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1.
J Bone Miner Metab ; 38(4): 522-532, 2020 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-32140784

RESUMEN

INTRODUCTION: Eldecalcitol increases bone mineral density (BMD) and reduces vertebral fracture in patients with primary osteoporosis. However, the effect of eldecalcitol on BMD and fracture in glucocorticoid-induced osteoporosis (GIO) patients is unknown. This study was undertaken to compare the effect of eldecalcitol on BMD and fracture with that of alfacalcidol in GIO patients. MATERIALS AND METHODS: A randomized, open-label, parallel group study was conducted to identify the effectiveness and safety of monotherapy with 0.75 µg eldecalcitol compared with 1.0 µg alfacalcidol in GIO patients. RESULTS: Lumbar spine BMD increased with eldecalcitol, but decreased with alfacalcidol at 12 and 24 months (between group difference 1.29%, p < 0.01, and 1.10%, p < 0.05, respectively). Total hip and femoral neck BMD were maintained until 24 months by eldecalcitol, but decreased by alfacalcidol (between group difference 0.97%, p < 0.05 and 1.22%, p < 0.05, respectively). Both bone formation and resorption markers were more strongly suppressed by eldecalcitol than by alfacalcidol. Eldecalcitol showed better effect on BMD than alfacalcidol in patients with no prevalent fracture and BMD > 70% of the young adult mean, and with ≤ 3 months of previous glucocorticoid treatment. No significant difference in the incidence of vertebral fracture was found, and the incidence of adverse events was similar between the two groups. CONCLUSIONS: Eldecalcitol was more effective than alfacalcidol in maintaining BMD in GIO patients. Because eldecalcitol was effective in patients with no or short-term previous glucocorticoid treatment, as well as those without prevalent fracture or low BMD, eldecalcitol can be a good candidate for primary prevention of GIO. CLINICAL TRIAL REGISTRATION NUMBER: UMIN000011700.


Asunto(s)
Densidad Ósea , Glucocorticoides/efectos adversos , Hidroxicolecalciferoles/uso terapéutico , Osteoporosis/tratamiento farmacológico , Osteoporosis/fisiopatología , Vitamina D/análogos & derivados , Biomarcadores/metabolismo , Densidad Ósea/efectos de los fármacos , Conservadores de la Densidad Ósea/uso terapéutico , Remodelación Ósea/efectos de los fármacos , Femenino , Cuello Femoral/efectos de los fármacos , Cuello Femoral/fisiopatología , Cadera/fisiopatología , Humanos , Hidroxicolecalciferoles/efectos adversos , Hidroxicolecalciferoles/farmacología , Estimación de Kaplan-Meier , Vértebras Lumbares/efectos de los fármacos , Vértebras Lumbares/fisiopatología , Masculino , Persona de Mediana Edad , Fracturas de la Columna Vertebral/epidemiología , Vitamina D/efectos adversos , Vitamina D/farmacología , Vitamina D/uso terapéutico
2.
J Bone Miner Metab ; 38(4): 511-521, 2020 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-31970477

RESUMEN

INTRODUCTION: This study compared the clinical usefulness of minodronate (50 mg/4 weeks) plus alfacalcidol (1 µg/day) (Group M) with that of alfacalcidol alone (1 µg/day) (Group A) for treating glucocorticoid-induced osteoporosis. MATERIALS AND METHODS: The primary endpoints were the changes from baseline in lumbar spine (LS) bone mineral density (BMD) and the cumulative incidence of vertebral fracture at 24 months; secondary endpoints included the changes from baseline in total hip (TH) BMD and bone turnover markers. RESULTS: Of 164 patients enrolled, 152 (Group M, n = 75; Group A, n = 77) were included in the analysis of efficacy. At each time point and at 24 months, LS BMD and TH BMD were significantly higher in Group M than in Group A. The 152 patients were divided into two subgroups that were previously treated with glucocorticoids for ≤ 3 months or > 3 months. In both subgroups, the changes from baseline in LS BMD and TH BMD from baseline at 24 months had increased more in Group M than in Group A. There were no differences found in the incidence of vertebral fracture between the groups, because the number of enrolled patients was lesser than that initially expected. In Group M, both bone formation and resorption markers significantly decreased from baseline at 3 months and maintained at 6, 12, and 24 months. CONCLUSIONS: Minodronate plus alfacalcidol was more effective than alfacalcidol alone in increasing BMD and was effective in increasing BMD for both prevention and treatment. Therefore, minodronate can be a good candidate drug for the treatment of glucocorticoid-induced osteoporosis.


Asunto(s)
Difosfonatos/uso terapéutico , Glucocorticoides/efectos adversos , Hidroxicolecalciferoles/uso terapéutico , Imidazoles/uso terapéutico , Osteoporosis/inducido químicamente , Osteoporosis/tratamiento farmacológico , Adulto , Anciano , Anciano de 80 o más Años , Biomarcadores/metabolismo , Densidad Ósea/efectos de los fármacos , Conservadores de la Densidad Ósea/uso terapéutico , Remodelación Ósea/efectos de los fármacos , Difosfonatos/efectos adversos , Difosfonatos/farmacología , Quimioterapia Combinada , Femenino , Humanos , Hidroxicolecalciferoles/efectos adversos , Hidroxicolecalciferoles/farmacología , Imidazoles/efectos adversos , Imidazoles/farmacología , Masculino , Persona de Mediana Edad , Osteoporosis/fisiopatología , Fracturas de la Columna Vertebral/tratamiento farmacológico , Fracturas de la Columna Vertebral/fisiopatología , Adulto Joven
3.
Opt Express ; 27(20): 28091-28103, 2019 Sep 30.
Artículo en Inglés | MEDLINE | ID: mdl-31684567

RESUMEN

In this study, we demonstrate the switching of the direction of the photocurrent in an n-type GaAs/Al0.3Ga0.7As modulation-doped quantum well using a polarization pulse-shaping apparatus containing a 4f setup. The right- and left-polarization-twisting pulses with a polarization rotation frequency in the THz-regime are incident on a modulation-doped quantum well. The results show that the sign of the photovoltage is dependent on the direction of rotation of the polarization-twisting pulses, which can be explained by the circular photogalvanic effect combined with the production of a classical edge photocurrent from the acceleration of free electrons in the vicinity of the sample edge by the incident optical electric field. The wide range over which the polarization-rotation frequency may be tuned makes this method a powerful tool to investigate the response of an extensive variety of materials in the THz-regime.

4.
J Bone Miner Metab ; 36(3): 336-343, 2018 May.
Artículo en Inglés | MEDLINE | ID: mdl-28389932

RESUMEN

The non-inferiority of oral ibandronate 100 mg to intravenous (i.v.) ibandronate 1 mg in increasing lumbar spine (LS) bone mineral density (BMD) after 12 months of treatment was demonstrated in the randomized, phase III MOVEST study. We conducted subgroup analyses in the per-protocol set of the study (n = 183 oral ibandronate; n = 189 i.v. ibandronate). In patients with LS BMD T score ≥ -3.0 or < -3.0 at screening, LS BMD gains from baseline were 4.42 and 5.79%, respectively, with oral ibandronate, and 4.60 and 5.83%, respectively, with i.v. ibandronate. LS BMD gains in patients with or without prevalent vertebral fractures were 5.21 and 5.23%, respectively, with oral ibandronate, and 5.01 and 5.49%, respectively, with i.v. ibandronate. In patients aged <75 or ≥75 years, LS BMD gains were 5.46 and 4.51%, respectively, with oral ibandronate, and 5.25 and 5.77%, respectively, with i.v. ibandronate. LS BMD gains in patients with baseline 25-hydroxyvitamin D levels ≥20 or <20 ng/mL were 5.35 and 4.76%, respectively, with oral ibandronate, and 5.05 and 6.57%, respectively, with i.v. ibandronate. Similar results were obtained in patients with or without prior bisphosphonate (BP) treatment, and in those receiving osteoporosis drug treatment other than BPs. In conclusion, oral ibandronate 100 mg demonstrated comparable BMD gains with monthly i.v. ibandronate, and thus shows high utility in the lifestyle and disease conditions associated with osteoporosis in Japanese patients.


Asunto(s)
Difosfonatos/administración & dosificación , Difosfonatos/uso terapéutico , Osteoporosis/tratamiento farmacológico , Osteoporosis/patología , Administración Intravenosa , Administración Oral , Anciano , Densidad Ósea/efectos de los fármacos , Conservadores de la Densidad Ósea/farmacología , Conservadores de la Densidad Ósea/uso terapéutico , Difosfonatos/farmacología , Esquema de Medicación , Femenino , Humanos , Ácido Ibandrónico , Vértebras Lumbares/efectos de los fármacos , Vértebras Lumbares/patología , Masculino , Persona de Mediana Edad , Osteoporosis/fisiopatología
5.
Biosci Biotechnol Biochem ; 82(11): 1889-1901, 2018 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-30079840

RESUMEN

Polyinosinic-polycytidylic acid (PIC), a double-stranded RNA that induces innate immunity in mammals, is a candidate immunopotentiator for pharmaceuticals. The potency and adverse effects of PIC are strongly correlated with the nucleotide length, and the inability to precisely control the length in PIC production limits its practical use. Length extension during the annealing process is the major factor underlying the lack of control, but tuning the annealing conditions is insufficient to resolve this issue. In this study, we developed a novel method to produce accurate nucleotide length PIC at an industrial scale. The length extension was significantly suppressed by the assembly of multiple short polyinosinic acid molecules with one long polycytidylic acid molecule. A newly developed PIC, uPIC100-400, demonstrated a reproducible length and better storage stability than that of corresponding evenly structured PIC. Human dsRNA receptors exhibited equivalent responsiveness to uPIC100-400 and the evenly structured PIC with the same length.


Asunto(s)
Conformación de Ácido Nucleico , Nucleótidos/química , Poli I-C/química , Poli I-C/síntesis química , Línea Celular , Calor , Humanos , Inmunidad Innata , Poli C/química , Poli I/química , ARN Bicatenario/química
6.
J Bone Miner Metab ; 35(4): 375-384, 2017 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-27465912

RESUMEN

The aim of this study was to compare the efficacy of elcatonin injections and oral nonsteroidal anti-inflammatory drugs (NSAIDs) for patients with osteoporosis who have acute lumbar pain after experiencing new vertebral compression fractures. Two hundred twenty-eight Japanese female patients (mean age 77.3 years) with acute lumbar pain from osteoporotic vertebral fractures were randomly divided into two groups. Patients in one group were given an NSAID (NSAIDs group) and patients in the other group were given weekly intramuscular injections of 20 units of elcatonin (elcatonin group). All patients underwent follow-up examinations up to 6 weeks from the start of the trial. Outcome measures were the level of functional impairment according to the Japan Questionnaire for Osteoporotic Pain (JQ22), the Roland-Morris Disability Questionnaire (RDQ), and a visual analog scale (VAS) of pain intensity. Statistical analyses focused on (1) the time course of pain and functional level using linear mixed effects models to analyze the longitudinal data and (2) the effectiveness of elcatonin injection with mean difference values and 95 % confidence intervals. Significant differences were seen over time between the initial values and the postintervention values (4 and 6 weeks) in JQ22, RDQ, and VAS scores (effect size d > 0.4) in each group. The mean differences between the elcatonin group and the NSAIDs group in each measure at 4 and 6 weeks were -4.8 and -8.3 for the JQ22, -1.3 and -2.6 for the RDQ, and -11.3 and -11.5 for the VAS, shifted to elcatonin. Once weekly elcatonin injection was more effective than NSAIDs for treating acute lumbar pain and improving mobility in Japanese women with osteoporotic vertebral fractures.


Asunto(s)
Antiinflamatorios no Esteroideos/uso terapéutico , Dolor de Espalda/tratamiento farmacológico , Calcitonina/análogos & derivados , Fracturas Osteoporóticas/tratamiento farmacológico , Fracturas de la Columna Vertebral/tratamiento farmacológico , Enfermedad Aguda , Anciano , Antiinflamatorios no Esteroideos/efectos adversos , Antiinflamatorios no Esteroideos/farmacología , Calcitonina/efectos adversos , Calcitonina/farmacología , Calcitonina/uso terapéutico , Intervalos de Confianza , Femenino , Humanos , Japón , Imagen por Resonancia Magnética , Fracturas Osteoporóticas/complicaciones , Fracturas de la Columna Vertebral/complicaciones , Encuestas y Cuestionarios , Resultado del Tratamiento
7.
J Bone Miner Metab ; 34(6): 678-684, 2016 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-26462480

RESUMEN

We examined response to bone mineral density (BMD) gains in the MOVER study following treatment with intravenous (IV) ibandronate 1 mg/month, and investigated the characteristics of a non-responder group. At 1 year, responder rates for patients with BMD increases >0 % were similar with IV ibandronate 0.5 or 1 mg/month and oral risedronate 2.5 mg/day. However, after 3 years, responder rates with BMD increases ≥3 % were highest with ibandronate 1 mg at all bone sites (>80 % at the lumbar spine [L2-L4] and >50 % at all femur sites, which was significantly higher than with risedronate). Non-responders were defined by BMD increases ≤3 % at L2-L4 or ≤0 % at total hip, and ≤50 % reduction in creatinine-corrected urinary collagen type 1 cross-linked C-telopeptide (uCTX) from baseline to 1 year. There were a small number of non-responders in the ibandronate 1 mg group: 3.3 % (10/299) with ≤0 % total hip BMD increase and ≤50 % uCTX reduction from baseline. These non-responders had lower 25-hydroxyvitamin D (25[OH]D) levels than responders, but no differences in kidney function, L2-L4 BMD or bone turnover marker baseline values. Throughout the study, non-responders failed to show any increases in BMD. Our analysis demonstrates significantly higher responder rates with IV ibandronate 1 mg/month than with risedronate at 3 years. A small number of non-responders in the ibandronate group had lower 25(OH)D baseline levels than responders, suggesting that 25(OH)D levels could be a useful indicator of BMD response to therapy.


Asunto(s)
Densidad Ósea/efectos de los fármacos , Difosfonatos/administración & dosificación , Vértebras Lumbares/metabolismo , Osteoporosis/tratamiento farmacológico , Ácido Risedrónico/administración & dosificación , Administración Intravenosa , Administración Oral , Anciano , Colágeno Tipo I/orina , Creatinina/orina , Método Doble Ciego , Femenino , Fémur/metabolismo , Humanos , Ácido Ibandrónico , Pruebas de Función Renal , Masculino , Persona de Mediana Edad , Osteoporosis/sangre , Osteoporosis/orina , Péptidos/orina , Fracturas de la Columna Vertebral/sangre , Fracturas de la Columna Vertebral/etiología , Fracturas de la Columna Vertebral/prevención & control , Fracturas de la Columna Vertebral/orina , Vitamina D/análogos & derivados , Vitamina D/sangre
8.
J Bone Miner Metab ; 32(4): 441-6, 2014 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-24213216

RESUMEN

Once-weekly teriparatide (human parathyroid hormone [1-34]) (56.5 µg for 72 weeks) injections provided a vertebral fracture risk reduction in Japanese osteoporotic patients evaluated in the Teriparatide Once-Weekly Efficacy Research (TOWER) trial. Using data from the TOWER trial, a subgroup analysis was performed to study the efficacy of once-weekly teriparatide for a variety of baseline clinical risk factors in placebo (n = 281) and teriparatide (n = 261) groups. Significant fracture risk reductions were observed in the subgroups of individuals aged <75 years [relative risk (RR) 0.06, p = 0.007] and ≥75 years (RR 0.32, p = 0.015). A significant risk reduction was observed among patients with prevalent vertebral fracture in the subgroup with 1 (RR 0.08, p = 0.015) or ≥2 (RR 0.29, p = 0.009) prevalent vertebral fractures, and in those with grade 3 deformity (RR 0.26, p = 0.003). Significant risk reduction was observed in the subgroup with lumbar bone mineral density (BMD) < -2.5 SD (RR 0.25, p = 0.035). In the teriparatide group, no incident fracture was observed in the subgroups with a prevalent vertebral fracture number of 0, with grade 0-2 vertebral deformity, or with lumbar BMD ≥2.5 SD. Significant risk reduction was observed in all of the bone turnover marker and estimated glomerular filtration rate subgroups. In conclusion, once-weekly 56.5 µg teriparatide injection reduced the vertebral fracture risk in patients with varying degrees of fracture risk, age, vertebral fracture number and grade, bone turnover level, and renal function.


Asunto(s)
Fracturas Óseas/tratamiento farmacológico , Osteoporosis/tratamiento farmacológico , Fracturas de la Columna Vertebral/tratamiento farmacológico , Teriparatido/uso terapéutico , Anciano , Anciano de 80 o más Años , Animales , Densidad Ósea/efectos de los fármacos , Femenino , Humanos , Masculino
9.
Clin Calcium ; 24(1): 100-5, 2014 Jan.
Artículo en Japonés | MEDLINE | ID: mdl-24369286

RESUMEN

Teriparatide (human PTH 1-34) transiently stimulate both bone formation and bone resorption and subsequently bone formation markers increased. The changes in bone turnover markers 24 h after each injection of once-weekly 56.5µg teriparatide were constant for 24 weeks. Once-weekly injections of teriparatide increased bone mineral density by 8.1% at the lumbar spine and reduced the risk of new vertebral fracture with a relative risk reduction of 80% compared to placebo for the patients with osteoporosis. Significant vertebral fracture risk reductions were also observed in the patients with high risk for fracture such as higher age, low bone mineral density, or sever vertebral fracture grade. Once-weekly teriparatide improved cortical bone parameters at proximal femur, may have the potential to prevent hip fracture. The duration of teriparatide treatment was limited. Therefore subsequent treatment for osteoporosis should be need. Bisphosphonates seem to be a useful choice as a subsequent treatment to once-weekly teriparatide.


Asunto(s)
Conservadores de la Densidad Ósea/uso terapéutico , Osteoporosis/tratamiento farmacológico , Teriparatido/uso terapéutico , Densidad Ósea/efectos de los fármacos , Densidad Ósea/fisiología , Conservadores de la Densidad Ósea/administración & dosificación , Difosfonatos/uso terapéutico , Fracturas Óseas/tratamiento farmacológico , Fracturas Óseas/prevención & control , Humanos , Osteoporosis/metabolismo , Teriparatido/administración & dosificación
10.
Calcif Tissue Int ; 93(2): 137-46, 2013 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-23644930

RESUMEN

This randomized, double-blind study assessed the antifracture efficacy and safety of intermittent intravenous (IV) ibandronate versus oral daily risedronate in Japanese patients with primary osteoporosis. Ambulatory patients aged ≥60 years were randomized to receive 0.5 or 1 mg/month IV ibandronate plus oral daily placebo or 2.5 mg/day oral risedronate, the licensed dose in Japan, plus IV placebo. The primary end point was noninferiority of ibandronate versus risedronate for first new or worsening vertebral fracture over 3 years. A total of 1,265 patients were randomized. A total of 1,134 patients formed the per-protocol set. Both ibandronate doses were noninferior to risedronate: 0.5 mg, hazard ratio (HR) 1.09 [95 % confidence interval (CI) 0.77-1.54]; 1 mg, HR 0.88 (95 % CI 0.61-1.27). The rate of first new vertebral fracture over 3 years was 16.8 % (95 % CI 12.8-20.8) for 0.5 mg ibandronate, 11.6 % (95 % CI 8.2-15.0) for 1 mg ibandronate, and 13.2 % (95 % CI 9.6-16.9) for risedronate. Significant increases in bone mineral density relative to baseline were observed with all treatments after 6 months, with substantial reductions in bone turnover markers after 3 months. Greatest efficacy was obtained with 1 mg ibandronate. Analyses in women only showed similar results to the overall population. No new safety concerns were identified. This study demonstrated the noninferiority of IV ibandronate to the licensed Japanese dose of oral risedronate and suggested that 1 mg/month is an effective dose in Japanese patients with primary osteoporosis.


Asunto(s)
Conservadores de la Densidad Ósea/administración & dosificación , Difosfonatos/administración & dosificación , Ácido Etidrónico/análogos & derivados , Fracturas Óseas/prevención & control , Osteoporosis/tratamiento farmacológico , Administración Oral , Anciano , Conservadores de la Densidad Ósea/efectos adversos , Difosfonatos/efectos adversos , Método Doble Ciego , Ácido Etidrónico/administración & dosificación , Ácido Etidrónico/efectos adversos , Femenino , Humanos , Ácido Ibandrónico , Infusiones Intravenosas , Japón , Masculino , Persona de Mediana Edad , Modelos de Riesgos Proporcionales , Ácido Risedrónico , Fracturas de la Columna Vertebral/prevención & control , Factores de Tiempo , Resultado del Tratamiento
11.
J Bone Miner Metab ; 31(5): 544-50, 2013 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-23529800

RESUMEN

The aim was to evaluate the risk of new vertebral fractures with the increasing number and severity of prevalent vertebral fractures in women who received placebo or minodronate in a post hoc analysis of a 2-year randomized, double-blind, placebo-controlled study. The subjects were women aged 55-80 years old with 1-5 fragility fractures between the T4 and L4 vertebrae and bone mineral density <80 % of the young adult mean. A total of 704 subjects were randomized to take minodronate 1 mg (n = 359) or placebo (n = 345) once a day for 24 months. In the placebo group, the risk of incident vertebral fractures during the 2-year observational period was significantly related to the number and severity of prevalent vertebral fractures at baseline. The number of prevalent vertebral fractures was an independent risk factor for incident vertebral fracture in multivariate analysis. The relative risk reductions of vertebral fractures by minodronate treatment were 45.2, 61.1, and 64.2 % for patients with 1, 2, and ≥3 prevalent vertebral fractures, respectively, and 87.8, 64.6, and 50.1 % for patients with mild, moderate, and severe prevalent vertebral fractures, respectively. In conclusion, the number of prevalent vertebral fractures is an independent risk factor for incident vertebral fracture and minodronate reduces the fracture risk even in patients at a higher risk for fracture.


Asunto(s)
Conservadores de la Densidad Ósea/uso terapéutico , Difosfonatos/uso terapéutico , Imidazoles/uso terapéutico , Osteoporosis/tratamiento farmacológico , Fracturas de la Columna Vertebral/prevención & control , Anciano , Anciano de 80 o más Años , Método Doble Ciego , Femenino , Humanos , Persona de Mediana Edad
12.
J Bone Miner Metab ; 31(3): 258-61, 2013 May.
Artículo en Inglés | MEDLINE | ID: mdl-23620095

RESUMEN

Justification Criteria for Vertebral Fractures 2012 version was made based on new clinical findings. Major differences in this version compared to the 1996 version are inclusion of the semiquantitative method (SQ), statements to improve considerations during radiographic analysis, and the need for more detailed evaluation by MRI.


Asunto(s)
Fracturas de la Columna Vertebral/diagnóstico por imagen , Humanos , Guías de Práctica Clínica como Asunto , Radiografía , Fracturas de la Columna Vertebral/patología
13.
Calcif Tissue Int ; 90(1): 14-21, 2012 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-22076525

RESUMEN

We investigated the incidence of additional fractures and the rate of prescription of osteoporotic pharmacotherapy after an initial hip fracture. We surveyed female patients aged 65 and over who sustained their first hip fracture between January 1, 2006, and December 31, 2007, treated at 25 hospitals in five geographic areas in Japan. Data for 1 year after the first hip fracture were collected from medical records, and questionnaires were mailed to all patients. In total, 2,663 patients were enrolled, and 335 patients were excluded based on exclusion criteria. The analysis was performed on 2,328 patients. During the 1-year follow-up period 160 fractures occurred in 153 patients and 77 subsequent hip fractures occurred in 77 patients. The incidence of all additional fractures among patients who sustained their first hip fracture was 70 (per 1,000 person-year) and that for second hip fracture was 34. In comparison to the general population, women ≥65 years of age who sustained an initial hip fracture were four times as likely to sustain an additional hip fracture. Antiosteoporosis pharmacotherapy was prescribed for 436 patients (18.7%), while 1,240 patients (53.3%) did not receive any treatment during the 1-year period. Patients who have sustained one hip fracture have a higher risk of a second hip fracture compared to the general population, and most of these women receive no pharmaceutical treatment for osteoporosis.


Asunto(s)
Fracturas de Cadera/epidemiología , Anciano , Anciano de 80 o más Años , Femenino , Estudios de Seguimiento , Fracturas de Cadera/etiología , Fracturas de Cadera/terapia , Humanos , Incidencia , Japón , Masculino , Osteoporosis/complicaciones , Osteoporosis/tratamiento farmacológico , Recurrencia
14.
J Bone Miner Metab ; 30(4): 439-46, 2012 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-22134624

RESUMEN

The objective of this study was to determine the safety and efficacy of long-term minodronate treatment in women with postmenopausal osteoporosis based on re-analysis of a phase III 2-year clinical trial with a 1-year extension. Women aged 55-80 years old with fragility fractures were enrolled and randomized to take 1 mg minodronate or placebo once a day in the original 2-year study. The subjects who completed the 2-year study were invited to participate in an additional 1-year extension in which all subjects were to receive minodronate. Finally, a total 380 subjects completed the extension study (186 from the placebo group and 194 from the minodronate group). Fracture results observed in the extension study were consistent with those observed in the first 2 years in minodronate group. In contrast, the placebo/minodronate group showed a decreased incidence of new vertebral fractures during year 3 compared to that in year 2. In the patients who received minodronate in the original 2-year study, lumbar bone mineral density (BMD) increased consistently during year 3 and bone turnover markers decreased within the first 6 months and remained constant thereafter over 3 years. Similar positive effects of minodronate on BMD and bone turnover markers occurred when therapy was initiated in the placebo/minodronate group. No new safety concerns observed during the extension period compared to the safety observations made during the 2-year study. It was concluded that daily administration of 1 mg oral minodronate is safe and well tolerated, and that the efficacy of this dose in reducing vertebral fracture risk in postmenopausal women over 2 years is sustained with continuing treatment.


Asunto(s)
Conservadores de la Densidad Ósea/uso terapéutico , Difosfonatos/uso terapéutico , Imidazoles/uso terapéutico , Osteoporosis Posmenopáusica/tratamiento farmacológico , Fracturas Osteoporóticas/prevención & control , Anciano , Anciano de 80 o más Años , Conservadores de la Densidad Ósea/efectos adversos , Resorción Ósea/prevención & control , Calcio de la Dieta/uso terapéutico , Colecalciferol/uso terapéutico , Estudios de Cohortes , Terapia Combinada , Suplementos Dietéticos , Difosfonatos/efectos adversos , Método Doble Ciego , Femenino , Humanos , Imidazoles/efectos adversos , Incidencia , Vértebras Lumbares/efectos de los fármacos , Persona de Mediana Edad , Osteogénesis/efectos de los fármacos , Osteoporosis Posmenopáusica/dietoterapia , Osteoporosis Posmenopáusica/metabolismo , Fracturas Osteoporóticas/epidemiología , Fracturas Osteoporóticas/etiología , Factores de Tiempo
15.
Clin Calcium ; 22(6): 833-7, 2012 Jun.
Artículo en Japonés | MEDLINE | ID: mdl-22653021

RESUMEN

The concept and terminology for bone fractures is now in some confusion between two academic fields, one of osteoporosis and the other of orthopedic fracture treatment, concerning the treatment of osteoporosis and the prevention of fragility fractures. In the former field, the terms of "incident or prevalent" fracture are commonly used ; by contrast, bone fracture simply means "fresh" fracture in the latter. Used to be based of X-ray films, diagnosis of osteoporotic fracture are now changing to depend on MRI, because its sensitivity and specificity of detecting fresh fracture of vertebral body is far better than other methods.


Asunto(s)
Fracturas Osteoporóticas/diagnóstico , Terminología como Asunto , Densidad Ósea , Humanos , Imagen por Resonancia Magnética , Fracturas Osteoporóticas/clasificación
16.
J Orthop Sci ; 16(4): 418-23, 2011 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-21594670

RESUMEN

BACKGROUND: Serum 25-hydroxyvitamin D (25(OH)D) is used as an index that reflects the level of vitamin D. We have previously reported, on the basis of a study in Sado in Niigata, that patients with hip fracture have lower serum 25(OH)D levels than non-hip-fracture cases. In this study, the serum 25(OH)D status in hip-fracture cases was examined in four regions in Japan. Although most hip-fracture patients have experienced past spine-compression fractures, the relationship of these fractures and 25(OH)D is unknown. Therefore, we also examined the 25(OH)D level in spine-compression fracture patients in the same locations and time periods. METHODS: The levels of 25(OH)D, intact parathyroid hormone (intact PTH), undercarboxylated osteocalcin (ucOC), urine N-terminal crosslinking telopeptide of type I collagen (NTX), and bone mineral density were examined in patients with hip and spine fracture due to osteoporosis in several regions in Japan. RESULTS: There were no significant differences in age, BMI, serum 25(OH)D, serum intact PTH, and serum ucOC among the regions. Levels of serum 25(OH)D were low in patients with hip fracture and spine fracture. The average serum 25(OH)D level was significantly lower in hip-fracture patients than in spine-fracture patients (16.3 vs. 18.1 ng/mL, P < 0.05). High serum ucOC was found in 37% of hip-fracture patients and 44% of spine-fracture patients. CONCLUSIONS: Both hip and spine-fracture patients have vitamin D insufficiency, with similar results found in elderly patients in four areas of Japan. The severity of this condition tends to be more serious in hip-fracture patients than in spine-fracture patients.


Asunto(s)
Fracturas de Cadera/sangre , Fracturas de la Columna Vertebral/sangre , Vitamina D/análogos & derivados , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Japón , Masculino , Vitamina D/sangre
17.
Clin Calcium ; 21(11): 131-5, 2011 Nov.
Artículo en Japonés | MEDLINE | ID: mdl-22040830

RESUMEN

The vertebral fractures of the elderly people are correctly diagnosed about 60% of the time if the X-ray is the only one used for diagnosis.The additional physical examination increases the rate dramatically, but it does not help locate the fracture.The follow-up X-ray examination increases the rate ; it becomes, however, too late to start an effective treatment. MRI is the best tool for the accurate diagnosis in the early stage.


Asunto(s)
Imagen por Resonancia Magnética , Fracturas de la Columna Vertebral/diagnóstico , Columna Vertebral/patología , Diagnóstico Precoz , Humanos , Radiografía , Fracturas de la Columna Vertebral/patología , Factores de Tiempo
18.
J Orthop Sci ; 15(1): 79-85, 2010 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-20151255

RESUMEN

BACKGROUND: The status of hip fracture incidence and treatment is well known through nationwide surveys in Japan. However, there have been no similar studies on spine fractures. Therefore, we investigated current medical practices for them. METHODS: Altogether, 1200 hospitals were randomly selected for the survey with consideration of region and hospital characteristics. Questionnaire items included the number of hospitalized spine patients, imaging test implementation, type of conservative treatment, use of open surgery and vertebroplasty, and the number of these procedures performed in 2005. RESULTS: Responses were received from 473 hospitals. On the day of response, there were 14 372 hospitalized orthopedic patients (average 32.8/hospital). Among them were 1403 spine fracture patients (3.1/hospital), accounting for 13.5% of orthopedic patients. Of them, 91.9% received conservative treatment. The mean percentage of spine fracture patients who were hospitalized was 39.5%. The most reliable imaging test was said to be magnetic resonance imaging. Casting or bracing was used in most of the institutions. The most common analgesic treatment was oral nonsteroidal antiinflammatory drugs. Open surgery and vertebroplasty were conducted for spine fractures in the elderly at 26.5% and 16.3% of hospitals, respectively. In these hospitals, 624 and 257 patients underwent open surgery and vertebroplasty, respectively, in 2005. CONCLUSIONS: In Japan, more than 90% of elderly patients hospitalized with spine fractures received conservative treatment. Surgical treatment, either open surgery or vertebroplasty, was performed at 30% of the hospitals. This study provides basic data that will contribute to planning improvements in spinal fracture treatment in the elderly.


Asunto(s)
Moldes Quirúrgicos/estadística & datos numéricos , Encuestas de Atención de la Salud , Fracturas de la Columna Vertebral/epidemiología , Fracturas de la Columna Vertebral/cirugía , Vertebroplastia/estadística & datos numéricos , Anciano , Anciano de 80 o más Años , Antiinflamatorios no Esteroideos/uso terapéutico , Humanos , Incidencia , Japón/epidemiología , Fracturas de la Columna Vertebral/tratamiento farmacológico
19.
J Orthop Sci ; 15(3): 289-93, 2010 May.
Artículo en Inglés | MEDLINE | ID: mdl-20559794

RESUMEN

BACKGROUND: Although many surgical procedures are available for treating osteoporotic vertebral fractures, there have been no comprehensive multicenter surveys in Japan focusing on surgical treatments for these fractures. This study aimed at (1) conducting a retrospective multicenter study to survey surgical treatments performed at referral center hospitals in various regions in Japan and (2) analyzing situations and problems related to the surgical treatments of osteoporotic vertebral fractures in Japanese hospitals. METHODS: Among 738 patients who were hospitalized in 13 hospitals in various regions in Japan between 2005 and 2006 for osteoporotic vertebral fractures, 84 patients (11.4%) who underwent spinal surgery were enrolled. These patients were retrospectively analyzed regarding cause of injury, preoperative symptoms, preoperative neurological function, surgical procedures, periods of bed rest, length of hospital stay, and ambulatory status at discharge from hospital. RESULTS: As to the cause of spinal fracture, 38 patients (45% of the surgical patients) could not identify a specific cause of their spinal fracture. Preoperative neurological motor weakness in legs was observed in 41 (49%). With regard to surgical treatment, posterior spinal reconstruction surgery was performed in 50 patients (60%), vertebroplasty in 26 (31%), anterior reconstruction surgery in 6 (7%), anterior and posterior combined reconstruction surgery in 1, and posterior decompression alone in 1 patient. In all, 70 patients (83.3%), whose periods of hospital stay averaged 52.8 days, could walk by themselves at the time of discharge; 14 (16.7%), whose periods of hospital stay averaged 44.7 days, could not walk by themselves at the time of discharge. CONCLUSIONS: Even after a large variety of surgical procedures were tried to treat osteoporotic vertebral fractures and long hospital stays, about 17% of the patients were unable to walk by themselves at the time of discharge from hospital.


Asunto(s)
Osteoporosis/cirugía , Fracturas de la Columna Vertebral/cirugía , Vertebroplastia/métodos , Anciano , Anciano de 80 o más Años , Femenino , Fijación Interna de Fracturas , Humanos , Tiempo de Internación , Masculino , Persona de Mediana Edad , Limitación de la Movilidad , Osteoporosis/complicaciones , Recuperación de la Función , Estudios Retrospectivos , Fracturas de la Columna Vertebral/etiología , Fracturas de la Columna Vertebral/rehabilitación , Vertebroplastia/rehabilitación
20.
J Orthop Sci ; 15(6): 737-45, 2010 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-21116890

RESUMEN

BACKGROUND: To elucidate the characteristics of hip fractures and the current status of their treatment in Japan, the Japanese Orthopaedic Association (JOA) conducted a nationwide hip fracture survey from 1998 to the present. The aim of the current report was to present the changes in patient distribution by age and fracture type, cause of fracture, treatment selection, and duration of hospitalization for a study period of one decade. METHODS: A tally of all hip fractures that occurred in patients between 2001 and 2008 was conducted in JOA-authorized hospitals and in Japanese Clinical Orthopaedic Association (JCOA) hospitals. Registration forms were sent to these hospitals each year, and registration was performed based on their hospital records. RESULTS: The mean response rate was 51.8%, and the total number of patients aged ≥35 with new hip fractures between 2001 and 2008 was 402 760. A drastic increase in the number of patients, especially those aged ≥90 was observed over the course of the decade. More trochanteric fractures occurred than neck fractures during the observational period; however, the neck/trochanter ratio increased over time. Simple falls were the most common cause of fracture. About 94% patients were treated surgically with about a 5-day presurgical hospital stay, and the mean hospitalization period was 40.7 days in 2008. CONCLUSIONS: This one-decade survey demonstrated a drastic increase in the number of patients over the course of the decade in Japan. Appropriate treatment and prevention of hip fractures, including the treatment of osteoporosis and more effective interventions for preventing falls, are important issues to address to reduce the burden of this fracture.


Asunto(s)
Fracturas de Cadera/epidemiología , Adulto , Distribución por Edad , Anciano , Anciano de 80 o más Años , Femenino , Fijación de Fractura , Encuestas Epidemiológicas , Fracturas de Cadera/diagnóstico , Fracturas de Cadera/terapia , Hospitalización/estadística & datos numéricos , Humanos , Japón/epidemiología , Masculino , Persona de Mediana Edad , Selección de Paciente , Factores de Riesgo , Distribución por Sexo
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