FRAX without BMD can be used to risk-stratify Veterans who recently sustained a low trauma non-vertebral/non-hip fracture.

We evaluated the fracture risk assessment tool (FRAX) without bone mineral density (BMD) in predicting treatment recommendations for patients with a recent low trauma fracture other than hip or vertebral. The concordance, sensitivity, and specificity were 75.6%, 67.3%, and 78.2%, respectively. FRAX without BMD can be used after a fracture to expedite treatment. INTRODUCTION: The objective of this study was to evaluate the performance of the fracture risk assessment tool (FRAX) without bone mineral density (BMD) in predicting treatment recommendations for patients who recently sustained a low trauma fracture other than hip or vertebral. METHODS: We utilized a clinical database established by the Fracture Liaison Service at the Durham Veterans Affairs Medical Center to identify male and female Veterans age ≥ 50 years who sustained a low trauma non-hip/non-vertebral fracture and underwent dual-energy x-ray absorptiometry (DXA) between October 2013 and April 2018. FRAX without BMD (FRAX-BMI) and FRAX with BMD (FRAX-BMD) were calculated for the 229 patients identified, and whether or not they met the National Osteoporosis Foundation (NOF) guideline treatment thresholds was compared. RESULTS: There were 55 (24.0%) patients that met criteria for treatment based on NOF guideline established FRAX-BMD thresholds including 27 (11.8%) patients with osteoporosis by DXA. The concordance of FRAX-BMI in predicting treatment recommendations was 75.6% with a sensitivity of 67.3% and a specificity of 78.2%. The area under the curve (AUC) of FRAX-BMI hip fracture risk was 0.79. Assessment/treatment thresholds for hip fracture risk of 1% < FRAX-BMI < 4% were proposed to maximize sensitivity and specificity. CONCLUSION: Among patients who sustained a low trauma non-hip/non-vertebral fracture, FRAX-BMI can be used to stratify risk and identify high-risk patients who could be treated without DXA, low-risk patients who may not need treatment, and intermediate-risk patients to undergo DXA testing.

Zoledronic acid reduces the rate of clinical fractures after surgical repair of a hip fracture regardless of the Pretreatment bone mineral density.

In patients with surgical repair of a low-trauma hip fracture, zoledronic acid (ZA) reduced the risk of subsequent fractures regardless of pretreatment femoral neck and total hip bone mineral density (BMD). INTRODUCTION: Zoledronic acid reduces the risk of subsequent fractures after repair of a hip fracture. It is still unclear whether the benefits in fracture reduction with ZA depend upon hip bone mineral density at the time of fracture. METHODS: We preformed additional post hoc analyses of data from the HORIZON Recurrent Fracture Trial to determine if ZA treatment reduced the risk of new clinical fractures regardless of pretreatment BMD. We modeled femoral neck and total hip BMD as both continuous and dichotomous variables (BMD T-score above and below -2.5). RESULTS: There are no evidence that baseline femoral neck and total hip BMD modified the anti-fracture efficacy of ZA when pretreatment BMD was analyzed as a continuous or a dichotomous variable (interaction p-values > 0.20). The clinical fracture efficacy of ZA was similar among patients with pretreatment femoral neck BMD values above and below -2.5 (relative hazards = 0.60 and 0.67, respectively, interaction p-value = 0.95). A similar result was obtained using pretreatment total hip BMD values (relative hazards = 0.72 and 0.57, respectively, interaction p-value = 0.41). CONCLUSION: There data should provide more comfort in prescribing ZA after surgical repair of a hip fracture, regardless of pretreatment BMD.

Association between timing of zoledronic acid infusion and hip fracture healing.

UNLABELLED: Patients in the Health Outcomes and Reduced Incidence with Zoledronic Acid Once Yearly (HORIZON) Recurrent Fracture Trial were assessed for evidence of delayed hip fracture healing. No association was observed between zoledronic acid (ZOL) and delayed healing. We conclude that ZOL has no clinically evident effect on fracture healing, even when the drug is infused in the immediate postoperative period. INTRODUCTION: Intravenous zoledronic acid 5 mg (ZOL) given after a hip fracture reduces secondary fracture rates and mortality. It has been postulated that bisphosphonates may affect healing if given soon after a fracture. We sought to determine whether the timing of ZOL infusion affected the risk of delayed hip fracture healing. METHODS: In the HORIZON Recurrent Fracture Trial, patients were randomized within 90 days of a low-trauma hip fracture to receive either once-yearly ZOL (n = 1,065) or placebo (n = 1,062). Clinical symptoms of delayed hip fracture healing were sought at randomization, 6 months and 12 months after fracture; if present, a central adjudication committee blinded to treatment assignment reviewed radiographs and clinical records. Median follow-up was 1.9 years. RESULTS: The overall incidence of delayed healing was 3.2% (ZOL) and 2.7% (placebo; odds ratio [OR], 1.17; 95% confidence interval [CI], 0.72-1.90; p = 0.61). Logistic regression models revealed no association between ZOL and delayed healing even after adjusting for other risk factors (OR, 1.21; 95% CI, 0.74-1.99; p = 0.44). There was no interaction by timing of infusion, and nonunion rates were similar even when ZOL was given within 2 weeks of hip fracture repair. NSAID use was significantly associated with delayed fracture healing (OR, 2.55; 95% CI, 1.49-4.39; p < 0.001). CONCLUSIONS: ZOL has no clinically evident effect on fracture healing, even when the drug is infused in the immediate postoperative period.

Zoledronic acid results in better health-related quality of life following hip fracture: the HORIZON-Recurrent Fracture Trial.

UNLABELLED: This study evaluated the benefits of ZOL versus placebo on health-related quality of life (HRQoL) among patients from HORIZON-RFT. At month 24 and end of the study visit, ZOL significantly improved patients' overall health state compared to placebo as assessed by the EQ-5D VAS. INTRODUCTION: To evaluate the benefits of zoledronic acid (ZOL) versus placebo on health-related quality of life (HRQoL) among patients from The Health Outcomes and Reduced Incidence With Zoledronic Acid Once Yearly Recurrent Fracture Trial (HORIZON-RFT). METHODS: In this randomized, double-blind, placebo-controlled trial, 2,127 patients were randomized to receive annual infusion of ZOL 5 mg (n = 1,065) or placebo (n = 1,062) within 90 days after surgical repair of low-trauma hip fracture. HRQoL was measured using EQ-5D Visual Analogue Scale (VAS) and utility scores (EuroQol instrument) at months 6, 12, 24, 36, and end of the study visit. Analysis of covariance model included baseline EQ-5D value, region, and treatment as explanatory variables. RESULTS: At baseline, patients (mean age 75 years; 24% men and 76% women) were well matched between treatment groups with mean EQ-5D VAS of 65.82 in ZOL and 65.70 in placebo group. At the end of the study, mean change from baseline in EQ-5D VAS was greater for ZOL vs. placebo in all patients (7.67 ± 0.56 vs. 5.42 ± 0.56), and in subgroups of patients experiencing clinical vertebral fractures (8.86 ± 4.91 vs. -1.69 ± 3.42), non-vertebral fractures (5.03 ± 2.48 vs. -1.07 ± 2.16), and clinical fractures (5.19 ± 2.25 vs. -0.72 ± 1.82) with treatment difference significantly in favor of ZOL. EQ-5D utility scores were comparable for ZOL and placebo groups, but more patients on placebo consistently had extreme difficulty in mobility (1.74% for ZOL vs. 2.13% for placebo; p = 0.6238), self-care (4.92% vs. 6.69%; p = 0.1013), and usual activities (10.28% vs. 12.91%; p = 0.0775). CONCLUSION: ZOL significantly improves HRQoL in patients with low-trauma hip fracture.

Transitional care from skilled nursing facilities to home: study protocol for a stepped wedge cluster randomized trial.

BACKGROUND: Skilled nursing facility (SNF) patients are medically complex with multiple, advanced chronic conditions. They are dependent on caregivers and have experienced recent acute illnesses. Among SNF patients, the rate of mortality or acute care use is over 50% within 90 days of discharge, yet these patients and their caregivers often do not receive the quality of transitional care that prepares them to manage serious illnesses at home. METHODS: The study will test the efficacy of Connect-Home, a successfully piloted transitional care intervention targeting seriously ill SNF patients discharged to home and their caregivers. The study setting will be SNFs in North Carolina, USA, and, following discharge, in patients' home. Using a stepped wedge cluster randomized trial design, six SNFs will transition at randomly assigned intervals from standard discharge planning to the Connect-Home intervention. The SNFs will contribute data for patients (N = 360) and their caregivers (N = 360), during both the standard discharge planning and Connect-Home time periods. Connect-Home is a two-step intervention: (a) SNF staff create an individualized Transition Plan of Care to manage the patient's illness at home; and (b) a Connect-Home Activation RN visits the patient's home to implement the written Transition Plan of Care. A key feature of the trial includes training of the SNF and Home Care Agency staff to complete the transition plan rather than using study interventionists. The primary outcomes will be patient preparedness for discharge and caregiver preparedness for caregiving role. With the proposed sample and using a two-sided test at the 5% significance level, we have 80% power to detect a 18% increase in the patient's preparedness for discharge score. We will employ linear mixed models to compare observations between intervention and usual care periods to assess primary outcomes. Secondary outcomes include (a) patients' quality of life, functional status, and days of acute care use and (b) caregivers' burden and distress. DISCUSSION: Study results will determine the efficacy of an intervention using existing clinical staff to (a) improve transitional care for seriously ill SNF patients and their caregivers, (b) prevent avoidable days of acute care use in a population with persistent risks from chronic conditions, and (c) advance the science of transitional care within end-of-life and palliative care trajectories of SNF patients and their caregivers. While this study protocol was being implemented, the COVID-19 pandemic occurred and this protocol was revised to mitigate COVID-related risks of patients, their caregivers, SNF staff, and the study team. Thus, this paper includes additional material describing these modifications. TRIAL REGISTRATION: ClinicalTrials.gov NCT03810534 . Registered on January 18, 2019.

Do physicians within the same practice setting manage osteoporosis patients similarly? Implications for implementation research.

UNLABELLED: Using data from long-term glucocorticoid users and long-term care residents, we evaluated osteoporosis prescribing patterns related to physician behavior and common practice settings. We found no significant clustering effect for common practice setting, suggesting that osteoporosis quality improvement (QI) efforts may be able to ignore this factor in designing QI interventions. INTRODUCTION: Patients' receipt of prescription therapies are significantly influenced by their physician's prescribing patterns. If physicians in the same practice setting influence one another's prescribing, evidence implementation interventions must consider targeting the practice as well as individual physicians to achieve maximal success. METHODS: We examined receipt of osteoporosis treatment (OP Rx) from two prior evidence implementation studies: long-term glucocorticoid (GC) users and nursing home (NH) residents with prior fracture or osteoporosis. Common practice setting was defined as doctors practicing at the same address or in the same nursing home. Alternating logistic regression evaluated the relationship between OP Rx, common practice setting, and individual physician treatment patterns. RESULTS: Among 6,281 GC users in 1,296 practices, the proportion receiving OP Rx in each practice was 6-100%. Among 779 NH residents in 66 nursing homes, the proportion in each NH receiving OP Rx was 0-100%. In both, there was no significant relationship between receipt of OP Rx and common practice setting after accounting for treatment pattern of individual physicians. CONCLUSION: Physicians practicing together were not more alike in prescribing osteoporosis medications than those in different practices. Osteoporosis quality improvement may be able to ignore common practice settings and maximize statistical power by targeting individual physicians.

Expert physician recommendations and current practice patterns for evaluating and treating men with osteoporotic hip fracture.

OBJECTIVES: To develop recommendations for the evaluation and the treatment of men with osteoporotic hip fracture from expert publications in the field of male osteoporosis, and to define the current practice patterns in a tertiary care VA Medical Center in Durham, North Carolina. DESIGN: Survey research; a retrospective cohort study. SETTING: Tertiary care VA Medical Center in Durham, North Carolina. PARTICIPANTS: (1) US physicians who published on the subject of male osteoporosis in the peer-reviewed literature between 1993 and 1997 identified by MEDLINE database search. (2) All 119 men admitted to the Durham VA Medical Center with ICD9 code for hip fracture between 1994 and 1998. OUTCOME MEASURES: (1) Osteoporosis evaluation and treatment recommendations of published physicians obtained by survey instrument. (2) Actual osteoporosis evaluation completed and therapy prescribed during index hospitalization in a cohort of men with hip fractures, determined by chart and database review. RESULTS: (1) Forty-three physician-researchers were surveyed with an 84% response rate. For an osteoporosis evaluation, 89% of respondents recommended measuring serum testosterone, 85% serum calcium, 75% 25-OH vitamin D levels, 73% myeloma screen, and 61% serum thyroid-stimulating hormone (TSH). Dual Energy X-ray Absorptiometry would be obtained by 92%. More than 70% recommended calcium, vitamin D, and bisphosphonates for men with a normal metabolic evaluation, and 60% suggested weight-bearing exercise. (2) In the cohort of men admitted with hip fractures, 50% had a serum calcium level and 3% had a serum TSH level measured. Vitamin D was prescribed to 25% of patients in the form of a multivitamin, and 4% received calcium. There was no bisphosphonate, testosterone, or calcitonin use. CONCLUSIONS: Physicians who have published on osteoporosis recommended metabolic evaluation and osteoporosis therapy after hip fracture. Only minimal evaluation and treatment occurred in a cohort of men with osteoporotic hip fractures.

Hip and other osteoporotic fractures increase the risk of subsequent fractures in nursing home residents.

UNLABELLED: Nursing home residents with a history of hip fractures or prior osteoporotic fractures were found to have an increased risk of another osteoporotic fracture over the ensuing two years when compared to nursing home residents with no fracture history. INTRODUCTION: Because of the high prevalence of osteoporosis and fall risk factors in nursing home residents, it is possible that the importance of previous fracture as a marker for subsequent fracture risk may be diminished. We tested whether a history of prior osteoporotic fractures would identify residents at increased risk of additional fractures after nursing home admission. METHODS: We identified all Medicare enrollees aged 50 and older who were in a nursing home in North Carolina in 2000 (n=30,655). We examined Medicare hospitalization claims to determine which enrollees had been hospitalized in the preceding 4 years for a hip fracture (n=7,257) or other fracture (n=663). We followed participants from nursing home entry until the end of 2002 using Medicare hospital claims to determine which participants were hospitalized with a subsequent fracture (n=3,381). RESULTS: Among residents with no recent fracture history, 6.8% had a hospital claim for a subsequent fracture, while 15.1% of those with a prior non-hip fracture and 23.9% of participants with a prior hip fracture sustained subsequent fractures. Multivariate proportional hazards models of time to fracture indicated that persons with prior hip fractures are at three times higher risk (HR=2.99, 95% CI: 2.78, 3.21) and those hospitalized with other non-hip fractures are at 1.8 times higher risk of subsequent fractures (HR=1.84, 95% CI: 1.50, 2.25). CONCLUSION: Nursing home residents hospitalized with a prior osteoporotic fracture are at increased risk of a fracture.

Prevalence and predictors of osteoporosis treatment in nursing home residents with known osteoporosis or recent fracture.

SUMMARY: We studied nursing home residents with osteoporosis or recent fracture to determine the frequency and predictors of osteoporosis treatment. There was wide variation in performance, and both clinical and systems variables predicted use. This study shows that improvement in osteoporosis care is possible and important for many nursing homes. INTRODUCTION: We determined the prevalence and predictors of osteoporosis evaluation and treatment in high-risk nursing home residents. METHODS: We identified 67 nursing facilities in North Carolina and Arizona with > 10 residents with osteoporosis or recent hip fracture. Medical records (n=895) were abstracted for osteoporosis evaluation [dual-energy X-ray absorptiometry (DXA), vitamin D level, serum calcium), treatment (calcium, vitamin D, osteoporosis medication, hip protectors), clinical, and systems covariates. Data were analyzed at the facility level using mixed models to account for the complex nesting of residents within providers and nursing facilities. RESULTS: Calcium and vitamin D was prescribed for 69% of residents, bisphosphonates for 19%, calcitonin for 14%, other pharmacologic therapies for 6%, and hip protectors for 2%. Overall, 36% received any bone protection (medication or hip protectors), with wide variation among facilities (0-85%). Factors significantly associated with any bone protection included female gender [odds ratio (OR) 2.4, (1.5-3.7)] and nonurban/suburban location [1.5, (1.1-2.2)]. Residents with esophagitis, peptic ulcer disease (PUD), or dysphagia [0.6, (0.4-0.9)] and alcohol abuse [0.2, (0.0-0.9)] were less likely to receive treatment. CONCLUSIONS: There is substantial variation in the quality of osteoporosis treatment across nursing homes. Interventions that improve osteoporosis quality of care are needed.

Can historical and functional risk factors be used to predict fractures in community-dwelling older adults? development and validation of a clinical tool.

The objectives of the study were: (1) to evaluate the contribution of impaired functional status, cognition and medication to fracture risk; (2) to determine whether risk factor profiles differ between regionally and socially diverse populations; and (3) to develop and validate a simple fracture prediction instrument for use in older adults using easily obtainable clinical information. A prospective population-based cohort study with 6-10 years of follow-up was carried out: the Duke and Iowa Established Populations for the Epidemiologic Study of the Elderly (EPESE), with in-person interviews in North Carolina and Iowa. The participants were community-dwelling men and women aged 65 years or over without a history of previous fracture at the baseline interview ( n = 7654). The measurements were potential risk factors for osteoporosis and falls including: demographic factors, co-morbidities, medications, functional status measures, and physical measures. These were examined for association with self-reported subsequent hip fractures and fractures at any site using survival analysis. The resulting multivariable model was simplified and validated in a separate cohort. Test operating characteristics at 3 years were estimated using logistic regression. There were a total of 842 fractures in both cohorts including 382 hip fractures. Significant risk factors for all subsequent fractures and/or hip fracture in the developmental cohort included female sex (relative hazard 1.9-2.3), lowest quartile of body mass index (1.3), Caucasian race (2.1-2.8), one or more Rosow-Breslau physical function impairments (1.8-2.1), age over 75 years (2.1), history of stroke (1.9), cognitive impairment (2.2), one or more impairments in the activities of daily living (1.5) and anti-seizure medication use (2.0). Three predicitive models were highly significantly correlated with subsequent fractures with c-statistics in the developmental cohort at 3 and 6 years of 0.640-0.789. A simple count of risk factors had similar discriminative ability to the full model with a linear 35-65% increase in hazard of all fractures and hip fracture for each additional risk factor. In the validation cohort, the above variables were less potent predictors of fracture with only sex, body mass index and Rosow-Breslau impairment achieving significance. The predictive models including risk factor count remained significant in the validation set although the discriminative ability of the model was poor, with c-statistics of 0.574-0.749. Although there is no cut-point where fracture risk dramatically increases, patients can be counselled that there is a linear 77% increase in risk of hip fracture, and 29% increase in any fracture risk, with each additional risk factor they possess. Functional status impairment is an important predictor of fracture in older community-dwelling adults. The contribution of risk factors to fracture risk may differ between distinct populations.