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Summary 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.

SummaryIn 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).IntroductionZoledronic 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.MethodsWe 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).ResultsThere 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).ConclusionThere data should provide more comfort in prescribing ZA after surgical repair of a hip fracture, regardless of pretreatment BMD.

Summary 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.

Summary 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.

Summary Patients with cognitive impairment (CI) often do not receive secondary fracture prevention. Use of zoledronic acid led to a similar reduction in re-fracture risk but the survival benefit was limited to those without CI. Introduction We tested whether the effects of zoledronic acid (Zol) on re-fracture and mortality differed in patients presenting with a hip fracture by cognitive status. Methods We used data from the Health Outcomes and Reduced Incidence with Zoledronic Acid Once Yearly Recurrent Fracture Trial, of yearly intravenous 5 mg Zol vs. placebo in patients presenting with a hip fracture. Primary outcome was new fracture and secondary outcome mortality. Short Portable Mental Status Questionnaire (SPMSQ) with a cut-point of >2 was used to identify CI. Fine–Gray models for competing events were fitted to study the effect of Zol on re-fracture and Cox regression for death. A multiplicative term was introduced to study a potential interaction between treatment and cognitive status on outcomes. Results Baseline SPMSQ of 1,966/2,127 (92.4 %) patients was measured. Three hundred fifty (17.8 %) had CI, balanced between treatment arms. In the placebo arm, there was similar fracture incidence between those with and without CI (15.4 vs. 12.3 %, p  = 0.26). There was no significant interaction for the effect of CI on Zol and re-fracture ( p  = 0.66). CI was associated with higher 1-year mortality (12.6 vs. 4.3 %, p  < 0.001) and the interaction was bordering significance (interaction, p  = 0.066). Zol prolonged survival only in patients with normal cognitive status [HR 0.56 (95 % CI 0.40–0.80)] and not in those with CI [HR 0.90 (95 % CI 0.59–1.38)]. Conclusions While these results require confirmation, the findings support the use of bisphosphonates in patients with osteoporotic fracture and CI expected to live for more than 6 months.

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. We determined the prevalence and predictors of osteoporosis evaluation and treatment in high-risk nursing home residents. 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. 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. There is substantial variation in the quality of osteoporosis treatment across nursing homes. Interventions that improve osteoporosis quality of care are needed.

Summary COVID-19 infection has resulted in significant morbidity and mortality globally, especially among older adults. Repurposed drugs have demonstrated activity in respiratory illnesses, including nitrogen-containing bisphosphonates. In this retrospective longitudinal study at 4 academic medical centers, we show no benefit of nitrogen-containing bisphosphonates regarding ICU admission, ventilator use, and mortality among older adults with COVID-19 infection. We specifically evaluated the intravenous bisphosphonate zoledronic acid and found no difference compared to oral bisphosphonates. Background Widely used in osteoporosis treatment, nitrogen-containing bisphosphonates (N-BP) have been associated with reduced mortality and morbidity among older adults. Based on prior studies, we hypothesized that prior treatment with N-BP might reduce intensive care unit (ICU) admission, ventilator use, and death among older adults diagnosed with COVID-19. Methods This retrospective analysis of the PCORnet Common Data Model across 4 academic medical centers through 1 September 2021 identified individuals age >50 years with a diagnosis of COVID-19. The composite outcome included ICU admission, ventilator use, or death within 15, 30, and 180 days of COVID-19 diagnosis. Use of N-BP was defined as a prescription within 3 years prior. ICU admission and ventilator use were determined using administrative codes. Death included both in-hospital and out-of-hospital events. Patients treated with N-BP were matched 1:1 by propensity score to patients without prior N-BP use. Secondary analysis compared outcomes among those prescribed zoledronic acid (ZOL) to those prescribed oral N-BPs. Results Of 76,223 COVID-19 patients identified, 1,853 were previously prescribed N-BP, among whom 559 were prescribed ZOL. After propensity score matching, there were no significant differences in the composite outcome at 15 days (HR 1.22, 95% CI: 0.89–1.67), 30 days (HR 1.24, 95% CI: 0.93–1.66), or 180 days (HR 1.17, 95% CI: 0.93–1.48), comparing those prescribed and not prescribed N-BP. Compared to those prescribed oral N-BP, there were no significant differences in outcomes among those prescribed ZOL. Conclusion Among older COVID-19 patients, prior exposure to N-BP including ZOL was not associated with a reduction in ICU admission, ventilator use, or death.

The contribution of hip fracture to the risk of subsequent fractures is unclear. Data from the Baltimore Hip Studies and the Established Populations for Epidemiologic Studies of the Elderly (EPESE) were used. Baltimore subjects enrolled at the time of hip fracture ( n=549) and EPESE subjects without previous fractures at baseline ( n=10,680) were followed for 2-10 years. Self-reported nonhip skeletal fracture was the outcome, and hip fracture was a time-varying covariate in a survival analysis stratified by study site. The model was adjusted for race, sex, age, BMI, stroke, cancer, difficulty walking across a room, dependence in grooming, dependence in transferring, and cognitive impairment. The rate of all subsequent self-reported fractures after hip fracture was 10.4 fractures/100 person-years. The unadjusted hazard of nonhip skeletal fracture was 2.52 (95% confidence interval 2.05 to 3.12) for subjects with hip fracture compared with subjects without; when adjusted for other known fracture risk factors the hazard ratio was 1.62 (1.30 to 2.02). Men and women had a similar relative risk increase. The increased risk of secondary fracture after hip fracture persisted over time. A hip fracture is associated with a 2.5-fold increased risk of subsequent fracture, which is not entirely explained by prefracture risk factors. Careful attention to secondary prevention is warranted in these patients.

Mortality is increased in the year after a hip fracture, and strategies that improve the outcome are needed. This randomized, double-blind, placebo-controlled trial compared yearly intravenous zoledronic acid with placebo first administered within 90 days after surgical repair of a hip fracture in patients who were unable or unwilling to take oral bisphosphonates. Zoledronic acid was associated with a reduced relative risk of a new clinical fracture and a reduction in mortality from all causes. This trial compared yearly zoledronic acid with placebo after surgical repair of a hip fracture. Zoledronate was associated with a reduced relative risk of a new clinical fracture and a reduction in mortality from all causes. Hip fractures are associated with increased morbidity, functional decline, and death in older adults, as well as increased use of health care services. 1 , 2 Mortality is increased in the year after hip fracture, with reported rates of 15 to 25% and an estimated 9 excess deaths per 100 patients among women 70 years of age or older. 2 – 10 One source of the excess morbidity and cost incurred by patients with hip fractures is new osteoporotic fractures. Such fractures occur at a rate of 10.4 per 100 patients per year, which is 2.5 times as high as the rate in age-matched . . .

Chronic back tiredness or fatigue is a common complaint of people who have a history of osteoporotic vertebral fracture. Trunk muscle endurance has not been studied in people with vertebral osteoporosis, partly due to the lack of assessment tools. We developed a measure of combined trunk and arm endurance suitable for people with vertebral osteoporosis, timed loaded standing (TLS). TLS measures the time a person can stand while holding a two-pound dumbbell in each hand with the arms at 90 degrees of shoulder flexion and the elbows extended. Intraclass correlation coefficients (ICCs) for same day inter-trial and six to ten day test-retest reliability were 0.89 (lower bound 95% confidence interval [LB 95% CI] 0.79) and 0.84 (LB 95% CI 0.68), respectively, in a sample of 21 older women with no known osteoporosis. In 127 women with vertebral fractures, the ICC for same day inter-trial reliability was 0.81 (LB 95% CI 0.75). In a sub-sample of 30 of these women with vertebral fractures, the six to ten day test-retest reliability was 0.85 (LB 95% CI 0.75). Moderately strong and statistically significant (p < or = 0.05) correlations were found between TLS and sixteen of eighteen measures of physical impairment and function. Functional reach distance, gait velocity, MOS-36 Physical Function Subscale, shoulder flexion strength, and six minute walk distance were most strongly associated with TLS time. Women with vertebral fractures who endorsed having back tiredness when standing and working with the arms in front of the body, sitting to rest because of back tiredness or pain, and planning rest periods because of back tiredness or pain had significantly lower TLS times. TLS is a simple, safe physical performance measure of combined trunk and arm endurance that demonstrates acceptable reliability (inter-trial and test- retest) and concurrent validity.