Treatment dynamics of bone-targeting agents among men with bone metastases from prostate cancer in the United States.

PURPOSE: To examine the dynamics of treatment with 2 bone-targeting agents (BTAs)-denosumab and zoledronic acid-among men with bone metastases from prostate cancer. METHODS: Using electronic health record data from oncology practices across the US, we identified prostate cancer patients diagnosed with bone metastasis in 2012/2013 without evidence of BTA use within 6 months prior to diagnosis. We examined the risk and predictors of BTA initiation, interruption, and re-initiation. RESULTS: Among 897 men diagnosed with prostate cancer, the cumulative incidence of BTA initiation after bone metastasis diagnosis was 34% (95% confidence interval [CI], 31-37%) at 30 days, 64% (95% CI, 61-68%) at 180 days, and 88% (95% CI, 85-91%) at 2 years. Denosumab was initiated more frequently than zoledronic acid. Men with diabetes, more bone lesions, history of androgen deprivation therapy, or no hospice enrollment were more likely to initiate treatment. Following initiation, the cumulative incidence of treatment interruption was 17% (95% CI, 14-19%) at 60 days and 70% (95% CI, 66-74%) at 2 years, with interruption more likely among patients receiving emerging therapies for prostate cancer or enrolling in hospice. The cumulative incidence of re-initiation following interruption was 36.3% (95% CI, 32.7-40.2%) at 15 days, 49.8% (95% CI, 45.9-54.1%) at 30 days, and 81.0% (95% CI, 77.5-84.7%) at 1 year. CONCLUSIONS: Bone-targeting agent therapy is initiated by the majority of men living with bone metastases following a prostate cancer diagnosis; however, the timing of initiation is highly variable. Once on treatment, gaps or interruptions in therapy are common.

Target weight achievement and ultrafiltration rate thresholds: potential patient implications.

BACKGROUND: Higher ultrafiltration (UF) rates and extracellular hypo- and hypervolemia are associated with adverse outcomes among maintenance hemodialysis patients. The Centers for Medicare and Medicaid Services recently considered UF rate and target weight achievement measures for ESRD Quality Incentive Program inclusion. The dual measures were intended to promote balance between too aggressive and too conservative fluid removal. The National Quality Forum endorsed the UF rate measure but not the target weight measure. We examined the proposed target weight measure and quantified weight gains if UF rate thresholds were applied without treatment time (TT) extension or interdialytic weight gain (IDWG) reduction. METHODS: Data were taken from the 2012 database of a large dialysis organization. Analyses considered 152,196 United States hemodialysis patients. We described monthly patient and dialysis facility target weight achievement patterns and examined differences in patient characteristics across target weight achievement status and differences in facilities across target weight measure scores. We computed the cumulative, theoretical 1-month fluid-related weight gain that would occur if UF rates were capped at 13 mL/h/kg without concurrent TT extension or IDWG reduction. RESULTS: Target weight achievement patterns were stable over the year. Patients who did not achieve target weight (post-dialysis weight ≥ 1 kg above or below target weight) tended to be younger, black and dialyze via catheter, and had shorter dialysis vintage, greater body weight, higher UF rate and more missed treatments compared with patients who achieved target weight. Facilities had, on average, 27.1 ± 9.7% of patients with average post-dialysis weight ≥ 1 kg above or below the prescribed target weight. In adjusted analyses, facilities located in the midwest and south and facilities with higher proportions of black and Hispanic patients and higher proportions of patients with shorter TTs were more likely to have unfavorable facility target weight measure scores. Without TT extension or IDWG reduction, UF rate threshold (13 mL/h/kg) implementation led to an average theoretical 1-month, fluid-related weight gain of 1.4 ± 3.0 kg. CONCLUSIONS: Target weight achievement patterns vary across clinical subgroups. Implementation of a maximum UF rate threshold without adequate attention to extracellular volume status may lead to fluid-related weight gain.

Bone Density Screening and Re-screening in Postmenopausal Women and Older Men.

Clinical practice guidelines universally recommend bone mineral density (BMD) screening to identify osteoporosis in women aged 65 years and older. Risk assessment is recommended to guide BMD screening in postmenopausal women under age 65. Insufficient data are available to inform standard ages to start and stop BMD screening in postmenopausal women. Based on longitudinal studies of incident osteoporosis and fracture in postmenopausal women, an initial BMD test should be ordered for all women aged 65, and the frequency of re-screening should be based on age and BMD T score (more frequent testing for older age and lower T score). Although clinical practice guidelines recommend BMD screening according to risk factors for fracture in postmenopausal women under age 65, no standard approach to risk assessment exists. Minimal evidence is available to guide osteoporosis screening in men, but some experts recommend initiation of BMD screening in men at age 70.

DXA Utilization Between 2006 and 2012 in Commercially Insured Younger Postmenopausal Women.

Reimbursement for dual-energy X-ray absorptiometry (DXA) scans in the outpatient setting has declined significantly since 2006. Research through 2011 has suggested reimbursement reductions for DXA scans have corresponded with an overall decreased utilization of DXA. This study updates utilization estimates for DXAs through 2012 in patients with commercial insurance and compares DXA rates before and after reimbursement changes. We evaluated DXA utilization for women aged 50-64 yr from Marketscan Commercial Claims and Encounter database between January 2006 and December 2012 based on CPT codes. We estimated utilization rates per 1000 person years (PY). We also used segmented regression analysis of monthly rates to evaluate the change in utilization rates after a proposed reimbursement reduction in July 2009. In women aged 50-64 yr, 451,656 DXAs were performed in 2006, a rate of 144 DXAs per 1000 PY. This rate increased to 149 DXAs per 1000 PY in 2009 before decreasing to 110 DXAs per 1000 PY or 667,982 scans in 2012. DXA utilization increased by 2.24 per 1000 PY until July 2009 then declined by 12.98 DXAs per 1000 persons, resulting in 37.5 DXAs per PY fewer performed in 2012 compared with 2006. Since July 2009 a significant decline in DXA utilization occurred in a younger postmenopausal commercially insured population. This decline corresponds with a time period of reductions in Medicare DXA reimbursement.

Observation stays in administrative claims databases: underestimation of hospitalized cases.

PURPOSE: Recent policy changes in the USA have led to an increasing number of patients being placed into observation units rather than admitted directly to the hospital. Studies of administrative data that use inpatient diagnosis codes to identify cohorts, outcomes, or covariates may be affected by this change in practice. To understand the potential impact of observation stays on research using administrative healthcare data, we examine the trends of observation stays, short (≤2 days) inpatient admissions, and all inpatient admissions. METHODS: We examined a large administrative claims database of commercially insured individuals in the USA between 2002 and 2011. Observation stays were defined on the basis of the procedure codes reimbursable by Medicare or commercial insurers. We report monthly rates of observation stays and short inpatient admissions overall and by patient demographics. RESULTS: We identified 5 355 752 observation stays from 2002 to 2011. Over the course of study, the rate of observation stays increased, whereas the rate of short inpatient stays declined. The most common reason for observation stays was nonspecific chest pain, also the third most common reason for short inpatient stays. The increasing trend of observation stays related to circulatory diseases mirrors the decreasing trend of short inpatient stays. CONCLUSIONS: The use of observation stays has increased in patients with commercial insurance. Failure to account for observation stays may lead to an under-ascertainment of hospitalizations in contemporary administrative healthcare data from the USA.

Salmon calcitonin use and associated cancer risk.

OBJECTIVE: To evaluate the strength of evidence supporting a possible association between salmon calcitonin (SCT) use and cancer incidence. DATA SOURCES: Searches of MEDLINE/PubMed, MEDLINE/OVID, and EMBASE (January 1973 to September 2013) were performed using the key search terms salmon calcitonin, humans, nasal calcitonin, and (for EMBASE only) randomized controlled trial. We also performed a manual review of data reviewed by the US Food and Drug Administration (FDA) committee in 2013. STUDY SELECTION AND DATA EXTRACTION: All articles identified from the data sources were evaluated and all information deemed relevant was included for this review. DATA SYNTHESIS: Intranasal and injectable SCT are FDA-approved for the treatment of postmenopausal osteoporosis. After a safety signal suggested a possible link between SCT use and prostate cancer, the European Medicines Agency and FDA regulatory agencies conducted analyses of SCT randomized controlled trial data to assess cancer-related adverse events and to readdress the approval status of SCT. Eighteen studies were found that compared nasal or oral SCT and placebo. In 15 of the 18 studies, the percentage of malignancy was greater in the SCT arm. The studies varied in quality, outcomes, and length. Most of the studies had poor-quality methods to assess new cancer cases. CONCLUSIONS: Current evidence may suggest an association between SCT use and cancer incidence based on studies with poor-quality cancer assessment methods. However, considering the lack of demonstrated efficacy of SCT to reduce fractures, clinicians should consider discontinuing its use for osteoporosis treatment regardless of the FDA's final approval decision.

Trends in Pediatric Emergency and Inpatient Healthcare Use for Mental and Behavioral Health Among North Carolinians During the Early COVID-19 Pandemic.

BACKGROUND: Widespread school closures and health care avoidance during the COVID-19 pandemic led to disruptions in access to pediatric mental health care. METHODS: We conducted a retrospective study of emergency and inpatient administrative claims from privately insured children aged 6-20 years in North Carolina between January 2019 and December 2020. We compared rates of emergency department (ED) visits (per 100 000 person-days) and risks of hospitalizations (per 100 000 persons) with diagnosis codes in each category (mental/behavioral health; suicidal ideation, suicide attempt, and intentional self-harm [SI/SA/ISH]; and social issues) across 3 time periods (pre-pandemic, lockdown, and reopening). We calculated the proportion and 95% confidence intervals (CI) of total ED visits and total hospitalizations attributable to mental/behavioral health and SI/SA/ISH across the 3 time periods. RESULTS: Rates of all categories of ED visits decreased from pre-pandemic to the lockdown period; from pre-pandemic to the reopening period, mental/behavioral health visits decreased but rates of SI/SA/ISH visits were unchanged. The proportion of ED visits attributable to mental/behavioral health increased from 3.5% (95% CI 3.2%-3.7%) pre-pandemic to 4.0% (95% CI 3.7%-4.3%) during reopening, and the proportion of SI/SA/ISH diagnoses increased from 1.6% (95% CI 1.4%-1.8%) pre-pandemic to 2.4% (95% CI 2.1%-2.7%) during the reopening period. Emergency care use for social issues and hospital admissions for mental/behavioral health and SI/SA/ISH diagnoses were unchanged across the study periods. CONCLUSIONS: In the early pandemic, pediatric mental health care and acute suicidal crises accounted for increased proportions of emergency care. During pandemic recovery, understanding the populations most impacted and increasing access to preventative mental health care is critical.

Treatment Patterns Among Adults with Primary Immune Thrombocytopenia Diagnosed in Hematology Clinics in the United States.

PURPOSE: Patients with immune thrombocytopenia (ITP) have low platelet counts and an increased risk of bleeding. We described treatment patterns and clinical outcomes in routine practice in the United States (US). PATIENTS AND METHODS: Using electronic health record data from hematology/oncology clinics linked to administrative claims in the US, we studied 447 adults newly diagnosed with primary ITP from 2011 to 2016. Patients with a secondary cause of thrombocytopenia were excluded. The incidence of ITP treatment initiation, bleeding events, and rescue therapy use were estimated using competing risk models. RESULTS: At 1-year post-ITP diagnosis, 50% of patients were prescribed an oral corticosteroid, with the majority being prescribed immediately following diagnosis. Of the more common second-line options, rituximab use was the most frequent (1-year cumulative incidence: 16% [95% confidence interval: 12, 19]), followed by romiplostim (9% [7, 12] and eltrombopag (5% [3, 8]). Use of these drugs was similar at 2 years post-diagnosis. At 6 months post-ITP treatment initiation, the cumulative incidence of bleeding was similar among eltrombopag and romiplostim initiators (17% [6, 33] and 19% [9, 31], respectively) and was slightly lower in rituximab users (12% [6, 20]). However, during this same timeframe, rituximab users had a higher incidence of rescue therapy use (48% [36, 58] versus 29% [14, 46] in eltrombopag and 26% [14, 39] in romiplostim users). Although splenectomy was rare, at 6 months post-surgery nearly 20% had experienced a bleed and nearly 20% had required rescue. CONCLUSION: This study describes the health trajectory of adults with ITP who are managed in hematology clinics in the US and could inform the design of non-interventional studies of comparative effectiveness among treatments.

Use of Low-Density Lipoprotein-Lowering Therapies Before and After PCSK9 Inhibitor Initiation.

Background Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) are used to reduce low-density lipoprotein (LDL) cholesterol. PCSK9i use after initiation, as well as persistence with or alterations to other LDL-lowering therapy after PCSK9i initiation, is not well understood. Methods and Results We conducted a retrospective study of alirocumab or evolocumab (PCSK9i) new users from July 2015 to December 2017 in the MarketScan Early View database of US commercial insurance beneficiaries. We determined the prevalence of PCSK9i interruption (≥30-day gap in supply) and LDL-lowering therapy use in the year after PCSK9i initiation. The average age of 6151 patients initiating PCSK9i therapy was 63 years, 44.4% were women, and 76.8% had atherosclerotic cardiovascular disease. Overall, 52.2% (95% CI, 50.8%-53.7%) of patients had an interruption in PCSK9i therapy in the first year after treatment initiation and 62.5% remained on PCSK9i therapy at 1-year postinitiation. Also, 27.7% of patients were taking a statin at the time of PCSK9i initiation, with only 22.4% on statin therapy at 1 year after PCSK9i initiation. Ezetimibe use decreased from 20.9% at the time of PCSK9i initiation to 12.0% a year later. By 1 year after PCSK9i initiation, 44.0% of patients had experienced an interruption in all LDL-lowering therapies, and 26.6% were no longer on any LDL-lowering therapies. Conclusions After PCSK9i initiation, statins were often discontinued, whereas more than half of patients experienced an interruption in PCSK9i therapy. These results suggest that many new PCSK9i users may remain at high risk for cardiovascular events because of interruptions in LDL-lowering therapy.

Use of bone-modifying agents among breast cancer patients with bone metastasis: evidence from oncology practices in the US.

PURPOSE: Bone-modifying agents (BMAs) are recommended for women with bone metastasis from breast cancer to prevent skeletal-related events. We examined the usage patterns and identified the factors associated with the use of BMAs (denosumab and intravenous bisphosphonates) among women in the US. PATIENTS AND METHODS: Electronic health records from oncology clinics were used to identify women diagnosed with bone metastasis from breast cancer between 2013 and 2014. Patients were excluded if they had recently used a BMA or had concurrent cancer at an additional primary site. The incidence of BMA initiation, interruption, and reinitiation were estimated using competing risk regression models. A generalized linear model was used to estimate risk factors for treatment initiation and interruption. RESULTS: There were 589 women diagnosed with bone metastasis from breast cancer. By 1 year, 68% of these patients (95% CI: 64%, 71%) had initiated treatment with a BMA. Denosumab and zoledronic acid were the most commonly used agents, whereas pamidronate was used infrequently. Young women were more likely to initiate a BMA than older women (adjusted risk difference: 6.4 [95% CI: 1.5, 10.9]). Of the 412 patients who initiated a BMA, 46% (95% CI: 41%, 51%) experienced an interruption within 1 year. Seventy-four percent (95% CI: 68%, 79%) of patients who interrupted their treatment had reinitiated therapy within 1 year of interruption. CONCLUSION: The majority of women diagnosed with bone metastasis from breast cancer initiate a BMA within 1 year of diagnosis, but a large proportion, particularly among the elderly, do not use these therapies.

Sanders II/III Calcaneus Fractures in Laborers: A Cost-Effectiveness Analysis and Call for Effectiveness Research.

OBJECTIVE: This study compares the cost and cost-effectiveness of treatments options for Sanders II/III displaced intra-articular calcaneus fractures (DIACFs) in laborers. METHODS: Literature on Sanders type II and III fractures was reviewed to determine complication rates and utility values for each treatment option. Costs were calculated using Medicare reimbursement and implant prices from our institution. Monte Carlo simulations were used to analyze a decision tree to determine the cost and cost-effectiveness of each treatment from a societal perspective. Sensitivity analysis was performed on all variables. RESULTS: Minimally invasive open reduction internal fixation (ORIF) (sinus tarsi approach with 4 screws alone) was least expensive ($23,329), followed by nonoperative care ($24,530) and traditional ORIF using extensile lateral approach ($27,963) (P < 0.001); this result was most sensitive to time out of work. Available cost-effectiveness data were limited, but our analysis suggests that minimally invasive ORIF is a dominant strategy, and traditional ORIF is superior to nonoperative care (incremental cost-effectiveness ratio $57,217/quality-adjusted life year). CONCLUSIONS: Our findings suggest that minimally invasive ORIF (sinus tarsi approach) is the least expensive option for managing Sanders II/III displaced intra-articular calcaneus fractures, followed by nonoperative care. Our cost-effectiveness results favor operative management but are highly sensitive to utility values and are weakened by scarce utility data. We therefore cannot currently recommend a treatment course based on value, and our primary conclusion must be that more extensive effectiveness research (ie, health-related quality of life data, not just functional outcomes) is desperately needed to elucidate the value of treatment options in this field. LEVEL OF EVIDENCE: Economic Level III. See Instructions for Authors for a complete description of levels of evidence.

Time to Clinically Relevant Fracture Risk Scores in Postmenopausal Women.

BACKGROUND: Clinical practice guidelines recommend use of fracture risk scores for screening and pharmacologic treatment decisions. The timing of occurrence of treatment-level (according to 2014 National Osteoporosis Foundation guidelines) or screening-level (according to 2011 US Preventive Services Task Force guidelines) fracture risk scores has not been estimated in postmenopausal women. METHODS: We conducted a retrospective competing risk analysis of new occurrence of treatment-level and screening-level fracture risk scores in postmenopausal women aged 50 years and older, prior to receipt of pharmacologic treatment and prior to first hip or clinical vertebral fracture. RESULTS: In 54,280 postmenopausal women aged 50 to 64 years without a bone mineral density test, the time for 10% to develop a treatment-level FRAX score could not be estimated accurately because of rare incidence of treatment-level scores. In 6096 women who had FRAX scores calculated with bone mineral density, the estimated unadjusted time to treatment-level FRAX ranged from 7.6 years (95% confidence interval [CI], 6.6-8.7) for those aged 65 to 69, to 5.1 years (95% CI, 3.5-7.5) for those aged 75 to 79 at baseline. Of 17,967 women aged 50 to 64 with a screening-level FRAX at baseline, 100 (0.6%) experienced a hip or clinical vertebral fracture by age 65 years. CONCLUSIONS: Postmenopausal women with sub-threshold fracture risk scores at baseline were unlikely to develop a treatment-level FRAX score between ages 50 and 64 years. After age 65, the increased incidence of treatment-level fracture risk scores, osteoporosis, and major osteoporotic fracture supports more frequent consideration of FRAX and bone mineral density testing.

Comparison of fracture risk assessment tools in older men without prior hip or spine fracture: the MrOS study.

Femoral neck bone mineral density (BMD), age plus femoral neck BMD T score, and three externally generated fracture risk tools had similar accuracy to identify older men who developed osteoporotic fractures. Risk tools with femoral neck BMD performed better than those without BMD. The externally developed risk tools were poorly calibrated. INTRODUCTION: We compared the performance of fracture risk assessment tools in older men, accounting for competing risks including mortality. METHODS: A comparative ROC curve analysis assessed the ability of the QFracture, FRAX® and Garvan fracture risk tools, and femoral neck bone mineral density (BMD) T score with or without age to identify incident fracture in community-dwelling men aged 65 years or older (N = 4994) without hip or clinical vertebral fracture or antifracture treatment at baseline. RESULTS: Among risk tools calculated with BMD, the discriminative ability to identify men with incident hip fracture was similar for FRAX (AUC 0.77, 95% CI 0.73, 0.81), the Garvan tool (AUC 0.78, 95% CI 0.74, 0.82), age plus femoral neck BMD T score (AUC 0.79, 95% CI 0.75, 0.83), and femoral neck BMD T score alone (AUC 0.76, 95% CI 0.72, 0.81). Among risk tools calculated without BMD, the discriminative ability to identify hip fracture was similar for QFracture (AUC 0.69, 95% CI 0.66, 0.73), FRAX (AUC 0.70, 95% CI 0.66, 0.73), and the Garvan tool (AUC 0.71, 95% CI 0.67, 0.74). Correlated ROC curve analyses revealed better diagnostic accuracy for risk scores calculated with BMD compared with QFracture (P < 0.0001). Calibration was good for the internally generated BMD T score predictor with or without age and poor for the externally developed risk tools. CONCLUSION: In untreated older men without fragility fractures at baseline, an age plus femoral neck BMD T score classifier identified men with incident hip fracture as accurately as more complicated fracture risk scores.

Correction to: Comparison of fracture risk assessment tools in older men without prior hip or spine fracture: the MrOS study.

Owing to an oversight by the authors, the acknowledgments were incomplete.

Global Experiential and Didactic Education Opportunities at US Colleges and Schools of Pharmacy.

OBJECTIVE: To assess the characteristics of global experiential and didactic education offerings in the pharmacy curricula. METHODS: A 2-stage web-based review of US colleges and schools of pharmacy identified country locations of international advanced pharmacy practice experiences (APPE), globally focused didactic courses, and whether these offerings were interprofessional. Schools were contacted to confirm their offerings and were asked about student participation and demand. RESULTS: Sixty-four percent of responding schools confirmed an international APPE offering in 67 different countries with an average graduating class participation of 6.1%. Forty-seven percent of responding schools confirmed a globally focused course offering with an average graduating class participation of 13.1%. Almost two thirds of international APPEs and a majority of courses were designated as interprofessional. Student demand did not outweigh supply for either. CONCLUSION: Colleges and schools of pharmacy in the United States are continuing to develop global education opportunities for students in the classroom and throughout the world.

Time to Osteoporosis and Major Fracture in Older Men: The MrOS Study.

INTRODUCTION: For older men who undergo bone mineral density (BMD) testing, the optimal osteoporosis screening schedule is unknown. Time-to-disease estimates are necessary to inform screening intervals. METHODS: A prospective cohort study of 5,415 community-dwelling men aged ≥65 years without hip or clinical vertebral fracture or antifracture treatment at baseline was conducted. Participants had concurrent BMD and fracture follow-up between 2000 and 2009, and additional fracture follow-up through 2014. Data were analyzed in 2015. Time to incident osteoporosis (lowest T-score ≤ -2.50) for men without baseline osteoporosis, and time to hip or clinical vertebral fracture or major osteoporotic fracture for men without or with baseline osteoporosis, were estimated. RESULTS: Nine men (0.2%) with BMD T-scores >-1.50 at baseline developed osteoporosis during follow-up. The adjusted estimated time for 10% to develop osteoporosis was 8.5 (95% CI=6.7, 10.9) years for those with moderate osteopenia (lowest T-score, -1.50 to -1.99) and 2.7 (95% CI=2.1, 3.4) years for those with advanced osteopenia (lowest T-score, -2.00 to -2.49) at baseline. The adjusted times for 3% to develop a first hip or clinical vertebral fracture ranged from 7.1 (95% CI=6.0, 8.3) years in men with baseline T-scores > -1.50 to 1.7 (95% CI=1.0, 3.1) years in men with baseline osteoporosis. CONCLUSIONS: Men aged 65 years and older with femoral neck, total hip, and lumbar spine BMD T-scores >-1.50 on a first BMD test were very unlikely to develop osteoporosis during follow-up. Additional BMD testing may be most informative in older men with T-scores ≤-1.50.

Evaluating Indeterminate Interferon-γ-Release Assay Results in Patients With Chronic Inflammatory Diseases Receiving Immunosuppressive Therapy.

OBJECTIVE: To analyze the rate of indeterminate interferon-γ-release assay (specifically the QuantiFeron-TB Gold In-Tube [QFT-GIT]) testing for Mycobacterium tuberculosis in patients with chronic inflammatory disease (CID) compared with the general hospital population (GH) and a healthy reference group of hospital employees (HR), and to analyze factors associated with an indeterminate test result. METHODS: Adults with a QFT-GIT result within a large regional US health system were included. We compared the likelihood of having an indeterminate test across each patient group. Among patients with CID, we estimated the effect of glucocorticoids, biologic agents, and disease-modifying antirheumatic drug (DMARD) use on the likelihood of having an indeterminate test, controlling for age, sex, comorbidities, and prior health services use. RESULTS: Of the 55,108 patients who met the inclusion criteria, CID made up 5.2% (n = 2,864), GH 48.2%, and HR 46.6% of the study population. Indeterminate results were present in 5.3% of the CID group, 1.9% of the GH group, and 1.5% of the HR group. Compared with HR, patients with CID were 2.4 times as likely to have indeterminate test results (adjusted risk ratio [RR] 2.4, 95% confidence interval [95% CI] 1.9-2.9). In adjusted models restricted to patients with CID, glucocorticoid use significantly increased the likelihood of an indeterminate test (adjusted RR 1.4 [95% CI 1.02-2.0]) while DMARD use decreased this likelihood (adjusted RR 0.7 [95% CI 0.5-0.97]) when compared to patients not receiving medications. CONCLUSION: Patients with CID were more likely to have indeterminate QFT-GIT results when compared to HR subjects. Among patients with CID, only glucocorticoid use was associated with an increased likelihood of having an indeterminate test result.

Baseline age and time to major fracture in younger postmenopausal women.

OBJECTIVE: This study aims to estimate the incidence of first hip or clinical vertebral fracture or major osteoporotic (hip, clinical vertebral, proximal humerus, or wrist) fracture in postmenopausal women undergoing their first bone mineral density (BMD) test before age 65 years. METHODS: We studied 4,068 postmenopausal women, aged 50 to 64 years without hip or clinical vertebral fracture or antifracture treatment at baseline, who were participating in the Women's Health Initiative BMD cohort study. BMD tests were performed between October 1993 and April 2005, with fracture follow-up through 2012. Outcomes were the time for 1% of women to sustain a hip or clinical vertebral fracture and the time for 3% of women to sustain a major osteoporotic fracture before initiating treatment, adjusting for clinical risk factors and accounting for competing risks. Women without osteoporosis and women with osteoporosis on their first BMD test were analyzed separately. RESULTS: During a maximum of 11.2 years of concurrent BMD and fracture follow-up, the adjusted estimated time for 1% of women to have a hip or clinical vertebral fracture was 12.8 years (95% CI, 8.0-20.4) for women aged 50 to 54 years without baseline osteoporosis, 7.6 years (95% CI, 4.8-12.1) for women aged 60 to 64 years without baseline osteoporosis, and 3.0 years (95% CI, 1.3-7.1) for all women aged 50 to 64 years with baseline osteoporosis. Results for major osteoporotic fracture were similar. CONCLUSIONS: Because of very low rates of major osteoporotic fracture, postmenopausal women aged 50 to 64 years without osteoporosis on their first BMD test are unlikely to benefit from frequent rescreening before age 65 years.

United States adults meeting 2010 American College of Rheumatology criteria for treatment and prevention of glucocorticoid-induced osteoporosis.

OBJECTIVE: The American College of Rheumatology (ACR) updated its guidelines on the prevention and treatment of glucocorticoid-induced osteoporosis (GIO) in 2010. An unknown proportion of US adults at risk of fracture due to glucocorticoid use would be recommended antiosteoporosis pharmaceutical (AOP) therapies based on the ACR guidelines. METHODS: Using the 2005-2010 National Health and Nutrition Examination Survey (NHANES) data for postmenopausal women (PMW), and men age ≥50 years reporting current glucocorticoid use, we categorized individuals according to ACR criteria for low, medium, and high fracture risk (<10%, ≥10%, and ≥20%, respectively) and provided percentages of treatment recommendations for chronic (≥90 days) medium and all high-risk patients. RESULTS: Glucocorticoids were used by 1.66% of PMW and 1.65% of men age ≥50 years. Of these patients, 0.80% of PMW and 0.45% of men age ≥50 years were at high risk of fracture. A majority of PMW (81.2%) and men age ≥50 years (75.8%) were chronic glucocorticoid users. In patients for whom treatment recommendations could be made, 64.9% of PMW and 51.9% of men age ≥50 years would be recommended therapy, but only 28.4% of PMW and 9.7% of men age ≥50 years reported AOP use. CONCLUSION: Based on the NHANES (2005-2010) data, we estimate glucocorticoid use in >1.5 million US PMW and men age ≥50 years. Treatment would be recommended in at least 50% of this population based on the 2010 ACR guidelines. Self-reported AOP use was documented in <30%, suggesting a treatment gap in the management of GIO in the US before the guideline release.