Glycemic Trends in Patients with Thyroid Eye Disease Treated with Teprotumumab in 3 Clinical Trials.

PURPOSE: Assess incidence, severity, and glucose excursion outcomes in thyroid eye disease (TED) patients receiving the insulin-like growth factor-1 receptor inhibitor teprotumumab from 3 clinical trials. DESIGN: Analysis of pooled glycemic data over time. PARTICIPANTS: Eighty-four teprotumumab- and 86 placebo-treated active TED patients from the phase 2 and phase 3 (OPTIC) controlled clinical trials and 51 teprotumumab-treated patients from the OPTIC extension (OPTIC-X) trial. METHODS: Eight intravenous infusions were given over 21 weeks. Phase 2 serum glucose was measured at weeks 1, 4, 15, and 21, with fasting measurements at weeks 1 and 4. Serum glucose was measured at each study visit in OPTIC and OPTIC-X, with fasting measurements at weeks 1 and 4 (in patients without diabetes) or all visits (in patients with diabetes). In all studies, hemoglobin A1c (HbA1c) was measured at baseline, 12, and 24 weeks plus weeks 36 and 48 in OPTIC-X. MAIN OUTCOME MEASURES: Serum glucose and HbA1c. RESULTS: In the phase 2 and 3 studies, 9 hyperglycemic episodes occurred in 8 teprotumumab patients; mean HbA1c level increased 0.22% from baseline to week 24 (to 5.8%; range, 5.0%-7.9%) versus 0.04% in patients receiving the placebo (to 5.6%; range, 4.6%-8.1%). At study end, 78% (59/76) of teprotumumab patients and 87% (67/77) of patients receiving placebo had normoglycemic findings. Normoglycemia was maintained in 84% (57/68) of patients receiving teprotumumab and 93% (64/69) of patients receiving placebo. Among baseline prediabetic patients, 43% (3/7) remained prediabetic in both groups, and 29% (2/7) of teprotumumab patients and 14% (1/7) of patients receiving placebo had diabetic findings at week 24. OPTIC-X patients trended toward increased fasting glucose and HbA1c whether initially treated or retreated with teprotumumab. Fasting glucose commonly rose after 2 or 3 infusions and stabilized thereafter. Most hyperglycemic incidents occurred in patients with baseline prediabetes/diabetes but were controlled with medication. No evidence was found for progression or increased incidence of hyperglycemia with subsequent doses. CONCLUSIONS: Serious glycemic excursions are uncommon in patients with normoglycemia before teprotumumab therapy. Patients with controlled diabetes or impaired glucose tolerance can be treated safely if baseline screening, regular monitoring of glycemic control, and timely treatment of hyperglycemia are practiced. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

The SPEER: An interprofessional team behavior rubric to optimize geriatric clinical care.

Geriatric patients with complex health care needs can benefit from interprofessional (IP) care; however, a major gap in health professional education is determining how to prepare future providers for IP collaboration. Effective IP team behavior assessment tools are needed to teach, implement, and evaluate IP practice skills. After review of IP evaluation tools, the Standardized Patient Encounter Evaluation Rubric (SPEER) was created to evaluate team dynamics in IP practice sites.Independent sample t-tests between faculty and learner SPEER scores showed learners scored themselves 15 points higher than their faculty scores (p < .001). Cronbach's α showed high internal consistency (α = 0.91). Paired t-tests found that learners identified improvements in the team's ability to address the patient's education needs and to allow the patients to voice their expectations. Faculty identified improvements in the teams' ability to make recommendations. Faculty evaluations of learner teams showed improvements in raw ratings on all but two items. Qualitative data analysis for emergent themes showed learners desired team functioning feedback and how teamwork could improve to provide optimal IP care.In conclusion, the SPEER can help faculty and learners identify growth in their teams' ability to perform key IP skills in clinical sites.

Characteristics of Diabetic and Nondiabetic Patients With Thyroid Eye Disease in the United States: A Claims-Based Analysis.

OBJECTIVE: Thyroid eye disease (TED) is a debilitating autoimmune disease characterized by ocular and periorbital tissue inflammation, proptosis, and visual impairment. The known risk factors for TED include radioactive iodine therapy, female sex, and smoking. The risk factors for severe TED include hyperthyroidism, male sex, smoking, and diabetes; however, little is known about how diabetes mellitus (DM) influences TED. This claims-based analysis examined TED characteristics in patients with and without diabetes. METHODS: Symphony database (2010-2015 U.S. claims) was mined for patients with ≥1 Graves' disease diagnosis code and ≥1 TED-associated eye code, including proptosis, strabismus, diplopia, lid retraction, exposure keratoconjunctivitis, and optic neuropathy (ON). DM status was determined based on type 1 or type 2 diabetes coding. Sight-threatening TED was defined as ≥1 ON or exposure keratoconjunctivitis code. RESULTS: A total of 51 220 patients were identified. Of them, 2618 (5.1%) and 12 846 (25.1%) had type 1 and type 2 DM, respectively. Patients with and without DM had similar characteristics, but patients with DM were more often men (type 1: 30.3%, type 2: 28.7% vs no DM: 20.5%; both P < .001) and older at the first TED code. In patients with DM, strabismus (25.4%, 22.6% vs 19.9%) and diplopia (38.6%, 37.9% vs 29.9%) occurred more often but proptosis occurred less often (42.3%, 46.3% vs 58.5%; all P < .001). Sight-threatening TED occurred more often in patients with DM because of higher ON rates. CONCLUSION: Patients with TED and DM may have more extraocular muscle involvement. Furthermore, the higher prevalence of severe TED stemmed from higher ON rates, possibly associated with diabetes-related vasculopathies. These hypothesis-generating data warrant further exploration.

Novel model to teach health care delivery in geriatrics.

Introducing health policy to interprofessional graduate students, anchoring health policy to older adult health needs, while conveying how current policy issues will affect their individual careers is challenging, yet essential, for health profession education. This novel program integrated graduate level health profession learners from medicine, nurse practitioner, pharmacy, psychology, social work, physical therapy and occupational therapy disciplines. The aim was to embed health policy into an existing interprofessional (IP) geriatrics course at an academic medical center. Selection of disciplines was based on prior collaborative work and faculty interest. The objectives were to 1. Introduce current health policies that affect older adults; 2. Understand the effects of health policy and social determinants of health on the older adults in their future practice; 3. Challenge learners to apply their knowledge and develop health advocacy strategies for older adults; and 4) Teach the importance of teamwork in interprofessional practice within a geriatric population.The health policy curriculum impacted 487 learners for 12 sessions over three years. Four themes emerged with the sessions: health policy awareness, interprofessional appreciation, patient care "pearls," and pharmacological considerations in geriatrics. Each of the eight modules generated thoughtful recommendations by the learners, providing a glimpse into future workforce priorities.

Is there an increased risk of hip fracture in Parkinson's disease? A nationwide inpatient sample.

OBJECTIVE: The aim of this study was to determine whether people with Parkinson's disease (PD) are overrepresented in a national cohort of hip-fracture admissions. BACKGROUND: Frequent falls, combined with a higher rate of osteoporosis in people with PD, should lead to an increased risk of hip fracture. METHODS: This work was a retrospective cohort analysis from the Nationwide Inpatient Sample from 1988 to 2007, a stratified sample of 20% of U.S. hospital admissions. Admissions with a primary diagnosis of acute hip fracture were identified, as was a subset with a secondary diagnosis of PD. RESULTS: A total of 3.63% of 1,066,404 hip-fracture admissions had PD. When compared to the population of prevalence among patients with hip fracture, the prevalence of PD was up to 4.48 times (95% confidence interval [CI]: 4.46, 4.49) more than predicted, and when adjusted for gender and age, it was 4.02 (95% CI: 4.00, 4.03). CONCLUSIONS: In this 20-year nationwide sample of hip fractures, patients with PD were overrepresented by a factor of 4.

The effect of testosterone supplementation on depression symptoms in hypogonadal men from the Testim Registry in the US (TRiUS).

OBJECTIVE: To determine the effect of long-term testosterone replacement therapy (TRT) on depression symptoms in hypogonadal men. METHODS: Data were from TRiUS, a multicenter, 12-month observational registry (N = 849) of hypogonadal men prescribed 1% testosterone gel. Measures including total testosterone (TT) were assessed at baseline and months 3, 6, and 12. Depression symptoms were measured with Patient Health Questionnaire-9 (PHQ-9), a validated self-report questionnaire. A PHQ-9 score decrease of ≥5 represents clinical improvement. RESULTS: PHQ-9 scores were available for 762/849 TRiUS participants at baseline. Overall, 92.4% (704/762) demonstrated some level of depressive symptoms, with 17.3% (132/762) having moderately severe (score 15-19) to severe (score 20-27) symptoms. Subcohorts with significantly (p ≤ 0.03) more moderately severe to severe symptoms were: <60 years old, TT levels <250 ng/dl (<8.68 nmol/l), HIV/AIDS-positive, or used antidepressants or opioids. TT levels and PHQ-9 scores improved significantly (p < 0.01) by 3 months of TRT. At 12 months PHQ-9 scores showed a clinically meaningful mean improvement of 5.62 points, patients with moderately severe to severe symptoms decreased from 17.3% to 2.1% (5/233), and subcohorts, including those defined by age (<60 years) and antidepressant use, had improved PHQ-9 scores ≥5. CONCLUSION: TRT may reduce depression symptoms in hypogonadal men, including middle-aged men and those using antidepressants.

Testosterone replacement therapy outcomes among opioid users: the Testim Registry in the United States (TRiUS).

OBJECTIVE: Among patients with hypogonadism-associated comorbidities, opioid users have the highest incidence of hypogonadism. Data from the Testim Registry in the United States were analyzed to determine the efficacy of testosterone replacement therapy in opioid users vs nonusers. DESIGN: Prospective, 12-month observational cohort registry. SUBJECTS: Hypogonadal men (N = 849) prescribed Testim (but not necessarily testosterone replacement) for the first time. INTERVENTIONS: Testim 1% testosterone gel (5-10 g/day). OUTCOME MEASURES: Total and free testosterone, sex hormone-binding globulin, prostate-specific antigen, sexual function, mood/depression, and anthropometric data were assessed. Changes from baseline were analyzed using repeated measures mixed-effects analysis of variance; multiple linear regressions of changes in testosterone levels with sexual function, mood, and opioid use were computed. RESULTS: 90/849 patients (10.6%) reported opioid use at baseline; 75/90 (83%) used opioids for ≥ 30 days prior to baseline. Baseline total testosterone and prostate-specific antigen were not statistically different between opioid users and nonusers; there was a trend for higher sex hormone-binding globulin (P = 0.08) and lower free testosterone (P = 0.05) in opioid users. After 1 month, both opioid users and nonusers had significant (P < 0.001) increases in total and free testosterone, which continued through 12 months. Sexual function and mood improved significantly in both opioid users and nonusers over 12 months, and significantly correlated with change in total testosterone. CONCLUSIONS: Testosterone replacement therapy increased serum testosterone in hypogonadal opioid users and nonusers alike. The data suggest that with testosterone replacement, hypogonadal opioid users might be expected to have similar improvements in sexual function and mood as opioid nonusers.

Changes in prostate specific antigen in hypogonadal men after 12 months of testosterone replacement therapy: support for the prostate saturation theory.

PURPOSE: We measured prostate specific antigen after 12 months of testosterone replacement therapy in hypogonadal men. MATERIALS AND METHODS: Data were collected from the TRiUS (Testim® Registry in the United States), an observational registry of hypogonadal men on testosterone replacement therapy (849). Participants were Testim naïve, had no prostate cancer and received 5 to 10 gm Testim 1% (testosterone gel) daily. RESULTS: A total of 451 patients with prostate specific antigen and total testosterone values were divided into group A (197 with total testosterone less than 250 ng/dl) and group B (254 with total testosterone 250 ng/dl or greater). The groups differed significantly in free testosterone and sex hormone-binding globulin, but not in age or prostate specific antigen. In group A but not group B prostate specific antigen correlated significantly with total testosterone (r=0.20, p=0.005), free testosterone (r=0.22, p=0.03) and sex hormone-binding globulin (r=0.59, p=0.002) at baseline. After 12 months of testosterone replacement therapy, increase in total testosterone (mean±SD) was statistically significant in group A (+326±295 ng/dl, p<0.001; final total testosterone 516±28 ng/dl) and group B (+154±217 ng/dl, p<0.001; final total testosterone 513±20 ng/dl). After 12 months of testosterone replacement therapy, increase in prostate specific antigen was statistically significant in group A (+0.19±0.61 ng/ml, p=0.02; final prostate specific antigen 1.26±0.96 ng/ml) but not in group B (+0.28±1.18 ng/ml, p=0.06; final prostate specific antigen 1.55±1.72 ng/ml). The average percent prostate specific antigen increase from baseline was higher in group A (21.9%) than in group B (14.1%). Overall the greatest prostate specific antigen was observed after 1 month of treatment and decreased thereafter. CONCLUSIONS: Patients with baseline total testosterone less than 250 ng/dl were more likely to have an increased prostate specific antigen after testosterone replacement therapy than those with baseline total testosterone 250 ng/dl or greater, supporting the prostate saturation hypothesis. Clinicians should be aware that severely hypogonadal patients may experience increased prostate specific antigen after testosterone replacement therapy.

Improved sexual function with testosterone replacement therapy in hypogonadal men: real-world data from the Testim Registry in the United States (TRiUS).

INTRODUCTION: Up to 30% of erectile dysfunction (ED) patients treated with phosphodiesterase type 5 (PDE5) inhibitors do not show improved sexual function, which may be due in part to low serum testosterone. Hypogonadal patients already receiving testosterone replacement therapy (TRT) likewise can still suffer from symptoms of sexual dysfunction. In these patient populations, augmenting with, or switching, TRT treatment may improve sexual function. AIM: To determine if 12-month treatment with a testosterone gel improves sexual function in hypogonadal men, as measured by the Brief Male Sexual Function Inventory (BMSFI), and in subgroups defined by low testosterone, PDE5 inhibitor use, and prior TRT. METHODS: The Testim Registry in the United States (TRiUS) was a large (N = 849) multicenter registry of hypogonadal men treated with Testim (testosterone 1%) topical gel and followed for 12 months. MAIN OUTCOME MEASURES: Data collected at suggested visits (baseline; 1, 3, 6, and 12 months) included total testosterone (TT), free testosterone (FT), BMSFI scores, physical exam, and body measurements. RESULTS: TRiUS had 271 patients with baseline testosterone and BMSFI measurements. At 12 months of TRT, TT and FT levels significantly increased from baseline (P < 0.001), with mean ± standard deviation final TT = 17.37 ± 8.61 nmol/L (500.6 ± 248.2 ng/dL) and FT = 240.1 ± 296.0 pmol/L (69.2 ± 85.3 pg/mL). The mean total BMSFI score significantly increased from baseline at 12 months (27.4 ± 10.3 to 33.8 ± 9.8, P < 0.001) and at each visit in all domains (sex drive/libido, erectile function, ejaculatory function, level of bother), overall and for all subgroups. Regression analysis indicated that increased total BMSFI score was significantly associated with increased TT levels at 6 months. CONCLUSIONS: In hypogonadal patients, 12-month administration of topical testosterone gel resulted in increased TT and FT levels and significantly improved sexual function. All subgroups studied, including men taking PDE5 inhibitors for ED and those previously on TRT, demonstrated significant improvement in sexual function from baseline scores.

Effect of 12 months of testosterone replacement therapy on metabolic syndrome components in hypogonadal men: data from the Testim Registry in the US (TRiUS).

BACKGROUND: Recent evidence suggests that there may be a bidirectional, physiological link between hypogonadism and metabolic syndrome (MetS), and testosterone replacement therapy (TRT) has been shown to improve some symptoms of MetS in small patient populations. We examined the effect of 12 months of TRT on MetS components in a large cohort of hypogonadal men. METHODS: Data were obtained from TRiUS (Testim® Registry in the United States), a 12-month, multicenter, prospective observational registry (N = 849) of hypogonadal men prescribed Testim 1% testosterone gel (5-10 g/day). Data analyzed included age, total testosterone (TT), free testosterone (FT), sex hormone-binding globulin (SHBG), and MetS components: waist circumference, blood pressure, fasting blood glucose, plasma triglycerides, and HDL cholesterol. RESULTS: Of evaluable patients (581/849) at baseline, 37% were MetS+ (n = 213) and 63% were MetS- (n = 368). MetS+ patients had significantly lower TT (p < 0.0001) and SHBG (p = 0.01) levels. Patients with the lowest quartile TT levels (<206 ng/dL [<7.1 nmol/L]) had a significantly increased risk of MetS+ classification vs those with highest quartile TT levels (≥331 ng/dL [≥11.5 nmol/L]) (odds ratio 2.66; 95% CI, 1.60 to 4.43). After 12 months of TRT, TT levels significantly increased in all patients (p < 0.005). Despite having similar TT levels after TRT, only MetS+ patients demonstrated significant decreases in waist circumference, fasting blood glucose levels, and blood pressure; lowest TT quartile patients demonstrated significant decreases in waist circumference and fasting blood glucose. Neither HDL cholesterol nor triglyceride levels changed significantly in either patient population. CONCLUSION: Hypogonadal MetS+ patients were more likely than their MetS- counterparts to have lower baseline TT levels and present with more comorbid conditions. MetS+ patients and those in the lowest TT quartile showed improvement in some metabolic syndrome components after 12 months of TRT. While it is currently unclear if further cardiometabolic benefit can be seen with longer TRT use in this population, testing for low testosterone may be warranted in MetS+ men with hypogonadal symptoms.

PHOSPHATURIC MESENCHYMAL HEEL TUMOR PRESENTING WITH TUMOR-INDUCED OSTEOMALACIA.

OBJECTIVE: To help clinicians identify and treat patients with tumor-induced osteomalacia (TIO) resulting from a phosphaturic mesenchymal tumor, mixed connective tissue variant (PMTMCT). METHODS: Describe the history, presentation, laboratory findings, diagnostic studies, treatment, and literature review. RESULTS: A 58-year-old female with no significant past medical history presents with ongoing multiple bone pain for years. She had a bone scan showing multiple focal areas of increased uptake involving bilateral ribs, distal right tibia, and left femoral neck, representing previously healed fractures. Her bilateral lower-extremity magnetic resonance imaging showed stress fractures of the anteromedial cortex, right tibia, and the left femoral neck. Phosphorus was noted to be 1.9 mg/dL (normal range, 2.0 to 4.0 mg/dL), and alkaline phosphatase was 179 U/L (normal range, 25 to 110 U/L). Tubular maximum re-absorption of phosphate to glomerular filtration rate ratio was 0.438, which was low. An outside physician initiated patient on teriparatide, which showed bone mineral density improvement after 1 year, and then the teriparatide was stopped. Later, she developed a nontraumatic pubic ramus fracture; teriparatide was resumed. While on teriparatide, she developed several new rib fractures. Due to declining phosphorus levels, further investigation led to an elevated fibroblast growth factor 23 (FGF-23) level of 243 RU/mL (normal, <50 RU/mL). TIO was strongly suspected, and a nuclear medicine positron emission tomography/computed tomography trunk with 68Ga-1,4,7,10-tetraazacyclododecane 1,4,7,10-tetraacetic acid tyrosine-3-octreotate (i.e., 68Ga-DOTATATE) showed a right heel soft-tissue nodule. Fine-needle aspiration biopsy was performed, confirming PMTMCT, positive for FGF-23 mRNA. After surgery, her symptoms resolved and her phosphorus normalized. CONCLUSION: TIO is a rare paraneoplastic syndrome characterized by bone pain, muscle weakness, and fractures associated with persistent hypophosphatemia. Clinicians now have new imaging tools to help identify and treat patients with PMTMCT.

Prevention of bone loss in survivors of breast cancer: A randomized, double-blind, placebo-controlled clinical trial.

BACKGROUND: Few data are available on the safety and efficacy of once-weekly oral bisphosphonate therapy in breast cancer survivors. OBJECTIVE: Our objective was to determine whether risedronate, 35 mg weekly, is efficacious and safe in preventing bone loss associated with chemotherapy-induced menopause. DESIGN: The study was a randomized, double-blind, placebo-controlled clinical trial over 12 months. SETTING AND PARTICIPANTS: Participants included 87 newly postmenopausal women with status post chemotherapy, recruited from a breast cancer clinic in an academic medical center. INTERVENTION: Participants were randomly assigned to receive risedronate 35 mg/wk or placebo. MAIN OUTCOME MEASURES: The primary outcomes were the 12-month changes in spine and hip bone mineral density. Secondary outcomes included changes in markers of bone resorption (urine N-telopeptide cross-linked collagen type I) and formation (osteocalcin, N-terminal propeptide of type I procollagen, and bone-specific alkaline phosphatase). RESULTS: After 12 months, bone mineral density increased by 1.2% at the spine and 1.3% at the hip in women on risedronate vs. significant decreases for women in the placebo group of 0.9% at the spine and 0.8% at the hip (P < 0.01, difference between groups). N-telopeptide cross-linked collagen type I, a marker of bone resorption, decreased by 19.3%, and N-terminal propeptide of type I procollagen, a marker of bone formation, decreased by 26.6% in participants on active therapy compared with increases in the control group. Risedronate was well tolerated, and the retention rate was 95% at 1 yr. CONCLUSIONS: Risedronate once weekly prevented bone loss and reduced bone turnover in women with breast cancer treated with chemotherapy. Early measures to prevent bone loss should be considered in this cohort of breast cancer survivors.

Osteoporosis management in older patients who experienced a fracture.

BACKGROUND: Fractures in older patients are common, morbid, and associated with increased risk of subsequent fractures. Inpatient and outpatient management and treatment of fractures can be costly. With more emphasis placed on quality care for Medicare beneficiaries, we studied if patients were receiving proper screening for osteoporosis and treatment after diagnosis of fracture. This study aims to determine if adequate screening and treatment for osteoporosis occurs in the postfracture period. METHODS: A retrospective analysis of Medicare beneficiaries aged 67 years or older was gathered from a single institution in both inpatient and outpatient visits. Based on International Classification of Diseases ninth revision codes, primary diagnosis of fractures of neck and trunk, upper limb, and lower limb were obtained in addition to current procedural terminology codes for fracture procedures. We studied patients who had been screened for osteoporosis with a bone mineral study or received osteoporosis treatment after their fracture. RESULTS: Medicare beneficiaries totaling 1,375 patients were determined to have an inclusion fracture between June 1, 2013 and November 30, 2014. At the time of our analysis on December 1, 2014, 1,219 patients were living and included in the analysis. Of these patients, 256 (21.0%) either received osteoporosis testing with bone mineral density or received treatment for osteoporosis. On sex breakdown, 208/820 (25.4%) females received proper evaluation or treatment of osteoporosis in comparison to 48/399 (12.0%) males. This is in comparison to the Centers for Medicare and Medicaid Services' national average of 19.1% for osteoporosis management in females. CONCLUSION: A minority of studied patients received evaluation or treatment for osteoporosis after their fracture. Postfracture investigation and treatment for osteoporosis in Medicare beneficiaries is inadequate. If improved, Medicare costs could be reduced by prevention of future fractures. Future studies could determine how best to ensure this intervention occurs.

Late-Onset Hypogonadism and Testosterone Replacement in Older Men.

Late-onset hypogonadism is an underdiagnosed and easily treated condition defined by low serum testosterone levels in men older than 65 years. When treated, a significant improvement in quality of life may be reached in this rapidly rising sector of the population. During the evaluation, laboratory tests and a full medication review should be performed to exclude other illnesses or adverse effects from medications. The major goal of treatment in this population is treating the symptoms related to hypogonadism. There has not been clear evidence supporting universally giving older men with low serum testosterone levels and hypogonadal symptoms testosterone replacement therapy.

Is there an increased risk of hip fracture in multiple sclerosis? Analysis of the Nationwide Inpatient Sample.

BACKGROUND: Impaired ambulation, frequent falls, and prolonged immobilization combined with the high rate of vitamin D deficiency in people with multiple sclerosis (MS) could lead to an increased risk of hip fracture. METHODS: A retrospective cohort analysis of 20 years of the Nationwide Inpatient Sample (AHRQ.gov), a 20% stratified yearly sample of USA hospital admissions from the year 1988-2007, was performed. Based on International Classification of Diseases Ninth Revision (ICD9) codes, admissions with a primary diagnosis of acute hip fracture (ICD9 code 226.xx) and a secondary diagnosis of MS (ICD9 code 340) was identified. Indirect adjustment was used to compare the prevalence of MS in this population with that of the USA. Significance was set a priori at P<0.0001 due to the large number of records and multiple comparisons. RESULTS: A total of 1,066,404 hip fracture admissions were identified and 0.25% had MS. Those with MS were younger, had lower mortality rates (0.25% for people with MS versus 2.97% for those without MS, P<0.0001) and lower rates of discharge to nursing home or rehabilitation (69.25% for people with MS versus 72.17% for those without MS, P<0.0001). When compared with the population prevalence, the predicted prevalence of MS among patients with hip fracture was 2.844 (95% confidence interval [CI] 2.837-2.852) greater than expected when adjusted for age, 2.505 (95% CI 2.499-2.512) when adjusted for sex and age, and 2.175 (95% CI 2.168-2.182) when adjusted for race (white, black). Race was specified for only 65% of the sample. CONCLUSION: In this nationwide sample of 20 years of hospital admissions in the USA, the prevalence of MS in the population with hip fracture was greater than twice that predicted, and MS patients suffered an acute fracture at an earlier age.

Impact of admission blood glucose level on outcomes in community-acquired pneumonia in older adults.

BACKGROUND: Community-acquired pneumonia (CAP) is a common cause of morbidity and mortality in older adults. Although diabetes mellitus is a risk factor for pneumonia, the clinical impact of blood glucose level at the time of admission is not clear. Our goal was to examine the association between admission hyperglycemia and subsequent mortality, length of stay, and readmission outcomes in older adults with CAP. METHODS: A retrospective observational study was conducted using hospital data for community-acquired pneumonia admissions in 857 persons from January 1, 2008 to December 31, 2010. We examined the effects of admission glucose level on mortality, length of stay, and 30 day readmission, adjusted for demographic factors and comorbidity. RESULTS: The mean age of the sample was 64 years, and 51% of the subjects were female. Inpatient mortality occurred in 4.6% and the median length of stay was 5 days (interquartile range 3-9 days). Readmission within 30 days occurred in 17%. We found little impact of first glucose measures on in-hospital mortality (P = 0.94), length of stay (P = 0.95), and 30-day readmission (P = 0.56). Subjects 65 years and older trended towards higher in-hospital mortality. Older age, cancer, heart failure, and cirrhosis were associated with adverse outcomes. CONCLUSION: Glucose level upon admission for community-acquired pneumonia was not associated with adverse outcomes within 30 days in older adults.

12-month observation of testosterone replacement effectiveness in a general population of men.

BACKGROUND: Testosterone decline becomes more prevalent as men age and symptomatic testosterone deficiency is associated with potentially serious comorbidities. Despite limitations, registries can provide an opportunity to accumulate data regarding disease management in a typical patient population, including diagnosis, treatment, and outcomes. MATERIALS AND METHODS: The Testim Registry in the United States (TRiUS) was a prospective, 12-month, observational cohort registry of men prescribed Testim® (1% testosterone gel; Auxilium Pharmaceuticals, Inc.) for the first time; patients previously on other forms of testosterone replacement therapy (TRT) were eligible to participate in the study as well. The registry recorded total testosterone (TT) and free testosterone (FT) levels, prostate-specific antigen (PSA), sexual function, mood/depression, and cardiometabolic and anthropometric criteria before and after TRT. Changes over time were analyzed by analysis of variance, and linear regression and Pearson product-moment correlation coefficients were used to examine relationships between variables. RESULTS: At baseline, 849 patients from 72 sites were enrolled, with 743 of 849 started on 5 g gel/day (50 mg testosterone/day) and 106 of 849 started on 10 g gel/day (100 mg testosterone/day). Mean TT and FT levels increased significantly after 3 months of TRT (TT level, 16.8 ± 9.87 nmol/L [485 ± 284 ng/dL], P < 0.001; FT level, 286.3 ± 224.9 pmol/L [82.5 ± 64.8 pg/mL], P < 0.001) and were maintained at eugonadal levels. Mean PSA levels increased significantly (P = 0.004) from 1.12 ± 1.11 µg/L (1.12 ± 1.11 ng/mL) at baseline to 1.26 ± 1.22 µg/L (1.26 ± 1.22 ng/mL) after 12 months of TRT, although changes were well within guidelines (< 1.4 µg/L/year increase). Significant improvements were seen in sexual function and mood/depression at 3 months and in metabolic parameters at 12 months. CONCLUSION: Testosterone deficiency symptoms improved with TRT use in men; sexual function and mood/depression improvements were seen before metabolic improvements. Prostate-specific antigen levels increased, although increases were within guideline-determined safety limits.

Testosterone replacement therapy in men with hypogonadism and HIV/AIDS: results from the TRiUS registry.

BACKGROUND: Although hypogonadism is common in men with human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS), testosterone levels after testosterone replacement therapy (TRT) in this population have not been reported. METHODS: The Testim Registry in the United States (TRiUS) was the first prospective, observational registry of men with hypogonadism who were prescribed TRT. The TRiUS cohorts with (n = 82) and without (n = 767) HIV/AIDS were followed during 12 months of treatment with Testim® (1% testosterone gel; Auxilium Pharmaceuticals, Inc.). Total testosterone (TT) and free testosterone levels, symptoms of depression, sexual function, body composition profiles, and prostate-specific antigen levels were evaluated. RESULTS: The HIV/AIDS and non-HIV/AIDS cohorts differed at baseline in age (48.3 vs 52.5 years), TT level (13.0 vs 9.6 nmol/L), duration of hypogonadism (27.1 vs 14.6 months), prior TRT (36.6% vs 22.6%), body mass index (26.5 vs 32.0 kg/m2), and antidepressant (29% vs 15%) and opioid (20% vs 10%) use (P ≤ 0.01 for all comparisons). During the 12 months, both cohorts experienced significant elevations in TT and free testosterone levels to within normal ranges. Sexual function and depression scores improved and antidepressant medication use decreased in both cohorts. Body composition profiles improved significantly (P ≤ 0.05) in men without HIV/AIDS and remained stable in men with HIV/AIDS during the 12 months of follow-up. CONCLUSION: This 12-month, non-placebo-controlled, observational study of Testim® use in men with and without HIV/AIDS suggests that TRT may provide clinical benefits irrespective of the patient's HIV/AIDS status. This conclusion is supported by the higher testosterone levels, better sexual function, lower depression scores, and better body composition profiles found in both groups. However, given the loss of patients to follow-up, these results may reflect a bias toward drug responders.