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1.
Arch Osteoporos ; 18(1): 101, 2023 07 19.
Artigo em Inglês | MEDLINE | ID: mdl-37466787

RESUMO

Participation in Orthogeriatrics TeleECHO was associated with improvement in physicians' knowledge and self-confidence in managing elderly patients with fractures. PURPOSE: To develop and conduct an interactive case-based virtual TeleECHO program to expand the knowledge of healthcare professionals in the field of orthogeriatrics. METHODS: The project included twelve 90-min sessions for physicians and healthcare managers. Each session was based on real clinical cases discussed by the multidisciplinary group of faculty. The efficacy of the project was assessed using questionnaires. RESULTS: The attendance of individual sessions ranged from 129 to 224 with the total number of participants 829; 25% of participants were from remote rural regions. A survey conducted at the beginning of the project showed insufficient knowledge and ability to apply the concepts of orthogeriatrics. A final questionnaire showed that 74% of respondents participated in most sessions, with 94% wishing to continue participating in further sessions. There was a statistically significant overall improvement in confidence of caring for fragility fracture patients with an effect size of 0.75 (p<0.001). The proportion of responders who were able to apply their new knowledge in clinical practice shortly after TeleECHO showed a substantial increase (p<0.0001). CONCLUSION: The Orthogeriatrics TeleECHO program was effective in changing perceptions and self-confidence of the participants, and applying knowledge acquired to patient care. This model of learning could be applied in other countries in other languages to improve post-fracture care worldwide.


Assuntos
Fraturas Ósseas , Médicos , Humanos , Idoso , Pessoal de Saúde , Atenção à Saúde , Inquéritos e Questionários
4.
Arch Osteoporos ; 17(1): 87, 2022 06 28.
Artigo em Inglês | MEDLINE | ID: mdl-35763133

RESUMO

The IOF Epidemiology and Quality of Life Working Group has reviewed the potential role of population screening for high hip fracture risk against well-established criteria. The report concludes that such an approach should strongly be considered in many health care systems to reduce the burden of hip fractures. INTRODUCTION: The burden of long-term osteoporosis management falls on primary care in most healthcare systems. However, a wide and stable treatment gap exists in many such settings; most of which appears to be secondary to a lack of awareness of fracture risk. Screening is a public health measure for the purpose of identifying individuals who are likely to benefit from further investigations and/or treatment to reduce the risk of a disease or its complications. The purpose of this report was to review the evidence for a potential screening programme to identify postmenopausal women at increased risk of hip fracture. METHODS: The approach took well-established criteria for the development of a screening program, adapted by the UK National Screening Committee, and sought the opinion of 20 members of the International Osteoporosis Foundation's Working Group on Epidemiology and Quality of Life as to whether each criterion was met (yes, partial or no). For each criterion, the evidence base was then reviewed and summarized. RESULTS AND CONCLUSION: The report concludes that evidence supports the proposal that screening for high fracture risk in primary care should strongly be considered for incorporation into many health care systems to reduce the burden of fractures, particularly hip fractures. The key remaining hurdles to overcome are engagement with primary care healthcare professionals, and the implementation of systems that facilitate and maintain the screening program.


Assuntos
Fraturas do Quadril , Osteoporose , Feminino , Fraturas do Quadril/epidemiologia , Fraturas do Quadril/prevenção & controle , Humanos , Programas de Rastreamento/métodos , Osteoporose/diagnóstico , Osteoporose/epidemiologia , Pós-Menopausa , Qualidade de Vida
5.
Osteoporos Int ; 33(9): 2035-2040, 2022 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-35593943

RESUMO

Bone Health TeleECHO Moscow is the first Russian-speaking Project ECHO (Extension for Community Healthcare Outcomes) program that is modeled after the original Bone Health TeleECHO created in the USA. Bone Health TeleECHO Moscow was effective (effect size of 0.87 p < 0.001) at improving clinicians' skills in the management of osteoporosis based on self-evaluation over 3 years. INTRODUCTION: Bone Health TeleECHO (Extension for Community Healthcare Outcomes) Moscow is the first Russian-speaking ECHO program, modeled after Bone Health TeleECHO at the University of New Mexico, USA. The bone ECHO programs are designed to expand the capacity to deliver best practice skeletal healthcare worldwide through ongoing technology-enabled case-based collaborative learning. To evaluate the impact of the first 3 years of Bone Health TeleECHO Moscow on physicians' knowledge in the management of bone diseases. METHODS: Demographic data were obtained, and outcomes were assessed through an electronic blinded self-efficacy questionnaire focusing on competence and skills in 20 domains of osteoporosis care before and after each year of participation in the Bone Health TeleECHO Moscow. RESULTS: Over 3 years, a total of 296 participants completed the questionnaire. Average attendance for each monthly session increased from 64 in 2019 to 73 in 2020 and to 96 in 2021. Participants were from all regions of Russia and Russian-speaking countries. The mean age of respondents was 43 years with the youngest being 23 and the eldest 74. The most common participants' primary specialties were endocrinology (n = 263), gynecology (n = 20), orthopedics (n = 3), and other (n = 10). All of our participants were physicians, including 73 MD PhDs. This educational intervention was associated with a statistically significant improvement in each of the 20 domains of osteoporosis care, with an effect size of 0.87 (p < 0.001). CONCLUSION: Bone Health TeleECHO is effective at improving clinicians' skills in the management of osteoporosis based on self-evaluation over 3 years.


Assuntos
Osteoporose , Relatório de Pesquisa , Adulto , Densidade Óssea , Serviços de Saúde Comunitária , Humanos , Moscou , Osteoporose/complicações , Osteoporose/terapia
6.
Osteoporos Int ; 33(10): 2049-2102, 2022 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-35478046

RESUMO

Osteoporosis is the most common metabolic bone disease in the USA and the world. It is a subclinical condition until complicated by fracture(s). These fractures place an enormous medical and personal burden on individuals who suffer from them and take a significant economic toll. Any new fracture in an adult aged 50 years or older signifies imminent elevated risk for subsequent fractures, particularly in the year following the initial fracture. What a patient perceives as an unfortunate accident may be seen as a sentinel event indicative of bone fragility and increased future fracture risk even when the result of considerable trauma. Clinical or subclinical vertebral fractures, the most common type of osteoporotic fractures, are associated with a 5-fold increased risk for additional vertebral fractures and a 2- to 3-fold increased risk for fractures at other sites. Untreated osteoporosis can lead to a vicious cycle of recurrent fracture(s), often resulting in disability and premature death. In appropriate patients, treatment with effective antifracture medication prevents fractures and improves outcomes. Primary care providers and medical specialists are critical gatekeepers who can identify fractures and initiate proven osteoporosis interventions. Osteoporosis detection, diagnosis, and treatment should be routine practice in all adult healthcare settings. The Bone Health and Osteoporosis Foundation (BHOF) - formerly the National Osteoporosis Foundation - first published the Clinician's Guide in 1999 to provide accurate information on osteoporosis prevention and treatment. Since that time, significant improvements have been made in diagnostic technologies and treatments for osteoporosis. Despite these advances, a disturbing gap persists in patient care. At-risk patients are often not screened to establish fracture probability and not educated about fracture prevention. Most concerning, the majority of highest risk women and men who have a fracture(s) are not diagnosed and do not receive effective, FDA-approved therapies. Even those prescribed appropriate therapy are unlikely to take the medication as prescribed. The Clinician's Guide offers concise recommendations regarding prevention, risk assessment, diagnosis, and treatment of osteoporosis in postmenopausal women and men aged 50 years and older. It includes indications for bone densitometry as well as fracture risk thresholds for pharmacologic intervention. Current medications build bone and/or decrease bone breakdown and dramatically reduce incident fractures. All antifracture therapeutics treat but do not cure the disease. Skeletal deterioration resumes sooner or later when a medication is discontinued-sooner for nonbisphosphonates and later for bisphosphonates. Even if normal BMD is achieved, osteoporosis and elevated risk for fracture are still present. The diagnosis of osteoporosis persists even if subsequent DXA T-scores are above - 2.5. Ongoing monitoring and strategic interventions will be necessary if fractures are to be avoided. In addition to pharmacotherapy, adequate intake of calcium and vitamin D, avoidance of smoking and excessive alcohol intake, weight-bearing and resistance-training exercise, and fall prevention are included in the fracture prevention armamentarium. Where possible, recommendations in this guide are based on evidence from RCTs; however, relevant published data and guidance from expert clinical experience provides the basis for recommendations in those areas where RCT evidence is currently deficient or not applicable to the many osteoporosis patients not considered for RCT participation due to age and morbidity.


Assuntos
Conservadores da Densidade Óssea , Osteoporose Pós-Menopausa , Osteoporose , Fraturas por Osteoporose , Adulto , Idoso , Densidade Óssea , Conservadores da Densidade Óssea/farmacologia , Cálcio/uso terapêutico , Difosfonatos/uso terapêutico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Osteoporose/complicações , Osteoporose/diagnóstico , Osteoporose/tratamento farmacológico , Osteoporose Pós-Menopausa/tratamento farmacológico , Fraturas por Osteoporose/complicações , Fraturas por Osteoporose/prevenção & controle , Vitamina D/uso terapêutico
8.
Osteoporos Int ; 31(11): 2073-2076, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-32676822

RESUMO

Core principles for fracture prevention address fundamental concepts for the evaluation and management of patients at risk for fracture. These are intended to form the foundation of clinical practice guidelines and represent a first step toward guideline harmonization. INTRODUCTION: The large number of clinical practice guidelines for osteoporosis and discordance of recommendations has led to confusion among clinicians and patients, and likely contributes to the large osteoporosis treatment gap. We propose that stakeholder organizations reach agreement on fundamental principles in the management of osteoporosis and prevention of fracture as a first step toward a goal of guideline harmonization. METHODS: The best available evidence, as interpreted by an ad hoc working group of expert representatives from major osteoporosis societies in North America, was considered in the development of core principles for skeletal healthcare. These principles were subsequently endorsed by the USA National Osteoporosis Foundation, Osteoporosis Canada, and Academia Nacional de Medicina de Mexico (National Academy of Medicine of Mexico). RESULTS: Core principles are summarized here in bullet format. Categories include evaluation, lifestyle and nutrition, pharmacological therapy, and monitoring. A pathway forward to achieve guideline harmonization, at least in part, is proposed. CONCLUSION: Greater concordance of recommendations for the care of patients at risk for fracture are expected to lead to improved patient care across jurisdictions, with a narrowing of the osteoporosis treatment gap and reduced burden of fractures.


Assuntos
Fraturas Ósseas , Osteoporose , Canadá , Consenso , Fraturas Ósseas/prevenção & controle , Humanos , México , Osteoporose/tratamento farmacológico , Osteoporose/prevenção & controle , Estados Unidos
9.
Osteoporos Int ; 31(7): 1299-1304, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-32062687

RESUMO

This study expands on previous findings that hip fracture rates may no longer be declining. We found that age- and sex-adjusted fracture rates in the US plateaued or increased through mid-2017 in a population of commercially insured and Medicare Advantage health plan enrollees, in contrast to a decline from 2007 to 2013. INTRODUCTION: The purpose of this study was to evaluate fracture trends in US commercial and Medicare Advantage health plan members aged ≥ 50 years between 2007 and 2017. METHODS: Retrospective analysis of the Optum Research Database from January 1, 2007, to May 31, 2017. RESULTS: Of 1,841,263 patients identified with an index fracture, 930,690 were case-qualifying and included in this analysis. The overall age- and sex-adjusted fracture rate decreased from 14.67/1000 person-years (py) in 2007 to 11.79/1000 py in 2013, followed by a plateau for the next 3 years and then an increase to 12.50/1000 py in mid-2017. In females aged ≥ 65 years, fracture rates declined from 27.49/1000 py in 2007 to 22.08/1000 py in 2013, then increased to 24.92/1000 py in mid-2017. Likewise, fracture rates in males aged ≥ 65 years declined from 2007 (12.00/1000 py) to 2013 (10.72/1000 py), then increased to 12.04/1000 py in mid-2017. The age- and sex-adjusted fracture rates for most fracture sites declined from 2007 to 2013 by 3.7% per year (P = 0.310). CONCLUSIONS: Following a consistent decline in fracture rate from 2007 to 2013, trends from 2014 to 2017 indicate fracture rates are no longer declining and, for some fracture types, rates are rising.


Assuntos
Fraturas do Quadril , Fraturas por Osteoporose , Adolescente , Idoso , Feminino , Fraturas do Quadril/epidemiologia , Humanos , Incidência , Masculino , Programas de Assistência Gerenciada , Medicare , Fraturas por Osteoporose/epidemiologia , Estudos Retrospectivos , Estados Unidos/epidemiologia
10.
Osteoporos Int ; 30(12): 2401-2406, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31471665

RESUMO

Clinical practice guidelines provide helpful information for managing patients with metabolic bone disease. Good guidelines are based on the best available medical evidence; however, guidelines from different societies can conflict. Additionally, it is not possible for a guideline to anticipate the vast variability of circumstances, comorbidities, previous medical experiences, cultural differences, and preferences in real-world patients. Bone Health TeleECHO is a strategy for sharing knowledge on the care of patients with skeletal diseases through ongoing interactive videoconferences. We report three cases based on those presented at Bone Health TeleECHO, where, through discussion, treatment outside of commonly used guidelines was ultimately recommended. Guidelines developed by different organizations may provide "evidence-based" or "informed" recommendations which do not account for the variability of clinical circumstances encountered in the care of individual patients. This highlights the importance of Bone Health TeleECHO, where healthcare professionals can share knowledge, individualize treatment decisions, and improve patient care.Learning objectives At the end of this activity participants should be able to:• Distinguish between the onset and off of bisphosphonates versus other medications used in the prevention and treatment of osteoporosis and how this affects choice of a "drug holiday."• Understand the limitations of clinical practices guidelines in the care of an individual patient and how interactive video conferencing can assist with decision making.• Recognize that patients treated with glucocorticoids at high risk for fracture can benefit from more aggressive interventions for osteoporosis.


Assuntos
Tomada de Decisão Clínica/métodos , Osteoporose/tratamento farmacológico , Guias de Prática Clínica como Assunto/normas , Telecomunicações , Idoso , Conservadores da Densidade Óssea/uso terapêutico , Denosumab/uso terapêutico , Difosfonatos/uso terapêutico , Feminino , Glucocorticoides/efeitos adversos , Humanos , Masculino , Pessoa de Meia-Idade , Osteoporose/induzido quimicamente
11.
J Bone Miner Res ; 34(6): 1033-1040, 2019 06.
Artigo em Inglês | MEDLINE | ID: mdl-30919997

RESUMO

Although treat-to-target strategies are being discussed in osteoporosis, there is little evidence of what the target should be to reduce fracture risk maximally. We investigated the relationship between total hip BMD T-score and the incidence of nonvertebral fracture in women who received up to 10 years of continued denosumab therapy in the FREEDOM (3 years) study and its long-term Extension (up to 7 years) study. We report the percentages of women who achieved a range of T-scores at the total hip or femoral neck over 10 years of denosumab treatment (1343 women completed 10 years of treatment). The incidence of nonvertebral fractures was lower with higher total hip T-score. This relationship plateaued at a T-score between -2.0 and -1.5 and was independent of age and prevalent vertebral fractures, similar to observations in treatment-naïve subjects. Reaching a specific T-score during denosumab treatment was dependent on the baseline T-score, with higher T-scores at baseline more likely to result in higher T-scores at each time point during the study. Our findings highlight the importance of follow-up BMD measurements in patients receiving denosumab therapy because BMD remains a robust indicator of fracture risk. These data support the notion of a specific T-score threshold as a practical target for therapy in osteoporosis. © 2019 The Authors Journal of Bone and Mineral Research published by Wiley Periodicals, Inc. on behalf of American Society for Bone and Mineral Research (ASBMR).


Assuntos
Densidade Óssea , Denosumab/uso terapêutico , Fraturas Ósseas/tratamento farmacológico , Fraturas Ósseas/fisiopatologia , Idoso , Idoso de 80 Anos ou mais , Densidade Óssea/efeitos dos fármacos , Denosumab/farmacologia , Feminino , Quadril/fisiopatologia , Humanos , Fatores de Risco
12.
Osteoporos Int ; 30(1): 71-78, 2019 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-30244369

RESUMO

This post-hoc analysis queried whether women experiencing fracture on denosumab indicates inadequate treatment response or whether the risk of subsequent fracture remains low with continuing denosumab. Results showed that denosumab decreases the risk of subsequent fracture and fracture sustained while on denosumab is not necessarily indicative of inadequate treatment response. INTRODUCTION: This analysis assessed whether a fracture sustained during denosumab therapy indicates inadequate treatment response and if the risk of a subsequent fracture decreases with continuing denosumab treatment. METHODS: In FREEDOM, a clinical trial to evaluate the efficacy and safety of denosumab, postmenopausal women with osteoporosis were randomized to placebo or denosumab for 3 years. In the 7-year FREEDOM Extension, all participants were allocated to receive denosumab. Here we compare subsequent osteoporotic fracture rates between denosumab-treated subjects during FREEDOM or the Extension and placebo-treated subjects in FREEDOM. RESULTS: During FREEDOM, 438 placebo- and 272 denosumab-treated subjects had an osteoporotic fracture. Exposure-adjusted subject incidence per 100 subject-years was lower for denosumab (6.7) vs placebo (10.1). Combining all subjects on denosumab from FREEDOM and the Extension for up to 10 years (combined denosumab), 794 (13.7%) had an osteoporotic fracture while on denosumab. Of these, one or more subsequent fractures occurred in 144 (18.1%) subjects, with an exposure-adjusted incidence of 5.8 per 100 subject-years, similar to FREEDOM denosumab (6.7 per 100 subject-years) and lower than FREEDOM placebo (10.1 per 100 subject-years). Adjusting for prior fracture, the risk of having a subsequent on-study osteoporotic fracture was lower in the combined denosumab group vs placebo (hazard ratio [95% CI]: 0.59 [0.43-0.81]; P = 0.0012). CONCLUSIONS: These data demonstrate that denosumab decreases the risk of subsequent fracture and a fracture sustained while on denosumab is not necessarily indicative of inadequate treatment response.


Assuntos
Conservadores da Densidade Óssea/uso terapêutico , Denosumab/uso terapêutico , Fraturas por Osteoporose/prevenção & controle , Idoso , Idoso de 80 Anos ou mais , Densidade Óssea/efeitos dos fármacos , Método Duplo-Cego , Feminino , Seguimentos , Humanos , Pessoa de Meia-Idade , Osteoporose Pós-Menopausa/complicações , Osteoporose Pós-Menopausa/tratamento farmacológico , Osteoporose Pós-Menopausa/fisiopatologia , Fraturas por Osteoporose/etiologia , Fraturas por Osteoporose/fisiopatologia , Recidiva , Fraturas da Coluna Vertebral/etiologia , Fraturas da Coluna Vertebral/fisiopatologia , Fraturas da Coluna Vertebral/prevenção & controle
13.
Osteoporos Int ; 30(1): 45-57, 2019 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-30382319

RESUMO

Economic evaluations are increasingly used to assess the value of health interventions, but variable quality and heterogeneity limit the use of these evaluations by decision-makers. These recommendations provide guidance for the design, conduct, and reporting of economic evaluations in osteoporosis to improve their transparency, comparability, and methodologic standards. INTRODUCTION: This paper aims to provide recommendations for the conduct of economic evaluations in osteoporosis in order to improve their transparency, comparability, and methodologic standards. METHODS: A working group was convened by the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis to make recommendations for the design, conduct, and reporting of economic evaluations in osteoporosis, to define an osteoporosis-specific reference case to serve a minimum standard for all economic analyses in osteoporosis, to discuss methodologic challenges and initiate a call for research. A literature review, a face-to-face meeting in New York City (including 11 experts), and a review/approval by a larger group of experts worldwide (including 23 experts in total) were conducted. RESULTS: Recommendations on the type of economic evaluation, methods for economic evaluation, modeling aspects, base-case analysis and population, excess mortality, fracture costs and disutility, treatment characteristics, and model validation were provided. Recommendations for reporting economic evaluations in osteoporosis were also made and an osteoporosis-specific checklist was designed that includes items to report when performing an economic evaluation in osteoporosis. Further, 12 minimum criteria for economic evaluations in osteoporosis were identified and 12 methodologic challenges and need for further research were discussed. CONCLUSION: While the working group acknowledges challenges and the need for further research, these recommendations are intended to supplement general and national guidelines for economic evaluations, improve transparency, quality, and comparability of economic evaluations in osteoporosis, and maintain methodologic standards to increase their use by decision-makers.


Assuntos
Osteoporose/economia , Osteoporose/terapia , Análise Custo-Benefício , Custos de Cuidados de Saúde/estatística & dados numéricos , Humanos , Modelos Econométricos , Fraturas por Osteoporose/economia , Anos de Vida Ajustados por Qualidade de Vida , Projetos de Pesquisa
14.
Arch Osteoporos ; 13(1): 85, 2018 08 07.
Artigo em Inglês | MEDLINE | ID: mdl-30088189

RESUMO

Persistence with prescribed medications for chronic diseases is important; however, persistence with osteoporosis treatments is historically poor. In this prospective cohort study of postmenopausal women treated for osteoporosis in real-world clinical practice settings in the USA and Canada, 24-month persistence with denosumab was 58%. PURPOSE: Patients who persist with their prescribed osteoporosis treatment have increased bone mineral density (BMD) and reduced risk of fracture. Twelve-month persistence with denosumab in routine clinical practice is as high as 95%, but there are limited data on longer-term persistence with denosumab in this setting. METHODS: This single-arm, prospective, cohort study evaluated 24-month persistence with denosumab administered every 6 months in postmenopausal women receiving treatment for osteoporosis in real-world clinical practice in the USA and Canada. Endpoints and analyses included the percentage of patients who persist with denosumab at 24 months (greater than or equal to four injections with a gap between injections of no more than 6 months plus 8 weeks), the total number of injections received by each patient, changes in BMD in persistent patients, and the incidence of serious adverse events (SAEs) and fractures. RESULTS: Among 935 enrolled patients, 24-month persistence was 58% (50% in US patients and 75% in Canadian patients). A majority of patients received at least four injections over the observation period (62% of US patients and 81% of Canadian patients). Among patients who were persistent at 24 months and who had a baseline, 12-month, and 24-month DXA scan, mean BMD increased from baseline to 24 months by 7.8% at the lumbar spine and 2.1% at the femoral neck. SAEs and fractures were reported for 122 (13.0%) patients and 54 (5.8%) patients, respectively. CONCLUSIONS: Persistence with denosumab for 24 months yields improvement in BMD among postmenopausal women with osteoporosis treated in routine clinical practice in the USA and Canada.


Assuntos
Absorciometria de Fóton/estatística & dados numéricos , Conservadores da Densidade Óssea/uso terapêutico , Denosumab/uso terapêutico , Adesão à Medicação/estatística & dados numéricos , Osteoporose Pós-Menopausa/tratamento farmacológico , Idoso , Densidade Óssea/efeitos dos fármacos , Canadá , Feminino , Colo do Fêmur/diagnóstico por imagem , Humanos , Vértebras Lombares/diagnóstico por imagem , Pessoa de Meia-Idade , Osteoporose Pós-Menopausa/complicações , Osteoporose Pós-Menopausa/diagnóstico por imagem , Fraturas por Osteoporose/etiologia , Pós-Menopausa , Estudos Prospectivos , Fatores de Tempo , Estados Unidos
15.
Osteoporos Int ; 29(11): 2583, 2018 11.
Artigo em Inglês | MEDLINE | ID: mdl-30151621

RESUMO

The name of the first author, E.M. Lewiecki, was rendered incorrectly in the original publication. The publisher regrets any inconvenience and is pleased to correct the error here.

17.
Osteoporos Int ; 28(8): 2495-2503, 2017 08.
Artigo em Inglês | MEDLINE | ID: mdl-28540506

RESUMO

The Effectiveness of Discontinuing Bisphosphonates (EDGE) study is a planned pragmatic clinical trial to guide "drug holiday" clinical decision making. This pilot study assessed work flow and feasibility of such a study. While participant recruitment and treatment adherence were suboptimal, administrative procedures were generally feasible and minimally disrupted clinic flow. INTRODUCTION: The comparative effectiveness of continuing or discontinuing long-term alendronate (ALN) on fractures is unknown. A large pragmatic ALN discontinuation study has potential to answer this question. METHODS: We conducted a 6-month pilot study of the planned the EDGE study among current long-term ALN users (women aged ≥65 with ≥3 years of ALN use) to determine study work flow and feasibility including evaluating the administrative aspects of trial conduct (e.g., time to contract, institutional review board (IRB) approval), assessing rates of site and participant recruitment, and evaluating post-randomization outcomes, including adherence, bisphosphonate-associated adverse events, and participant and site satisfaction. We assessed outcomes 1 and 6 months after randomization. RESULTS: Nine sites participated, including seven community-based medical practices and two academic medical centers. On average (SD), contract execution took 3.4 (2.3) months and IRB approval took 13.9 (4.1) days. Sites recruited 27 participants (13 to continue ALN and 14 to discontinue ALN). Over follow-up, 22% of participants did not adhere to their randomization assignment: 30.8% in the continuation arm and 14.3% in the discontinuation arm. No fractures or adverse events were reported. Sites reported no issues regarding work flow, and participants were highly satisfied with the study. CONCLUSIONS: Administrative procedures of the EDGE study were generally feasible, with minimal disruption to clinic flow. In this convenience sample, participant recruitment was suboptimal across most practice sites. Accounting for low treatment arm adherence, a comprehensive recruitment approach will be needed to effectively achieve the scientific goals of the EDGE study.


Assuntos
Conservadores da Densidade Óssea/administração & dosagem , Difosfonatos/administração & dosagem , Osteoporose Pós-Menopausa/tratamento farmacológico , Idoso , Idoso de 80 Anos ou mais , Tomada de Decisão Clínica , Esquema de Medicação , Estudos de Viabilidade , Feminino , Humanos , Adesão à Medicação/estatística & dados numéricos , Fraturas por Osteoporose/prevenção & controle , Projetos Piloto , Suspensão de Tratamento
18.
Osteoporos Int ; 28(5): 1723-1732, 2017 05.
Artigo em Inglês | MEDLINE | ID: mdl-28144701

RESUMO

Stopping denosumab after 8 years of continued treatment was associated with bone loss during a 1-year observation study in patients who were not prescribed osteoporosis treatment. Bone loss was attenuated in patients who began another osteoporosis therapy. Treatment to prevent bone loss upon stopping denosumab should be considered. INTRODUCTION: This study aimed to understand osteoporosis management strategies during a 1-year observational follow-up after up to 8 years of denosumab treatment in a phase 2 study. METHODS: During the observational year, patients received osteoporosis management at the discretion of their physician and returned to the clinic for BMD assessment and completion of an osteoporosis management questionnaire. Incidence of serious adverse events and fractures was collected. Analyses were descriptive. RESULTS: Of 138 eligible patients, 82 enrolled in and completed the observation study. Most (65 [79%]) did not receive prescription osteoporosis medication, with "my doctor felt I no longer needed a medication" being the most common reason (23 [35%]). Of the 17 patients who took osteoporosis medications, 8 discontinued therapy during the observation study. In patients treated with denosumab for 8 years (N = 52), BMD decreased during the 1-year observation study (6.7% [lumbar spine], 6.6% [total hip]). Those who took osteoporosis medication during the observation study showed a smaller decline in BMD than those who did not. No new safety concerns were identified. Eight patients (9.8%), all of whom had at least one predisposing risk factor, experienced 17 fractures. This included seven patients who experienced one or more vertebral fractures. CONCLUSIONS: Consistent with denosumab's mechanism of action, treatment cessation led to reversal of the drug's effect on BMD and perhaps fracture risk. For patients who took osteoporosis therapy, bone loss was attenuated. For patients at high fracture risk, switching to another osteoporosis therapy if denosumab is discontinued seems appropriate.


Assuntos
Conservadores da Densidade Óssea/administração & dosagem , Denosumab/administração & dosagem , Osteoporose Pós-Menopausa/tratamento farmacológico , Idoso , Densidade Óssea/efeitos dos fármacos , Conservadores da Densidade Óssea/efeitos adversos , Denosumab/efeitos adversos , Esquema de Medicação , Feminino , Articulação do Quadril/fisiopatologia , Humanos , Vértebras Lombares/fisiopatologia , Pessoa de Meia-Idade , Osteoporose Pós-Menopausa/complicações , Osteoporose Pós-Menopausa/fisiopatologia , Fraturas por Osteoporose/etiologia , Fraturas por Osteoporose/fisiopatologia , Fraturas por Osteoporose/prevenção & controle , Suspensão de Tratamento
19.
Osteoporos Int ; 28(4): 1355-1363, 2017 04.
Artigo em Inglês | MEDLINE | ID: mdl-28058444

RESUMO

Little is known about treatment patterns with injectable osteoporosis therapies. At 12 months, the probability of discontinuation was 69.1% among patients using ibandronate, followed by teriparatide (67.1%), zoledronic acid (59.2%), and denosumab (48.8%). By 24 months, discontinuation was higher for each treatment. The majority of US patients discontinue injectable osteoporosis treatment by the end of the first year following initiation. INTRODUCTION: This study was designed to assess the frequency of treatment discontinuation over time among patients who initiate injectable osteoporosis therapies. METHODS: This retrospective observational study utilized an administrative claims database to measure discontinuation of injectable osteoporosis therapy, reported at 6-month intervals over 2 years. Eligible patients were aged ≥55 years, had newly initiated injectable osteoporosis therapy between January 2008 and June 2012, and were continuously enrolled in the health plan for ≥1 year prior to and ≥1.5 years after the date the first injectable medication was received (the index date). Follow-up time ranged from 18 to 24 months. Injectable osteoporosis treatments included in the analysis were denosumab, ibandronate, teriparatide, and zoledronic acid. Discontinuation was assessed using Kaplan-Meier survival analysis and was defined at each time point as the percentage of patients who did not receive the dose scheduled for that time point. A 90-day grace period was allowed to accommodate flexibility in the scheduling of post-index re-administrations. Sensitivity analyses assessed discontinuation using grace periods of 60 and 30 days. RESULTS: A total of 4756 patients met the inclusion criteria for the study, with 617 utilizing denosumab, 233 ibandronate, 778 teriparatide, and 3128 zoledronic acid. At 12 months, discontinuation was highest among patients using ibandronate (69.1%), followed by teriparatide (67.1%), zoledronic acid (59.2%), and denosumab (48.8%). By 24 months, discontinuation was higher for each treatment: 87.5% for ibandronate, 87.9% for teriparatide, 79.8% for zoledronic acid, and 64.3% for denosumab. CONCLUSIONS: The majority of US patients discontinue injectable osteoporosis treatment by the end of the first year following initiation.


Assuntos
Conservadores da Densidade Óssea/administração & dosagem , Adesão à Medicação/estatística & dados numéricos , Osteoporose Pós-Menopausa/tratamento farmacológico , Idoso , Idoso de 80 Anos ou mais , Conservadores da Densidade Óssea/uso terapêutico , Bases de Dados Factuais , Denosumab/administração & dosagem , Denosumab/uso terapêutico , Difosfonatos/administração & dosagem , Difosfonatos/uso terapêutico , Uso de Medicamentos/tendências , Feminino , Seguimentos , Humanos , Ácido Ibandrônico , Imidazóis/administração & dosagem , Imidazóis/uso terapêutico , Injeções Intravenosas , Estimativa de Kaplan-Meier , Pessoa de Meia-Idade , Estudos Retrospectivos , Teriparatida/administração & dosagem , Teriparatida/uso terapêutico , Estados Unidos , Ácido Zoledrônico
20.
Osteoporos Int ; 28(1): 407-411, 2017 01.
Artigo em Inglês | MEDLINE | ID: mdl-27439373

RESUMO

Bone Health ECHO telementors healthcare professionals to develop the clinical skills needed to provide advanced levels of care for patients with skeletal disorders. The goal of this mentorship model is to improve osteoporosis care in underserved areas, decrease the need for referral to specialty centers, and reduce the osteoporosis treatment gap. INTRODUCTION: The Project ECHO (Extension for Community Healthcare Outcomes) model of telementoring has been shown to improve the care individuals with chronic hepatitis C. ECHO has since been adapted to the address unmet needs in the care of other chronic complex diseases and recently applied to the care of osteoporosis and metabolic bone diseases. METHODS: Bone Health ECHO outcomes are assessed through an electronic data collector asking qualitative questions about self-efficacy. This is a progress report of Bone Health ECHO from its launch in October 2015 through May 2016. RESULTS: A total of 31 weekly Bone Health ECHO clinics were held over 8 months, with 43 individuals participating at least one clinic session. The number of clinics attended range from 1 to 30, with 13 learners attending more than 10 clinics and an average of 11 learners per clinic. Self-efficacy information provided by learners was diverse with many favorable anticipated changes in clinical practice. CONCLUSIONS: Bone Health ECHO telementors healthcare professionals in underserved areas to provide advanced levels of care for patients with skeletal disorders. The experience of Bone Health ECHO will guide the development of similar telementoring clinics in other locations. More data are needed to fully evaluate this novel approach to reducing the osteoporosis treatment gap.


Assuntos
Atenção à Saúde/métodos , Tutoria/métodos , Osteoporose/terapia , Telemedicina/métodos , Instituições de Assistência Ambulatorial/organização & administração , Competência Clínica , Serviços de Saúde Comunitária/organização & administração , Acessibilidade aos Serviços de Saúde/organização & administração , Pesquisa sobre Serviços de Saúde/métodos , Humanos , Área Carente de Assistência Médica , New Mexico
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