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1.
Osteoporos Int ; 31(7): 1283-1290, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-32020264

RESUMO

We investigated the factors associated with readiness for initiating osteoporosis treatment in women at high risk of fracture. We found that women in the contemplative stage were more likely to report previously being told having osteoporosis or osteopenia, acknowledge concern about osteoporosis, and disclose prior osteoporosis treatment. INTRODUCTION: Understanding factors associated with reaching the contemplative stage of readiness to initiate osteoporosis treatment may inform the design of behavioral interventions to improve osteoporosis treatment uptake in women at high risk for fracture. METHODS: We measured readiness to initiate osteoporosis treatment using a modified form of the Weinstein Precaution Adoption Process Model (PAPM) among 2684 women at high risk of fracture from the Activating Patients at Risk for OsteoPOroSis (APROPOS) clinical trial. Pre-contemplative participants were those who self-classified in the unaware and unengaged stages of PAPM (stages 1 and 2). Contemplative participants were those in the undecided, decided not to act, or decided to act stages of PAPM (stages 3, 4, and 5). Using multivariable logistic regression, we evaluated participant characteristics associated with levels of readiness to initiate osteoporosis treatment. RESULTS: Overall, 24% (N = 412) self-classified in the contemplative stage of readiness to initiate osteoporosis treatment. After adjusting for age, race, education, health literacy, and major osteoporotic fracture in the past 12 months, contemplative women were more likely to report previously being told they had osteoporosis or osteopenia (adjusted odds ratio [aOR] (95% CI) 11.8 (7.8-17.9) and 3.8 (2.5-5.6), respectively), acknowledge concern about osteoporosis (aOR 3.5 (2.5-4.9)), and disclose prior osteoporosis treatment (aOR 4.5 (3.3-6.3)) than women who self-classified as pre-contemplative. CONCLUSIONS: For women at high risk for future fractures, ensuring women's recognition of their diagnosis of osteoporosis/osteopenia and addressing their concerns about osteoporosis are critical components to consider when attempting to influence stage of behavior transitions in osteoporosis treatment.


Assuntos
Doenças Ósseas Metabólicas , Osteoporose , Fraturas por Osteoporose , Escolaridade , Feminino , Humanos , Lactente , Modelos Logísticos , Osteoporose/tratamento farmacológico , Fraturas por Osteoporose/etiologia , Fraturas por Osteoporose/prevenção & controle , Fatores de Risco
2.
Osteoporos Int ; 27(7): 2197-2206, 2016 07.
Artigo em Inglês | MEDLINE | ID: mdl-27112766

RESUMO

UNLABELLED: We used the RAND UCLA appropriateness method to decide appropriateness of use of osteoporosis medication after incident fracture and potential for fracture healing and make suggestions for trial design for clinical and preclinical research. PURPOSE: To develop appropriateness criteria to assist in the use and study of osteoporosis medications in patients with recent fracture and in the potential use of osteoporosis medications to enhance delayed fracture healing. To promote further research by suggesting preclinical and clinical trial design for studies where fracture healing is the endpoint. DESIGN: RAND/UCLA appropriateness method (RUAM). PARTICIPANTS: A panel of experts, both members and non-members of the International Osteoporosis Foundation Fracture Working Group, were identified consisting of geriatricians, rheumatologists, orthopedists, endocrinologists, and internists. This resulted in a round 1 panel of 15 panelists, round 2 panel of 15 members, and a round 3 panel of 14 members. MAIN OUTCOME MEASURE: Agreement on statements and scenarios using RUAM. Three rounds of voting by panelists took place. Agreement in a third round was reached for 111 statements and scenarios, measured by median panel ratings and the amount of dispersion of panel ratings, based on the interpercentile range. RESULTS: An expert panel validated a set of statements and scenarios about the use of osteoporosis medications after incident fracture and use of these medications to enhance delayed fracture healing and made recommendations for study designs to investigate the effect of osteoporosis medications on fracture healing. CONCLUSIONS: The result of this exercise is intended to assist in improving patient care by identifying the appropriateness of use of osteoporosis medications after fracture and in fracture healing and to make suggestions for further preclinical and clinical research.


Assuntos
Conservadores da Densidade Óssea/uso terapêutico , Consolidação da Fratura , Osteoporose/tratamento farmacológico , Fraturas por Osteoporose/tratamento farmacológico , Consenso , Humanos
3.
Osteoporos Int ; 27(1): 75-80, 2016 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-26174879

RESUMO

UNLABELLED: Two comorbidity indices were adapted for use in the FREEDOM trial and significantly correlated with the number of medications and impaired health status at baseline. The indices have applications for the analysis of clinical trial data and would allow for the appropriate adjustment of comorbidities when evaluating clinical trial outcomes. INTRODUCTION: The purpose of this study is to adapt two published comorbidity indices for use with the FREEDOM clinical trial evaluating postmenopausal women with osteoporosis. METHODS: FREEDOM enrolled women aged 60-90 years with a bone mineral density T-score <-2.5 at the lumbar spine or total hip and ≥-4.0 at both sites. Comorbidity indices were calculated using methods described by Sangha (Arthritis Rheum 49:156-163, 2003) and Wolfe (J Rheumatol 37:305-315, 2010) following modification. The adapted Sangha index included 12 conditions with a summary score of 0-12; the adapted Wolfe index included 7 conditions with a weighted summary score of 0-8. Higher scores indicated greater comorbidity. A panel of clinicians independently reviewed subjects' medical histories using a systematic process based on Medical Dictionary for Regulatory Activities (MedDRA) preferred terms to map specified comorbid conditions. Spearman correlations between the adapted indices and baseline subject characteristics expected to be associated with comorbidities were examined. RESULTS: Of the 7808 subjects in this study, 74 % had ≥1 comorbidities based on the adapted Sangha or Wolfe comorbidity indices. The mean (SD) adapted Sangha and Wolfe comorbidity indices were 1.4 (1.2) and 1.4 (1.3), respectively. Both indices correlated positively with age, body mass index, and the number of medications (r = 0.54 to 0.55) at baseline and inversely correlated with health-related quality of life (r = -0.22 to -0.30) (all P < 0.0001). Further, when either the adapted Sangha or Wolfe index was included as a covariate for assessing mortality over 36 months in the FREEDOM population, the hazard ratio of the comorbidity index indicated that the mortality risk increased by 27 or 28 %, respectively, for each unit increase in the adapted index (both P < 0.0001). CONCLUSIONS: Our work suggests these comorbidity indices may be adapted for use with clinical trial data, thereby allowing for the appropriate adjustment and reporting of covariates in the evaluation of clinical trial outcomes in an osteoporotic population.


Assuntos
Indicadores Básicos de Saúde , Osteoporose Pós-Menopausa/epidemiologia , Distribuição por Idade , Idoso , Idoso de 80 Anos ou mais , Densidade Óssea/fisiologia , Conservadores da Densidade Óssea/uso terapêutico , Comorbidade , Denosumab/uso terapêutico , Método Duplo-Cego , Feminino , Humanos , Pessoa de Meia-Idade , Osteoporose Pós-Menopausa/tratamento farmacológico , Osteoporose Pós-Menopausa/fisiopatologia , Estudos Retrospectivos , Resultado do Tratamento , Estados Unidos/epidemiologia
4.
Osteoporos Int ; 26(1): 361-72, 2015 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-25236877

RESUMO

UNLABELLED: To determine persistence with subcutaneous denosumab every 6 months in women being treated for osteoporosis, we conducted a single-arm prospective, observational study in the United States and Canada. Among 935 patients enrolled, 12-month persistence was 82%, with 66 patients (7%) reporting serious adverse events and 19 patients (2%) reporting fractures. INTRODUCTION: Increased persistence with osteoporosis therapy is associated with reduced fracture risk. Denosumab reduced fracture risk in clinical trials; persistence in community settings is undetermined. This study evaluates persistence with denosumab in community practice in the United States (US) and Canada. METHODS: In a 24-month multicenter, prospective, single-arm, observational study, women being treated for osteoporosis were enrolled ≤4 weeks after the first subcutaneous injection of denosumab. For this 12-month prespecified interim analysis, endpoints include persistence (one injection at study entry and another within 6 months + 8 weeks), attributes associated with persistence (univariate analysis), and serious adverse events (SAEs). RESULTS: Among 935 patients (mean age 71 years), mean baseline T-scores were -2.18 (femoral neck) and -2.00 (lumbar spine); 50% of patients had experienced osteoporotic fracture(s). At 12 months, 82 % of patients were persistent with denosumab. Baseline factors significantly (p < 0.05) associated with higher persistence included use of osteoporosis medications >5 years previously, lumbar spine T-score > -2.5, and treatment by female physicians (US). Lower persistence was associated (p < 0.05) with psychiatric diagnoses including depression, southern US residence, being divorced, separated, or widowed (US), and prior hip fracture (Canada). SAEs were reported in 66 patients (7%); no SAEs of osteonecrosis of the jaw, atypical femoral fracture, fracture healing complications, hypocalcemia, eczema, or hypersensitivity were reported. Nineteen patients (2%) reported osteoporotic fractures. CONCLUSIONS: The 12-month persistence observed in this single-arm open-label study of US and Canadian community practice extends the evidence regarding denosumab's potential role in reducing fracture risk in postmenopausal women with osteoporosis.


Assuntos
Anticorpos Monoclonais Humanizados/administração & dosagem , Conservadores da Densidade Óssea/administração & dosagem , Adesão à Medicação/estatística & dados numéricos , Osteoporose Pós-Menopausa/tratamento farmacológico , Fraturas por Osteoporose/prevenção & controle , Idoso , Idoso de 80 Anos ou mais , Anticorpos Monoclonais Humanizados/uso terapêutico , Densidade Óssea/efeitos dos fármacos , Conservadores da Densidade Óssea/uso terapêutico , Canadá/epidemiologia , Denosumab , Esquema de Medicação , Feminino , Colo do Fêmur/fisiopatologia , Humanos , Injeções Subcutâneas , Vértebras Lombares/fisiopatologia , Pessoa de Meia-Idade , Osteoporose Pós-Menopausa/complicações , Osteoporose Pós-Menopausa/epidemiologia , Fraturas por Osteoporose/epidemiologia , Fraturas por Osteoporose/etiologia , Estudos Prospectivos , Estados Unidos/epidemiologia
5.
Osteoporos Int ; 24(8): 2345-52, 2013 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-23612793

RESUMO

UNLABELLED: This observational study showed that after 2 years, both risedronate and alendronate lowered the risk of hip and nonvertebral fractures compared with patients filling in a single bisphosphonate prescription. INTRODUCTION: Post hoc analyses of the placebo-controlled trials suggested earlier effects for risedronate (6-12 months) than for alendronate (18-24 months). The present study extends our 1-year observational data that confirmed an earlier fracture reduction with risedronate and evaluated the absolute and relative effectiveness of alendronate and risedronate in clinical practice over 2 years. METHODS: We observed three cohorts of women aged 65 years and older who initiated once-a-week dosing of bisphosphonate therapy; (1) patients adherent to alendronate (n = 21,615), (2) patients adherent to risedronate (n = 12,215), or (3) patients filling only a single bisphosphonate prescription (n = 5,390) as a referent population. Proportional hazard modeling compared the incidence of hip and nonvertebral fractures among the cohorts over 2 years after the initial prescription. RESULTS: In this cohort, we previously showed at 12 months a significant reduction of hip and nonvertebral fractures with risedronate but not with alendronate. At the end of 2 years, the cumulative incidence of hip fractures in the referent cohort was 1.9 %, and incidence of nonvertebral fractures was 6.3 %. Relative to the referent, 6 months after initiating therapy and continuing through 2 years, both risedronate and alendronate cohorts had approximately a 45 % lower incidence of hip fractures and a 30 % lower incidence of nonvertebral fractures. CONCLUSION: These observations suggest that both risedronate and alendronate are effective at reducing the risk of hip and nonvertebral fracture after 2 years of treatment and support the post hoc analyses of placebo-controlled trials indicating an earlier effect of risedronate.


Assuntos
Alendronato/uso terapêutico , Conservadores da Densidade Óssea/uso terapêutico , Ácido Etidrônico/análogos & derivados , Fraturas por Osteoporose/prevenção & controle , Idoso , Alendronato/administração & dosagem , Conservadores da Densidade Óssea/administração & dosagem , Difosfonatos/administração & dosagem , Difosfonatos/uso terapêutico , Esquema de Medicação , Ácido Etidrônico/administração & dosagem , Ácido Etidrônico/uso terapêutico , Feminino , Fraturas do Quadril/epidemiologia , Fraturas do Quadril/etiologia , Fraturas do Quadril/prevenção & controle , Humanos , Incidência , Adesão à Medicação/estatística & dados numéricos , Osteoporose Pós-Menopausa/complicações , Osteoporose Pós-Menopausa/tratamento farmacológico , Osteoporose Pós-Menopausa/epidemiologia , Fraturas por Osteoporose/epidemiologia , Fraturas por Osteoporose/etiologia , Ácido Risedrônico , Resultado do Tratamento , Estados Unidos/epidemiologia
6.
Osteoporos Int ; 24(11): 2763-4, 2013 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-23884436

RESUMO

UNLABELLED: The Committee of Scientific Advisors of International Osteoporosis Foundation (IOF) recommends that papers describing the descriptive epidemiology of osteoporosis using bone mineral density (BMD) at the femoral neck include T-scores derived from an international reference standard. INTRODUCTION: The prevalence of osteoporosis as defined by the T-score is inconsistently reported in the literature which makes comparisons between studies problematic. METHODS: The Epidemiology and Quality of Life Working Group of IOF convened to make its recommendations and endorsement sought thereafter from the Committee of Scientific Advisors of IOF. RESULTS: The Committee of Scientific Advisors of IOF recommends that papers describing the descriptive epidemiology of osteoporosis using BMD at the femoral neck include T-scores derived from the National Health and Nutrition Examination Survey III reference database for femoral neck measurements in Caucasian women aged 20-29 years. CONCLUSIONS: It is expected that the use of the reference standard will help resolve difficulties in the comparison of results between studies and the comparative assessment of new technologies.


Assuntos
Osteoporose/epidemiologia , Absorciometria de Fóton , Adulto , Densidade Óssea/fisiologia , Feminino , Colo do Fêmur/fisiopatologia , Humanos , Osteoporose/diagnóstico , Osteoporose/fisiopatologia , Prevalência , Valores de Referência , Adulto Jovem
7.
Osteoporos Int ; 23(3): 1069-74, 2012 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-21755401

RESUMO

UNLABELLED: We examined how the use of bone turnover markers and educational information affects persistence of bisphosphonate use in osteoporotic patients. We found that reporting bone turnover results and/or educational information did not affect persistence. INTRODUCTION: Long-term adherence and persistence to osteoporosis medication are poor. We examined whether reporting of bone turnover marker results, education about osteoporosis, or a combination of both would increase persistence to oral bisphosphonates. METHODS: Two hundred and forty women who were 5 years postmenopausal with BMD at least 2.0 standard deviations below normal were recruited for the study. All women were given a new prescription for alendronate and randomly assigned to one of four groups: (1) bone marker results at baseline, 3 and 12 months; (2) educational materials every month and a membership in the National Osteoporosis Foundation; (3) bone marker and educational information; and (4) control, no information other than usual care. Persistence among randomization groups was tested using survival analysis adjusting for the delay between intervention methods. RESULTS: Of those filling their initial prescription, 95.5% refilled their prescription at the end of the first month, 87% at 3 months, 82% at 6 months, and 78% at 10 months. Overall persistence through 12 months was 54%. There was no difference found among the four groups for persistence time using (p > 0.58). CONCLUSION: Providing bone turnover marker results is not an effective way to enhance early compliance and persistence with drug therapy. While the women in our study felt that bone marker results and educational information were helpful to them, there was no difference in persistence between those who received either bone marker information and/or educational information and those who did not. Because of the unexpected rate of primary nonadherence, this study may be underpowered.


Assuntos
Conservadores da Densidade Óssea/administração & dosagem , Adesão à Medicação , Osteoporose Pós-Menopausa/tratamento farmacológico , Educação de Pacientes como Assunto/métodos , Administração Oral , Idoso , Biomarcadores/urina , Conservadores da Densidade Óssea/uso terapêutico , Remodelação Óssea/fisiologia , Serviços de Saúde Comunitária , Esquema de Medicação , Retroalimentação Psicológica , Feminino , Humanos , Pessoa de Meia-Idade , Osteoporose Pós-Menopausa/psicologia , Estados Unidos
8.
Osteoporos Int ; 23(3): 841-52, 2012 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-21528362

RESUMO

UNLABELLED: The Male Osteoporosis Assessment Questionnaire (OPAQ™) is a health-related quality of life (HRQOL) instrument that can differentiate between men with and without fracture. The Male OPAQ™ is a reliable and validated instrument that may be utilized in clinical trials seeking to include male populations. INTRODUCTION: Men with osteoporosis (OP) experience poorer clinical outcomes than do women with the disorder, but little is known about the impact of OP on men's HRQOL. This study aimed to test the validity, reliability, and ability to differentiate between men with and without fracture of an HRQOL for men with osteoporosis, the Male OPAQ™. METHODS: The OPAQ and OPAQ-SV were tested for face validity in interviews with male OP patients, and a revised, male-specific instrument was developed. Thirty-seven men ages 50+ completed the Male OPAQ™ and SF-12 at baseline and a two-week retest of the Male OPAQ™. To analyze both the domain and dimension scores, a normalization procedure was performed on the data to determine health status scores from 0 to 100. Descriptive statistics were calculated for each item and site. Reliability and validity of the Male OPAQ™ were assessed using Pearson's r. RESULTS: The Male OPAQ™ can discriminate between men with and without fracture, and men who have more fractures have poorer scores. Instrument domains correspond to those of the SF-12. CONCLUSIONS: The Male OPAQ(TM) is a brief and sensitive tool for measuring HRQOL in men with OP. Further testing in a more diverse and large sample is warranted.


Assuntos
Indicadores Básicos de Saúde , Osteoporose/reabilitação , Qualidade de Vida , Atividades Cotidianas , Idoso , Idoso de 80 Anos ou mais , California , Emoções , Humanos , Masculino , Pessoa de Meia-Idade , Osteoporose/psicologia , Fraturas por Osteoporose/psicologia , Fraturas por Osteoporose/reabilitação , Reprodutibilidade dos Testes , Fatores Sexuais , Fatores Socioeconômicos , Inquéritos e Questionários
9.
Osteoporos Int ; 23(1): 351-63, 2012 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-21779819

RESUMO

UNLABELLED: In this 2-year extension of a 3-year study, bazedoxifene showed sustained efficacy in preventing new vertebral fractures in postmenopausal women with osteoporosis and in preventing non-vertebral fractures in higher-risk women. Bazedoxifene significantly increased bone mineral density and reduced bone turnover versus placebo and was generally safe and well tolerated. INTRODUCTION: This study evaluated the efficacy and safety of bazedoxifene for the treatment of postmenopausal osteoporosis over 5 years. METHODS: A total of 4,216 postmenopausal women with osteoporosis were enrolled in this 2-year extension of a 3-year, randomized, double-blind, placebo-controlled, phase 3 trial. In the core study (N = 7,492), subjects received bazedoxifene 20 or 40 mg/day, raloxifene 60 mg/day, or placebo. The raloxifene arm was discontinued after 3 years; subjects receiving bazedoxifene 40 mg were transitioned to bazedoxifene 20 mg after 4 years. Five-year findings are reported for bazedoxifene 20 and 40/20 mg and placebo. Endpoints included incidence of new vertebral fractures (primary) and non-vertebral fractures, and changes in bone mineral density (BMD) and bone turnover markers. RESULTS: At 5 years, the incidence of new vertebral fractures in the intent-to-treat population was significantly lower with bazedoxifene 20 mg (4.5%) and 40/20 mg (3.9%) versus placebo (6.8%; P < 0.05), with relative risk reductions of 35% and 40%, respectively. Non-vertebral fracture incidence was similar among groups. In a subgroup of higher-risk women (n = 1,324; femoral neck T-score ≤-3.0 and/or ≥ 1 moderate or severe or ≥ 2 mild vertebral fracture[s]), bazedoxifene 20 mg reduced non-vertebral fracture risk versus placebo (37%; P = 0.06); combined data for bazedoxifene 20 and 40/20 mg reached statistical significance (34% reduction; P < 0.05). Bazedoxifene significantly increased BMD and reduced bone turnover versus placebo (P < 0.05) and was generally safe and well tolerated. CONCLUSIONS: The findings support a sustained anti-fracture effect of bazedoxifene on new vertebral fractures in postmenopausal osteoporotic women and on non-vertebral fractures in the higher-risk subgroup of women.


Assuntos
Conservadores da Densidade Óssea/uso terapêutico , Indóis/uso terapêutico , Osteoporose Pós-Menopausa/tratamento farmacológico , Fraturas por Osteoporose/prevenção & controle , Idoso , Densidade Óssea/efeitos dos fármacos , Conservadores da Densidade Óssea/administração & dosagem , Conservadores da Densidade Óssea/efeitos adversos , Remodelação Óssea/efeitos dos fármacos , Relação Dose-Resposta a Droga , Método Duplo-Cego , Feminino , Seguimentos , Humanos , Indóis/administração & dosagem , Indóis/efeitos adversos , Pessoa de Meia-Idade , Osteoporose Pós-Menopausa/complicações , Fraturas por Osteoporose/etiologia , Placebos , Moduladores Seletivos de Receptor Estrogênico/administração & dosagem , Moduladores Seletivos de Receptor Estrogênico/efeitos adversos , Moduladores Seletivos de Receptor Estrogênico/uso terapêutico , Fraturas da Coluna Vertebral/etiologia , Fraturas da Coluna Vertebral/prevenção & controle , Resultado do Tratamento
10.
Osteoporos Int ; 23(8): 2141-50, 2012 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-22159672

RESUMO

UNLABELLED: The effect of teriparatide and risedronate on back pain was tested, and there was no difference in the proportion of patients experiencing a reduction in back pain between groups after 6 or 18 months. Patients receiving teriparatide had greater increases in bone mineral density and had fewer vertebral fractures. INTRODUCTION: This study aimed to understand the effect of teriparatide in reducing back pain in patients with prevalent back pain and vertebral fracture compared to risedronate. METHODS: In an 18-month randomized, double-blind, double-dummy trial, we investigated the effects of teriparatide (20 µg/day) vs. risedronate (35 mg/week) in postmenopausal women with back pain likely due to vertebral fracture. The primary objective was to compare the proportion of subjects reporting ≥30% reduction in worst back pain severity from baseline to 6 months as assessed by a numeric rating scale in each treatment group. Pre-specified secondary and exploratory outcomes included assessments of average and worst back pain at additional time points, disability and quality of life, bone mineral density, incidence of fractures, and safety. RESULTS: At 6 months, 59% of teriparatide and 57% of risedronate patients reported ≥30% reduction in worst back pain and there were no differences between groups in the proportion of patients experiencing reduction in worst or average back pain at any time point, disability, or quality of life. There was a greater increase from baseline in bone mineral density at the lumbar spine (p = 0.001) and femoral neck (p = 0.02) with teriparatide compared to risedronate and a lower incidence of vertebral fractures at 18 months (4% teriparatide and 9% risedronate; p = 0.01). Vertebral fractures were less severe (p = 0.04) in the teriparatide group. There was no difference in the overall incidence of adverse events. CONCLUSIONS: Although there were no differences in back pain-related endpoints, patients receiving teriparatide had greater skeletal benefit than those receiving risedronate.


Assuntos
Dor nas Costas/tratamento farmacológico , Conservadores da Densidade Óssea/uso terapêutico , Osteoporose Pós-Menopausa/tratamento farmacológico , Fraturas por Osteoporose/tratamento farmacológico , Fraturas da Coluna Vertebral/tratamento farmacológico , Idoso , Dor nas Costas/etiologia , Densidade Óssea/efeitos dos fármacos , Método Duplo-Cego , Ácido Etidrônico/análogos & derivados , Ácido Etidrônico/uso terapêutico , Feminino , Colo do Fêmur/efeitos dos fármacos , Humanos , Vértebras Lombares/efeitos dos fármacos , Osteoporose Pós-Menopausa/complicações , Fraturas por Osteoporose/complicações , Medição da Dor , Qualidade de Vida , Ácido Risedrônico , Fraturas da Coluna Vertebral/complicações , Teriparatida/uso terapêutico , Resultado do Tratamento
12.
Osteoporos Int ; 22(1): 21-6, 2011 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-20458571

RESUMO

Compliance to oral bisphosphonates is suboptimal, with negative consequences of increased healthcare utilization and less effective fracture risk reduction. Extending dose interval increased adherence only moderately. We used literature derived from multiple chronic conditions to examine the problem of noncompliance with osteoporosis medication. We reviewed the literature on adherence to osteoporosis medication as well as that across multiple chronic conditions to understand what is known about the cause of the poor adherence. Poor compliance to oral medications is due mostly, not to forgetfulness, but to deliberate choice. Gender differences and style of healthcare management also play a role. Preliminary data suggest psychobehavioral interventions may help to improve motivation. We need to understand better reasons for poor compliance before effective interventions can be developed. Forgetfulness is only a small part of poor compliance. Patient preferences must be considered in medication decision making.


Assuntos
Conservadores da Densidade Óssea/administração & dosagem , Difosfonatos/administração & dosagem , Adesão à Medicação/psicologia , Osteoporose/tratamento farmacológico , Atitude Frente a Saúde , Conservadores da Densidade Óssea/uso terapêutico , Difosfonatos/uso terapêutico , Esquema de Medicação , Humanos , Fraturas por Osteoporose/prevenção & controle
13.
Osteoporos Int ; 22(8): 2337-45, 2011 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-21116816

RESUMO

UNLABELLED: A randomized, double-blind, placebo-controlled study assessed the efficacy of acetaminophen or fluvastatin in preventing post-dose symptoms (increases in body temperature or use of rescue medication) following a single infusion of the intravenous (IV) bisphosphonate zoledronic acid (ZOL). Acetaminophen, but not fluvastatin, significantly reduced the incidence and severity of post-dose symptoms. INTRODUCTION: Transient symptoms including myalgia and pyrexia have been reported post-infusion of IV bisphosphonates, typically starting the day after infusion and resolving within several days. The cause is unknown but may be related to transient cytokine elevations. Statins' potential to block release of these cytokines has been hypothesized. This study was aimed to evaluate efficacy of acetaminophen and fluvastatin in preventing/reducing post-dose symptoms following ZOL 5 mg infusion. METHODS: Randomized, double-blind, placebo-controlled study of efficacy of acetaminophen or fluvastatin in preventing increases in body temperature or use of rescue medication (ibuprofen) following a single ZOL infusion. Bisphosphonate-naive postmenopausal women with low bone mass (N = 793) were randomized into three treatment groups and given 650 mg acetaminophen or 80 mg fluvastatin or placebo 45 min before ZOL infusion. The acetaminophen group continued taking 650 mg acetaminophen every 6 h over the next 3 days, and the other two groups took matching placebo according to the same schedule. Subjects recorded body temperature, symptoms in a diary. Inflammatory cytokines and C-reactive protein (CRP) were measured at baseline, 24, and 72 h in a study subset. RESULTS: Acetaminophen four times/day significantly reduced the incidence and severity of post-dose symptoms following ZOL infusion. Single-dose fluvastatin 80 mg prior to ZOL infusion did not prevent/reduce post-dose symptoms. Cytokine levels increased by 24 h and returned towards baseline by 72 h, similar to the pattern for post-infusion symptoms. CRP levels increased from baseline to 72 h. CONCLUSIONS: Acetaminophen four times/day for 3 days significantly reduced the incidence and severity of post-dose symptoms following ZOL infusion.


Assuntos
Acetaminofen/uso terapêutico , Reação de Fase Aguda/prevenção & controle , Conservadores da Densidade Óssea/efeitos adversos , Difosfonatos/efeitos adversos , Ácidos Graxos Monoinsaturados/uso terapêutico , Imidazóis/efeitos adversos , Indóis/uso terapêutico , Acetaminofen/administração & dosagem , Reação de Fase Aguda/sangue , Reação de Fase Aguda/induzido quimicamente , Idoso , Antipiréticos/administração & dosagem , Antipiréticos/uso terapêutico , Conservadores da Densidade Óssea/administração & dosagem , Conservadores da Densidade Óssea/uso terapêutico , Difosfonatos/administração & dosagem , Difosfonatos/uso terapêutico , Método Duplo-Cego , Esquema de Medicação , Ácidos Graxos Monoinsaturados/administração & dosagem , Feminino , Febre/induzido quimicamente , Febre/prevenção & controle , Fluvastatina , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/administração & dosagem , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Imidazóis/administração & dosagem , Imidazóis/uso terapêutico , Indóis/administração & dosagem , Mediadores da Inflamação/sangue , Infusões Intravenosas , Pessoa de Meia-Idade , Osteoporose Pós-Menopausa/tratamento farmacológico , Resultado do Tratamento , Ácido Zoledrônico
14.
Osteoporos Int ; 20(9): 1595-601, 2009 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-19145396

RESUMO

UNLABELLED: Bone turnover markers such as serum C-terminal cross-linking telopeptide of type I collagen (CTX-I) can be used to assess drug efficacy in osteoporosis. This study evaluated the pattern of CTX-I suppression in postmenopausal osteoporotic women receiving ibandronate. Ibandronate decreased serum CTX-I levels within 3 days of therapy initiation. Over 6 months, the levels remained suppressed below baseline. INTRODUCTION: This randomized, double-blind, placebo-controlled study evaluated the rapidity of onset and pattern of suppression of the bone resorption marker serum CTX-I in women with postmenopausal osteoporosis (PMO) who received once-monthly oral ibandronate. METHODS: Women diagnosed with PMO received once-monthly oral ibandronate (150 mg) or placebo for 6 months. Serum CTX-I was measured at baseline and after study dose administration on day 3 (month 1 only) and days 7, 14, 21, and 28 (months 1-6). Bone-specific alkaline phosphatase was measured on days 7 and 28 (months 1-6). RESULTS: This study enrolled 67 women: 49 received ibandronate, 17 received placebo, and one took no study drug. At day 3, median reduction in serum CTX-I from baseline was 70.2% with ibandronate and 6.0% with placebo (difference, -64.2%; 95% confidence interval, -80.3% to -46.2%; p < 0.0001). In women receiving ibandronate, serum CTX-I levels remained consistently below baseline, exhibiting a regular monthly fluctuating pattern of suppression over 6 months. Ibandronate was well-tolerated. CONCLUSIONS: Monthly ibandronate decreased serum CTX-I within 3 days. Over 6 months, in women receiving once-monthly ibandronate, serum CTX-I remained suppressed below baseline. A monthly fluctuation, related to time from last dose, was observed.


Assuntos
Conservadores da Densidade Óssea/uso terapêutico , Remodelação Óssea/efeitos dos fármacos , Reabsorção Óssea/tratamento farmacológico , Colágeno Tipo I/sangue , Difosfonatos/uso terapêutico , Osteoporose Pós-Menopausa/tratamento farmacológico , Peptídeos/sangue , Reabsorção Óssea/sangue , Reabsorção Óssea/prevenção & controle , Método Duplo-Cego , Esquema de Medicação , Feminino , Humanos , Ácido Ibandrônico , Pessoa de Meia-Idade , Osteoporose Pós-Menopausa/sangue , Estudos Prospectivos , Resultado do Tratamento
15.
J Bone Miner Res ; 12(1): 16-23, 1997 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-9240721

RESUMO

To assess the cost-effectiveness of interventions to prevent osteoporosis, it is necessary to estimate total health care expenditures for the treatment of osteoporotic fractures. Resources utilized for the treatment of many diseases can be estimated from secondary databases using relevant diagnosis codes, but such codes do not indicate which fractures are osteoporotic in nature. Therefore, a panel of experts was convened to make judgments about the probabilities that fractures of different types might be related to osteoporosis according to patient age, gender, and race. A three-round Delphi process was applied to estimate the proportion of fractures related to osteoporosis (i.e., the osteoporosis attribution probabilities) in 72 categories comprised of four specific fracture types (hip, spine, forearm, all other sites combined) stratified by three age groups (45-64 years, 65-84 years, 85 years and older), three racial groups (white, black, all others), and both genders (female, male). It was estimated that at least 90% of all hip and spine fractures among elderly white women should be attributed to osteoporosis. Much smaller proportions of the other fractures were attributed to osteoporosis. Regardless of fracture type, attribution probabilities were less for men than women and generally less for non-whites than whites. These probabilities will be used to estimate the total direct medical costs associated with osteoporosis-related fractures in the United States.


Assuntos
Fraturas Ósseas/etiologia , Osteoporose Pós-Menopausa/complicações , Osteoporose/complicações , Idoso , Idoso de 80 Anos ou mais , Envelhecimento/patologia , Povo Asiático , População Negra , Bases de Dados Factuais , Técnica Delphi , Feminino , Fraturas Ósseas/epidemiologia , Fraturas Ósseas/fisiopatologia , Fraturas do Quadril/epidemiologia , Fraturas do Quadril/etiologia , Fraturas do Quadril/fisiopatologia , Humanos , Masculino , Pessoa de Meia-Idade , Osteoporose/fisiopatologia , Osteoporose Pós-Menopausa/fisiopatologia , Fraturas do Rádio/epidemiologia , Fraturas do Rádio/etiologia , Fraturas do Rádio/fisiopatologia , Fatores Sexuais , Sociedades Médicas , Fraturas da Coluna Vertebral/epidemiologia , Fraturas da Coluna Vertebral/etiologia , Fraturas da Coluna Vertebral/fisiopatologia , Estados Unidos/epidemiologia , População Branca
16.
Bone ; 13 Suppl 2: S27-31, 1992.
Artigo em Inglês | MEDLINE | ID: mdl-1627411

RESUMO

Vertebral compression fractures (VCFs) may be defined radiographically or as a clinical event. The prevalence of these fractures in women aged 50 and over has been estimated at 26% when defined as a reduction in vertebral height greater than 15%. Retrospective reviews of case records have shown a clinical detection rate of VCF in white women of 153/100,000 person years. Of these clinically detected VCFs, 84% were associated with pain. VCF may be defined as a clinical event characterised by loss of height and acute pain. The pain of acute fracture usually lasts 4 to 6 weeks with intense pain at the site of fracture. Chronic pain may also occur in patients with multiple compression fractures, height loss and low bone density but is probably due to structural changes or osteoarthritis. Radiographic VCF may not be symptomatic. The greater the deformity, the greater the likelihood of pain and disability. As height is lost, patients experience discomfort from the rib cage pressing downward on the pelvis. Patients develop a thoracic kyphosis, a lumbar lordosis, and a protuberant abdomen with prominent horizontal skinfold creases. The reduced thoracic space may result in decreased exercise tolerance and reduced abdominal space may give rise to early satiety and weight loss. Sleep disorders may also occur. Patients lose self esteem. Self care may become difficult. They are often depressed. They become fearful of further fracture. They have distorted body image and poor health perception. Patients with one vertebral fracture are at increased risk of peripheral fracture and further vertebral fracture. The aims of acute management are to reduce symptoms and mobilise the patient as quickly as possible.(ABSTRACT TRUNCATED AT 250 WORDS)


Assuntos
Estatura , Dor/etiologia , Fraturas da Coluna Vertebral/complicações , Feminino , Hospitalização , Humanos , Masculino , Dor/fisiopatologia , Manejo da Dor , Radiografia , Fraturas da Coluna Vertebral/diagnóstico por imagem , Fraturas da Coluna Vertebral/fisiopatologia
17.
Rheum Dis Clin North Am ; 27(1): 187-96, 2001 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-11285994
18.
Obstet Gynecol ; 89(3): 321-5, 1997 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-9052578

RESUMO

OBJECTIVE: To determine the effect of bone density information on a woman's decision about hormone replacement therapy (HRT). METHODS: One hundred forty women were assigned randomly to receive either educational information about osteoporosis and a voucher for a bone mineral density test 12 months later or the same educational information plus an immediate dual-energy x-ray absorptiometry test for bone mineral density. Women in both groups were offered prescription for HRT. RESULTS: Of the 93 women who received a bone mineral density test, 63.4% elected HRT and filled their prescription, compared with only 20.0% of the 43 women who did not have a bone mineral density test (P < .01). Women who were classified as osteopenic (between -1 and -2.5 standard deviations [SDs] of the young normal bone mineral density) or osteoporotic (more than 2.5 SDs below young normals) were more likely to choose HRT (69.4%) than were women whose bone mineral density was in the normal range (51.6%) (above -1 SD of the young normal bone mineral density value). CONCLUSIONS: A bone mineral density test, regardless of the result, had a significant effect on women's decisions to accept HRT. Within the group having the test, women with lower bone mineral density were more likely to choose HRT.


Assuntos
Absorciometria de Fóton , Terapia de Reposição de Estrogênios , Osteoporose/prevenção & controle , Aceitação pelo Paciente de Cuidados de Saúde , Educação de Pacientes como Assunto , Densidade Óssea , Feminino , Humanos , Pessoa de Meia-Idade
19.
Arthritis Care Res ; 3(1): 11-8, 1990 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-2285734

RESUMO

Thirty-five individuals with fibromyalgia (fibrositis), 22 of their physicians, and 49 rheumatologists on an Arthritis Foundation referral list rated the importance of 24 aspects of fibromyalgia treatment. These encompassed symptom control, psychosocial factors, information, and physical therapy. Respondents with fibromyalgia rated their satisfaction with the way each aspect of treatment had been managed by their physician, and each completed a health status questionnaire. Fibromyalgia patients viewed 8 of the 24 aspects of treatment as significantly more important than did their own physician, and 18 of the 24 as significantly more important than did area rheumatologists. Satisfaction with the way treatment had been managed was generally low. Some evidence suggested that patients' health status was affected positively by the extent to which their physician viewed certain aspects of treatment as important. The results are expected to be useful in the design of fibromyalgia education programs for both lay and health professional audiences.


Assuntos
Atitude do Pessoal de Saúde , Atitude Frente a Saúde , Fibromialgia/terapia , Médicos/psicologia , Adulto , Idoso , Comportamento do Consumidor , Feminino , Fibromialgia/psicologia , Nível de Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Inquéritos e Questionários
20.
Steroids ; 56(10): 518-23, 1991 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-1805453

RESUMO

We studied 70 patients (48 women and 22 men) with either rheumatic disease (n = 25) or lung disease (n = 45) who had been treated with glucocorticoids for at least 6 months (mean cumulative dose, 24.2 +/- 27.1 g of prednisone; mean current dose, 11.0 +/- 8.6 mg/d, mean duration of therapy, 8.1 years. We measured bone mineral density (BMD) of the hip (femoral neck) and spine (L2-L4) using dual-photon absorptiometry and BMD of the distal one third radius using single-photon absorptiometry. Compared with age-matched controls, the study population had decreased BMD of the spine (87.0%), hip (87.2%), and radius (90.6%). Current dose, cumulative dose, and duration of therapy were not correlated with BMD in the spine or hip in the total study population. The most significant correlations with low bone mass at the hip and spine were short height and low weight. There was a high incidence of hypercalciuria (30%) as compared with an age- and sex-matched control group (6.4%). Glucocorticoids are known to decrease vertebral and radial bone density. We conclude that glucocorticoids also decrease hip bone density as measured at the femoral neck. The high incidence of hypercalciuria may have implications for therapy of glucocorticoid-induced osteoporosis.


Assuntos
Glucocorticoides/efeitos adversos , Osteoporose/induzido quimicamente , Absorciometria de Fóton , Adulto , Idoso , Idoso de 80 Anos ou mais , Densidade Óssea/efeitos dos fármacos , Estudos Transversais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Valores de Referência , Fatores de Tempo
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