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1.
JAMA Netw Open ; 3(12): e2025190, 2020 Dec 01.
Artigo em Inglês | MEDLINE | ID: mdl-33284336

RESUMO

Importance: Clinical trials have demonstrated the antifracture efficacy of bisphosphonate drugs for the first 3 to 5 years of therapy. However, the efficacy of continuing bisphosphonate for as long as 10 years is uncertain. Objective: To examine the association of discontinuing bisphosphonate at study entry, discontinuing at 2 years, and continuing for 5 additional years with the risk of hip fracture among women who had completed 5 years of bisphosphonate treatment at study entry. Design, Setting, and Participants: This cohort study included women who were members of Kaiser Permanente Northern and Southern California, 2 integrated health care delivery systems, and who had initiated oral bisphosphonate and completed 5 years of treatment by January 1, 2002, to September 30, 2014. Data analysis was conducted from January 2018 to August 2020. Exposure: Discontinuation of bisphosphonate at study entry (within a 6-month grace period), discontinuation at 2 years (within a 6-month grace period), and continuation for 5 additional years. Main Outcomes and Measures: The outcome was hip fracture determined by principal hospital discharge diagnoses. Demographic, clinical, and pharmacological data were ascertained from electronic health records. Results: Among 29 685 women (median [interquartile range] age, 71 [64-77] years; 17 778 [60%] non-Hispanic White individuals), 507 incident hip fractures were identified. Compared with bisphosphonate discontinuation at study entry, there were no differences in the cumulative incidence (ie, risk) of hip fracture if women remained on therapy for 2 additional years (5-year risk difference [RD], -2.2 per 1000 individuals; 95% CI, -20.3 to 15.9 per 1000 individuals) or if women continued therapy for 5 additional years (5-year RD, 3.8 per 1000 individuals; 95% CI, -7.4 to 15.0 per 1000 individuals). While 5-year differences in hip fracture risk comparing continuation for 5 additional years with discontinuation at 2 additional years were not statistically significant (5-year RD, 6.0 per 1000 individuals; 95% CI, -9.9 to 22.0 per 1000 individuals), interim hip fracture risk appeared lower if women discontinued after 2 additional years (3-year RD, 2.8 per 1000 individuals; 95% CI, 1.3 to 4.3 per 1000 individuals; 4-year RD, 9.3 per 1000 individuals; 95% CI, 6.3 to 12.3 per 1000 individuals) but not without a 6-month grace period to define discontinuation. Conclusions and Relevance: In this study of women treated with bisphosphonate for 5 years, hip fracture risk did not differ if they discontinued treatment compared with continuing treatment for 5 additional years. If women continued for 2 additional years and then discontinued, their risk appeared lower than continuing for 5 additional years. Discontinuation at other times and fracture rates during intervening years should be further studied.

3.
Clin Orthop Surg ; 12(3): 304-311, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32904116

RESUMO

Backgroud: To determine patient factors that lead to treatment of meniscal tears with osteoarthritis (OA) with knee arthroscopy (KA) or physical therapy only (PT-only); and to assess differences in clinical outcomes including the time to knee arthroplasty. Methods: Patients aged ≥ 45 years with OA at meniscal tear diagnosis were followed up from the date of surgery (KA) or first PT visit (PT-only) until partial/total knee replacement surgery, death, disenrollment, or end of study. Demographic and clinical characteristics were compared and used to derive propensity scores. A Cox proportional hazards model was used to estimate the risk of knee replacement surgery and greater healthcare utilization associated with KA vs. PT-only. Results: Among 7,026 patients (KA, 69%; PT-only, 31%), 27% had partial or total knee replacement surgery during follow-up. PT-only patients were older and more likely to be women and had more comorbidities. After accounting for differences between groups, the cumulative incidence of knee replacement was modestly but significantly higher for those who received KA than those who underwent PT-only (hazard ratio, 1.30; 95% confidence interval, 1.17-1.44; p < 0.001), although there was no significant difference in health service utilization, narcotic medication dispenses, or knee injections after initiating treatment. Conclusions: For patients with meniscal damage complicated by OA, those who underwent KA were 30% more likely to have partial or total knee replacement surgery at any given time than those who had PT alone.

4.
N Engl J Med ; 383(8): 743-753, 2020 08 20.
Artigo em Inglês | MEDLINE | ID: mdl-32813950

RESUMO

BACKGROUND: Bisphosphonates are effective in reducing hip and osteoporotic fractures. However, concerns about atypical femur fractures have contributed to substantially decreased bisphosphonate use, and the incidence of hip fractures may be increasing. Important uncertainties remain regarding the association between atypical femur fractures and bisphosphonates and other risk factors. METHODS: We studied women 50 years of age or older who were receiving bisphosphonates and who were enrolled in the Kaiser Permanente Southern California health care system; women were followed from January 1, 2007, to November 30, 2017. The primary outcome was atypical femur fracture. Data on risk factors, including bisphosphonate use, were obtained from electronic health records. Fractures were radiographically adjudicated. Multivariable Cox models were used. The risk-benefit profile was modeled for 1 to 10 years of bisphosphonate use to compare associated atypical fractures with other fractures prevented. RESULTS: Among 196,129 women, 277 atypical femur fractures occurred. After multivariable adjustment, the risk of atypical fracture increased with longer duration of bisphosphonate use: the hazard ratio as compared with less than 3 months increased from 8.86 (95% confidence interval [CI], 2.79 to 28.20) for 3 years to less than 5 years to 43.51 (95% CI, 13.70 to 138.15) for 8 years or more. Other risk factors included race (hazard ratio for Asians vs. Whites, 4.84; 95% CI, 3.57 to 6.56), height, weight, and glucocorticoid use. Bisphosphonate discontinuation was associated with a rapid decrease in the risk of atypical fracture. Decreases in the risk of osteoporotic and hip fractures during 1 to 10 years of bisphosphonate use far outweighed the increased risk of atypical fracture among Whites but less so among Asians. After 3 years, 149 hip fractures were prevented and 2 bisphosphonate-associated atypical fractures occurred in Whites, as compared with 91 and 8, respectively, in Asians. CONCLUSIONS: The risk of atypical femur fracture increased with longer duration of bisphosphonate use and rapidly decreased after bisphosphonate discontinuation. Asians had a higher risk than Whites. The absolute risk of atypical femur fracture remained very low as compared with reductions in the risk of hip and other fractures with bisphosphonate treatment. (Funded by Kaiser Permanente and others.).


Assuntos
Conservadores da Densidade Óssea/efeitos adversos , Difosfonatos/efeitos adversos , Fraturas do Fêmur/induzido quimicamente , Fraturas do Quadril/prevenção & controle , Osteoporose Pós-Menopausa/tratamento farmacológico , Fraturas por Osteoporose/prevenção & controle , Idoso , Idoso de 80 Anos ou mais , Americanos Asiáticos , Conservadores da Densidade Óssea/uso terapêutico , Difosfonatos/uso terapêutico , Grupo com Ancestrais do Continente Europeu , Feminino , Fraturas do Fêmur/epidemiologia , Fraturas do Fêmur/etnologia , Fraturas do Quadril/epidemiologia , Humanos , Incidência , Pessoa de Meia-Idade , Análise Multivariada , Osteoporose Pós-Menopausa/complicações , Fraturas por Osteoporose/induzido quimicamente , Fraturas por Osteoporose/epidemiologia , Modelos de Riscos Proporcionais , Medição de Risco , Fatores de Risco , Fatores de Tempo
6.
J Manag Care Spec Pharm ; 26(2): 197-202, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-32011964

RESUMO

BACKGROUND: Few studies have examined factors that determine bisphosphonate (BP) continuation beyond 5 years in clinical practice. OBJECTIVE: To investigate factors associated with BP continuation among women who completed 5 years of BP therapy. METHODS: Women who received 5 consecutive years of oral BP treatment entered the cohort during 2002-2014 and were followed up to 5 additional years. Multivariable logistic regression was used to evaluate the association of demographic and clinical factors with adherent treatment continuation. RESULTS: The cohort included 19,091 women with a median age of 72 years. Baseline and time-varying factors associated with increased odds of BP continuation after 5 years were (a) most recent bone mineral density (BMD) T-score -2 to -2.4 (OR = 1.31, 95% CI = 1.25-1.38), T-score -2.5 to -2.9 (OR = 1.48, 95% CI = 1.39-1.57), and T-score ≤ -3.0 (OR = 1.57, 95% CI = 1.47-1.68) versus T-scores above -2.0; (b) index date before 2008 (OR =1.35, 95% CI = 1.29-1.41); and (c) diabetes mellitus (OR = 1.08, 95% CI = 1.01-1.16). In contrast, factors associated with decreased odds of BP continuation were (a) recent hip (OR = 0.61, 95% CI = 0.52-0.71) or humerus (OR = 0.79, 95% CI = 0.66-0.94) fracture or fracture other than hip, wrist, spine, or humerus (OR = 0.90, 95% CI = 0.84-0.97); (b) Charlson Comorbidity Index score > 2 (OR = 0.91, 95% CI = 0.84-0.98); (c) history of rheumatoid arthritis (OR = 0.89, 95% CI = 0.80-0.99); (d) Hispanic (OR = 0.89, 95% CI=0.85-0.94) or Asian (OR = 0.90, 95% CI = 0.85-0.94) race/ethnicity; and (e) use of proton pump inhibitors (OR = 0.65, 95% CI = 0.59-0.71). Patient age and fracture before BP initiation were not associated with treatment continuation. CONCLUSIONS: Clinical factors predicting continued BP treatment beyond 5 years include low BMD T-score, absence of recent fracture, and earlier era of treatment. Use of proton pump inhibitors was associated with lower likelihood of BP continuation. Other clinical and demographic factors were also noted to have variable effects on BP treatment continuation. DISCLOSURES: This study was supported by a grant from the National Institute on Aging and National Institute of Arthritis, Musculoskeletal and Skin Diseases at the National Institutes of Health (NIH; R01AG047230, S1). The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH or Kaiser Permanente. Lo has received previous research funding from Amgen and Sanofi, unrelated to the current study. Adams has received previous research funding from Merck, Amgen, Otsuka, and Radius Health, unrelated to the current study. Ettinger has served as an expert witness for Teva Pharmaceuticals, unrelated to the current study. Ott previously attended a scientific advisory meeting for Amgen but declined the honorarium. The other authors have nothing to disclose. These data were presented at the 2018 Annual Meeting of the American Society of Bone and Mineral Research (ASBMR), September 28-October 1, 2018, Montreal, Quebec, Canada.


Assuntos
Conservadores da Densidade Óssea/administração & dosagem , Difosfonatos/administração & dosagem , Osteoporose/tratamento farmacológico , Fraturas por Osteoporose/prevenção & controle , Administração Oral , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Feminino , Humanos , Pessoa de Meia-Idade , Osteoporose/complicações , Fraturas por Osteoporose/epidemiologia , Inibidores da Bomba de Prótons/administração & dosagem , Fatores de Tempo
7.
Surgery ; 167(1): 144-148, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-31582307

RESUMO

BACKGROUND: Parathyroidectomy (PTX) increases bone mineral density and decreases fracture risk in patients with primary hyperparathyroidism. This study examined the effect of adding bisphosphonates either before or after PTX on skeletal outcomes. METHODS: A retrospective cohort study of bisphosphonate-naïve patients (1995-2016) with osteoporosis and primary hyperparathyroidism (calcium >10.5 mg/dL; PTH >65) was performed. Time-varying Cox regression was used to estimate an adjusted risk of any fracture in 5 comparison groups: observation, bisphosphonates alone, PTX alone, bisphosphonates then PTX, and PTX then bisphosphonates. The secondary outcome was change in bone mineral density of the hip. RESULTS: The cohort comprised 1,737 patients, of whom 303 underwent PTX (17%), 433 received bisphosphonates only (25%), 125 had bisphosphonates then PTX (7%), and 69 had PTX then bisphosphonates (4%). PTX was associated with a decrease in fracture risk (HR 0.55, 95% CI 0.35-0.84), as was bisphosphonates then PTX (HR 0.46, 95% CI 0.25-0.83). In contrast, the fracture risks associated with PTX then bisphosphonates (HR 1.09, 95% CI 0.65-1.81) and bisphosphonates alone (HR 0.82, 95% CI 0.62-1.08) were similar to observation. Hip bone mineral density increased after both PTX (5.50%, 95% CI 3.39-7.61) and PTX then bisphosphonates (6.30%, 95% CI 2.53-10.07). CONCLUSION: Bisphosphonate initiation after PTX may interfere with the beneficial effects of PTX on fracture risk in osteoporotic patients with primary hyperparathyroidism.


Assuntos
Conservadores da Densidade Óssea/administração & dosagem , Hiperparatireoidismo Primário/terapia , Osteoporose/diagnóstico por imagem , Fraturas por Osteoporose/epidemiologia , Paratireoidectomia , Absorciometria de Fóton , Idoso , Densidade Óssea/efeitos dos fármacos , Cálcio/sangue , Terapia Combinada/métodos , Difosfonatos/administração & dosagem , Feminino , Humanos , Hiperparatireoidismo Primário/sangue , Hiperparatireoidismo Primário/complicações , Masculino , Pessoa de Meia-Idade , Osteoporose/sangue , Osteoporose/etiologia , Osteoporose/prevenção & controle , Fraturas por Osteoporose/sangue , Fraturas por Osteoporose/etiologia , Fraturas por Osteoporose/prevenção & controle , Hormônio Paratireóideo/sangue , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Resultado do Tratamento
8.
Intern Med J ; 50(9): 1100-1108, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-31707754

RESUMO

BACKGROUND: Falls and hip fractures among older people are associated with high morbidity and mortality. Hyponatraemia may be a risk for falls/hip fractures, but the effect of hyponatraemia duration is not well understood. AIMS: To evaluate individuals with periods of sub-acute and chronic hyponatraemia on subsequent risk for serious falls and/or hip fractures. METHODS: Retrospective cohort study in the period 1 January 1998 to 14 June 2016 within an integrated health system of individuals aged ≥55 years with ≥2 outpatient serum sodium measurements. Hyponatraemia was defined as sodium <135 mEq/L with sub-acute (<30 days) and chronic (≥30 days) analysed as a time-dependent exposure. Multivariable Cox proportional-hazards modelling was used to estimate hazard ratios (HR) for serious falls/hip fractures based on sodium category. RESULTS: Among 1 062 647 individuals totalling 9 762 305 sodium measurements, 96 096 serious falls/hip fracture events occurred. Incidence (per-1000-person-years) of serious falls/hip fractures were 11.5, 27.9 and 19.8 for normonatraemia, sub-acute and chronic hyponatraemia. Any hyponatraemia duration compared to normonatraemia had a serious falls/hip fractures HR (95%CI) of 1.18 (1.15, 1.22), with sub-acute and chronic hyponatraemia having HR of 1.38 (1.33, 1.42) and 0.91 (0.87, 0.95), respectively. Examined separately, the serious falls HR was 1.37 (1.32, 1.42) and 0.92 (0.88, 0.96) in sub-acute and chronic hyponatraemia, respectively. Hip fracture HR were 1.52 (1.42, 1.62) and 1.00 (0.92, 1.08) for sub-acute and chronic hyponatraemia, respectively, compared to normonatraemia. CONCLUSIONS: Our findings suggest that early/sub-acute hyponatraemia appears more vulnerable and associated with serious falls/hip fractures. Whether hyponatraemia is a marker of frailty or a modifiable risk factor for falls remains to be determined.

9.
J Manag Care Spec Pharm ; 25(6): 719-723, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31134854

RESUMO

BACKGROUND: Assigning drug exposure is a necessary first step in examining bisphosphonate (BP) treatment in observational studies using pharmacy data. OBJECTIVE: To determine whether the choice of adherence level using the proportion of days covered (PDC) affected BP exposure assignment. METHODS: 10,381 female health plan members who initiated oral BP therapy between 2002 and 2010 and had received 5 consecutive years of treatment were identified and subsequently followed up to 5 additional years. In each 90-day interval of follow-up, a woman was considered "on treatment" if she received the drug for more than a predetermined PDC based on pharmacy days supply and "off treatment" if she received the drug for less than that PDC. Women who continued on therapy above the PDC threshold during follow-up were considered continuously on therapy. Women who were off treatment during the first 90-days of follow-up were classified as off therapy and were followed to determine if they remained continuously off treatment. This study evaluated the extent to which varying the PDC threshold (≥ 0.5, ≥ 0.6, and ≥ 0.7) affected the proportion of women classified as "continuously on" or "continuously off" BP during follow-up. RESULTS: Under PDC thresholds of 0.5, 0.6, and 0.7, 48%, 43%, and 36% of women who remained on follow-up were categorized as continuously on treatment at year 2 of follow-up, and 18%, 14%, and 12% were categorized as continuously on treatment by the end of follow-up. Using these same PDC thresholds, 9%, 12%, and 15% of women were categorized as off therapy during the first quarter of follow-up and were highly likely to remain off therapy: 4%, 5%, and 5% were classified as continuously off therapy at year 2, and 4% of women were classified as such by the end of follow-up for all 3 thresholds. CONCLUSIONS: A PDC of 0.6 was chosen as a practical threshold for drug adherence. Varying the PDC to 0.5 or 0.7 resulted in modest changes in the proportions of women considered continuously on BP therapy. DISCLOSURES: This study was supported by a grant from the National Institute of Aging and National Institute of Arthritis, Musculoskeletal and Skin Diseases at the National Institutes of Health (R01AG047230, S1). Lo has received previous research funding from Amgen and Sanofi, outside of the current study. Chandra has received previous research funding from Amgen outside of the current study. Adams has received previous research funding from Merck, Amgen, Otsuka, and Radius Health, outside of the current study. Ott previously attended a scientific advisory meeting for Amgen but declined the honorarium. Ettinger previously served as an expert witness for Teva Pharmaceuticals.


Assuntos
Conservadores da Densidade Óssea/uso terapêutico , Difosfonatos/uso terapêutico , Adesão à Medicação/estatística & dados numéricos , Fraturas por Osteoporose/prevenção & controle , Assistência Farmacêutica/estatística & dados numéricos , Idoso , Prescrições de Medicamentos/estatística & dados numéricos , Feminino , Seguimentos , Humanos , Osteoporose/complicações , Fraturas por Osteoporose/etiologia , Estudos Retrospectivos , Fatores de Tempo , Resultado do Tratamento , Estados Unidos
10.
Endocr Pract ; 25(5): 470-476, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-30720335

RESUMO

Objective: The natural biochemical history of untreated primary hyperparathyroidism (PHPT) is poorly understood. The purpose of this study was to determine the extent of biochemical fluctuations in patients with PHPT. Methods: Retrospective cohort study from January 1, 1995, to December 31, 2014. Serum calcium and parathyroid hormone (PTH) levels in patients with classic (Ca >10.5 mg/dL, PTH >65 pg/mL) and nonclassic (Ca >10.5 mg/dL, PTH 40 to 65 pg/mL) PHPT were followed longitudinally at 1, 2, and 5 years. Biochemical profiles in follow-up were ranked in descending biochemical severity as classic PHPT, nonclassic PHPT, normal calcium with elevated PTH (Ca <10.5 mg/dL, PTH >65 pg/mL), possible PHPT (Ca >10.5 mg/dL, PTH 21 to 40 pg/mL), or absent PHPT (Ca >10.5 mg/dL, PTH <21 pg/mL or Ca <10.5 mg/dL, PTH <65 pg/mL). Results: Of 10,598 patients, 1,570 were treated with parathyroidectomy (n = 1,433) or medications (n = 137), and 4,367 were censored due to study closure, disenrollment, or death. In the remaining 4,661 untreated patients with 5 years of follow-up, 235 (5.0%) progressed to a state of increased biochemical severity, whereas 972 (20.8%) remained the same, and 3,454 (74.1%) regressed to milder biochemical states. In 2,522 untreated patients with classic PHPT, patients most frequently transitioned to the normal calcium with elevated PTH group (n = 1,257, 49.8%). In 2,139 untreated patients with nonclassic PHPT, patients most frequently transitioned to the absent PHPT group (n = 1,354, 63.3%). Conclusion: PHPT is a biochemically dynamic disease with significant numbers of patients exhibiting both increases and decreases in biochemical severity. Abbreviations: IQR = interquartile range; KPSC = Kaiser Permanente Southern California; PHPT = primary hyperparathyroidism; PTH = parathyroid hormone; PTx = parathyroidectomy.


Assuntos
Hiperparatireoidismo Primário , Cálcio , California , Humanos , Hormônio Paratireóideo , Paratireoidectomia , Estudos Retrospectivos
11.
Surgery ; 165(1): 99-104, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30420089

RESUMO

BACKGROUND: Patients with primary hyperparathyroidism are at risk for skeletal and renal end-organ damage. METHODS: We studied patients with biochemically confirmed primary hyperparathyroidism from 1995-2014 and quantified the frequency of osteoporosis, nephrolithiasis, hypercalciuria, and decrease in renal function. RESULTS: The cohort comprised 9,485 patients. In total, 3,303 (35%) had preexisting end-organ effects (osteoporosis, 24%; nephrolithiasis, 10%; hypercalciuria, 5%). Of 6,182 remaining patients, 1,769 (29%) exhibited progression to 1 or more end-organ effects over a median 3.7 years. Among patients with classic primary hyperparathyroidism (calcium and parathyroid hormone increased), progression was unrelated to the degree of hypercalcemia (calcium >11.5 mg/dL, hazard ratio 1.03, 95% confidence interval 0.85-1.25; 11.1-11.5 mg/dL, HR 1.07, 95% confidence interval 0.93-1.23; 10.5-11.0 mg/dL = reference). Patients with nonclassic primary hyperparathyroidism (calcium increased, parathyroid hormone 40-65 pg/mL) had a lesser risk of progression (calcium >11.5 mg/dL, hazard ratio 0.68, 95% confidence interval 0.50-0.94; 11.1-11.5 mg/dL, hazard ratio 0.68, 95% confidence interval 0.56-0.82; 10.5-11.0 mg/dL, hazard ratio 0.66, 95% confidence interval 0.59-0.74). End-organ damage developed before or within 5 years of diagnosis for 62% of patients. CONCLUSION: End-organ manifestations of primary hyperparathyroidism develop before biochemical diagnosis or within 5 years in most patients. End-organ damage occurred more frequently in patients with classic primary hyperparathyroidism versus nonclassic primary hyperparathyroidism, regardless of severity of hypercalcemia.


Assuntos
Hipercalciúria/etiologia , Hiperparatireoidismo Primário/complicações , Nefrolitíase/etiologia , Osteoporose/etiologia , Idoso , Cálcio/sangue , Estudos de Coortes , Progressão da Doença , Feminino , Taxa de Filtração Glomerular , Humanos , Masculino , Pessoa de Meia-Idade , Índice de Gravidade de Doença
12.
J Bone Miner Res ; 33(7): 1291-1301, 2018 07.
Artigo em Inglês | MEDLINE | ID: mdl-29665068

RESUMO

Methods now exist for analyzing previously taken clinical computed tomography (CT) scans to measure a dual-energy X-ray absorptiometry (DXA)-equivalent bone mineral density (BMD) at the hip and a finite element analysis-derived femoral strength. We assessed the efficacy of this "biomechanical CT" (BCT) approach for identifying patients at high risk of incident hip fracture in a large clinical setting. Using a case-cohort design sampled from 111,694 women and men aged 65 or older who had a prior hip CT scan, a DXA within 3 years of the CT, and no prior hip fracture, we compared those with subsequent hip fracture (n = 1959) with randomly selected sex-stratified controls (n = 1979) and analyzed their CT scans blinded to all other data. We found that the age-, race-, and body mass index (BMI)-adjusted hazard ratio (HR; per standard deviation) for femoral strength was significant before (women: HR = 2.8, 95% confidence interval [CI] 2.2-3.5; men: 2.8, 2.1-3.7) and after adjusting also for the (lowest) hip BMD T-score by BCT (women: 2.1, 1.4-3.2; men: 2.7, 1.6-4.6). The hazard ratio for the hip BMD T-score was similar between BCT and DXA for both sexes (women: 2.1, 1.8-2.5 BCT versus 2.1, 1.7-2.5 DXA; men: 2.8, 2.1-3.8 BCT versus 2.5, 2.0-3.2 DXA) and was higher than for the (lowest) spine/hip BMD T-score by DXA (women: 1.6, 1.4-1.9; men: 2.1, 1.6-2.7). Compared with the latter as a clinical-practice reference and using both femoral strength and the hip BMD T-score from BCT, sensitivity for predicting hip fracture was higher for BCT (women: 0.66 versus 0.59; men: 0.56 versus 0.48), with comparable respective specificity (women: 0.66 versus 0.67; men: 0.76 versus 0.78). We conclude that BCT analysis of previously acquired routine abdominal or pelvic CT scans is at least as effective as DXA testing for identifying patients at high risk of hip fracture. © 2018 American Society for Bone and Mineral Research.


Assuntos
Fraturas do Quadril/diagnóstico por imagem , Osteoporose/diagnóstico por imagem , Tomografia Computadorizada por Raios X , Absorciometria de Fóton , Idoso , Idoso de 80 Anos ou mais , Área Sob a Curva , Fenômenos Biomecânicos , Densidade Óssea , Feminino , Fêmur/diagnóstico por imagem , Fêmur/patologia , Fêmur/fisiopatologia , Fraturas do Quadril/complicações , Humanos , Masculino , Osteoporose/complicações , Fatores de Risco , Sensibilidade e Especificidade
13.
J Bone Miner Res ; 33(7): 1252-1259, 2018 07.
Artigo em Inglês | MEDLINE | ID: mdl-29529334

RESUMO

Holidays from bisphosphonates (BPs) may help to prevent rare adverse events such as atypical femoral fractures, but may be appropriate only if risk of osteoporosis-related fractures does not increase. Our objective was to compare the incidence of osteoporosis-related fractures among women who had a BP holiday to those who continued to use BPs. This retrospective cohort study, conducted within four Kaiser Permanente integrated health system regions, included 39,502 women aged ≥45 years with ≥3 years exposure to BP. Participants with a BP holiday (≥12 months with no use) were compared to persistent (use with ≥50% adherence) and nonpersistent (use with <50% adherence) users for incident osteoporosis-related fractures. The BP holiday (n = 11,497), nonpersistent user (n = 10,882), and persistent user groups (n = 17,123) were observed for 156,657 person-years. A total of 5199 osteoporosis-related fractures (including 1515 hip fractures and 2147 vertebral fractures) were observed. Compared to the persistent use group, there was a slight difference in overall osteoporosis-related fracture risk (HR 0.92; 95% CI, 0.84 to 0.99)and no difference in hip fracture risk (HR 0.95; 95% CI, 0.83 to 1.10) for the BP holiday group. A slight reduction in risk of vertebral fracture was observed (HR 0.83; 95% CI, 0.74 to 0.95). Compared to the nonpersistent user group, the BP holiday group was at decreased risk for osteoporosis-related fractures (HR 0.71; 95% CI, 0.65 to 0.79), vertebral fractures (HR 0.68; 95% CI, 0.59 to 0.78), and hip fractures (HR 0.59; 95% CI, 0.50 to 0.70). Women who undertake a BP holiday from BP of ≥12 months duration for any reason after ≥3 years of BP use do not appear to be at greater risk of osteoporosis-related fragility fracture, hip, or vertebral fractures compared to ongoing BP users. In our cohort, BP holiday remains a viable strategy for balancing the benefits and potential harms associated with long-term BP use. © 2018 American Society for Bone and Mineral Research.


Assuntos
Difosfonatos/efeitos adversos , Fraturas Ósseas/induzido quimicamente , Fraturas Ósseas/epidemiologia , Fraturas por Osteoporose/induzido quimicamente , Fraturas por Osteoporose/epidemiologia , Estudos de Coortes , Feminino , Humanos , Pessoa de Meia-Idade , Fatores de Risco , Estados Unidos/epidemiologia
14.
Surgery ; 163(1): 17-21, 2018 01.
Artigo em Inglês | MEDLINE | ID: mdl-29108699

RESUMO

BACKGROUND: Parathyroidectomy improves bone mineral density and decreases risk for fracture in patients with primary hyperparathyroidism. The aim of this study was to determine skeletal consequences of failed parathyroidectomy. METHODS: A retrospective, cohort study of patients with biochemically confirmed primary hyperparathyroidism within a vertically integrated health system was performed (1995-2014). Failed parathyroidectomy was defined by hypercalcemia within 6 months of initial parathyroidectomy. Time-varying Cox regression was used to estimate the risk for any fracture and hip fracture in 3 comparison groups: observation, successful parathyroidectomy, and failed parathyroidectomy. Bone mineral density changes also were compared. RESULTS: The cohort included 7,169 patients, of whom 5,802 (81%) were observed, 1,228 underwent successful parathyroidectomy (17%), and 137 underwent failed parathyroidectomy (2%). The adjusted risk for any fracture (hazard ratio, 1.28; 95% confidence interval, 0.85-1.92) and hip fracture (hazard ratio, 1.63; 95% CI, 0.77-3.45) associated with failed parathyroidectomy was similar to that associated with observation. Successful parathyroidectomy was associated with a decrease in any fracture (hazard ratio, 0.68; 95% confidence interval, 0.57-0.82) and hip fracture (hazard ratio, 0.43; 95% confidence interval, 0.27-0.68) compared with observation. Bone mineral density changes in the failed parathyroidectomy group paralleled those associated with observation. CONCLUSION: Failed parathyroidectomy is associated with a high risk for fracture similar to that seen with observation.


Assuntos
Densidade Óssea , Fraturas Ósseas/epidemiologia , Paratireoidectomia , Complicações Pós-Operatórias/epidemiologia , Idoso , California/epidemiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Falha de Tratamento
15.
Am J Manag Care ; 23(12): e421-e422, 2017 Dec 01.
Artigo em Inglês | MEDLINE | ID: mdl-29261250

RESUMO

In the setting of changing temporal trends in the management of osteoporosis, we examined how select characteristics of new oral bisphosphonate (BP) initiators changed over time among 94,073 women within a large, integrated healthcare organization during the period 2004 to 2012. In the earlier era (2004-2007), approximately half of women younger than 65 years initiating BP therapy (47%-54%) had osteoporosis by bone mineral density (BMD) criteria, but this proportion increased sharply in the later era (2008-2012), with 55% to 81% having osteoporosis. This trend was not evident in older women (≥65 years). The proportion of younger women with prior fracture increased from 15% in 2008 to 32% in 2012, after remaining relatively stable (10%-15%) during the earlier era. Again, this trend was not observed among older women. Thus, among women younger than 65 years, we observed a marked temporal shift in initiation of BP treatment toward women at high risk (including those with prior fracture and those with osteoporosis by BMD testing) and away from those at lower risk (such as those with osteopenia and/or no prior fracture).


Assuntos
Conservadores da Densidade Óssea/administração & dosagem , Doenças Ósseas Metabólicas/complicações , Doenças Ósseas Metabólicas/tratamento farmacológico , Prestação Integrada de Cuidados de Saúde , Difosfonatos/administração & dosagem , Fraturas Ósseas/etiologia , Fatores Etários , Idoso , Densidade Óssea , Doenças Ósseas Metabólicas/prevenção & controle , Feminino , Humanos , Adesão à Medicação , Pessoa de Meia-Idade , Osteoporose Pós-Menopausa/tratamento farmacológico , Estados Unidos
16.
J Manag Care Spec Pharm ; 23(4): 503-512, 2017 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-28345435

RESUMO

BACKGROUND: Examining drug exposure is essential to pharmacovigilance, especially for bisphosphonate (BP) therapy. OBJECTIVE: To examine differences in 4 measures of oral BP exposure: treatment discontinuation, adherence, persistence, and nonpersistence. METHODS: Among women aged ≥ 50 years who initiated oral BP therapy during 2002-2007 with at least 3 years of health plan membership follow-up, discontinuation was defined by evidence of no further treatment during the study observation period. Among those with at least 2 filled BP prescriptions during the study period, adherence was calculated for each year of follow-up using the (modified) proportion of days covered (mPDC) metric that allows for stockpiling of prescription/refills overlap ≤ 30 days supply. Persistence was quantified by treatment duration, allowing a gap of up to 60 days between prescription/refill days covered. Nonpersistence was quantified by the periods without drugs outside this allowable gap. Multivariable logistic regression was used to compare age and race groups and the relationships of early adherence (adherence during the first year) with subsequent adherence. RESULTS: Among 48,390 women initiating oral BP therapy and followed for 3 years, 26.7% discontinued in year 1, and 14.7% of the remaining 35,456 women discontinued in year 2. Discontinuation rates were slightly higher (29.4%, P < 0.001) for women aged ≥ 75 years and somewhat lower (21.1%, P < 0.001) for Asian women. During the first year, 60.4% of the women achieved an mPDC of ≥ 75%, with demographic differences in adherence similar to that seen for treatment discontinuation. Over the 3 years, the median mPDC levels for BP therapy were 86%, 84%, and 85% in years 1, 2, and 3, respectively, for those receiving treatment. Cumulative persistence was 2.3 years (median, IQR = 1.0-3.0) overall and slightly greater for Asian versus white women and lower for older women. There were 18,174 (42.9%) women with at least 1 period of nonpersistence during 3 years follow-up in excess of the 60-day allowable gap between prescription/refills (median cumulative nonpersistence = 0.65, IQR = 0.30-1.25 years). Women with mPDC ≥ 75% during the first year had a 12-fold and 6-fold increased odds of mPDC ≥ 75% during year 2 and year 3, respectively. CONCLUSIONS: BP discontinuation rates are highest for women during the first year. Among those continuing treatment in subsequent years, adherence rates were relatively stable. Persistence and adherence varied slightly by age and was somewhat higher in Asians, contributing to differences in cumulative BP exposure. We also found evidence that optimal adherence in the first year was highly predictive of optimal adherence in the subsequent 1-2 years. Hence, subgroups of patients receiving oral BP drugs may require different levels of support and monitoring to maximize treatment benefit, especially based on early patterns of use. DISCLOSURES: This study was supported by grants from the Kaiser Permanente Northern California Community Benefit Program and the National Institutes of Health, 1R01AG047230-01A1. The opinions expressed in this publication are solely the responsibility of the authors and do not represent the official views of Kaiser Permanente or the National Institutes of Health. Hui, Yi, and Chandra have received past research funding from Amgen not related to the current study. Adams has received research funding from Amgen, Merck, and Otsuka not related to the current study. Niu has received research funding from Bristol-Myers Squibb not related to the current study. Ettinger has received past legal fees in litigation involving Fosamax. Lo has received past research funding from Amgen and current research funding from Sanofi not related to the current study. The data from this study were presented at the Academy of Managed Care Pharmacy Annual Meeting; April 19-22, 2016; San Francisco, California. Study concept and design were contributed primarily by Hui and Lo, along with Adams, Niu, Yi, and Ettinger. Hui took the lead in data collection, along with Chandra, and data interpretation was performed by Niu, Yi, and Lo, along with the other authors. The manuscript was written by Hui, Adams, and Lo, along with Niu, Yi, and Ettinger, and revised by Ettinger, Hui, Lo, and Niu, along with the other authors.


Assuntos
Conservadores da Densidade Óssea/uso terapêutico , Atenção à Saúde/estatística & dados numéricos , Difosfonatos/uso terapêutico , Adesão à Medicação/estatística & dados numéricos , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Algoritmos , Americanos Asiáticos , Prestação Integrada de Cuidados de Saúde , Prescrições de Medicamentos/estatística & dados numéricos , Grupos Étnicos , Grupo com Ancestrais do Continente Europeu , Feminino , Humanos , Estados Unidos
17.
Ann Intern Med ; 164(11): 715-23, 2016 Jun 07.
Artigo em Inglês | MEDLINE | ID: mdl-27043778

RESUMO

BACKGROUND: The comparative effectiveness of surgical and medical treatments on fracture risk in primary hyperparathyroidism (PHPT) is unknown. OBJECTIVE: To measure the relationship of parathyroidectomy and bisphosphonates with skeletal outcomes in patients with PHPT. DESIGN: Retrospective cohort study. SETTING: An integrated health care delivery system. PARTICIPANTS: All enrollees with biochemically confirmed PHPT from 1995 to 2010. MEASUREMENTS: Bone mineral density (BMD) changes and fracture rate. RESULTS: In 2013 patients with serial bone density examinations, total hip BMD increased transiently in women with parathyroidectomy (4.2% at <2 years) and bisphosphonates (3.6% at <2 years) and declined progressively in both women and men without these treatments (-6.6% and -7.6%, respectively, at >8 years). In 6272 patients followed for fracture, the absolute risk for hip fracture at 10 years was 20.4 events per 1000 patients who had parathyroidectomy and 85.5 events per 1000 patients treated with bisphosphonates compared with 55.9 events per 1000 patients without these treatments. The risk for any fracture at 10 years was 156.8 events per 1000 patients who had parathyroidectomy and 302.5 events per 1000 patients treated with bisphosphonates compared with 206.1 events per 1000 patients without these treatments. In analyses stratified by baseline BMD status, parathyroidectomy was associated with reduced fracture risk in both osteopenic and osteoporotic patients, whereas bisphosphonates were associated with increased fracture risk in these patients. Parathyroidectomy was associated with fracture risk reduction in patients regardless of whether they satisfied criteria from consensus guidelines for surgery. LIMITATION: Retrospective study design and nonrandom treatment assignment. CONCLUSION: Parathyroidectomy was associated with reduced fracture risk, and bisphosphonate treatment was not superior to observation. PRIMARY FUNDING SOURCE: National Institute on Aging.


Assuntos
Difosfonatos/efeitos adversos , Fraturas Ósseas/etiologia , Hiperparatireoidismo Primário/tratamento farmacológico , Hiperparatireoidismo Primário/cirurgia , Paratireoidectomia/efeitos adversos , Idoso , Densidade Óssea , Feminino , Fraturas do Quadril/etiologia , Humanos , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias , Estudos Retrospectivos , Fatores de Risco
18.
Ann Epidemiol ; 25(11): 844-8, 2015 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-26475981

RESUMO

PURPOSE: To estimate the association between hydroxymethylglutaryl-CoA inhibitor (statin) use and hip fracture. METHODS: We conducted a population-based case-control study. Cases were 6774 male enrollees in a large managed care organization, aged 45 or more years, with an incident hip fracture from 1997 to 2006. Controls without fracture (n = 6774) were matched to cases on age, race, and medical center. Electronic information on pharmaceutical use was used to identify the dispensing of statins from 1991 forward. RESULTS: Overall, 1884 (27.8%) cases and 2150 controls (31.7%) used a statin before index date (matched odds ratio [mOR] = 0.81, 95% confidence interval [CI] = 0.74-0.87). Adjustment for comorbidity burden strengthened the magnitude of the overall association (mOR = 0.68, CI = 0.62-0.74). The adjusted association was similar across age groups but was strongest among men aged 80 years or more (mOR = 0.62, CI = 0.54-0.71) and was most pronounced in African Americans (mOR = 0.43, CI = 0.28-0.64). Greater duration of statin use did not alter the odds ratios. CONCLUSIONS: These data add to the growing evidence of a potential protective effect of statin use on bone health. However, these results need to be replicated in a prospective study that can account for confounding by indication which may explain these findings.


Assuntos
Doenças Cardiovasculares/prevenção & controle , Grupos Étnicos/estatística & dados numéricos , Fraturas do Quadril/epidemiologia , Inibidores de Hidroximetilglutaril-CoA Redutases/administração & dosagem , Idoso , Idoso de 80 Anos ou mais , California/epidemiologia , Estudos de Casos e Controles , Comorbidade , Relação Dose-Resposta a Droga , Comportamentos Relacionados com a Saúde , Fraturas do Quadril/prevenção & controle , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/efeitos adversos , Incidência , Masculino , Adesão à Medicação/etnologia , Pessoa de Meia-Idade , Razão de Chances , Vigilância da População , Risco
19.
J Shoulder Elbow Surg ; 24(2): 191-8, 2015 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-25240809

RESUMO

HYPOTHESIS AND BACKGROUND: Proximal humeral fractures comprise 10% of fractures in the Medicare population. The effect, if any, of treating osteoporosis to prevent these fractures has not been determined. The primary objective is to determine the effectiveness of a systematic osteoporosis screening and treatment program on the hazard of developing a fracture over the treatment period. The secondary aim is to determine demographic risk factors. METHODS: This is a retrospective cohort study in a health care organization serving 3.3 million members. Individuals selected for dual-energy x-ray absorptiometry screening were (1) women aged 65 years or older; (2) men aged 70 years or older; and (3) individuals aged 50 years or older who have a history of fragility fracture, use glucocorticoids, have a parental history of hip fracture, have rheumatoid arthritis, use alcohol at a high rate, or are cigarette smokers. Treatment consisted primarily of pharmacologic intervention with bisphosphonates. RESULTS: Individuals diagnosed with osteoporosis had a hazard ratio of 7.43 for sustaining a fracture over the study period. Patients screened with dual-energy x-ray absorptiometry had a hazard ratio of 0.17 whereas those treated medically had a hazard ratio of 0.55 versus untreated controls. Risk factors that significantly increased the risk of a fracture developing included age, female gender, white race, diabetes mellitus, and history of a distal radius fracture. DISCUSSION AND CONCLUSION: Over the study period, screening and treatment for osteoporosis significantly decreased the hazard ratio for proximal humeral fracture. This information broadens the impact of such programs because current best practices are primarily based on prevention of spine and hip fractures.


Assuntos
Osteoporose/tratamento farmacológico , Fraturas do Ombro/epidemiologia , Absorciometria de Fóton , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Conservadores da Densidade Óssea/uso terapêutico , Diabetes Mellitus/epidemiologia , Difosfonatos/uso terapêutico , Grupo com Ancestrais do Continente Europeu , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Osteoporose/complicações , Osteoporose/diagnóstico por imagem , Fraturas do Rádio/epidemiologia , Estudos Retrospectivos , Fatores de Risco , Fatores Sexuais , Fraturas do Ombro/etnologia , Fraturas do Ombro/etiologia
20.
Ann Epidemiol ; 24(4): 286-90, 2014 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-24507954

RESUMO

PURPOSE: To estimate the association between proton-pump inhibitor (PPI) use and hip fracture. METHODS: We conducted a case-control study of 6774 pairs of men aged 45 years or older, matched on age, race, and medical center. Cases sustained incident hip fractures in 1997-2006. Fracture date was index date for each case-control pair. PPI exposure was identified from electronic pharmacy records, 1991-2006. PPI use was measured as (1) ever versus never; (2) adherence; (3) duration; and (4) recentness. Omeprazole and pantoprazole were analyzed separately using conditional logistic regression, adjusted for comorbidities. Nonusers were the referent group. RESULTS: Eight hundred ninety-six (13.2%) cases and 713 (10.5%) controls used omeprazole before index date (matched odds ratio [OR], 1.13; 95% confidence interval [CI], 1.01-1.27). Greatest adherence (medication possession ratio > 80%) (OR, 1.33; 95% CI, 1.09-1.62), highest tertile of duration (OR, 1.23; 95% CI, 1.02-1.48), and recent use (OR, 1.22; 95% CI, 1.02-1.47) were associated with hip fracture. Six hundred ninety-four (10.2%) cases and 576 (8.5%) controls had used pantoprazole (OR, 1.10; 95% CI, 0.97-1.24). Longest duration (OR, 1.25; 95% CI, 1.02-1.53) and most recent use (OR, 1.38; 95% CI, 1.12-1.71) were associated with hip fracture. Our study suggests that PPI use and hip fractures are associated, with risk increasing with longer duration and more recent use.


Assuntos
2-Piridinilmetilsulfinilbenzimidazóis/efeitos adversos , Fraturas do Quadril/epidemiologia , Omeprazol/efeitos adversos , Inibidores da Bomba de Prótons/efeitos adversos , 2-Piridinilmetilsulfinilbenzimidazóis/uso terapêutico , Idoso , Idoso de 80 Anos ou mais , California/epidemiologia , Estudos de Casos e Controles , Intervalos de Confiança , Humanos , Masculino , Pessoa de Meia-Idade , Razão de Chances , Omeprazol/uso terapêutico , Osteoporose/induzido quimicamente , Pantoprazol , Inibidores da Bomba de Prótons/uso terapêutico
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