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1.
Pak J Pharm Sci ; 33(1(Special)): 495-498, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-32173648

RESUMO

To evaluate the efficacy of combined medication of risedronate sodium and raloxifene, a selective estrogen receptor modulator (SERM) on the postmenopausal osteoporosis (PMOP). PMOP patients underwent the combined medication of risedronate sodium and raloxifene (SERM, Treatment group), or only medication of risedronate sodium (Control group). After medication, more significant increases were observed in the bone densities of the lumber vertebra (L1-4) and the neck of left femur of patients in the treatment group. Simultaneously, the levels of estrogen and progesterone in serum decreased sharply in the treatment group. After treatment, P1NP and ß-CTX levels in serum decreased significantly in two groups in comparison with the levels prior to treatment, with evident elevations in the levels of BAP and BGP; similarly, ameliorations in the treatment group were much more evident than those in the control group. In addition, significant declines were identified in the VAS scores of two groups after treatment when comparing to the scores prior to the treatment, and the decline in the treatment group was more evident than that in the control group. Combined medication of risedronate sodium and SERM (raloxifene) performs better in treatment of osteoporosis than the single use of risedronate sodium, without the deterioration of adverse effect of medication.


Assuntos
Osteoporose Pós-Menopausa/tratamento farmacológico , Cloridrato de Raloxifeno/administração & dosagem , Ácido Risedrônico/administração & dosagem , Moduladores Seletivos de Receptor Estrogênico/administração & dosagem , Idoso , Densidade Óssea , Osso e Ossos/metabolismo , Quimioterapia Combinada , Feminino , Humanos , Pessoa de Meia-Idade , Cloridrato de Raloxifeno/efeitos adversos , Ácido Risedrônico/efeitos adversos
2.
Medicine (Baltimore) ; 99(7): e19042, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-32049802

RESUMO

BACKGROUND: This meta-analysis was conducted to compare the effects and safety of teriparatide with risedronate in the treatment of osteoporosis. MATERIAL AND METHODS: PubMed, Embase, Web of Science and Cochrane library database were systematically reviewed for studies published up to February 24, 2019. Eligible studies that compared the effects of teriparatide with risedronate in osteoporosis were included in this meta-analysis. The outcomes included percentage change in bone mineral density (BMD) of lumbar spine, femoral neck, and total hip, the incidence of clinical fractures, serum bone markers, and adverse events. A random-effects or fixed-effects model was used to pool the estimate, according to the heterogeneity among the included studies. RESULTS: Seven studies were included in this meta-analysis. Compared with risedronate, teriparatide was associated with a significant increase in lumbar spine BMD [weight mean difference (WMD)=4.24, 95%CI: 3.11, 5.36; P < .001], femoral neck BMD (WMD=2.28, 95%CI: 1.39, 3.18; P < .001), and total hip BMD (WMD = 1.19, 95%CI: 0.47, 1.91; P = .001). Moreover, patients in teriparatide group had significantly lower incidences of clinical fracture (risk ratio [RR] = 0.48, 95%CI: 0.32, 0.72; P < .001), new vertebral fracture (RR = 0.45, 95%CI: 0.32, 0.63; P < .001), and non-vertebral fracture (RR = 0.63, 95%CI: 0.40, 0.98; P = .042) than those in risedronate group. There were significant differences between the 2 groups in serum change, including P1NP (WMD = 122.34, 95%CI: 68.89, 175.99; P < .001), CTx (WMD = 0.62, 95%CI: 0.29, 0.96; P < .001), and iPTH (WMD = -13.18, 95%CI: -15.04, -11.33; P < .001). The incidence of adverse events was similar between the 2 groups (RR = 0.93, 95%CI: 0.69, 1.25; P = .610). CONCLUSION: This study suggested that teriparatide was more effective than risedronate for increasing the BMD in lumbar spine, femoral neck, and total hip, as well as reducing the incidences of clinical fracture, new vertebral fracture and non-vertebral fracture. There was no significant difference in incidence of adverse events between the 2 drugs. Considering the potential limitations in the present study, further large-scale, well-performed randomized trials are needed to verify our findings.


Assuntos
Osteoporose/tratamento farmacológico , Ácido Risedrônico/uso terapêutico , Teriparatida/uso terapêutico , Densidade Óssea/efeitos dos fármacos , Feminino , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Ácido Risedrônico/efeitos adversos , Ácido Risedrônico/farmacologia , Teriparatida/efeitos adversos , Teriparatida/farmacologia , Resultado do Tratamento
3.
J Bone Miner Metab ; 38(1): 86-98, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31420748

RESUMO

Absorption of oral immediate-release (IR) risedronate tablets is reduced by food intake, thus a delayed-release (DR) tablet has been developed to overcome the necessity of taking IR tablets under fasting conditions. This randomized, double-blind, phase II/III study compared efficacy and safety of risedronate IR once-daily (QD) and DR once-monthly (QM) tablets in Japanese patients with involutional osteoporosis. Patients received 2.5 mg IR on awakening QD, or 25 or 37.5 mg DR on awakening, following breakfast, or 30 min after breakfast, QM for 12 months. Primary endpoint was non-inferiority in mean percent change from baseline to end of study (month 12, last observation carried forward [M12, LOCF]) in mean lumbar spine (L2-L4) bone mineral density (BMD) between risedronate IR on awakening and DR following breakfast. Mean percent changes in (L2-L4) BMD at M12, LOCF were 5.07% (IR at awakening, n = 190), 3.36% (25 mg DR following breakfast, n = 194), and 4.11% (37.5 mg DR following breakfast, n = 181). Mean percent change in (L2-L4) BMD was numerically lower in the DR following breakfast groups versus the respective on awakening and 30 min after breakfast DR groups. Overall incidences of treatment-emergent adverse events (TEAEs) were comparable between groups. In the DR groups, 1.5-4.0% of patients reported TEAEs potentially associated with acute-phase reactions versus 0% in the IR group. In this study, non-inferiority could not be declared for 37.5 or 25 mg DR following breakfast QM (p = 0.1346 or p = 0.6711, respectively) versus 2.5 mg IR on awakening QD.


Assuntos
Grupo com Ancestrais do Continente Asiático , Osteoporose/tratamento farmacológico , Ácido Risedrônico/uso terapêutico , Idoso , Biomarcadores/metabolismo , Densidade Óssea/efeitos dos fármacos , Conservadores da Densidade Óssea/uso terapêutico , Remodelação Óssea/efeitos dos fármacos , Método Duplo-Cego , Esquema de Medicação , Feminino , Humanos , Masculino , Osteoporose/complicações , Cooperação do Paciente , Ácido Risedrônico/efeitos adversos , Ácido Risedrônico/farmacologia , Fraturas da Coluna Vertebral/complicações , Resultado do Tratamento
4.
Artigo em Português | LILACS, Coleciona SUS, CONASS, SES-GO | ID: biblio-1118551

RESUMO

Tecnologia: Denosumabe e bifosfonados. Indicação: tratamento de osteoporose para prevenção de fraturas. Pergunta: O denosumabe é mais eficaz e seguro que os bifosfonados orais para tratamento da osteoporose e prevenção de fraturas secundárias à osteoporose? Métodos: Levantamento bibliográfico realizado na PUBMED seguindo estratégia de busca predefinida. Avaliação da qualidade metodológica das revisões sistemáticas com a ferramenta AMSTAR (Assessing the Methodological Quality of Systematic Reviews). Resultados: Foram selecionadas e incluídas 3 revisões sistemáticas, com pontuação de 9 a 11 no AMSTAR. Conclusão: Denosumabe tem menor risco relativo que alendronato e risedronato de sódio para fraturas vertebrais e maior efeito sobre densidade óssea mineral femoral, com risco similar de outros tipos de fratura e eventos adversos (infecções, transtornos cardiovasculares, óbito por infecção, morte cardiovascular ou por qualquer causa). Denosumabe evita 0,00154 fraturas, previne 0,00025 institucionalizações (ou cuidados permanentes de enfermagem no domicílio) e promove um ganho de 0,0018 anos de vida a mais que o alendronato de sódio por paciente tratado. Denosumabe é um pouco mais eficaz e tão seguro quanto os bifosfonados, mas a diferença de eficácia é mínima


Technology: Denosumab and bisphosphonates. Indication: osteoporosis treatment for fracture prevention. Question: Denosumab is more effective and safer than oral bisphosphonates for treating osteoporosis and preventing fractures related to osteoporosis? Methods: Bibliographic search was performed on PUBMED, following predefined search strategies. Evaluation of the methodological quality of systematic reviews was carried out using the AMSTAR (Assessing the Methodological Quality of Systematic Reviews) tool. Results: We selected and included 3 systematic reviews. Their scores ranged from 9 to 11 on AMSTAR. Conclusion: Denosumab has a lower relative risk than sodium alendronate and risedronate for vertebral fractures and greater effect on femoral mineral bone density, with a similar risk for non-vertebral fractures and adverse events (infections, cardiovascular disorders, death caused by infection, cardiovascular death or any cause mortality). Denosumab avoids 0.00154 fractures, prevents 0.00025 nursing home/ residential care admissions and get 0.0018 years of life gained per treated patient more than sodium alendronate. Denosumab is slightly more effective and as safe as bisphosphonates, but the effectiveness difference is minimal


Assuntos
Humanos , Osteoporose/tratamento farmacológico , Alendronato/uso terapêutico , Conservadores da Densidade Óssea/uso terapêutico , Fraturas por Osteoporose/prevenção & controle , Ácido Risedrônico/uso terapêutico , Denosumab/uso terapêutico , Resultado do Tratamento , Alendronato/efeitos adversos , Medicina Baseada em Evidências , Ácido Risedrônico/efeitos adversos , Denosumab/efeitos adversos
5.
Sci Rep ; 9(1): 18958, 2019 12 12.
Artigo em Inglês | MEDLINE | ID: mdl-31831865

RESUMO

Despite the high prevalence of osteoporosis in liver cirrhosis, the indication of bisphosphonates for patients with esophageal varices has been avoided due to risk of digestive mucosal damage. Therefore, this study aimed to evaluate the safety profile of risedronate treatment for patients with osteoporosis, liver cirrhosis and esophageal varices with low risk of bleeding. A total of 120 patients were allocated into two groups according to their bone mineral density measured by dual-energy X-ray absorptiometry. In the intervention group, 57 subjects with osteoporosis received oral risedronate at 35 mg weekly plus daily calcium and vitamin D supplementation. In the control group, 63 subjects with osteopenia received only calcium and vitamin D. The groups received the treatment for one year and underwent surveillance endoscopies at six and 12 months, as well as a control dual-energy X-ray absorptiometry after a 12-month follow-up. The study received Institutional Review Board approval. The groups had not only comparable Model for End-stage Liver Disease score and esophageal varices degree, but also similar incidence of digestive adverse effects. A significant improvement was achieved in the intervention group in the lumbar spine T score (p < 0.001). The results suggest that risedronate may be safely used in liver cirrhosis and esophageal varices with low bleeding risk under endoscopic surveillance, thus allowing bone mass recovery.


Assuntos
Varizes Esofágicas e Gástricas/tratamento farmacológico , Cirrose Hepática/tratamento farmacológico , Osteoporose/tratamento farmacológico , Ácido Risedrônico/administração & dosagem , Absorciometria de Fóton , Adulto , Idoso , Cálcio/administração & dosagem , Cálcio/efeitos adversos , Varizes Esofágicas e Gástricas/complicações , Varizes Esofágicas e Gástricas/patologia , Feminino , Seguimentos , Humanos , Cirrose Hepática/complicações , Cirrose Hepática/patologia , Masculino , Pessoa de Meia-Idade , Osteoporose/etiologia , Osteoporose/patologia , Estudos Prospectivos , Ácido Risedrônico/efeitos adversos , Vitamina D/administração & dosagem , Vitamina D/efeitos adversos
6.
Cir Cir ; 87(4): 396-401, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31264983

RESUMO

Background: The use of osteoclast inhibitors in metastatic bone disease, increase bone mineral density and reduce the risk of fracture, patients with osteonecrosis have been reported after the chronic use of these inhibitors. In our country, the use of osteoclast inhibitors is in the context of osteoporosis and bone metastases, so it is important to describe the incidence of this complication in Mexican population. Objective: To describe the incidence of osteonecrosis of the jaws at the Centro Médico Nacional 20 de Noviembre, during the period from January 1st, 2010 to June 1st, 2016. Methods: This is a retrospective cohort study developed at the Centro Medico Nacional 20 Noviembre, ISSSTE, Mexico. We included all patients who received bisphosphonates or denosumab in the context of metastatic bone disease due to solid tumors and who had osteonecrosis of the jaw. Results: A 802 patients who used bisphosphonates or denosumab in metastatic bone disease (699 bisphosphonates and 103 denosumab). Of these, 28 (3.5%) patients presented osteonecrosis. The median use of zoledronic acid for the presence of osteonecrosis was 25 months (15-49 months) and for Denosumab it was 16 months (11-35 months), without finding significant differences between the use of drugs p = 0.511 and the risk of osteonecrosis. Conclusions: Drug-induced osteonecrosis has a low incidence in Mexican population, denosumab does not show a greater number of cases of osteonecrosis compared to bisphosphonates; no association was found between functional status, number of metastatic bone sites, nor use of antigenic or tyrosine kinase inhibitors as factor associated with osteonecrosis of the jaws.


Assuntos
Osteonecrose da Arcada Osseodentária Associada a Difosfonatos/epidemiologia , Conservadores da Densidade Óssea/efeitos adversos , Neoplasias Ósseas/tratamento farmacológico , Denosumab/efeitos adversos , Difosfonatos/efeitos adversos , Adulto , Idoso , Idoso de 80 Anos ou mais , Alendronato/efeitos adversos , Neoplasias Ósseas/secundário , Feminino , Humanos , Incidência , Masculino , México/epidemiologia , Pessoa de Meia-Idade , Osteoclastos/efeitos dos fármacos , Estudos Retrospectivos , Ácido Risedrônico/efeitos adversos , Fatores de Tempo , Ácido Zoledrônico/efeitos adversos
7.
Rehabilitación (Madr., Ed. impr.) ; 53(2): 121-125, abr.-jun. 2019. ilus, tab
Artigo em Espanhol | IBECS | ID: ibc-185468

RESUMO

La osteoporosis es una enfermedad con una alta prevalencia e importantes consecuencias. Los bifosfonatos son los fármacos más utilizados para controlarla, sin embargo, su uso durante periodos prolongados se asocia con el riesgo de fracturas atípicas. Se presentan los casos de 2 pacientes en tratamiento con bifosfonatos que presentaron fracturas femorales atípicas bilaterales; en un caso fueron simultáneas, sin traumatismo desencadenante, y en el otro fueron diferidas tras sendos traumatismos banales. En ambos casos la fractura fue precedida de clínica dolorosa. Fueron tratadas mediante enclavado intramedular y supresión de los bifosfonatos, con buenos resultados. Aunque los bifosfonatos han demostrado su eficacia en la prevención de fracturas por fragilidad, su uso prolongado se ha asociado paradójicamente a fracturas atípicas. Estas fracturas suelen estar precedidas de dolor, por lo que ante ello es necesario realizar estudios de imagen, en los que pueden evidenciarse fracturas incompletas que podrían beneficiarse de un enclavamiento profiláctico antes de que se produzca la fractura completa


Osteoporosis is a highly prevalent disease with important consequences. The most widely used drugs to control this disease are bisphosphonates but their prolonged use is associated with the risk of atypical fractures. We report the cases of two patients under bisphosphonate treatment with bilateral atypical femoral fractures. In one patient the fractures occurred simultaneously, unprovoked by trauma, and in the other, they occurred as delayed fractures after mild trauma. In both cases, the fractures were preceded by pain. The fractures were treated with intramedullary nailing and bisphosphonate withdrawal with good outcomes. Although bisphosphonates have demonstrated effectiveness in preventing frailty-related fractures, their prolonged use has paradoxically been associated with atypical fractures. These fractures are usually preceded by pain. Consequently, when faced with this clinical picture, physicians should request imaging studies that could show incomplete fractures that could benefit from prophylactic nailing before becoming complete fractures


Assuntos
Humanos , Feminino , Idoso , Idoso de 80 Anos ou mais , Fraturas do Fêmur/induzido quimicamente , Difosfonatos/efeitos adversos , Osteoporose/tratamento farmacológico , Osteoporose/complicações , Suspensão de Tratamento , Ácido Risedrônico/efeitos adversos , Alendronato/efeitos adversos , Denosumab/efeitos adversos
8.
Respir Med ; 148: 13-23, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30827469

RESUMO

RATIONALE: Various determinants of osteoporosis have been previously identified. However, only a few longitudinal studies have examined related factors. We aimed to investigate factors predicting and modifying rapid decline of bone mineral density in patients with chronic obstructive pulmonary disease. METHODS: We analyzed patients with chronic obstructive pulmonary disease whose bone mineral density were measured at least three times over three years (n = 111). We divided annual per cent changes of bone mineral density in different body parts into tertiles. Rapid decliners (n = 33) were defined as those with the largest decline in at least two parts; all other participants were defined as non-rapid decliners (n = 78). RESULTS: At enrollment, bone mineral density did not differ between the two groups. However, rapid decliners had a significantly greater rate of new vertebral fractures over 3 years compared with non-rapid decliners. On multivariate logistic regression analysis, age, moderate to severe emphysema, no daily exercise habits, and anemia increased the likelihood of rapid decliners. Furthermore, patients who newly started and continued bisphosphonate exhibited higher annual per cent changes of bone mineral density than did those without bisphosphonate use. CONCLUSIONS: A rapid decline in bone mineral density correlates to a higher likelihood of vertebral fracture. We clarified the predictors of bone mineral density decline and demonstrated that bisphosphonate use might modify bone mineral density in patients with chronic obstructive pulmonary disease.


Assuntos
Densidade Óssea/efeitos dos fármacos , Osteoporose/diagnóstico por imagem , Doença Pulmonar Obstrutiva Crônica/complicações , Enfisema Pulmonar/diagnóstico por imagem , Fraturas da Coluna Vertebral/diagnóstico por imagem , Idoso , Idoso de 80 Anos ou mais , Densidade Óssea/fisiologia , Conservadores da Densidade Óssea/administração & dosagem , Conservadores da Densidade Óssea/efeitos adversos , Conservadores da Densidade Óssea/uso terapêutico , Comorbidade , Feminino , Humanos , Estudos Longitudinais , Masculino , Osteoporose/tratamento farmacológico , Osteoporose/etiologia , Valor Preditivo dos Testes , Prevalência , Estudos Prospectivos , Doença Pulmonar Obstrutiva Crônica/epidemiologia , Doença Pulmonar Obstrutiva Crônica/fisiopatologia , Enfisema Pulmonar/epidemiologia , Ácido Risedrônico/administração & dosagem , Ácido Risedrônico/efeitos adversos , Ácido Risedrônico/uso terapêutico , Fraturas da Coluna Vertebral/epidemiologia
9.
Intern Med ; 58(8): 1049-1056, 2019 Apr 15.
Artigo em Inglês | MEDLINE | ID: mdl-30626809

RESUMO

Objective The incidence of osteoporosis is increasing with the rapid aging of the Japanese population. Bisphosphonates are first-line agents used for the treatment of osteoporosis, but they can cause upper gastrointestinal mucosal injury. This study investigated symptoms and upper gastrointestinal mucosal injury associated with oral bisphosphonates. Methods Symptoms were evaluated using the F-scale questionnaire, and esophageal mucosal injury and gastroduodenal ulceration were assessed by endoscopy. Patients were stratified by the type of bisphosphonate (alendronate, risedronate, or minodronate), treatment schedule (once weekly or every four weeks), and the concomitant use of other medications [antithrombotic agents, nonsteroidal anti-inflammatory drugs (NSAIDs), or acid suppressants]. Patients The subjects included 221 patients treated with oral bisphosphonates for at least one month. Results The median F-scale total score was 4 (0-34), reflux score was 2 (0-20), and the mean dyspepsia score was 2 (0-16). Endoscopy showed esophageal mucosal injury of Grade A or worse (Los Angeles classification) in 22/221 patients (10.0%) and gastroduodenal ulcers in 9 patients (4.1%). The dyspepsia score in patients who took minodronate every four weeks was significantly lower (p<0.05) in comparison to patients who took other bisphosphonates. The dyspepsia score was significantly higher (p<0.05) and mucosal injury was significantly more frequent in patients who also used antithrombotic agents and NSAIDs. Conclusion Symptoms and upper gastrointestinal mucosal damage were not necessarily frequent or severe in patients treated with bisphosphonates. However, the concomitant use of bisphosphonates with antithrombotic agents and NSAIDs increased both symptoms and mucosal injury. The symptoms were milder in patients using minodronate once monthly.


Assuntos
Alendronato/efeitos adversos , Conservadores da Densidade Óssea/efeitos adversos , Trato Gastrointestinal/efeitos dos fármacos , Membrana Mucosa/efeitos dos fármacos , Osteoporose/tratamento farmacológico , Ácido Risedrônico/efeitos adversos , Adulto , Idoso , Idoso de 80 Anos ou mais , Alendronato/uso terapêutico , Conservadores da Densidade Óssea/uso terapêutico , Feminino , Trato Gastrointestinal/lesões , Humanos , Japão , Masculino , Pessoa de Meia-Idade , Membrana Mucosa/lesões , Ácido Risedrônico/uso terapêutico
10.
Osteoporos Int ; 30(5): 1117-1120, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-30675627

RESUMO

To report two cases of bisphosphonate-induced orbital inflammation, discuss the clinic-radiological features and management options, and highlight the increasing frequency of an association previously considered extremely rare. A retrospective review of two cases presenting to our department, and review of the literature reporting this association. Two new cases of bisphosphonate-induced orbital inflammation were added to the literature. The first occurred in the context of a risedronate re-challenge, and the second with zoledronic acid. Both cases were managed successfully with topical steroids. Clinicians prescribing bisphosphonates, particularly for the first time, should be aware of the increasingly reported association with orbital inflammation. The presence of suggestive clinical features should prompt urgent referral to an ophthalmologist for appropriate management.


Assuntos
Conservadores da Densidade Óssea/efeitos adversos , Difosfonatos/efeitos adversos , Inflamação/induzido quimicamente , Doenças Orbitárias/induzido quimicamente , Idoso , Feminino , Humanos , Inflamação/diagnóstico por imagem , Imagem por Ressonância Magnética , Pessoa de Meia-Idade , Doenças Orbitárias/diagnóstico por imagem , Ácido Risedrônico/efeitos adversos , Tomografia Computadorizada por Raios X , Ácido Zoledrônico/efeitos adversos
11.
J Bone Miner Res ; 34(1): 83-92, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30280425

RESUMO

Bisphosphonate use has been associated with atypical femoral fractures (AFFs), defined by the American Society of Bone and Mineral Research (ASBMR) Task Force criteria, which currently exclude periprosthetic fractures. The objectives of this study were to establish the prevalence of atypical periprosthetic femoral fractures (APFFs) in patients with hip and knee arthroplasties and to determine the clinical and radiological risk factors associated with these fractures. We performed a retrospective radiological review of all femoral fractures between January 1, 2006, and March 31, 2015, in Quebec City, Canada. Patients who sustained a periprosthetic femoral fracture (PFF) were identified and included in this study. We used the ASBMR Task Force criteria to identify atypical fractures and establish their prevalence. Data from medical records and radiological assessments of the femoral anatomy, the characteristics of the fracture, and the positioning of the prosthesis were collected. The prevalence of APFFs among PFFs was 8.3% (11/133). A strong association with bisphosphonates (p = 0.007) was observed, as well as an increased risk of APFFs among alendronate users compared to risedronate users (p = 0.04). A transverse fracture (p < 0.0001), a periosteal thickening of the lateral cortex at the fracture (p < 0.0001), a unicortical fracture (p = 0.02), and prodromal symptoms (p = 0.03) were associated with APFFs. The type of implant, its positioning, and the femoral geometry did not appear to be risk factors for APFFs compared to PFFs. © 2018 American Society for Bone and Mineral Research.


Assuntos
Artroplastia de Quadril , Fraturas do Fêmur/diagnóstico por imagem , Fraturas do Fêmur/epidemiologia , Fraturas Periprotéticas/diagnóstico por imagem , Fraturas Periprotéticas/epidemiologia , Idoso , Idoso de 80 Anos ou mais , Alendronato/administração & dosagem , Alendronato/efeitos adversos , Artroplastia do Joelho , Feminino , Fraturas do Fêmur/induzido quimicamente , Prótese de Quadril , Humanos , Prótese do Joelho , Masculino , Pessoa de Meia-Idade , Fraturas Periprotéticas/induzido quimicamente , Prevalência , Estudos Retrospectivos , Ácido Risedrônico/administração & dosagem , Ácido Risedrônico/efeitos adversos , Fatores de Risco
12.
J Bone Miner Metab ; 37(4): 730-740, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-30523414

RESUMO

Limited data are available on the safety and efficacy of anti-resorptive agents, particularly once-monthly bisphosphonates, for use in osteoporotic patients with chronic kidney disease (CKD). We conducted a post hoc analysis of data from a 12-month, randomized, double-blind, phase III study to evaluate the safety and efficacy of once-monthly risedronate (RIS-OM) 75 mg tablets in Japanese osteoporosis patients with mild-to-moderate CKD. Patients who received RIS-OM 75 mg were stratified by baseline estimated glomerular filtration rate (eGFR; ≥ 90, ≥ 60 to < 90, or ≥ 30 to < 60 mL/min/1.73 m2). Safety endpoints were incidence of adverse events (AEs) and percent change from baseline in eGFR, serum creatinine, calcium, and phosphorus. Efficacy endpoints were percent change from baseline in lumbar spine bone mineral density (BMD) and bone turnover markers (BTMs). In 420 patients included (age 67.7 ± 6.7 years, women 98.8%), the incidence of all AEs, gastrointestinal disorders, acute phase reaction, non-vertebral fractures, and renal and urinary disorders was not significantly different among subgroups. Interaction between subgroups and time was significant for eGFR (p = 0.010) and serum creatinine (p = 0.001) but considered to be regression to the mean and clinically insignificant. BMD significantly increased while BTMs significantly decreased from baseline with a similar degree of change among the subgroups. In conclusion, RIS-OM 75 mg showed consistent safety and efficacy in suppressing bone turnover and increasing BMD in Japanese primary osteoporosis patients with mild-to-moderate CKD. These results should, however, be interpreted with caution because the number of patients with moderate CKD was limited.


Assuntos
Osteoporose/complicações , Osteoporose/tratamento farmacológico , Insuficiência Renal Crônica/complicações , Ácido Risedrônico/efeitos adversos , Ácido Risedrônico/uso terapêutico , Idoso , Biomarcadores/sangue , Biomarcadores/urina , Densidade Óssea , Conservadores da Densidade Óssea/administração & dosagem , Conservadores da Densidade Óssea/efeitos adversos , Conservadores da Densidade Óssea/uso terapêutico , Remodelação Óssea , Cálcio/sangue , Creatinina/sangue , Difosfonatos/administração & dosagem , Difosfonatos/efeitos adversos , Difosfonatos/uso terapêutico , Método Duplo-Cego , Esquema de Medicação , Feminino , Taxa de Filtração Glomerular , Humanos , Vértebras Lombares/fisiopatologia , Masculino , Pessoa de Meia-Idade , Osteoporose/sangue , Osteoporose/fisiopatologia , Fósforo/sangue , Insuficiência Renal Crônica/sangue , Insuficiência Renal Crônica/fisiopatologia , Ácido Risedrônico/administração & dosagem , Resultado do Tratamento
13.
Osteoporos Int ; 29(7): 1637-1642, 2018 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-29574518

RESUMO

A head-to-head comparison of once-monthly oral bisphosphonates minodronate (MIN) and risedronate (RIS) in patients with rheumatoid arthritis (RA) demonstrated that MIN has the same effect as RIS on increase in bone mineral density (BMD) and a stronger effect on inhibition of bone resorption than RIS, suggesting that MIN is a promising treatment option for osteoporosis patients with RA. INTRODUCTION: To evaluate the effect of once-monthly oral MIN in patients with RA, a prospective, randomized, open-label, head-to-head comparison with once-monthly oral RIS was conducted. METHODS: A total of 83 patients with RA were randomly assigned to either once-monthly oral MIN 50 mg (n = 42) or once-monthly oral RIS 75 mg (n = 41). Serial BMD and bone turnover markers were measured and compared between the treatment groups. RESULTS: BMD (lumbar spine, total hip, femoral neck) increased significantly after 12 months of treatment with MIN (3.8, 2.0, and 2.2%, respectively, P < 0.05) and RIS (3.6, 1.9, and 1.9%, respectively, P < 0.05). There were no significant differences between the treatment groups. Percent changes of bone turnover markers from baseline to 12 months in the MIN group were significantly greater than those in the RIS group (TRACP-5b: - 36.3 vs - 19.3%, P < 0.05; NTX: - 27.1 vs - 17.3%, P < 0.05; BAP: -30.2 vs -19.4%, P < 0.05). CONCLUSIONS: The present study of RA patients demonstrated that MIN has the same effect as RIS on increase in BMD and a stronger effect on inhibition of bone resorption than RIS. The results suggest that MIN is a promising treatment option for osteoporosis patients with RA.


Assuntos
Artrite Reumatoide/complicações , Conservadores da Densidade Óssea/uso terapêutico , Difosfonatos/uso terapêutico , Imidazóis/uso terapêutico , Osteoporose/tratamento farmacológico , Ácido Risedrônico/uso terapêutico , Administração Oral , Idoso , Artrite Reumatoide/fisiopatologia , Densidade Óssea/efeitos dos fármacos , Conservadores da Densidade Óssea/administração & dosagem , Conservadores da Densidade Óssea/efeitos adversos , Remodelação Óssea/efeitos dos fármacos , Difosfonatos/administração & dosagem , Difosfonatos/efeitos adversos , Esquema de Medicação , Feminino , Colo do Fêmur/fisiopatologia , Articulação do Quadril/fisiopatologia , Humanos , Imidazóis/administração & dosagem , Imidazóis/efeitos adversos , Vértebras Lombares/fisiopatologia , Masculino , Pessoa de Meia-Idade , Osteoporose/etiologia , Osteoporose/fisiopatologia , Fraturas por Osteoporose/etiologia , Fraturas por Osteoporose/fisiopatologia , Fraturas por Osteoporose/prevenção & controle , Ácido Risedrônico/administração & dosagem , Ácido Risedrônico/efeitos adversos
14.
Lancet ; 391(10117): 230-240, 2018 01 20.
Artigo em Inglês | MEDLINE | ID: mdl-29129436

RESUMO

BACKGROUND: No clinical trials have compared osteoporosis drugs with incident fractures as the primary outcome. We compared the anti-fracture efficacy of teriparatide with risedronate in patients with severe osteoporosis. METHODS: In this double-blind, double-dummy trial, we enrolled post-menopausal women with at least two moderate or one severe vertebral fracture and a bone mineral density T score of less than or equal to -1·50. Participants were randomly assigned to receive 20 µg of teriparatide once daily plus oral weekly placebo or 35 mg of oral risedronate once weekly plus daily injections of placebo for 24 months. The primary outcome was new radiographic vertebral fractures. Secondary, gated outcomes included new and worsened radiographic vertebral fractures, clinical fractures (a composite of non-vertebral and symptomatic vertebral), and non-vertebral fractures. This study is registered with ClinicalTrials.gov (NCT01709110) and EudraCT (2012-000123-41). FINDINGS: We enrolled 680 patients in each group. At 24 months, new vertebral fractures occurred in 28 (5·4%) of 680 patients in the teriparatide group and 64 (12·0%) of 680 patients in the risedronate group (risk ratio 0·44, 95% CI 0·29-0·68; p<0·0001). Clinical fractures occurred in 30 (4·8%) of 680 patients in the teriparatide group compared with 61 (9·8%) of 680 in the risedronate group (hazard ratio 0·48, 95% CI 0·32-0·74; p=0·0009). Non-vertebral fragility fractures occurred in 25 (4·0%) patients in the teriparatide group and 38 (6·1%) in the risedronate group (hazard ratio 0·66; 95% CI 0·39-1·10; p=0·10). INTERPRETATION: Among post-menopausal women with severe osteoporosis, the risk of new vertebral and clinical fractures is significantly lower in patients receiving teriparatide than in those receiving risedronate. FUNDING: Lilly.


Assuntos
Conservadores da Densidade Óssea/uso terapêutico , Osteoporose Pós-Menopausa/tratamento farmacológico , Fraturas por Osteoporose/prevenção & controle , Ácido Risedrônico/uso terapêutico , Teriparatida/uso terapêutico , Idoso , Idoso de 80 Anos ou mais , América/epidemiologia , Densidade Óssea/efeitos dos fármacos , Conservadores da Densidade Óssea/efeitos adversos , Método Duplo-Cego , Europa (Continente)/epidemiologia , Feminino , Humanos , Incidência , Pessoa de Meia-Idade , Osteoporose Pós-Menopausa/complicações , Osteoporose Pós-Menopausa/epidemiologia , Osteoporose Pós-Menopausa/fisiopatologia , Fraturas por Osteoporose/diagnóstico por imagem , Fraturas por Osteoporose/etiologia , Fraturas por Osteoporose/fisiopatologia , Radiografia , Ácido Risedrônico/efeitos adversos , Teriparatida/efeitos adversos
16.
J Bone Miner Res ; 32(5): 1040-1051, 2017 May.
Artigo em Inglês | MEDLINE | ID: mdl-28019683

RESUMO

We present final results of a study comparing teriparatide 20 µg every day (QD) with risedronate 35 mg once per week (QW) started within 2 weeks after surgery for a pertrochanteric hip fracture. Patients with BMD T-score ≤ -2.0 and 25OHD ≥9.2 ng/mL were randomized to receive 26-week double-dummy treatment plus calcium and vitamin D, followed by 52-week open-label treatment with the same assigned active drug. Primary endpoint was change from baseline in lumbar spine (LS) BMD at 78 weeks. Secondary and exploratory endpoints were change in BMD at the proximal femur, function, hip pain (Charnley score and 100 mm Visual Analog Scale [VAS]), quality of life (Short Form-36), radiology outcomes, and safety. Data were analyzed with mixed models for repeated measures (MMRM) and logistic regression. Totally, 224 patients were randomized; 171 (teriparatide: 86) contributed to the efficacy analyses (mean ± SD age: 77 ± 7.7 years, 77% females). Mean baseline LS, femoral neck (FN), and total hip (TH) T-scores were -2.16, -2.63, and -2.51, respectively. At 78 weeks, BMD increased significantly more with teriparatide compared to risedronate at the LS (+11.08% versus +6.45%; p < 0.001) and FN (+1.96% versus -1.19%; p = 0.003), with no significant between-group difference in TH BMD. Timed up-and-go (TUG) test was significantly faster with teriparatide at 6, 12, 18, and 26 weeks (differences: -3.2 to -5.9 s; p = 0.045 for overall difference). Hip pain during TUG test by 100 mm VAS was significantly lower with teriparatide at 18 weeks (adjusted difference: -11.3 mm, p = 0.033; -10.0 and -9.3 mm at 12 and 26 weeks, respectively; p = 0.079 for overall difference). Other secondary and exploratory outcomes were not different. Teriparatide group showed two new hip fractures versus seven with risedronate (p = 0.171) and more frequent hypercalcemia and hyperuricemia. In conclusion, 78-week treatment with teriparatide showed significantly greater increases in LS and FN BMD, less pain, and a faster TUG test versus risedronate. © 2016 American Society for Bone and Mineral Research.


Assuntos
Fraturas do Quadril/tratamento farmacológico , Ácido Risedrônico/administração & dosagem , Teriparatida/administração & dosagem , Idoso , Idoso de 80 Anos ou mais , Fraturas do Quadril/sangue , Fraturas do Quadril/patologia , Humanos , Estudos Prospectivos , Ácido Risedrônico/efeitos adversos , Teriparatida/efeitos adversos , Fatores de Tempo
17.
J Bone Miner Metab ; 35(4): 385-395, 2017 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-27484436

RESUMO

The aim of this study was to investigate the efficacy of concurrent treatment with vitamin K2 and risedronate compared with treatment with risedronate alone in patients with osteoporosis and to explore subsets of patients for which concurrent treatment is particularly efficacious. Women with osteoporosis aged 65 years or older were recruited from 123 institutes in Japan and allocated to take either vitamin K2 (45 mg/day) and risedronate (2.5 mg/day or 17.5 mg/week) or risedronate (2.5 mg/day or 17.5 mg/week) alone. The primary end point was the incidence of any fracture (vertebral and nonvertebral). The secondary end points were bone mineral density, height, undercarboxylated osteocalcin concentration, quality of life, and safety. Over a 2-year follow-up, vertebral or nonvertebral fractures occurred in 117 or 22 sites respectively among 931 patients in the risedronate and vitamin K2 group and in 104 or 26 sites respectively among 943 patients in the risedronate alone group. The rates of any incident fracture were similar between the two groups (incidence rate ratio 1.074, 95 % confidence interval 0.811-1.422, p = 0.62), implying that the primary end point was not met. There were no differences in the degree of increase in bone mineral density between the two groups. Undercarboxylated osteocalcin concentration decreased from 5.81 ± 3.93 ng/mL to 2.59 ± 1.52 ng/mL at 6 months in the risedronate and vitamin K2 group, whereas the change in the risedronate alone group was minimal (from 5.96 ± 4.36 ng/mL to 4.05 ± 3.40 ng/mL at 6 months) (p < 0.01). The treatment discontinuation rate was higher in the risedronate and vitamin K2 group than in the risedronate alone group (10.0 % vs 6.7 %). No unknown adverse drug reactions were reported. In conclusion, concurrent treatment with vitamin K2 and risedronate was not efficacious compared with monotherapy with risedronate in terms of fracture prevention.


Assuntos
Osteoporose/tratamento farmacológico , Ácido Risedrônico/uso terapêutico , Vitamina K 2/uso terapêutico , Idoso , Conservadores da Densidade Óssea/efeitos adversos , Conservadores da Densidade Óssea/uso terapêutico , Quimioterapia Combinada , Determinação de Ponto Final , Feminino , Humanos , Incidência , Japão , Adesão à Medicação , Pessoa de Meia-Idade , Fraturas por Osteoporose/tratamento farmacológico , Fraturas por Osteoporose/epidemiologia , Qualidade de Vida , Ácido Risedrônico/efeitos adversos , Vitamina K 2/efeitos adversos
18.
J Bone Miner Metab ; 35(2): 209-214, 2017 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-27026435

RESUMO

The purpose of this study was to determine fracture location and the characteristics of patients with atypical femoral fractures (AFFs). We studied 38 AFFs in 34 patients admitted to our institution between November 2007 and July 2013. The diagnostic criteria for the AFFs were based on 2014 American Society of Bone and Mineral Research guidelines. We classified the fracture location as proximal, middle, or distal to trisect the femoral diaphysis from just distal to the lesser trochanter to just proximal to the supracondylar flare. Bowing was defined as a line through the inside of the tip of the great trochanter and a condylar center that was outside the medullary cavity. We investigated the fracture's location, existence of coronal bowing, and bisphosphonates (BPs), glucocorticoids (GCs), and proton pump inhibitors therapy. We analyzed associations between fracture location and demographic and clinical factors. Twelve fractures were proximal, 25 were middle, and one was distal. Nineteen limbs showed femoral bowing. Thirty-one patients received BP treatment-20 patients received alendronic acid, eight risedronic acid, and three minodronic acid. Fourteen patients received a GC, and 16 received a proton pump inhibitor. There was a significant association between coronal bowing and middle fracture locations, GC therapy and proximal fracture locations, and older age and middle fracture locations. Tall height and heavy weight had an association with proximal fracture location, and short height and light weight had an association with middle fracture location. In conclusion, we provide evidence supporting a causal relationship between BP-related severely suppressed bone turnover and AFFs. We also provide evidence supporting additional influences from altered distribution of mechanical stress with femoral bowing and various factors, such as GC therapy, age, body weight, and height, which might negatively affect bone intensity and quality and result in fracture.


Assuntos
Conservadores da Densidade Óssea/efeitos adversos , Difosfonatos/efeitos adversos , Fraturas do Fêmur/diagnóstico , Fêmur/patologia , Idoso , Idoso de 80 Anos ou mais , Alendronato/efeitos adversos , Alendronato/uso terapêutico , Grupo com Ancestrais do Continente Asiático , Conservadores da Densidade Óssea/uso terapêutico , Remodelação Óssea , Difosfonatos/uso terapêutico , Feminino , Fraturas do Fêmur/patologia , Glucocorticoides/efeitos adversos , Glucocorticoides/uso terapêutico , Humanos , Imidazóis/efeitos adversos , Imidazóis/uso terapêutico , Japão , Masculino , Pessoa de Meia-Idade , Inibidores da Bomba de Prótons/efeitos adversos , Inibidores da Bomba de Prótons/uso terapêutico , Estudos Retrospectivos , Ácido Risedrônico/efeitos adversos , Ácido Risedrônico/uso terapêutico
19.
J Oral Pathol Med ; 46(5): 398-404, 2017 May.
Artigo em Inglês | MEDLINE | ID: mdl-27766688

RESUMO

OBJECTIVE: To evaluate microarchitectural changes in condylar cartilage and associated subchondral bone after bisphosphonates treatment using an ovariectomized (OVX) osteoporosis rat model. METHODS: Thirty six-month-old female Sprague-Dawley rats were randomly divided into sham, OVX, and risedronate (RIS)-treated groups. Both OVX and RIS groups received bilateral ovariectomy. OVX group was treated subcutaneously with saline, whereas RIS group received risedronate treatment (2.4 µg/kg) subcutaneously for 3 months. At the end of 3 months, animals were sacrificed and the entire condyles were harvested for micro-CT and histological analyses. Immunohistochemistry (IHC) was performed to assess the expression of type I/II collagen protein by semiquantitative imaging analysis. RESULTS: Micro-CT analysis showed OVX group had significant condylar subchondral bone loss compared to sham as shown by significant decrease in bone volume fraction (P = 0.028), trabecular thickness (P = 0.041), and significant increase in trabecular spacing (P = 0.003). In RIS group, partial inhibition of OVX-induced bone loss was detected. HE staining showed proliferative layer of condylar cartilage reduced, while hypertrophic chondrocyte layer increased significantly in RIS group compared to sham and OVX groups. IHC showed reduced expression of Col I in both the OVX and RIS groups, whereas expression of Col II was reduced in the OVX group but increased in the RIS group. CONCLUSION: Our findings suggest that systemic bisphosphonate treatment influences the structure and ossification of condylar cartilage and it has a dual action on condyle in a postmenopausal osteoporosis rat model which raises the concerns for the potential side effects of BPs on condyle to elder patients.


Assuntos
Difosfonatos/efeitos adversos , Côndilo Mandibular/efeitos dos fármacos , Osteoporose/patologia , Animais , Osteonecrose da Arcada Osseodentária Associada a Difosfonatos/diagnóstico por imagem , Osteonecrose da Arcada Osseodentária Associada a Difosfonatos/etiologia , Osteonecrose da Arcada Osseodentária Associada a Difosfonatos/patologia , Feminino , Côndilo Mandibular/diagnóstico por imagem , Côndilo Mandibular/patologia , Osteoporose/diagnóstico por imagem , Ovariectomia , Ratos , Ratos Sprague-Dawley , Ácido Risedrônico/efeitos adversos , Microtomografia por Raio-X
20.
J Bone Miner Metab ; 35(4): 419-427, 2017 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-27565972

RESUMO

Currently, the only available evidence for the efficacy of once-weekly 17.5 mg risedronate in preventing vertebral fractures was obtained in a 48-week study in Japan. We performed a 156-week prospective, longitudinal, observational study to determine the efficacy of the 17.5 mg risedronate in preventing vertebral fractures. We included Japanese patients with established osteoporosis who were older than 50 years and had radiographically confirmed vertebral fractures. The primary endpoint was the incidence of vertebral fractures every 24 weeks, with the final interval spanning 36 weeks. We also calculated the change in bone mineral density of the lumbar spine (L2-4 BMD) and urinary N-telopeptide of type I collagen (u-NTX), and assessed the incidence of adverse drug reactions and the drug adherence rate. Data from 241 patients were available for analysis of vertebral fracture prevention. The incidence rate of vertebral fractures decreased in a time-dependent manner (P = 0.0006; Poisson regression analysis). The risk ratio (fracture incidence per 100 person-years in the final 36 weeks versus that in the first 24 weeks) was 0.21 (95 % confidence interval 0.08-0.55). Compared to baseline values, L2-4 BMD increased by 6.41 % at 156 weeks, while u-NTX decreased by 36 % at 24 weeks and was maintained thereafter (P < 0.0001). The incidence rate of adverse drug reactions was 9.18 %. Drug adherence rates assessed every 4 weeks were over 90 %. Our results indicate that 156 weeks of treatment with once-weekly 17.5 mg risedronate effectively reduced the risk of vertebral fracture in Japanese patients with established osteoporosis older than 50 years.


Assuntos
Grupo com Ancestrais do Continente Asiático , Osteoporose/tratamento farmacológico , Ácido Risedrônico/administração & dosagem , Ácido Risedrônico/uso terapêutico , Fraturas da Coluna Vertebral/epidemiologia , Idoso , Densidade Óssea/efeitos dos fármacos , Conservadores da Densidade Óssea/uso terapêutico , Colágeno Tipo I/urina , Esquema de Medicação , Feminino , Fraturas do Quadril/epidemiologia , Fraturas do Quadril/prevenção & controle , Humanos , Incidência , Japão , Estudos Longitudinais , Vértebras Lombares/efeitos dos fármacos , Masculino , Osteoporose/complicações , Osteoporose/fisiopatologia , Osteoporose/urina , Cooperação do Paciente , Peptídeos/urina , Prevalência , Estudos Prospectivos , Ácido Risedrônico/efeitos adversos , Fatores de Risco , Fraturas da Coluna Vertebral/complicações , Fraturas da Coluna Vertebral/fisiopatologia , Fraturas da Coluna Vertebral/urina
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