , Lumbar Vertebrae/diagnostic imaging
7.
Actual. osteol ; 14(1): 10-21, Ene - Abr. 2018. ilus, graf, tab
Article in Spanish | LILACS | ID: biblio-1116424

ABSTRACT

La suplementación con calcio reduciría, sola o asociada a otra medicación para osteoporosis, la pérdida de masa ósea y el riesgo de fracturas. Sin embargo, su tasa de adherencia es baja debido a la poca tolerancia. Objetivo: comparar la tasa de absorción neta de calcio entre dos formulaciones distintas de carbonato de calcio (500 mg): comprimidos vs. mousse. Material y métodos: 11 pruebas fueron realizadas en mujeres posmenopáusicas de 58,9±3 años. El diseño fue exploratorio abierto, aleatorizado, prospectivo cruzado de fase 4. Intervención: las participantes fueron aleatorizadas en dos grupos para recibir las dos formulaciones previa suplementación con vitamina D3. La tasa de absorción neta de calcio fue estudiada por la prueba de inhibición de hormona paratiroidea (PTH). Se obtuvieron muestras de sangre: basal y en la 1a, 2a y 3a hora posadministración del calcio asignado, y de orina de 2 horas basal y al final de la prueba. Determinaciones bioquímicas: calcio, fósforo, albúmina, 25-hidroxivitamina D y hormona paratiroidea intacta y calciuria. Análisis estadístico: método de los trapecios para calcular el área bajo la curva (AUC) de la concentración de calcio en el tiempo (R Development Core Team (2008). http://www.Rp-project.org) y Anova con dos términos de error para evaluar el efecto secuencia, período y formulación. Resultados: la mayor inhibición de PTH se observó a dos horas de la toma de ambas formulaciones (comprimidos -39,2% vs. mousse -38,0%; p=ns), con similar AUC0-3 h (comprimidos 3,35; IC 95%: 3,32; 3,37 vs. mousse 3,36; IC 95%: 3,33; 3,38). Cuando analizamos tolerancia y preferencias no se observaron diferencias estadísticamente significativas entre ambas formulaciones. Conclusión: el carbonato de calcio en mousse mostró similar tasa de absorción intestinal, preferencia y tolerancia gastrointestinal que en comprimido. (AU)


Calcium supplementation, administered alone or in combination with a specific medication for osteoporosis, would reduce bone mass loss and fracture risk in postmenopausal women. However, the adherence rate to calcium supplements is low, mainly due to low tolerance. Objective: comparisson of net calcium absorption rate between two different pharmaceutical formulations of calcium carbonate (PFCa) in postmenopausal women. Materials and Methods: 11 tests were performed in postmenopausal women aged 58.9±3 yrs. Design: Comparative, randomized, prospective, open-label exploratory crossover study of calcium mousse versus calcium pills. Intervention: Participants were randomized in 2 groups to receive the 2 different PFCa (500mg): pills vs. mousse, with previous vitamin D3 supplementation. The parathyroid hormone (PTH) inhibition test and the area-under-thecurve (AUC) of calcium were analyzed. Blood samples were taken at baseline and 1, 2 and 3 hrs after intake of the assigned PFCa. Urine samples (2hs) were obtained at -baseline, after 2hs of PFCa intake and at the end of the test. Biochemical Determinations: Serum: calcium, phosphorus, albumin, 25-hydroxyvitamin D, and intact PTH. In urine: calcium. Statistical Analysis: The trapezoid rule was applied to assess AUC in time (R Development Core Team (2008). http://www.Rp-project.org). An ANOVA model with 2 error terms was used to assess the effect of sequence, period, and formulation. Results: The highest inhibition PTH rates were observed after 2 hrs of PFCa (pills -39.2% vs. mousse -38.0%; p=ns). The AUC0-3hrs for both PFCa was similar (pills 3.35; 95%CI: 3.32; 3.37 vs. mousse 3.36; 95%CI: 3.33; 3.38). No statistically significant differences were observed when we analyze tolerance and predilection. Conclusion: The calcium carbonate in mousse showed an adequate rate of intestinal absorption, similarly predilection and gastrointestinal tolerance than the pill presentation. (AU)


Subject(s)
Humans , Female , Middle Aged , Calcium Carbonate/pharmacokinetics , Osteoporosis, Postmenopausal/prevention & control , Calcium/pharmacokinetics , Parathyroid Hormone/analysis , Achlorhydria , Calcitriol/pharmacokinetics , Calcium Carbonate/administration & dosage , Calcium Carbonate/therapeutic use , Body Mass Index , Bone Density , Nutrition Assessment , Osteoporosis, Postmenopausal/diet therapy , Osteoporosis, Postmenopausal/drug therapy , Mass Screening , Calcium/deficiency , Postmenopause/drug effects , Postmenopause/blood , Cholecalciferol/administration & dosage , Cholecalciferol/adverse effects , Cross-Over Studies , Calcium Citrate/therapeutic use , Fractures, Bone/prevention & control , Estrogens/deficiency , Gastrointestinal Absorption/drug effects , Treatment Adherence and Compliance , Anabolic Agents/therapeutic use
8.
Rev. bras. reumatol ; 57(6): 514-520, Nov.-Dec. 2017. tab, graf
Article in English | LILACS | ID: biblio-899474

ABSTRACT

Abstract Purpose: The use of bisphosphonates for osteoporosis is effective in reducing the risk of fractures. However, oral formulations are sometimes not well tolerated or are contraindicated. Due to its availability in Brazilian public health system, pamidronate is frequently prescribed for osteoporosis, despite the lack of studies demonstrating its anti-fracture efficacy and the absence of FDA or EMEA approval for this purpose. The aim of this study was to evaluate the bone mineral density (BMD) response to pamidronate in a group of women with osteoporosis in a tertiary care hospital. Patients and methods: The medical records of women with osteoporosis who received pamidronate for up to two years of treatment were reviewed. Patients were stratified at high or intermediate risk of fracture. Results: A total of 70 women were in treatment with pamidronate. Among them, 74% were at high risk of fracture. A significant gain in spine BMD after 24 months of treatment was observed (p = 0.012). There was no difference between the groups of high and not high risk of fracture. At the femur, no significant increase in BMD was present, though, a strong negative correlation with high PTH levels (r = −0.61; p = 0.003) was seen. In the multivariate analysis BMI at 12 months had impact in the response to the treatment. Conclusion The intravenous pamidronate in a group of postmenopausal women with predominant high risk of fracture promoted an isolated gain in the spine BMD, even though, clinical randomized trials are needed to confirm its anti-fracture efficacy.


Resumo Justificativa: O uso de bisfosfonatos para a osteoporose é eficaz na redução do risco de fraturas. No entanto, as formulações orais às vezes não são bem toleradas ou são contraindicadas. Em razão da sua disponibilidade no sistema público de saúde brasileiro, o pamidronato é frequentemente prescrito para a osteoporose, apesar da falta de estudos que demonstrem a sua eficácia antifratura e da ausência de aprovação da Food and Drug Administration (FDA) ou da European Medicine Agency (Emea) para essa finalidade. O objetivo deste estudo foi avaliar a resposta da densidade mineral óssea (DMO) ao pamidronato em um grupo de mulheres com osteoporose em um hospital terciário. Pacientes e métodos: Revisaram-se os prontuários médicos de mulheres com osteoporose que receberam pamidronato por até dois anos de tratamento. As pacientes foram estratificadas em risco alto ou intermediário de fratura. Resultados: Estavam em tratamento com pamidronato 70 mulheres. Entre elas, 74% tinham alto risco de fratura. Observou-se um ganho significativo na DMO da coluna vertebral após 24 meses de tratamento (p = 0,012). Não houve diferença entre os grupos de risco de fratura alto e não alto. No fêmur, não foi encontrado aumento significativo na massa óssea; contudo, observou-se uma forte correlação negativa com altos níveis de PTH (r = −0,61; p = 0,003). Na análise multivariada, o IMC aos 12 meses tinha impacto na resposta ao tratamento. Conclusão O pamidronato intravenoso em um grupo de mulheres na pós-menopausa predominantemente com alto risco de fratura promoveu um ganho isolado na DMO da coluna vertebral, embora sejam necessários ensaios clínicos randomizados para confirmar sua eficácia antifratura.


Subject(s)
Humans , Female , Aged , Aged, 80 and over , Bone Density/drug effects , Osteoporosis, Postmenopausal/drug therapy , Bone Density Conservation Agents/administration & dosage , Pamidronate/administration & dosage , Brazil , Logistic Models , Retrospective Studies , Bone Density Conservation Agents/pharmacology , Administration, Intravenous , Pamidronate/pharmacology , Middle Aged
9.
Rev. bras. reumatol ; 57(3): 254-263, May-June 2017. graf
Article in English | LILACS | ID: biblio-899421

ABSTRACT

ABSTRACT Bisphosphonates are considered first-line agents in the treatment of postmenopausal osteoporosis based on extensive experience of use, safety, and proven efficacy in reducing vertebral, non-vertebral and femur fractures. However, post-marketing reports based on the treatment of millions of patients/year over lengthy periods of time have revealed the occurrence of initially unexpected adverse effects, such as osteonecrosis of the jaw and atypical femoral fracture, leading to the restriction of treatment duration with bisphosphonates by global regulatory agencies. However, despite the association between these effects and bisphosphonates, this risk should be analyzed in the context of osteoporosis treatment, alongside the benefit of preventing osteoporotic fractures and their clinical consequences. Therefore, we consider it plausible to discuss the restriction to the use of bisphosphonates, possible indications for prolonged treatment and alternative therapies following the suspension of this drug class for patients with persistent high risk of fracture after initial treatment, especially considering the problems of public health funding in Brazil and the shortage of drugs provided by the government. Thus, to standardize the treatment of osteoporosis in the public health care system, we aim to develop a proposal for a scientifically-based pharmacological treatment for postmenopausal osteoporosis, establishing criteria for indication and allowing the rational use of each pharmacological agent. We discuss the duration of the initial bisphosphonate treatment, the therapeutic options for refractory patients and potential indications of other classes of drugs as first-choice treatment in the sphere of public health, in which assessing risk and cost effectiveness is a priority.


RESUMO Com base na vasta experiência de uso, segurança e eficácia comprovada na redução de fraturas vertebrais, não vertebrais e femorais, os bisfosfonatos são considerados agentes de primeira linha no tratamento da osteoporose pós-menopáusica. No entanto, os relatos pós-venda baseados no tratamento de milhões de pacientes/ano durante períodos prolongados de tempo revelaram a ocorrência de efeitos adversos inicialmente inesperados, como osteonecrose da mandíbula e fratura atípica do fêmur. Isso levou as agências reguladoras globais a restringirem a duração do tratamento com bisfosfonatos. No entanto, apesar da associação entre esses efeitos e os bisfosfonatos, esse risco deve ser analisado no contexto do tratamento da osteoporose, paralelamente ao benefício na prevenção de fraturas osteoporóticas e suas consequências clínicas. Portanto, considera-se plausível discutir a restrição ao uso dos bisfosfonatos, possíveis indicações para o tratamento prolongado e terapias opcionais após a suspensão dessa classe de fármaco para pacientes com alto risco persistente de fratura após o tratamento inicial, especialmente se considerarmos os problemas financeiros de saúde pública no Brasil e a escassez de fármacos fornecidos pelo governo. Assim, para padronizar o tratamento da osteoporose no sistema público de saúde pretende-se desenvolver uma proposta de tratamento farmacológico cientificamente fundamentada para a osteoporose pós-menopáusica, estabelecer critérios de indicação e permitir o uso racional de cada agente farmacológico. Discutem-se a duração do tratamento inicial com bisfosfonatos, as opções terapêuticas para pacientes refratários e potenciais indicações de outras classes de medicamentos como tratamento de primeira linha na esfera da saúde pública, em que a avaliação do risco e custo-efetividade é uma prioridade.


Subject(s)
Humans , Osteoporosis, Postmenopausal/drug therapy , Diphosphonates/therapeutic use , Bone Density Conservation Agents/therapeutic use , Clinical Decision-Making/methods , Algorithms , Brazil , Osteoporosis, Postmenopausal/complications , Osteoporosis, Postmenopausal/economics , Risk Factors , Cost-Benefit Analysis , Diphosphonates/economics , Bone Density Conservation Agents/economics , Osteoporotic Fractures/economics , Osteoporotic Fractures/chemically induced , Osteoporotic Fractures/prevention & control , Bisphosphonate-Associated Osteonecrosis of the Jaw/economics , Bisphosphonate-Associated Osteonecrosis of the Jaw/prevention & control , National Health Programs
10.
Actual. osteol ; 13(1): 9-16, Ene - Abr. 2017. tab
Article in Spanish | LILACS | ID: biblio-1118618

ABSTRACT

Tanto el ranelato de estroncio (RSr) como el denosumab (Dmab) son eficaces en el tratamiento de la osteoporosis (OP) posmenopáusica (PM). El efecto de cada fármaco por separado sobre la densidad mineral ósea (DMO) ha sido estudiado recientemente. Con ambas drogas se observó, al año de tratamiento, un aumento significativo de la DMO en columna lumbar (CL), cuello femoral (CF) y cadera total (CT). En este trabajo comparamos la respuesta densitométrica al año de tratamiento con una y otra droga. Utilizamos los registros de 425 pacientes PMOP tratadas con Dmab y 441 tratadas con RSr. En cada paciente analizamos el porcentaje de cambio; se clasificaron como respondedoras aquellas que mostraron un cambio ≥3%. Adicionalmente se comparó la respuesta en pacientes no previamente tratadas con bifosfonatos (BF-naïve) en comparación con pacientes que habían recibido previamente un BF. Al analizar el grupo completo para Dmab, el porcentaje de pacientes respondedoras fue de 68,4% en CL, 63,3% en CF y 49,3% en CT. Por otro lado, en el grupo de pacientes tratadas con RSr, el porcentaje de respondedoras (53,8% en CL, 40,0% en CF y 35,6% en CT) fue estadísticamente menor. Cuando comparamos la respuesta entre las pacientes BF-naïve que recibieron RSr o Dmab, el Dmab indujo mayor respuesta en CL y CF que el grupo RSr, sin diferencias en CT. Cuando se analizaron los subgrupos BF-previo, las tratadas con Dmab mostraron mayor respuesta en todas las regiones. Conclusión: en pacientes con OP-PM, el tratamiento con Dmab produjo mayores incrementos densitométricos que el RSr, siendo el porcentaje de pacientes respondedoras mayor con Dmab que con RSr. (AU)


Both strontium ranelate (SrR) and denosumab (Dmab) are effective in the treatment of postmenopausal osteoporosis (PMOP). The effect of each drug on bone mineral density (BMD) has been studied separately by us. With both treatments, there was a significant increase after one year of treatment at the lumbar spine (LS) and hip. In this paper we compared the densitometric response after one year of treatment with both drugs used separately. We used the clinical records of 425 PM patients treated with Dmab and 441 treated with SrR. For each patient we analyzed the percentage of change; those who showed a change ≥3% were classified as responders. Additionally, the response was compared in patients not previously treated with bisphosphonates (BP-naïve) compared to patients who had previously received a BP. When analyzing the complete group for Dmab, the percentage of "responders" was 65.2% at the LS, 62.9% at the femoral neck (FN) and 47.4% at the total hip (TH). On the other hand, in the group of patients treated with SrR the percentage of responders (53.8% at the LS, 40.0% at the FN and 35.6% at the TH) was statistically lower. When comparing the response between in BF-naïve patients receiving RSr or Dmab, Dmab induced a greater response at the LS and FN than the RSr group, with no statistical differences at the TH. When the subgroups with prior BP treatment were analyzed, those treated with Dmab showed greater response in all regions. Conclusion: in patients with PMOP treatment with Dmab produced greater densitometric increments than SrR, and the percentage of responders was higher with Dmab than with SrR. (AU)


Subject(s)
Humans , Female , Middle Aged , Aged , Aged, 80 and over , Strontium/therapeutic use , Osteoporosis, Postmenopausal/drug therapy , Denosumab/therapeutic use , Phosphates/blood , Strontium/administration & dosage , Strontium/chemistry , Vitamin D/administration & dosage , Biomarkers , Bone Density/drug effects , Fractures, Stress/prevention & control , Osteocalcin/blood , Osteoporosis, Postmenopausal/blood , Calcium/administration & dosage , Calcium/blood , Retrospective Studies , Teriparatide/therapeutic use , Densitometry , Diphosphonates/therapeutic use , Alkaline Phosphatase/blood , Bone Density Conservation Agents/therapeutic use , Femur Neck/drug effects , Denosumab/administration & dosage , Treatment Adherence and Compliance , Hip , Lumbosacral Region
11.
Arch. endocrinol. metab. (Online) ; 60(1): 54-59, Feb. 2016. tab, graf
Article in English | LILACS | ID: lil-774619

ABSTRACT

ABSTRACT Objective Vertebral fracture is the most common osteoporotic fracture, affecting quality of life and increasing mortality. Epidemiological data on incidence of vertebral fracture are scarce in Brazil and throughout Latin America. Our aim was to determine vertebral fracture incidence and risk factors in a female Brazilian population. Subjects and methods Postmenopausal women with low bone mass were studied from the Brazilian placebo group of Arzoxifene Generations Trial (n = 974), followed for up to 5 years. The primary endpoint was new vertebral fractures, detected by X-Ray. Experimental design defined two strata: A. Osteoporosis or previous vertebral fracture with osteopenia; B. Osteopenia without previous fracture. Previous fracture, T-score, ionized calcium, alkaline phosphatase, creatinine and glucose were analyzed at baseline. Crude and adjusted incidence rates of vertebral fractures were estimated and Poisson regression model was used. Results Incidence rate was 7.7 (95% CI of 5.4 to 10.9) per 1,000 person-years (PY), increasing as a function of age. Women with new vertebral fractures had higher prevalence of previous nonvertebral fracture after menopause, were older and had lower lumbar spine (LS) T-score. Fracture risk increased by 46% for each unit reduction in LS T-score. Variables correlated with new vertebral fracture were age (p = 0.034), LS T-score, stratum A (p = 0.001 for both) and previous nonvertebral fracture after menopause (p = 0.019). In the final model, LS T-score was the strongest predictor. Conclusions Incidence rate of vertebral fracture of 7.7 per 1,000 PY. Age and previous fractures were associated with new vertebral fracture, but LS T-score was the most important predictor.


Subject(s)
Aged , Aged, 80 and over , Female , Humans , Middle Aged , Bone Diseases, Metabolic/complications , Postmenopause , Spinal Fractures/epidemiology , Age Distribution , Bone Diseases, Metabolic/drug therapy , Brazil/epidemiology , Calcium/therapeutic use , Dietary Supplements/statistics & numerical data , Follow-Up Studies , Incidence , Osteoporosis, Postmenopausal/drug therapy , Piperidines/therapeutic use , Randomized Controlled Trials as Topic , Risk Factors , Thiophenes/therapeutic use , Vitamin D/therapeutic use
12.
Yonsei Medical Journal ; : 905-914, 2016.
Article in English | WPRIM | ID: wpr-63333

ABSTRACT

PURPOSE: The efficacy and safety of denosumab was compared with placebo in Korean postmenopausal women with osteoporosis in this phase III study. MATERIALS AND METHODS: Women aged 60 to 90 years with a T-score of <-2.5 and ≥-4.0 at the lumbar spine or total hip were randomized to a single 60 mg subcutaneous dose of denosumab or placebo for the 6-month double-blind phase. Eligible subjects entered the 6-month open-label extension phase and received a single dose of denosumab 60 mg. RESULTS: Baseline demographics were similar in the 62 denosumab- and 64 placebo-treated subjects who completed the double-blind phase. Treatment favored denosumab over placebo for the primary endpoint {mean percent change from baseline in lumbar spine bone mineral density (BMD) at Month 6 [3.2% (95% confidence interval 2.1%, 4.4%; p<0.0001)]}; and secondary endpoints (mean percent change from baseline in lumbar spine BMD at Month 1, total hip, femoral neck, and trochanter BMD at Months 1 and 6, and median percent change from baseline in bone turnover markers at Months 1, 3, and 6). Endpoint improvements were sustained over 12 months in the open-label extension (n=119). There were no new or unexpected safety signals. CONCLUSION: Denosumab was well tolerated and effective in increasing BMD and decreasing bone turnover markers over a 12-month period in Korean postmenopausal women. The findings of this study demonstrate that denosumab has beneficial effects on the measures of osteoporosis in Korean postmenopausal women.


Subject(s)
Aged , Aged, 80 and over , Asians , Bone Density , Bone Density Conservation Agents/therapeutic use , Denosumab/therapeutic use , Double-Blind Method , Female , Femur , Femur Neck , Humans , Lumbar Vertebrae , Middle Aged , Osteoporosis, Postmenopausal/drug therapy , Postmenopause , Republic of Korea
14.
Actual. osteol ; 12(1): 27-34, 2016. graf, tab
Article in Spanish | LILACS, BINACIS, UNISALUD | ID: biblio-1379961

ABSTRACT

El tratamiento de las formas graves de osteoporosis representa un desafío en la práctica asistencial. Reportamos tres pacientes con formas graves de osteoporosis tratadas en el Instituto de Diagnóstico e Investigaciones Metabólicas con un esquema secuencial de teriparatide 20 µg/día durante 18 meses, seguidos de 12 meses de denosumab 60 mg semestral. Luego de 18 meses de tratamiento con teriparatide la densidad mineral ósea en columna aumentó 5,86±1,01% y en cuello femoral 1,92±3,10%; al finalizar los doce meses de tratamiento con denosumab se constató un aumento total en columna de 10,45±1,70% y en cuello femoral 9,28±3,86%. El tratamiento con teriparatide se acompañó de un aumento en los niveles plasmáticos de telopéptidos del colágeno óseo (CTX) y en el período de tratamiento con denosumab dichos valores disminuyeron de manera significativa, mostrando el impacto de estos fármacos sobre el remodelado óseo. Concluimos que el tratamiento secuencial con teriparatide y denosumab en dosis convencionales resultó beneficioso en las tres pacientes tratadas. Sería de utilidad ampliar esta experiencia en un trabajo prospectivo. (AU)


High risk osteoporosis treatment is a challenge in daily medical practice. We report three patients that attended our institution with severe osteoporosis who received sequentially teriparatide (20 ug daily) for eighteen months followed by denosumab (60 mg every six months) for twelve months. After teriparatide treatment bone mineral density increased 5.86±1.01% at lumbar spine and 1.92±3.10 % at femoral neck, while after denosumab it continued increasing to reach a total of 10.45±1.70% at lumbar spine and 9.28±3.86% at femoral neck. Teriparatide treatment increased bone resorption evidenced by high serum CTX while after denosumab it fell abruptly, showing the impact of these two drugs on bone turnover. We conclude that sequential treatment with teriparatide and denosumab in approved doses was beneficial for these three patients. Prospective studies are needed. (AU)


Subject(s)
Humans , Female , Middle Aged , Aged , Osteoporosis/drug therapy , Osteoporosis, Postmenopausal/drug therapy , Teriparatide/administration & dosage , Denosumab/administration & dosage , Bone Density/drug effects , Osteoporosis, Postmenopausal/blood , Risk Factors , Treatment Outcome , Bone Remodeling/drug effects , Densitometry , Femur Neck/drug effects , Osteoporotic Fractures/prevention & control , Lumbar Vertebrae/drug effects
15.
Rev. bras. reumatol ; 55(2): 103-112, Mar-Apr/2015. tab, graf
Article in Portuguese | LILACS | ID: lil-746141

ABSTRACT

Objetivos: Este estudo foi desenvolvido para investigar a eficácia e a segurança do ácidozoledrônico (ZOL) e do propranolol (PRO) como monoterapia e terapia combinada em ummodelo de rato com osteoporose pós-menopáusica. Métodos: Ratas Wistar fêmeas foram ovariectomizadas (OVX) ou submetidas à cirurgia simulada (placebo) aos três meses de idade. Doze semanas depois da cirurgia, as ratas foram divididas em seis grupos: (1) placebo + veículo; (2) OVX + veículo; (3) OVX + ZOL (100 µg/kg, dose única intravenosa); (4) OVX + ZOL (50 µg/kg, dose única intravenosa); (5) OVX + PRO (0,1 mg/kg, via subcutânea, cinco dias por semana); (6) OVX + ZOL (50 µg/kg, dose única intravenosa) + PRO (0,1 mg/kg, via subcutânea, cinco dias por semana) durante 12 semanas. Depois do tratamento, testou-se a densidade óssea, a porosidade e a microarquitetura tra-becular dos fêmures. Também foram avaliados marcadores bioquímicos séricos e urinários. Resultados: A terapia combinada com ZOL mais PRO foi mais eficaz em corrigir a diminuição do cálcio sérico e o aumento do nível sérico de fosfatase alcalina e fosfatase ácida resistenteao tartarato do que a monoterapia com ZOL ou PRO. Além disso, a terapia combinada comZOL mais PRO foi mais eficaz em corrigir o aumento dos níveis urinários de cálcio, fósforo ecreatinina do que a monoterapia com ZOL ou PRO. A terapia combinada com ZOL mais PRO também preservou a microarquitetura trabecular e a porosidade do osso cortical. Conclusão: Os resultados sugerem que a terapia combinada com ZOL mais PRO pode ser aabordagem mais eficaz para o tratamento da osteoporose grave em humanos. .


Objectives: The present study was designed to investigate further the efficacy and safety of zoledronic acid (ZOL) and propranolol (PRO) as monotherapy and combination therapy in a rat model of postmenopausal osteoporosis. Methods: Female Wistar rats were ovariectomized (OVX) or sham-operated at 3 months ofage. Twelve weeks post-surgery, rats were randomized into six groups: (1) sham + vehicle; (2) OVX + vehicle; (3) OVX + ZOL (100 뀅g/kg, i.v. single dose); (4) OVX + ZOL (50 뀅g/kg, i.v. single dose); (5) OVX + PRO (0.1 mg/kg, s.c. 5 days per week); (6) OVX + ZOL (50 뀅g/kg, i.v. single dose) + PRO (0.1 mg/kg, s.c. 5 days per week) for 12 weeks. After treatment, femurs were tested for bone density, porosity and trabecular micro-architecture. Biochemical markers in serum and urine were also determined. Results: Combined treatment with ZOL plus PRO corrected the decrease in serum calcium and increase in serum alkaline phosphatase and tartarate resistant acid phosphatase level better than single-drug therapy using ZOL or PRO. Moreover, combined treatment with ZOL plus PRO corrected the increase in urine calcium, phosphorous and creatinine level better than single-drug therapy using ZOL or PRO. Combination therapy using ZOL plus PRO also preserved the trabecular micro-architecture and cortical bone porosity. Conclusion: These data suggest that combined treatment with ZOL plus PRO could be a more effective approach for treating severe osteoporosis in humans. .


Subject(s)
Humans , Animals , Female , Rats , Adrenergic beta-Antagonists/pharmacology , Adrenergic beta-Antagonists/therapeutic use , Bone Density Conservation Agents/pharmacology , Bone Density Conservation Agents/therapeutic use , Bone Density/drug effects , Bone Diseases, Metabolic/drug therapy , Bone Remodeling/drug effects , Diphosphonates/pharmacology , Diphosphonates/therapeutic use , Imidazoles/pharmacology , Imidazoles/therapeutic use , Osteoporosis, Postmenopausal/drug therapy , Propranolol/pharmacology , Propranolol/therapeutic use , Biomarkers , Drug Synergism , Drug Therapy, Combination , Ovariectomy , Random Allocation
16.
Arq. bras. endocrinol. metab ; 58(5): 493-503, 07/2014. tab
Article in English | LILACS | ID: lil-719205

ABSTRACT

The trabecular bone score (TBS) is a new method to describe skeletal microarchitecture from the dual energy X-ray absorptiometry (DXA) image of the lumbar spine. While TBS is not a direct physical measurement of trabecular microarchitecture, it correlates with micro-computed tomography (µCT) measures of bone volume fraction, connectivity density, trabecular number, and trabecular separation, and with vertebral mechanical behavior in ex vivo studies. In human subjects, TBS has been shown to be associated with trabecular microarchitecture and bone strength by high resolution peripheral quantitative computed tomography (HRpQCT). Cross-sectional and prospective studies, involving a large number of subjects, have both shown that TBS is associated with vertebral, femoral neck, and other types of osteoporotic fractures in postmenopausal women. Data in men, while much less extensive, show similar findings. TBS is also associated with fragility fractures in subjects with secondary causes of osteoporosis, and preliminary data suggest that TBS might improve fracture prediction when incorporated in the fracture risk assessment system known as FRAX. In this article, we review recent advances that have helped to establish this new imaging technology.


TBS (do inglês, “trabecular bone score”) é um novo método que estima a microarquitetura óssea a partir de uma imagem de densitometria óssea (DXA) da coluna lombar. Apesar de o TBS não ser uma medida física direta da microarquitetura trabecular, ele correlaciona-se com o volume ósseo, densidade da conectividade trabecular, número de trabéculas e separação trabecular medidos por microtomografia computadorizada (µCT), e com medidas mecânicas da resistência óssea vertebral em estudos ex vivo. Estudos em humanos confirmaram que o TBS associa-se a microarquitetura trabecular e resistência óssea medidas por tomografia computadorizada quantitativa periférica de alta resolução (HRpQCT). Estudos transversais e prospectivos, envolvendo um grande número de indivíduos, mostraram que o TBS é associado com fratura vertebral, de colo de fêmur e com outros tipos de fraturas osteoporóticas em mulheres na pós-menopausa. Dados em homens, apesar de escassos, mostram resultados semelhantes. Além disso, o TBS foi associado a fraturas por fragilidade em indivíduos com diversas causas secundárias de osteoporose e, dados preliminares, sugerem que o uso do TBS pode melhorar a previsão de fratura quando incorporado ao sistema de avaliação de risco de fratura (FRAX). Este artigo faz uma revisão de avanços recentes que têm ajudado a estabelecer esse novo método de imagem.


Subject(s)
Female , Humans , Male , Absorptiometry, Photon/methods , Bone Density , Bone and Bones/anatomy & histology , Bone and Bones/physiology , Lumbar Vertebrae , Osteoporotic Fractures/diagnosis , Absorptiometry, Photon/trends , Bone Density Conservation Agents/therapeutic use , Osteoporosis, Postmenopausal/complications , Osteoporosis, Postmenopausal/diagnosis , Osteoporosis, Postmenopausal/drug therapy , Osteoporotic Fractures/etiology , Osteoporotic Fractures/prevention & control , Postmenopause/physiology , Risk Factors
17.
Yonsei Medical Journal ; : 715-724, 2014.
Article in English | WPRIM | ID: wpr-159381

ABSTRACT

Vitamin D (vit-D) is essential for bone health, although many osteoporosis patients have low levels of 25-hydroxy-vit-D [25(OH)D]. This randomized, open-label study compared the effects of once weekly alendronate 70 mg containing 5600 IU vit-D3 (ALN/D5600) to alendronate 70 mg without additional vit-D (ALN) on the percent of patients with vit-D insufficiency [25(OH)D <15 ng/mL, primary endpoint] and serum parathyroid hormone (PTH, secondary endpoint) levels in postmenopausal, osteoporotic Korean women. Neuromuscular function was also measured. A total of 268 subjects were randomized. Overall, 35% of patients had vit-D insufficiency at baseline. After 16-weeks, there were fewer patients with vit-D insufficiency in the ALN/D5600 group (1.47%) than in the ALN group (41.67%) (p<0.001). Patients receiving ALN/D5600 compared with ALN were at a significantly decreased risk of vit-D insufficiency [odds ratio=0.02, 95% confidence interval (CI) 0.00-0.08]. In the ALN/D5600 group, significant increases in serum 25(OH)D were observed at weeks 8 (9.60 ng/mL) and 16 (11.41 ng/mL), where as a significant decrease was recorded in the ALN group at week 16 (-1.61 ng/mL). By multiple regression analysis, major determinants of increases in serum 25(OH)D were ALN/D5600 administration, seasonal variation, and baseline 25(OH)D. The least squares mean percent change from baseline in serum PTH in the ALN/D5600 group (8.17%) was lower than that in the ALN group (29.98%) (p=0.0091). There was no significant difference between treatment groups in neuromuscular function. Overall safety was similar between groups. In conclusion, the administration of 5600 IU vit-D in the ALN/D5600 group improved vit-D status and reduced the magnitude of PTH increase without significant side-effects after 16 weeks in Korean osteoporotic patients.


Subject(s)
Adult , Aged , Alendronate/adverse effects , Cholecalciferol/adverse effects , Female , Humans , Middle Aged , Osteoporosis, Postmenopausal/drug therapy , Vitamin D Deficiency/drug therapy
18.
Clinics ; 68(10): 1338-1343, out. 2013. tab, graf
Article in English | LILACS | ID: lil-689985

ABSTRACT

OBJECTIVE: Accelerated bone loss that occurs in postmenopausal women has been linked to oxidative stress and increased free radicals. We propose the use of antioxidants to prevent and reverse postmenopausal osteoporosis. This study aimed to examine the effects of tocotrienol, a vitamin E analog, on bone loss due to estrogen deficiency. Our previous study showed that tocotrienol increased the trabecular bone volume and trabecular number in ovariectomized rats. In the current study, we investigated the effects of tocotrienol supplementation on various biochemical parameters in a postmenopausal osteoporosis rat model. MATERIALS AND METHODS: A total of 32 female Wistar rats were randomly divided into four groups. The baseline group was sacrificed at the start of the study, and another group was sham operated. The remaining rats were ovariectomized and either given olive oil as a vehicle or treated with tocotrienol at a dose of 60 mg/kg body weight. After four weeks of treatment, blood was withdrawn for the measurement of interleukin-1 (IL1) and interleukin-6 (IL6) (bone resorbing cytokines), serum osteocalcin (a bone formation marker) and pyridinoline (a bone resorption marker). RESULTS: Tocotrienol supplementation in ovariectomized rats significantly reduced the levels of osteocalcin, IL1 and IL6. However, it did not alter the serum pyridinoline level. CONCLUSION: Tocotrienol prevented osteoporotic bone loss by reducing the high bone turnover rate associated with estrogen deficiency. Therefore, tocotrienol has the potential to be used as an anti-osteoporotic agent in postmenopausal women. .


Subject(s)
Animals , Female , Humans , Rats , Antioxidants/therapeutic use , Dietary Supplements , Osteoporosis, Postmenopausal/drug therapy , Tocotrienols/therapeutic use , Amino Acids/blood , Body Weight , Biomarkers/blood , Bone Resorption/drug therapy , Bone Resorption/prevention & control , Eating , Interleukin-1/blood , /blood , Ovariectomy , Osteocalcin/blood , Osteoporosis, Postmenopausal/prevention & control , Random Allocation , Rats, Wistar , Time Factors , Treatment Outcome
19.
Rev. saúde pública ; 47(2): 390-402, jun. 2013. tab
Article in Portuguese | LILACS | ID: lil-685567

ABSTRACT

OBJETIVO: Analisar os gastos com medicamentos para o tratamento da osteoporose na pós-menopausa e os fatores associados ao gasto médio per capita . MÉTODOS: Pareamento probabilístico-determinístico a partir das bases das Autorizações de Procedimentos de Alta Complexidade com o Sistema de Informação sobre Mortalidade, resultando em coorte histórica de pacientes que utilizaram medicamentos de alto custo para o tratamento da osteoporose na pós-menopausa de 2000 a 2006. O gasto médio mensal com medicamentos foi estratificado por faixas etárias e descrito de acordo com as características demográficas, clínicas e tipo de medicamento utilizado. Foi utilizado modelo de regressão linear para avaliar o impacto de características demográficas e clínicas sobre o gasto médio mensal per capita com os medicamentos. RESULTADOS: Foram identificadas 72.265 mulheres que receberam medicamentos para o tratamento da osteoporose na pós-menopausa. O gasto médio mensal per capita no primeiro ano de tratamento foi de R$ 90,00 (dp R$ 144,49). A maioria das mulheres tinha de 60 a 69 anos de idade, iniciaram tratamento em 2000, eram residentes na região Sudeste, tinham fraturas osteoporóticas prévias e o alendronato de sódio foi o medicamento mais utilizado no início do tratamento. A maioria das pacientes permaneceu em uso do mesmo princípio ativo durante o tratamento. Foram identificados 6.429 óbitos entre as participantes. Mais de um terço das mulheres permaneceram no programa por até 12 meses. Raloxifeno e calcitonina sintética foram as alternativas com maior impacto sobre o gasto médio mensal com medicamentos, tendo como padrão de referência o ...


OBJECTIVE: To analyze expenditure on treatment for postmenopausal osteoporosis and associated factors on mean per capita expenditure. METHODS: A probabilistic-deterministic linkage between the database of Authorizations for Highly Complex Procedures and the mortality information system was constructed, resulting in a historical cohort of patients using high-cost medications for the treatment of postmenopausal osteoporosis, between 2000-2006. Mean monthly spending on medicines was stratified by age group and described according to demographic and clinical characteristics and the type of drug used. A linear regression model was used to assess the impact of demographic and clinical characteristics on per capita mean monthly expenditure on medicines. RESULTS: We identified 72,265 women who received drugs for the treatment of postmenopausal osteoporosis. The average monthly expenditure per capita in the first year of treatment was $ 54.02 (sd $ 86.72). The population was predominantly composed of women aged 60-69 years old, who had started treatment in 2000, resident in the Southeast of Brazil, who had previously suffered osteoporotic fractures, and Alendronate sodium was the drug most commonly used at baseline. For most of the patients, the same active ingredient remained in use throughout the treatment period. During the program, 6,429 deaths were identified among participants. More than a third of women remained in treatment for up to 12 months. Raloxifen and calcitonin were the therapeutic alternatives with the greatest impact on the average monthly expenditure on medicine using alendronate sodium as a reference standard. CONCLUSIONS: Due to the high impact of the type of drug used on expenditure on medication, it is recommended that criteria for prescribing and dispensing ...


OBJETIVO: Analizar los gastos con medicamentos para el tratamiento de la osteoporosis en la post-menopausia y los factores asociados al gasto promedio per cápita. MÉTODOS: Pareamiento probabilístico-deterministico a partir de las bases de las Autorizaciones de Procedimientos de Alta Complejidad con el Sistema de Información sobre Mortalidad, resultando en cohorte histórica de pacientes que utilizaron medicamentos de alto costo para el tratamiento de la osteoporosis en la post-menopausia de 2000 a 2006. El gasto promedio mensual con medicamentos fue estratificado por grupos etarios y descrito de acuerdo con las características demográficas, clínicas y tipo de medicamento usado. Se utilizó modelo de regresión linear para evaluar el impacto de las características socio demográficas y clínicas sobre el gasto promedio mensual per cápita con los medicamentos. RESULTADOS: Se identificaron 72.265 mujeres que recibieron medicamentos para el tratamiento de la osteoporosis en la post-menopausia. El gasto promedio mensual per cápita en el primer año de tratamiento fue de R$ 90,00 (de R$ 144,49). La mayoría de las mujeres tenía de 60 a 69 años de edad, iniciaron tratamiento en 2000, eran residentes en la región Sureste, tenían fracturas osteoporóticas previas, y el alendronato de sodio fue el medicamento más utilizado en el inicio del tratamiento. La mayoría de los pacientes permaneció en uso del mismo principio activo durante el tratamiento. Se identificaron 6.429 óbitos entre las participantes. Más de un tercio de las mujeres permanecieron en el programa por 12 meses. Raloxifeno y calcitonina sintética fueron las alternativas con mayor impacto sobre el gasto promedio mensual con medicamentos, teniendo como patrón de referencia ...


Subject(s)
Adult , Aged , Aged, 80 and over , Female , Humans , Middle Aged , Bone Density Conservation Agents/economics , Drug Costs , Osteoporosis, Postmenopausal/drug therapy , Age Factors , Alendronate/economics , Alendronate/therapeutic use , Bone Density , Bone Density Conservation Agents/therapeutic use , Brazil/epidemiology , Cohort Studies , Cost-Benefit Analysis , National Health Programs , Osteoporosis, Postmenopausal/epidemiology , Osteoporotic Fractures/epidemiology , Unified Health System
20.
Rev. bras. reumatol ; 52(6): 924-937, nov.-dez. 2012. tab
Article in Portuguese | LILACS | ID: lil-658149

ABSTRACT

A osteoporose, principalmente na pós-menopausa, apresenta alto impacto socioeconômico para o indivíduo e para a sociedade. Existem vários medicamentos para sua prevenção e tratamento; entretanto, observa-se ampla variação na eficácia e nos custos relacionados. Diversas avaliações econômicas têm sido conduzidas a fim de se avaliar as estratégias mais eficientes. O objetivo desse trabalho foi conduzir uma revisão sistemática das avaliações econômicas realizadas no Brasil e no mundo, enfocando o tratamento da osteoporose na pós-menopausa. Foi realizada uma busca de artigos sobre avaliação econômica de medicamentos para o tratamento da osteoporose na pós-menopausa, nas bases de dados PubMed e LILACS. No geral, os bisfosfonatos foram as estratégias mais avaliadas e que resultaram em melhores relações custo-efetividade incrementais. Terapia hormonal, suplementação de cálcio e vitamina D, ranelato de estrôncio, raloxifeno, teriparatida e denosumabe foram avaliados e apresentaram resultados variáveis dependendo da perspectiva adotada, do país e das premissas assumidas para cada estudo. Não foi possível extrapolar nenhum dos resultados para a população brasileira, limitando sua utilização pelos tomadores de decisão.


Osteoporosis, especially in postmenopausal women, has a high socioeconomic impact on the individual and on the society. There are several drugs for its prevention and treatment; however, their effectiveness and costs vary considerably. Several economic assessments have been conducted in order to evaluate the most effective strategies. This study aimed at conducting a systematic review of complete economic assessments focusing on the treatment of postmenopausal osteoporosis performed in Brazil and worldwide. Articles about economic assessment of drugs for the treatment of postmenopausal osteoporosis were searched in the PubMed and LILACS databases. In general, bisphosphonates were the most frequently assessed strategies and had the best incremental cost-effectiveness ratios. Hormone therapy, vitamin D and calcium, strontium ranelate, raloxifene, teriparatide, and denosumab were assessed and showed variable results depending on the perspective of the country and the assumptions made for each study. None of the results could be extrapolated to the Brazilian population, which limits their use by decision makers.


Subject(s)
Female , Humans , Osteoporosis, Postmenopausal/drug therapy , Osteoporosis, Postmenopausal/economics , Brazil , Economics, Pharmaceutical
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