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OBJECTIVE: To describe rescue insulin use and associated factors in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE). RESEARCH DESIGN AND METHODS: GRADE participants (type 2 diabetes duration <10 years, baseline A1C 6.8%-8.5% on metformin monotherapy, N = 5,047) were randomly assigned to insulin glargine U-100, glimepiride, liraglutide, or sitagliptin and followed quarterly for a mean of 5 years. Rescue insulin (glargine or aspart) was to be started within 6 weeks of A1C >7.5%, confirmed. Reasons for delaying rescue insulin were reported by staff-completed survey. RESULTS: Nearly one-half of GRADE participants (N = 2,387 [47.3%]) met the threshold for rescue insulin. Among participants assigned to glimepiride, liraglutide, or sitagliptin, rescue glargine was added by 69% (39% within 6 weeks). Rescue aspart was added by 44% of glargine-assigned participants (19% within 6 weeks) and by 30% of non-glargine-assigned participants (14% within 6 weeks). Higher A1C values were associated with adding rescue insulin. Intention to change health behaviors (diet/lifestyle, adherence to current treatment) and not wanting to take insulin were among the most common reasons reported for not adding rescue insulin within 6 weeks. CONCLUSIONS: Proportionately, rescue glargine, when required, was more often used than rescue aspart, and higher A1C values were associated with greater rescue insulin use. Wanting to use noninsulin strategies to improve glycemia was commonly reported, although multiple factors likely contributed to not using rescue insulin. These findings highlight the persistent challenge of intensifying type 2 diabetes treatment with insulin, even in a clinical trial.

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After the first fracture, the risk of subsequent fractures increases significantly. Medical treatment can reduce the risk of a second fracture by about 50%, but many older adults do not receive osteoporosis medication following their first fracture. This observational study aimed to understand primary care management patterns of older adults after osteoporotic fractures at the Miami Veterans Affairs (VA) Healthcare System. A retrospective review of 219 fracture cases selected by International Classification of Disease (ICD-9) codes between October 2015 and September 2016 identified 114 individuals age ≥50 years who had a non-traumatic fracture code entered in their medical record for the first time. Among them, 72 (63%) did not undergo a bone mineral density (BMD) test or receive treatment in the 12 months following their fracture. Of the 40 individuals who had a BMD test post-fracture, 17 (100%) received or were considered for anti-osteoporosis treatment if their T-score indicated osteoporosis (T-score ≤-2.5), but only 8/23 (35%) if the T-score was >-2.5. Physicians are more likely to prescribe osteoporosis therapy based on a BMD T-score diagnosis of osteoporosis, rather than a clinical diagnosis of osteoporosis based on a low-trauma fracture. A change in practice patterns is necessary to decrease the incidence of fractures.

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The association between renal dysfunction and hypothyroidism is of increasing clinical importance as thyroid hormone replacement may attenuate decline in renal function and improve cardiovascular outcomes in patients with chronic kidney disease (CKD). Although multiple mechanisms for the induction of renal insufficiency in hypothyroidism have been described, the renal impact of short-term, acute hypothyroidism is unknown, which has possible implications for thyroid cancer patients preparing to receive radioactive iodine (RAI). A 56-year-old gentleman with history of unilateral renal agenesis and CKD stage III presented with intermediate-risk papillary thyroid cancer. In preparation for RAI, he underwent thyroid hormone withdrawal (THW) associated with acute kidney injury (AKI), as marked by a decrease in his estimated GFR from 53 to 32 mL/min/1.73 m(2). Upon resumption of thyroid hormone, renal function returned to baseline within months. Although AKI in this case was not otherwise associated with adverse outcome and reversed upon resumption of thyroid hormone, it is possible that this phenomenon could result in potential harm, particularly in the patient with baseline renal insufficiency. In CKD patients, preparation for RAI therapy may require special consideration; future studies should address the role of recombinant TSH to mitigate deleterious renal effects of acute hypothyroidism in this setting.

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Osteoporosis remains a challenging disease to treat due to a number of barriers including patient adherence to therapies. One of the most recent advances has been the development of the Fracture Risk Assessment Tool, which is helpful in conveying fracture risk to patients and providing treatment guidance to clinicians. The decision to use an anti-osteoporosis therapy must be tailored to the patient's specific clinical scenario. The bisphosphonates are first-line agents in the treatment of osteoporosis and are efficacious in substantially reducing fracture risk between 25% and 70% on average depending on fracture site. Compliance with oral bisphosphonate pills can be poor, resulting in a significant deterrent to the proper management of osteoporosis. Non-pill forms of bisphosphonate and nonbisphosphonate therapy are available for the treatment of osteoporosis and may increase compliance. Among these is Binosto, a new formulation of weekly effervescent alendronate, as well as intravenous bisphosphonates, teriparatide, and subcutaneously administered denosumab, which are all costly medications and are unlikely to become the mainstay of treatment over the oral bisphosphonate pills. Having a detailed conversation between the patient and physician is essential to the development of a tailored treatment plan that will decrease fracture risk.

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Hypovitaminosis D has been associated with age-related physical decline and an increased risk for falls. The objective of this study is to test whether supplementation with 4000IU of vitamin D(3) (vitD(3)) for 9 months will improve, or slow down the decline of the ability to perform physical tests which have been associated with the preservation of independence in sedentary older men. We describe the study design and the baseline characteristics of the 314 men screened in the VIVA-VA Study (Vitamin D In Vulnerable Adults in the VA), a 2-year, single-site, double-blind, placebo-controlled, randomized clinical trial that enrolled sedentary male veterans ages 65 to 95. The main inclusion criteria are 25-OH vitamin D (25-OHD) levels between 10 and 30 ng/ml, and a Short Performance Physical Battery (SPPB) score ≤ 9. The primary outcome of the study is the SPPB. Subjects were recruited from the Miami Veterans Medical Center clinics. The study recruited 314 male veterans of multiethnic backgrounds. The baseline characteristics observed from the 314 men screened in the VIVA-VA Study are consistent with what is expected in a cohort of elderly sedentary men: low physical performance scores, and low 25OHD levels despite living in South Florida. The results of this study that uses a high dose of vitamin D in a cohort of sedentary older men could provide an evidence-based indication for vitamin D supplementation to improve physical performance in this population.

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CONTEXT: Acute infectious thyroiditis, particularly fungal thyroiditis, is rare and typically presents in immunocompromised individuals. Here we report the first case of coccidiomycosis thyroiditis occurring in an organ recipient as a consequence of likely allograft contamination and discuss the management strategies for thyroid masses in the setting of disseminated infection. EVIDENCE ACQUISITION AND SYNTHESIS: In this clinical case seminar, we summarize the previously published cases of coccidiomycosis thyroiditis based on a MEDLINE search of all peer-reviewed publications (original articles and reviews) on this topic. We identified six other cases, five of which also occurred in immunocompromised hosts, although none occurred in organ recipients. CONCLUSION: A case of coccidiomycosis thyroiditis occurring in a post-liver transplant immunocompromised host is reported. Analysis of donor serum revealed the liver allograft as the likely infectious source, resulting in hematological spread to the thyroid. Although our patient's thyroid gland was lacking gross structural abnormalities at presentation, new-onset thyroid masses developed after relative immune restoration and initiation of antifungal therapies. The differential diagnosis of new-onset thyroid masses in immunocompromised hosts is discussed, with a focus on immune reconstitution inflammatory syndrome. The role of thyroidectomy in the management of fungal thyroiditis is also discussed.

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Women have always looked for non-hormonal options to alleviate menopausal vasomotor symptoms and prevent menopausal bone loss. The use of complementary and alternative medicine for these purposes has particularly increased after the publication of the Women's Health Initiative's results suggesting that there might be more risks than benefits with hormone replacement. Phytoestrogens are plant-derived estrogens that, although less potent than estradiol, bind to the estrogen receptor and can function as estrogen agonists or antagonists. Soy isoflavones extracted from soy are the phytoestrogens most commonly used by menopausal women. Because typical Western diets are low in phytoestrogens and taking into account the general difficulty in changing dietary habits, most clinical trials in Western women have used isoflavone-fortified foods or isoflavone tablets. Although some women might experience a reduction in the frequency or severity of hot flashes, most studies point towards the lack of effectiveness of isoflavones derived from soy or red clover, even in large doses, in the prevention of hot flashes and menopausal bone loss. This article is part of a Special Issue entitled 'Phytoestrogens'.

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Postmenopausal osteoporosis is a condition associated with low bone mass resulting from the increased bone resorption that occurs following a decline in estrogen levels. Phytoestrogens are plant-derived compounds that have affinity to the estrogen receptor and are able to act as either estrogen agonists or antagonists. Because of their structural similarity to 17-beta-estradiol, they have been studied extensively for their role in the prevention of postmenopausal bone loss. An extensive number of studies employing different types of isoflavone preparations (including soy foods, soy-enriched foods, and soy isoflavone tablets) have been conducted in a wide range of populations, including Western and Asian women. Although there is considerable variability in study design and duration, study population, type of soy isoflavone employed in the intervention, and study outcomes, the evidence points to a lack of a protective role of soy isoflavones in the prevention of postmenopausal bone loss.

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Diet, a modifiable osteoporosis risk factor, plays an important role in the acquisition and maintenance of bone mass. The influence of diet on bone begins in childhood; even maternal diet can influence bone mass in the offspring. A good general nutritional status and adequate dietary protein, calcium, vitamin D, fruits, and vegetables have a positive influence on bone health, while a high caloric diet and heavy alcohol consumption have been associated with lower bone mass and higher rates of fracture. The evidence for a role of other minerals and vitamins in skeletal health is not as strong, but recent evidence suggests that vitamins C and K might also have an effect on bone.

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OBJECTIVE: The adequate dose of vitamin D supplementation for community-dwelling elderly people has not been thoroughly investigated. This study aims to determine the efficacy of a low-dose and a higher dose of vitamin D3 in maintaining 25-hydroxyvitamin D [25(OH)D] levels at or above 30 ng/mL. METHODS: This was a single site, double-blind, randomized exploratory clinical trial that enrolled adults 65 years of age and older. Within strata of baseline 25(OH)D levels (<30 versus ≥ 30 ng/mL) subjects were randomized in a 1:2 ratio to receive either 400 or 2,000 IU vitamin D3 daily for 6 months. The main outcome measures were changes in serum 25(OH)D levels according to baseline 25(OH)D levels and dose of vitamin D3. RESULTS: At baseline, 41 of 105 participants (39%) had low 25(OH)D levels (<30 ng/mL). After 6 months of vitamin D3 supplementation, 21 of 32 participants (66%) receiving 400 IU and 14 of 59 participants (24%) receiving 2,000 IU of vitamin D3 still had low 25(OH)D levels. The largest increases in serum 25(OH)D levels were observed in subjects with baseline levels <30 ng/mL who received 2,000 IU of vitamin D daily. CONCLUSION: Regardless of baseline 25(OH)D level, in persons 65 years of age and older, 6-month vitamin D3 supplementation with 400 IU daily resulted in low 25(OH)D in most individuals, while 2,000 IU daily maintained 25(OH)D levels within an acceptable range in most people on this regimen.

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PURPOSE OF REVIEW: The present review summarizes the results of epidemiological studies and clinical trials assessing the skeletal effects of soy foods and soy dietary supplements. RECENT FINDINGS: Results from epidemiological studies suggest a beneficial skeletal effect in Asian women consuming typical Asian diets, but clinical trials are conflictive regarding the effects of phytoestrogens on bone mineral density and bone turnover markers in premenopausal and postmenopausal women. Much of the controversy lies in differences in study design, reporting of results, participants' age and menopausal status, and type and dose of phytoestrogen used. SUMMARY: Although western women will likely continue to incorporate soy foods and soy supplements into their diets with the increased availability of these products, published data are inconsistent and do not support soy's protective effect against bone loss. This conflicting evidence should be taken into account when considering using isoflavones in the prevention of bone loss and consequently fractures.

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