cholecalciferol and Fractures--Bone

Low serum vitamin D levels have been associated with adverse clinical outcomes; identifying and treating deficiency may improve outcomes.. To review the evidence about screening for vitamin D deficiency in adults.. PubMed, EMBASE, the Cochrane Library, and trial registries through March 12, 2020; bibliographies from retrieved articles, outside experts, and surveillance of the literature through November 30, 2020.. Fair- or good-quality, English-language randomized clinical trials (RCTs) of screening with serum 25-hydroxyvitamin D (25[OH]D) compared with no screening, or treatment with vitamin D (with or without calcium) compared with placebo or no treatment conducted in nonpregnant adults; nonrandomized controlled intervention studies for harms only. Treatment was limited to studies enrolling or analyzing participants with low serum vitamin D levels.. Two reviewers assessed titles/abstracts and full-text articles, extracted data, and assessed study quality; when at least 3 similar studies were available, meta-analyses were conducted.. Mortality, incident fractures, falls, diabetes, cardiovascular events, cancer, depression, physical functioning, and infection.. Forty-six studies (N = 16 205) (77 publications) were included. No studies directly evaluated the health benefits or harms of screening. Among community-dwelling populations, treatment was not significantly associated with mortality (pooled absolute risk difference [ARD], 0.3% [95% CI, -0.6% to 1.1%]; 8 RCTs, n = 2006), any fractures (pooled ARD, -0.3% [95% CI, -2.1% to 1.6%]; 6 RCTs, n = 2186), incidence of diabetes (pooled ARD, 0.1% [95% CI, -1.3% to 1.6%]; 5 RCTs, n = 3356), incidence of cardiovascular disease (2 RCTs; hazard ratio, 1.00 [95% CI, 0.74 to 1.35] and 1.09 [95% CI, 0.68 to 1.76]), incidence of cancer (2 RCTs; hazard ratio, 0.97 [95% CI, 0.68 to 1.39] and 1.01 [95% CI, 0.65 to 1.58], or depression (3 RCTs, various measures reported). The pooled ARD for incidence of participants with 1 or more falls was -4.3% (95% CI, -11.6% to 2.9%; 6 RCTs). The evidence was mixed for the effect of treatment on physical functioning (2 RCTs) and limited for the effect on infection (1 RCT). The incidence of adverse events and kidney stones was similar between treatment and control groups.. No studies evaluated the direct benefits or harms of screening for vitamin D deficiency. Among asymptomatic, community-dwelling populations with low vitamin D levels, the evidence suggests that treatment with vitamin D has no effect on mortality or the incidence of fractures, falls, depression, diabetes, cardiovascular disease, cancer, or adverse events. The evidence is inconclusive about the effect of treatment on physical functioning and infection.

Topics: Accidental Falls; Adult; Asymptomatic Diseases; Cholecalciferol; Fractures, Bone; Humans; Mass Screening; Practice Guidelines as Topic; Vitamin D; Vitamin D Deficiency; Vitamins

Middle East Respiratory Syndrome (MERS) is a novel respiratory illness firstly reported in Saudi Arabia in 2012. It is caused by a new corona virus, called MERS corona virus (MERS-CoV). Most people who have MERS-CoV infection developed severe acute respiratory illness.. This work is done to determine the clinical characteristics and the outcome of intensive care unit (ICU) admitted patients with confirmed MERS-CoV infection.. This study included 32 laboratory confirmed MERS corona virus infected patients who were admitted into ICU. It included 20 (62.50%) males and 12 (37.50%) females. The mean age was 43.99 ± 13.03 years. Diagnosis was done by real-time reverse transcription polymerase chain reaction (rRT-PCR) test for corona virus on throat swab, sputum, tracheal aspirate, or bronchoalveolar lavage specimens. Clinical characteristics, co-morbidities and outcome were reported for all subjects.. Most MERS corona patients present with fever, cough, dyspnea, sore throat, runny nose and sputum. The presence of abdominal symptoms may indicate bad prognosis. Prolonged duration of symptoms before patients' hospitalization, prolonged duration of mechanical ventilation and hospital stay, bilateral radiological pulmonary infiltrates, and hypoxemic respiratory failure were found to be strong predictors of mortality in such patients. Also, old age, current smoking, smoking severity, presence of associated co-morbidities like obesity, diabetes mellitus, chronic heart diseases, COPD, malignancy, renal failure, renal transplantation and liver cirrhosis are associated with a poor outcome of ICU admitted MERS corona virus infected patients.. Plasma HO-1, ferritin, p21, and NQO1 were all elevated at baseline in CKD participants. Plasma HO-1 and urine NQO1 levels each inversely correlated with eGFR (. SnPP can be safely administered and, after its injection, the resulting changes in plasma HO-1, NQO1, ferritin, and p21 concentrations can provide information as to antioxidant gene responsiveness/reserves in subjects with and without kidney disease.. A Study with RBT-1, in Healthy Volunteers and Subjects with Stage 3-4 Chronic Kidney Disease, NCT0363002 and NCT03893799.. HFNC did not significantly modify work of breathing in healthy subjects. However, a significant reduction in the minute volume was achieved, capillary [Formula: see text] remaining constant, which suggests a reduction in dead-space ventilation with flows > 20 L/min. (ClinicalTrials.gov registration NCT02495675).. 3 组患者手术时间、术中显性失血量及术后 1 周血红蛋白下降量比较差异均无统计学意义（. 对于肥胖和超重的膝关节单间室骨关节炎患者，采用 UKA 术后可获满意短中期疗效，远期疗效尚需进一步随访观察。.. Decreased muscle strength was identified at both time points in patients with hEDS/HSD. The evolution of most muscle strength parameters over time did not significantly differ between groups. Future studies should focus on the effectiveness of different types of muscle training strategies in hEDS/HSD patients.. These findings support previous adverse findings of e-cigarette exposure on neurodevelopment in a mouse model and provide substantial evidence of persistent adverse behavioral and neuroimmunological consequences to adult offspring following maternal e-cigarette exposure during pregnancy. https://doi.org/10.1289/EHP6067.. This RCT directly compares a neoadjuvant chemotherapy regimen with a standard CROSS regimen in terms of overall survival for patients with locally advanced ESCC. The results of this RCT will provide an answer for the controversy regarding the survival benefits between the two treatment strategies.. NCT04138212, date of registration: October 24, 2019.. Results of current investigation indicated that milk type and post fermentation cooling patterns had a pronounced effect on antioxidant characteristics, fatty acid profile, lipid oxidation and textural characteristics of yoghurt. Buffalo milk based yoghurt had more fat, protein, higher antioxidant capacity and vitamin content. Antioxidant and sensory characteristics of T. If milk is exposed to excessive amounts of light, Vitamins B. The two concentration of ZnO nanoparticles in the ambient air produced two different outcomes. The lower concentration resulted in significant increases in Zn content of the liver while the higher concentration significantly increased Zn in the lungs (p < 0.05). Additionally, at the lower concentration, Zn content was found to be lower in brain tissue (p < 0.05). Using TEM/EDX we detected ZnO nanoparticles inside the cells in the lungs, kidney and liver. Inhaling ZnO NP at the higher concentration increased the levels of mRNA of the following genes in the lungs: Mt2 (2.56 fold), Slc30a1 (1.52 fold) and Slc30a5 (2.34 fold). At the lower ZnO nanoparticle concentration, only Slc30a7 mRNA levels in the lungs were up (1.74 fold). Thus the two air concentrations of ZnO nanoparticles produced distinct effects on the expression of the Zn-homeostasis related genes.. Until adverse health effects of ZnO nanoparticles deposited in organs such as lungs are further investigated and/or ruled out, the exposure to ZnO nanoparticles in aerosols should be avoided or minimised.

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As the population of people living with HIV ages, the increase in non-AIDs morbidities is expected to increase in parallel. Maintaining bone health in those with HIV will be an important area of focus for the HIV clinician to prevent the morbidity and mortality associated with fragility fractures, the principal clinical sequela of low bone mineral density (BMD). Rates of fractures and prevalence of low bone mineral density, a risk factor for future fragility fractures, are already increased in the HIV positive population.. This review examines the strategies to maintain bone health in those living with HIV from screening through to managing those with established low BMD or fracture, including the role for choice of or modification of antiretroviral therapy to maintain bone health. Expert commentary: The increasing complexity of managing bone health in the age of succesful antiretroviral therapy and an aging patient population as well as future perspectives which may help achieve the long term aim of minimising the impact of low BMD in those with HIV are discussed and explored.

Topics: Absorptiometry, Photon; Anti-Retroviral Agents; Bone Density; Bone Density Conservation Agents; Cholecalciferol; Ergocalciferols; Fractures, Bone; HIV Infections; Humans; Osteoporosis; Risk Factors

Falls are a major health problem in elderly individuals. Although intensive physical therapy and management of hazards in the home can reduce falls by 25%, long-term practicality limits their use. Interest in vitamin D as a medical therapy has led to many trials; however, results using daily oral doses of vitamin D have been inconsistent. In the past 5 years, studies on the effect of bolus doses of vitamin D have produced surprising results. Bolus doses of vitamin D, given annually (at a dose of 300,000 IU or 500,000 IU) or monthly (at a dose of 24,000 IU or 60,000 IU) - equivalent to approximate daily doses of 800 IU, 1400 IU and 2,000 IU - result in a significant increase in the number of falls and fractures associated with serum levels of 25-hydroxyvitamin D greater than 40-45 ng/ml (equivalent to 100-112 nmol/l). These unexpected results show increased falls and fractures are adverse events related to vitamin D administration. Until further safety data is available, bolus dosing or daily doses should not exceed 3,000 IU and serum levels of 25-hydroxyvitamin D should not exceed 40-45 ng/ml (equivalent to 100-112 nmol/l) in elderly individuals.

Topics: Accidental Falls; Cholecalciferol; Ergocalciferols; Fractures, Bone; Humans; Physical Therapy Modalities; Vitamin D; Vitamin D Deficiency; Vitamins

The prevalence of vitamin D deficiency in hemodialysis patients is high. While most hemodialysis patients are treated with activated vitamin D (1,25[OH]2D) to prevent renal osteodystrophy, clinical practices of the screening and treatment of 25(OH)2D deficiency are highly variable. It is unclear if nutritional vitamin D supplementation with D2 or D3 provides an additional clinical benefit beyond that provided by activated vitamin D treatment in this population.. We will conduct a systematic review of nutritional vitamin D (D2/D3) supplementation and health-related outcomes in hemodialysis patients according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The primary objective is to assess the impact of nutritional vitamin D supplementation on clinical outcomes relevant in hemodialysis patients, such as mortality, cardiovascular events, infections, and fractures. Secondary outcomes will include anemia, hyperparathyroidism, medication use (erythrocyte-stimulating agents, activated vitamin D), and quality of life. We will search MEDLINE, Scopus, Web of Science, and ClinicalTrials.gov for randomized, controlled trials of nutritional vitamin D supplementation (ergocalciferol/D2 or cholecalciferol/D3) in chronic hemodialysis patients. The Cochrane Risk Assessment Tool will be used to assess the quality of eligible studies. We will perform meta-analyses using standard techniques for the outcomes listed above if pooling is deemed appropriate/sufficient. The results of this systematic review may highlight gaps in our knowledge of the relevance of nutritional vitamin D in end-stage renal disease, allowing for the informed design of clinical trials assessing the impact of nutritional vitamin D therapy in the hemodialysis population in the future.. PROSPERO CRD42014013931.

Topics: Cardiovascular Diseases; Cholecalciferol; Chronic Kidney Disease-Mineral and Bone Disorder; Clinical Protocols; Dietary Supplements; Ergocalciferols; Fractures, Bone; Humans; Infections; Renal Dialysis; Renal Insufficiency, Chronic; Research Design; Systematic Reviews as Topic; Vitamin D Deficiency; Vitamins

Although active vitamin D₃ only slightly increases bone mineral density (BMD) , it prevents fractures to a greater extent than is predicted, based on measurements of BMD. This effect is partly attributed to enhanced muscle strength and increased physical capabilities by vitamin D, which, in turn, decreases the risk of falls and fractures. In addition, active vitamin D₃ has been reported in animal studies to improve bone quality by enhancing trabecular bone microarchitecture and increasing enzymatic collagen cross-links in bone. A (large scale of) randomized controlled trial in Japanese postmenopausal women verified that the combination therapy of bisphosphonate (alendronate) plus active vitamin D₃ was more effective than monotherapy in terms of fracture prevention in high fracture risk group.

Topics: Animals; Bone and Bones; Bone Density; Bone Density Conservation Agents; Cholecalciferol; Collagen; Diphosphonates; Drug Therapy, Combination; Female; Fractures, Bone; Fractures, Spontaneous; Humans; Osteoporosis, Postmenopausal; Risk

Steroid-induced osteoporosis is a textbook example of the secondary type of this medical condition. Glucocorticosteroids suppress bone formation by their direct and indirect effect on osteoblasts, osteoclasts and osteocytes, increasing their resorption and, eventually, leading to negative bone balance. A clinical problem arises regarding the fact that approximately 50% of patients on chronic steroid therapy undergo asymptomatic bone fractures. The treatment mode includes minimising the dose of administered steroids, encouraging an improved lifestyle and supplementation with adequate calcium and vitamin D(3) doses. Bisphosphonates are a group of medical agents used both to prevent and treat steroid-induced osteoporosis, although new therapies have also become available in recent years.

Topics: Bone Density Conservation Agents; Calcium; Cholecalciferol; Diphosphonates; Female; Fractures, Bone; Glucocorticoids; Humans; Male; Osteoblasts; Osteoclasts; Osteogenesis; Osteoporosis

The efficacy of vitamin D(3) in preventing fractures and falls has been explored in a number of clinical trials. However, recent evidence revealed new questions about the adequate doses of vitamin D(3) supplementation and its efficacy in fracture prevention independent of calcium supplements for various types of fractures.. To conduct a meta-analysis to estimate the effectiveness of 800 IU daily vitamin D(3) supplementation for increasing bone mineral density (BMD) and preventing fractures in postmenopausal women.. Medline and EMBASE were searched for controlled trials comparing the effectiveness of cholecalciferol (vitamin D(3)) against placebo with or without background calcium supplementation in the treatment of postmenopausal women.. Eight controlled trials evaluating the effect of vitamin D(3) supplementation with or without calcium were assessed. Of 12 658 women included in a Bayesian meta-analysis, 6089 received vitamin D(3) (with or without calcium) and 6569 received placebo (with or without calcium). Compared to placebo, vitamin D(3) with calcium supplementation showed beneficial effects on the incidence of non-vertebral (odds ratio [OR] 0.77, 95% credibility limit [CL] 0.6-0.93) and hip (OR 0.70, 95% CL 0.53-0.90) fractures, while the effects on non-vertebral-non-hip fractures (OR 0.84, 95% CL 0.67-1.04) % point increase) were associated with more uncertainty. Vitamin D(3) supplementation showed a 70% probability of being a better treatment than placebo for the prevention of non-vertebral fractures, hip fractures, and non-vertebral, non-hip fractures. Compared to calcium supplementation, vitamin D(3) plus calcium reduced non-vertebral fractures (OR 0.68, 95% CL 0.43-1.01) and non-vertebral, non-hip fractures (OR 0.64, 95% CL 0.38-0.99), but did not reduce hip fractures (OR 1.03, 95% CL 0.39-2.25). Key limitations to this analysis include a small number of studies and heterogeneity in the study populations.. This meta-analysis supports the use of vitamin D3 of 800 IU daily to reduce the incidence of osteoporotic non-vertebral, hip, and non-vertebral-non-hip fractures in elderly women. Vitamin D(3) with calcium appears to achieve benefits above those attained with calcium supplementation alone for non-vertebral and non-vertebral-non-hip fractures.

Topics: Aged; Bone Density; Cholecalciferol; Dietary Supplements; Female; Fractures, Bone; Humans; Placebos; Postmenopause

Vitamins D and K are lipid-phase nutrients that are pleiotropic - endowed with versatile homeostatic capacities at the organ, tissue, and cellular levels. Their metabolic and physiologic roles overlap considerably, as evidenced in the bone and cardiovascular systems. Vitamin D₃ (cholecalciferol, D₃) is the prehormone for the vitamin D endocrine system. Vitamin D₃ undergoes initial enzymatic conversion to 25-hydroxyvitamin D (25D, calcidiol), then to the seco-steroid hormone 1alpha, 25-dihydroxyvitamin D (1,25D, calcitriol). Beyond its endocrine roles in calcium homeostasis, 1,25D likely has autocrine, paracrine, and intracrine effects. At least 17 tissues likely synthesize 1,25D, and 35 carry the vitamin D receptor (VDR). Vitamin D functional deficiency is widespread in human populations. Vitamin K₁ (phylloquinone) is more abundant in foods but less bioactive than the vitamin K₂ menaquinones (especially MK-4, menatetrenone). Menadione (vitamin K₃) has minimal K activity. Vitamin K compounds undergo oxidation-reduction cycling within the endoplasmic reticulum membrane, donating electrons to activate specific proteins via enzymatic gamma-carboxylation of glutamate groups before being enzymatically re-reduced. Warfarin inhibits this vitamin K reduction, necessitating K supplementation during anticoagulation therapy. Along with coagulation factors (II, VII, IX, X, and prothrombin), protein C and protein S, osteocalcin (OC), matrix Gla protein (MGP), periostin, Gas6, and other vitamin K-dependent (VKD) proteins support calcium homeostasis, facilitate bone mineralization, inhibit vessel wall calcification, support endothelial integrity, are involved in cell growth control and tissue renewal, and have numerous other effects. This review updates vitamin D and K skeletal and cardiovascular benefits and evidence for their synergy of action.

Topics: Bone and Bones; Bone Density; Bone Diseases; Calcification, Physiologic; Cardiovascular Diseases; Cardiovascular System; Cholecalciferol; Fractures, Bone; Humans; Nutritional Physiological Phenomena; Osteoblasts; Osteocytes; Vitamin D Deficiency; Vitamin K; Vitamin K 1; Vitamin K 2; Vitamin K 3; Vitamin K Deficiency

Vitamin D and calcium are indispensable for the maintenance of bone mass and integrity. Active vitamin D3 has been most widely used in Japan for the treatment of osteoporosis. These drugs mildly increase bone mineral density, but it has little consistent effects on bone metabolic markers. Although weak, there is also some clinical evidence for their efficacy as a fracture-preventing drug. Recent reports suggest that vitamin D3 not only enhances intestinal calcium absorption but may also improve neuromuscular function to reduce the number of falls, thereby contributing to fracture prevention. Besides such extraskeletal effects, vitamin D analogues may also have direct bone anabolic effects, preventing fractures even under native vitamin D and calcium supplement.

Topics: Accidental Falls; Bone and Bones; Bone Density; Calcium; Cholecalciferol; Evidence-Based Medicine; Fractures, Bone; Fractures, Spontaneous; Humans; Intestinal Absorption; Meta-Analysis as Topic; Osteoporosis; Quality of Life

A-TOP research consortium has been authorized at 2000 by the Japanese Society of Osteoporosis and assisted by Public Health Research Foundation in order to obtain the clinical evidences regarding osteoporosis treatment. Each clinical trial program was named as JOINT (Japanese Osteoporosis Intervention Trial), which was multi-center randomized open label trial and was registered into clinical trial registry. JOINT-02 was started at 2003 to confirm the effect of combination treatment of active vitamin D3 and alendronate in the prevention of osteoporotic bone fracture occurrence. This trial will be terminated at 2009 and the subsequent third clinical trial to obtain the evidence regarding the combination effects of risedronate and vitamin K2 as JOINT-03 project has been started from 2008. Each trial included around 2,000 participants mainly from practitioner and the registration of the cases in JOINT-02 has been finished within 3 years, suggesting that the participated practitioner would have sympathy with the research aims. The A-TOP research group would have carried out epidemiological studies regarding establishment of osteoporosis database (JOB study), which will contribute the additional knowledge of Japanese osteoporosis.

Topics: Alendronate; Bone Density Conservation Agents; Cholecalciferol; Drug Therapy, Combination; Evidence-Based Medicine; Fractures, Bone; Fractures, Spontaneous; Humans; Japan; Multicenter Studies as Topic; Osteoporosis; Practice Guidelines as Topic; Randomized Controlled Trials as Topic; Societies, Medical; Vitamin K 2

Intervention studies and meta-analyses have shown that vitamin D(3) at 700-800 IU/day decreases the fracture incidence. Higher phylloquinone (vitamin K(1)) intake or "natto" intake was associated with lower fracture incidence. In contrast, current intake of vitamin D and K in Japanese is likely to be unsatisfactory for preventing fracture. The intake of fish, abundant in vitamin D(3) is encouraged. Regarding vitamin K, "natto" intake is strongly recommended, since it contains extraordinary amount of menaquinone-7. Phylloquinone in green vegetables would be efficiently absorbed when cooked with oil. Thus Japanese traditional foods seem to be appropriate for bone health.

Topics: Cholecalciferol; Dietary Fats; Female; Food Analysis; Fractures, Bone; Humans; Male; Risk; Solubility; Soy Foods; Vitamin K 1; Vitamin K 2

The incidence of osteoporotic fractures increases along aging and the importance of their prevention is more emphasized in the elderly. Although the major determinants for fragile fractures in the elderly are not only the lower bone strength but also frailty and fall, treatments with anti-resorbers are effective also in the elderly. On the other hands, nutritional agents such as active vitamin D3 and vitamin K2 are effective in reducing the fracture incidences in spite of their modest effects on bone mineral density. Recently, the effects of vitamin Ds on the reduction of fall events are noticed and the prevention of osteoporotic fractures in the elderly through extra-skeletal mechanisms seems promising.

Topics: Accidental Falls; Aged; Aged, 80 and over; Bone Density; Bone Density Conservation Agents; Cholecalciferol; Diphosphonates; Estrogen Replacement Therapy; Fractures, Bone; Humans; Osteoporosis; Randomized Controlled Trials as Topic; Selective Estrogen Receptor Modulators; Vitamin K 2

Topics: Bone Density Conservation Agents; Calcitonin; Cholecalciferol; Diphosphonates; Fractures, Bone; Humans; Japan; Osteoporosis; Randomized Controlled Trials as Topic; Risk Assessment; Selective Estrogen Receptor Modulators; World Health Organization

Topics: Aged; Aged, 80 and over; Bone Density Conservation Agents; Calcium Carbonate; Cholecalciferol; Drug Therapy, Combination; Fractures, Bone; Fractures, Stress; Humans; Osteoporosis; Randomized Controlled Trials as Topic; Risk

Topics: Accidental Falls; Bone and Bones; Bone Density; Cholecalciferol; Evidence-Based Medicine; Fractures, Bone; Glucocorticoids; Humans; Osteoporosis

Topics: Absorptiometry, Photon; Animals; Biomarkers; Bone and Bones; Bone Density; Bone Density Conservation Agents; Cholecalciferol; Collagen; Diabetes Complications; Diphosphonates; Fractures, Bone; Glycation End Products, Advanced; Humans; Insulin Resistance; Insulin-Like Growth Factor I; Osteoporosis

It is well established that activated vitamin D(3) affects bone metabolism and its bone fracture reducing effect is prominent considering relatively weak effect on increase of bone mineral density. The risk of osteoporotic bone fracture generally correlates with bone mineral density. On the other hand, fall is a major cause of bone fracture in the elderly people. Therefore, bone fracture reducing effect of activated vitamin D(3) can be presumed as the result of reduction of fall incidents (such as the effects on the stability of body balance and muscle strength), as well as the effects on bone strength and quality. In this manuscript, the relation between fall, bone fracture and vitamin D would be introduced.

Topics: Accidental Falls; Aged; Aged, 80 and over; Bone and Bones; Bone Density; Cholecalciferol; Female; Fractures, Bone; Humans; Middle Aged; Muscle Weakness; Osteoporosis; Randomized Controlled Trials as Topic; Risk Factors

Osteoporosis is the most frequent adverse effect of glucocorticoids. Management guidelines for glucocorticoid-induced osteoporosis have been established in the United States, the United Kingdom, and many other countries. The 2004 edition of the guidelines on the management and treatment of glucocorticoid-induced osteoporosis have been proposed by The Japanese Society for Bone and Mineral Research. The subjects were patients with using or planning to use oral glucocorticoids for 3 months or longer. The criterion for starting treatment was patients with prior fragility fracture and with new fractures during treatment, patients with less bone mineral density (BMD) than 80% of young adult mean, and patients with using as a dose of 5mg/day or higher (mean daily dose) as prednisolone equivalent. The bisphosphonates have been recommended as first-line drugs and active vitamin D(3) and vitamin K(2) have been recommended as second-line drugs.

Topics: Bone Density; Bone Density Conservation Agents; Cholecalciferol; Diphosphonates; Evidence-Based Medicine; Fractures, Bone; Glucocorticoids; Humans; Japan; Osteoporosis; Practice Guidelines as Topic; Prednisolone; Time Factors; Vitamin K 2

Since the World Health Organisation's announcement of the "Bone and Joint Decade 2000-2010" diseases of the musculoskeletal system attract more and more attention throughout patients and professional health care providers. In an aging society especially osteoporosis represents a major public health concern. Fragility fractures are the most limiting condition in osteoporosis with the highest impact on both, life quality and health care systems worldwide. Orthopaedic surgeons play a key role in implementing primary diagnostics and therapy in patients with fragility fractures. Objective of this effort is the reduction of the common subsequent fractures in patients with osteoporosis. According to national and international guidelines implementation of contemporary clinical pathways to diagnose and treat patients with fractures due to diminished bone mineral density is fast, simple and proven to be effective.

Topics: Absorptiometry, Photon; Adult; Age Factors; Aged; Aged, 80 and over; Bone Density; Bone Density Conservation Agents; Bone Diseases, Metabolic; Calcium; Cholecalciferol; Diphosphonates; Estrogen Receptor Modulators; Female; Fractures, Bone; Humans; Male; Middle Aged; Osteoporosis; Practice Guidelines as Topic; Quality of Life; Risk Factors; World Health Organization

Osteoporosis is the most frequent adverse effect observed during glucocorticoids therapy. The 2004 edition of the guideline on the management and treatment of glucocorticoid-induced osteoporosis has been proposed by The Japanese Society for Bone and Mineral Research. The subjects were patients with using or planning to use oral glucocorticoids for 3 months or longer. The criterion for starting treatment consisted patients with prior fragility fracture and with new fractures during treatment, patients with less BMD than %YAM80, and patients with using as a dose of 5 mg/day or higher (mean daily dose) as prednisolone equivalent. The Bisphosphonates have been recommended as first-line drugs. Active vitamin D3 and vitamin K2 have been recommended as second-line drugs.

Topics: Bone and Bones; Bone Density; Cholecalciferol; Diphosphonates; Fractures, Bone; Glucocorticoids; Humans; Osteocalcin; Osteoporosis; Practice Guidelines as Topic; Prednisolone; Randomized Controlled Trials as Topic; Risk; Vitamin K 2

In the WHO technical report, vitamin D metabolites have been suggested to have a role as an adjunctive therapy when given with an antiresorptive agent. Beneficial effects on BMD have been reported following the addition of calcitriol to alendronate, etidronate, and HRT, but no data on fracture rates are available. Here we summarize our clinical study on the concurrent therapy and review reports on the concurrent treatments.

Topics: Aged; Bone Density; Cholecalciferol; Clinical Trials as Topic; Diphosphonates; Drug Therapy, Combination; Estrogen Replacement Therapy; Etidronic Acid; Female; Fractures, Bone; Humans; Male; Multicenter Studies as Topic; Osteoporosis; Vitamin K 2

The role and dose of oral vitamin D supplementation in nonvertebral fracture prevention have not been well established.. To estimate the effectiveness of vitamin D supplementation in preventing hip and nonvertebral fractures in older persons.. A systematic review of English and non-English articles using MEDLINE and the Cochrane Controlled Trials Register (1960-2005), and EMBASE (1991-2005). Additional studies were identified by contacting clinical experts and searching bibliographies and abstracts presented at the American Society for Bone and Mineral Research (1995-2004). Search terms included randomized controlled trial (RCT), controlled clinical trial, random allocation, double-blind method, cholecalciferol, ergocalciferol, 25-hydroxyvitamin D, fractures, humans, elderly, falls, and bone density.. Only double-blind RCTs of oral vitamin D supplementation (cholecalciferol, ergocalciferol) with or without calcium supplementation vs calcium supplementation or placebo in older persons (> or =60 years) that examined hip or nonvertebral fractures were included.. Independent extraction of articles by 2 authors using predefined data fields, including study quality indicators.. All pooled analyses were based on random-effects models. Five RCTs for hip fracture (n = 9294) and 7 RCTs for nonvertebral fracture risk (n = 9820) met our inclusion criteria. All trials used cholecalciferol. Heterogeneity among studies for both hip and nonvertebral fracture prevention was observed, which disappeared after pooling RCTs with low-dose (400 IU/d) and higher-dose vitamin D (700-800 IU/d), separately. A vitamin D dose of 700 to 800 IU/d reduced the relative risk (RR) of hip fracture by 26% (3 RCTs with 5572 persons; pooled RR, 0.74; 95% confidence interval [CI], 0.61-0.88) and any nonvertebral fracture by 23% (5 RCTs with 6098 persons; pooled RR, 0.77; 95% CI, 0.68-0.87) vs calcium or placebo. No significant benefit was observed for RCTs with 400 IU/d vitamin D (2 RCTs with 3722 persons; pooled RR for hip fracture, 1.15; 95% CI, 0.88-1.50; and pooled RR for any nonvertebral fracture, 1.03; 95% CI, 0.86-1.24).. Oral vitamin D supplementation between 700 to 800 IU/d appears to reduce the risk of hip and any nonvertebral fractures in ambulatory or institutionalized elderly persons. An oral vitamin D dose of 400 IU/d is not sufficient for fracture prevention.

Topics: Aged; Cholecalciferol; Dietary Supplements; Ergocalciferols; Fractures, Bone; Humans; Randomized Controlled Trials as Topic; Vitamin D

Topics: Alendronate; Bone Density; Cholecalciferol; Diphosphonates; Drug Design; Fractures, Bone; Humans; Osteoporosis; Parathyroid Hormone; Reference Standards; Risk; Selective Estrogen Receptor Modulators; Strontium

The physiologic range for circulating 25-hydroxyvitamin D3 [25(OH)D; the measure of Vitamin D nutrient status] concentration in humans and other primates extends to beyond 200 nmol/L (>80 ng/mL). This biologic "normal" value is greater than current population norms for 25(OH)D. Concentrations of 25(OH)D that correlate with desirable effects extend to at least 70 nmol/L, with no obvious threshold. Randomized clinical trials using 20 mcg (800 IU) per day of Vitamin D show that this suppresses parathyroid hormone, preserves bone mineral density, prevents fractures, lowers blood pressure and improves balance. Calcium absorption from diet correlates with 25(OH)D in the normal range. Health effects of Vitamin D beyond osteoporosis are mostly supported by the circumstantial evidence of epidemiologic studies and laboratory research. These include prevention of cancer and the autoimmune diseases, insulin-dependent diabetes and multiple sclerosis. One mcg per day of Vitamin D(3) (cholecalciferol) increases circulating 25(OH)D by about 1 nmol/L (0.4 ng/mL). A recommended dietary allowance (RDA) is the long-term daily intake level that meets the total requirements for the nutrient by nearly all healthy individuals (it would presume no sunshine). If 70 nmol/L is regarded as a minimum desirable target 25(OH)D concentration, then current recommendations of 15 mcg per day do not meet the criterion of an RDA.

Topics: Adult; Autoimmune Diseases; Blood Pressure; Cholecalciferol; Fractures, Bone; Humans; Neoplasms; Nutrition Policy

Topics: Alendronate; Bone Density; Cholecalciferol; Clinical Trials as Topic; Estrogen Replacement Therapy; Etidronic Acid; Fractures, Bone; Humans; Hydroxycholecalciferols; Osteoporosis; Raloxifene Hydrochloride; Vitamin K 2

Topics: Absorptiometry, Photon; Calcium; Cholecalciferol; Fractures, Bone; Humans; Osteoporosis; Risk Factors

Topics: Age Factors; Bone Density; Calcitriol; Calcium; Calcium Channel Blockers; Cholecalciferol; Dietary Supplements; Drug Therapy, Combination; Estrogen Replacement Therapy; Female; Fractures, Bone; Humans; Osteoporosis; Osteoporosis, Postmenopausal; Randomized Controlled Trials as Topic; Selective Estrogen Receptor Modulators; Vitamin D Deficiency

The Health Council of the Netherlands has issued a report on the recommended use of calcium, vitamin D and a number of other vitamins. The recommendations for calcium and vitamin D have been adjusted (upward) in view of recent evidence that these nutrients affect the occurrence of osteoporosis and bone fractures in all stages of life.

Topics: Adult; Age Factors; Aged; Calcifediol; Calcitriol; Calcium Channel Agonists; Calcium, Dietary; Child; Cholecalciferol; Dietary Supplements; Ergocalciferols; Fractures, Bone; Humans; Netherlands; Nutrition Policy; Osteoporosis; Vitamin D; Vitamin D Deficiency

Elderly women and men lose bone at a rate of < or = 1% per year. This results in an increasing risk of most fractures, of which hip fractures account for the greatest proportion of death, disability, and medical costs. Falls are the immediate precipitating factor for about 90% of hip fractures and 80% of other types of fractures in women. Since the rate of bone remodeling increases with age, antiresorptive therapies are likely to be at least as effective in the elderly as in younger adults. Calcium supplementation, for example, slows bone loss more effectively in older women than in those within 5 years of menopause, although the effectiveness of calcium for prevention of fractures remains uncertain. Vitamin D deficiency is more common in the elderly, and supplementation of deficient women appears to slow bone loss, at least during winter. Calcium plus vitamin D may substantially reduce the risk of hip fracture in the frail elderly. A randomized trial showed that estrogen remains effective in preventing vertebral fractures in older women. There is no reason to believe that the effectiveness of other agents would diminish with age. Preventive therapy offers greatest and most immediate benefit to those who have the highest risk of fracture: the elderly, those with previous fractures, those at increased risk of falling, and those with lowest bone mass. Since the relationship between bone mass and risk of fracture remains strong in elderly women, bone mass measurements may also be as useful in the elderly as in younger adults.

Topics: Aged; Aged, 80 and over; Bone Density; Bone Remodeling; Calcium, Dietary; Cholecalciferol; Female; Fractures, Bone; Humans; Male; Middle Aged; Osteoporosis; Osteoporosis, Postmenopausal

Topics: Calcium; Calcium Metabolism Disorders; Cholecalciferol; Cushing Syndrome; Diagnosis, Differential; Fanconi Syndrome; Fractures, Bone; Glomerular Filtration Rate; Humans; Hypercalcemia; Hyperparathyroidism; Hyperthyroidism; Kidney Calculi; Nephrocalcinosis; Osteitis Deformans; Osteoporosis; Parathyroid Hormone; Sarcoidosis

Vitamin D supplements are widely recommended for bone health in the general population, but data on whether they prevent fractures have been inconsistent.. In an ancillary study of the Vitamin D and Omega-3 Trial (VITAL), we tested whether supplemental vitamin D. Among 25,871 participants (50.6% women [13,085 of 25,871] and 20.2% Black [5106 of 25,304]), we confirmed 1991 incident fractures in 1551 participants over a median follow-up of 5.3 years. Supplemental vitamin D. Vitamin D

Topics: Aged; Cholecalciferol; Dietary Supplements; Double-Blind Method; Fatty Acids, Omega-3; Female; Fractures, Bone; Hip Fractures; Humans; Male; Middle Aged; Osteoporosis; Vitamin D Deficiency

Fractures in Charcot neuro-osteoarthropathy (CN) often fail to heal despite prolonged immobilization with below-knee casting. The aim of the study was to assess the efficacy of recombinant human parathyroid hormone (PTH) in reducing time to resolution of CN and healing of fractures.. People with diabetes and acute (active) Charcot foot were randomized (double-blind) to either full-length PTH (1-84) or placebo therapy, both in addition to below-knee casting and calcium and vitamin D3 supplementation. The primary outcome was resolution of CN, defined as a skin foot temperature difference >2°C at two consecutive monthly visits.. Median time to resolution was 5 months (95% CI 4, 12) in intervention and 6 months (95% CI 2, 9) in control. On univariate mixed Cox and logistic regression, there was no significant difference in time to resolution between the groups (. This double-blind placebo-controlled trial did not reduce time to resolution or enhance fracture healing of CN. There was no added benefit of daily intervention with PTH (1-84) to below-knee casting in achieving earlier resolution of CN.

Topics: Cholecalciferol; Diabetes Mellitus; Double-Blind Method; Fractures, Bone; Humans; Parathyroid Hormone

Accumulating evidence from observational studies indicates that vitamin D status is inversely associated with a many non-skeletal diseases. This has initiated the conduct of several large clinical trials to determine if high dose vitamin D supplementation (≥ 2000 IU/day or monthly equivalent) prevents non-skeletal disease including cardiovascular disease, cancer and mortality. One of these trials is the Vitamin D Assessment (ViDA) Study which recruited 5110 participants, aged 50-84 years, mostly from primary care practices in Auckland, New Zealand. The intervention was a capsule that contained either 100,000 IU vitamin D3 or placebo, two of which were taken by each participant soon after randomization, and then monthly up to 31 July 2015 (median follow-up 3.3 years). Information on study outcomes came from self-completed questionnaires and health data collected routinely by the Ministry of Health. There was no effect of vitamin D on the main outcomes: cardiovascular disease, acute respiratory infections, non-vertebral fractures, falls and all cancer. In contrast, vitamin D increased persistence with taking statins among participants on long term statin therapy. Beneficial effects were seen also for lung function among ever smokers (especially if vitamin D deficient), and in participants with low 25-hydroxyvitamin D levels for bone mineral density and arterial function. The findings support future research being carried out mainly in people who are vitamin D deficient, although there are practical and ethical issues in recruiting such people into future vitamin D supplementation trials.

Topics: Accidental Falls; Adult; Aged; Aged, 80 and over; Animals; Cardiovascular Diseases; Cholecalciferol; Female; Fractures, Bone; Humans; Male; Middle Aged; Neoplasms; Placebo Effect; Respiratory Tract Infections; Vitamins

The benefits of vitamin D, omega-3 fatty acids, and exercise in disease prevention remain unclear.. To test whether vitamin D, omega-3s, and a strength-training exercise program, alone or in combination, improved 6 health outcomes among older adults.. Double-blind, placebo-controlled, 2 × 2 × 2 factorial randomized clinical trial among 2157 adults aged 70 years or older who had no major health events in the 5 years prior to enrollment and had sufficient mobility and good cognitive status. Patients were recruited between December 2012 and November 2014, and final follow-up was in November 2017.. Participants were randomized to 3 years of intervention in 1 of the following 8 groups: 2000 IU/d of vitamin D3, 1 g/d of omega-3s, and a strength-training exercise program (n = 264); vitamin D3 and omega-3s (n = 265); vitamin D3 and exercise (n = 275); vitamin D3 alone (n = 272); omega-3s and exercise (n = 275); omega-3s alone (n = 269); exercise alone (n = 267); or placebo (n = 270).. The 6 primary outcomes were change in systolic and diastolic blood pressure (BP), Short Physical Performance Battery (SPPB), Montreal Cognitive Assessment (MoCA), and incidence rates (IRs) of nonvertebral fractures and infections over 3 years. Based on multiple comparisons of 6 primary end points, 99% confidence intervals are presented and P < .01 was required for statistical significance.. Among 2157 randomized participants (mean age, 74.9 years; 61.7% women), 1900 (88%) completed the study. Median follow-up was 2.99 years. Overall, there were no statistically significant benefits of any intervention individually or in combination for the 6 end points at 3 years. For instance, the differences in mean change in systolic BP with vitamin D vs no vitamin D and with omega-3s vs no omega-3s were both -0.8 (99% CI, -2.1 to 0.5) mm Hg, with P < .13 and P < .11, respectively; the difference in mean change in diastolic BP with omega-3s vs no omega-3s was -0.5 (99% CI, -1.2 to 0.2) mm Hg; P = .06); and the difference in mean change in IR of infections with omega-3s vs no omega-3s was -0.13 (99% CI, -0.23 to -0.03), with an IR ratio of 0.89 (99% CI, 0.78-1.01; P = .02). No effects were found on the outcomes of SPPB, MoCA, and incidence of nonvertebral fractures). A total of 25 deaths were reported, with similar numbers in all treatment groups.. Among adults without major comorbidities aged 70 years or older, treatment with vitamin D3, omega-3s, or a strength-training exercise program did not result in statistically significant differences in improvement in systolic or diastolic blood pressure, nonvertebral fractures, physical performance, infection rates, or cognitive function. These findings do not support the effectiveness of these 3 interventions for these clinical outcomes.. ClinicalTrials.gov Identifier: NCT01745263.

Topics: Aged; Aged, 80 and over; Cholecalciferol; Cognition Disorders; Dietary Supplements; Double-Blind Method; Fatty Acids, Omega-3; Female; Follow-Up Studies; Fractures, Bone; Health Status; Humans; Hypertension; Immunity; Male; Physical Fitness; Resistance Training; Treatment Outcome; Vitamins

The Vitamin D Assessment (ViDA) study is a randomised, double-blind, placebo-controlled trial to evaluate the efficacy of monthly vitamin D supplementation in reducing the incidence of a range of acute and chronic diseases and intermediate outcomes.. The study was carried out in Auckland, New Zealand, among 5110 adults, aged 50-84 years, who were followed for a median 3.3 years. The intervention was vitamin D3 (2.5 mg or 100,000 IU) or placebo softgel oral capsules, mailed monthly to participants' homes, with two capsules sent in the first mail-out post-randomisation (i.e. 200,000 IU bolus, or placebo), followed 1 month later (and thereafter monthly) with 100,000 IU vitamin D3 or placebo capsules. Outcomes were monitored through routinely collected health data and self-completed questionnaires.. The results showed no beneficial effect of vitamin D supplementation on incidence of cardiovascular disease, falls, non-vertebral fractures and all cancer. However, beneficial effects from vitamin D supplementation were seen: for persistence with taking statins in participants on long-term statin therapy; and also in bone mineral density and arterial function in participants with low 25-hydroxyvitamin D levels, and in lung function among ever smokers (especially if vitamin D deficient). The latter findings are consistent with several previous studies, CONCLUSION: Monthly high-dose vitamin D supplementation does not prevent a range of diseases, but may be beneficial for some intermediate outcomes in people who are vitamin D deficient.. Australian New Zealand Clinical Trials Registry identifier: ACTRN12611000402943.

Topics: Accidental Falls; Aged; Aged, 80 and over; Arteries; Bone Density; Cardiovascular Diseases; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Fractures, Bone; Humans; Incidence; Male; Middle Aged; Neoplasms; New Zealand; Surveys and Questionnaires

It has been hypothesized that high protein intakes are associated with lower bone mineral content (BMC). Previous studies yield conflicting results and thus far no studies have undertaken the interaction of body mass index (BMI) and physical activity with protein intakes in relation to BMC and bone mineral density (BMD).. To evaluate the associations of dietary total protein (TP), animal protein (AP) and plant protein (PP) intakes with BMC and BMD and their changes. We tested also the interactions of protein intake with, obesity (BMI ≤30 vs. >30 kg/m2) and physical activity level (passive vs. active). Design/ Setting: Prospective cohort study (Osteoporosis Risk-Factor and Fracture-Prevention Study). Participants/measures: At the baseline, 554 women aged 65-72 years filled out a 3-day food record and a questionnaire covering data on lifestyle, physical activity, diseases, and medications. Intervention group received calcium 1000 mg/d and cholecalciferol 800 IU for 3 years. Control group received neither supplementation nor placebo. Bone density was measured at baseline and year 3, using dual energy x-ray absorptiometry. Multivariable regression analyses were conducted to examine the associations between protein intake and BMD and BMC.. In cross-sectional analyses energy-adjusted TP (P≤0·029) and AP (P≤0·045) but not PP (g/d) were negatively associated with femoral neck (FN) BMD and BMC. Women with TP≥1·2 g/kg/body weight (BW) (Ptrend≤0·009) had lower FN, lumbar spine (LS) and total BMD and BMC. In follow-up analysis, TP (g/kg/BW) was inversely associated with LS BMD and LS BMC. The detrimental associations were stronger in women with BMI<30 kg/m2. In active women, TP (g/kg/BW) was positively associated with LS BMD and FN BMC changes.. This study suggests detrimental associations between protein intake and bone health. However, these negative associations maybe counteracted by BMI>30 kg/m2 and physical activity.

Topics: Absorptiometry, Photon; Aged; Aged, 80 and over; Animals; Body Mass Index; Bone and Bones; Bone Density; Calcium, Dietary; Cholecalciferol; Cross-Sectional Studies; Diet; Dietary Proteins; Dietary Supplements; Energy Intake; Exercise; Female; Fractures, Bone; Humans; Osteoporosis, Postmenopausal; Prospective Studies; Regression Analysis; Surveys and Questionnaires

To evaluate the effect of a single early high-dose vitamin D supplement on fracture union in patients with hypovitaminosis D and a long bone fracture.. Between July 2011 and August 2013, 113 adults with a long bone fracture were enrolled in a prospective randomised double-blind placebo-controlled trial. Their serum vitamin D levels were measured and a total of 100 patients were found to be vitamin D deficient (< 20 ng/ml) or insufficient (< 30 ng/mL). These were then randomised to receive a single dose of vitamin D. In all, 100 (89%) patients had hypovitaminosis D. Both treatment and control groups had similar demographics and injury characteristics. The initial median vitamin D levels were 16 ng/mL (interquartile range 5 to 28) in both groups (p = 0.885). A total of 14 patients were lost to follow-up (seven from each group), two had fixation failure (one in each group) and one control group patient developed an infection. Overall, the nonunion rate was 4% (two per group). No patient showed signs of clinical toxicity from their supplement.. Despite finding a high level of hypovitaminosis D, the rate of union was high and independent of supplementation with vitamin D

Topics: Adult; Aged; Aged, 80 and over; Cholecalciferol; Double-Blind Method; Drug Administration Schedule; Female; Follow-Up Studies; Fracture Fixation; Fractures, Bone; Fractures, Ununited; Humans; Male; Middle Aged; Prospective Studies; Treatment Outcome; Vitamin D Deficiency; Vitamins

Middle East Respiratory Syndrome (MERS) is a novel respiratory illness firstly reported in Saudi Arabia in 2012. It is caused by a new corona virus, called MERS corona virus (MERS-CoV). Most people who have MERS-CoV infection developed severe acute respiratory illness.. This work is done to determine the clinical characteristics and the outcome of intensive care unit (ICU) admitted patients with confirmed MERS-CoV infection.. This study included 32 laboratory confirmed MERS corona virus infected patients who were admitted into ICU. It included 20 (62.50%) males and 12 (37.50%) females. The mean age was 43.99 ± 13.03 years. Diagnosis was done by real-time reverse transcription polymerase chain reaction (rRT-PCR) test for corona virus on throat swab, sputum, tracheal aspirate, or bronchoalveolar lavage specimens. Clinical characteristics, co-morbidities and outcome were reported for all subjects.. Most MERS corona patients present with fever, cough, dyspnea, sore throat, runny nose and sputum. The presence of abdominal symptoms may indicate bad prognosis. Prolonged duration of symptoms before patients' hospitalization, prolonged duration of mechanical ventilation and hospital stay, bilateral radiological pulmonary infiltrates, and hypoxemic respiratory failure were found to be strong predictors of mortality in such patients. Also, old age, current smoking, smoking severity, presence of associated co-morbidities like obesity, diabetes mellitus, chronic heart diseases, COPD, malignancy, renal failure, renal transplantation and liver cirrhosis are associated with a poor outcome of ICU admitted MERS corona virus infected patients.. Plasma HO-1, ferritin, p21, and NQO1 were all elevated at baseline in CKD participants. Plasma HO-1 and urine NQO1 levels each inversely correlated with eGFR (. SnPP can be safely administered and, after its injection, the resulting changes in plasma HO-1, NQO1, ferritin, and p21 concentrations can provide information as to antioxidant gene responsiveness/reserves in subjects with and without kidney disease.. A Study with RBT-1, in Healthy Volunteers and Subjects with Stage 3-4 Chronic Kidney Disease, NCT0363002 and NCT03893799.. HFNC did not significantly modify work of breathing in healthy subjects. However, a significant reduction in the minute volume was achieved, capillary [Formula: see text] remaining constant, which suggests a reduction in dead-space ventilation with flows > 20 L/min. (ClinicalTrials.gov registration NCT02495675).. 3 组患者手术时间、术中显性失血量及术后 1 周血红蛋白下降量比较差异均无统计学意义（. 对于肥胖和超重的膝关节单间室骨关节炎患者，采用 UKA 术后可获满意短中期疗效，远期疗效尚需进一步随访观察。.. Decreased muscle strength was identified at both time points in patients with hEDS/HSD. The evolution of most muscle strength parameters over time did not significantly differ between groups. Future studies should focus on the effectiveness of different types of muscle training strategies in hEDS/HSD patients.. These findings support previous adverse findings of e-cigarette exposure on neurodevelopment in a mouse model and provide substantial evidence of persistent adverse behavioral and neuroimmunological consequences to adult offspring following maternal e-cigarette exposure during pregnancy. https://doi.org/10.1289/EHP6067.. This RCT directly compares a neoadjuvant chemotherapy regimen with a standard CROSS regimen in terms of overall survival for patients with locally advanced ESCC. The results of this RCT will provide an answer for the controversy regarding the survival benefits between the two treatment strategies.. NCT04138212, date of registration: October 24, 2019.. Results of current investigation indicated that milk type and post fermentation cooling patterns had a pronounced effect on antioxidant characteristics, fatty acid profile, lipid oxidation and textural characteristics of yoghurt. Buffalo milk based yoghurt had more fat, protein, higher antioxidant capacity and vitamin content. Antioxidant and sensory characteristics of T. If milk is exposed to excessive amounts of light, Vitamins B. The two concentration of ZnO nanoparticles in the ambient air produced two different outcomes. The lower concentration resulted in significant increases in Zn content of the liver while the higher concentration significantly increased Zn in the lungs (p < 0.05). Additionally, at the lower concentration, Zn content was found to be lower in brain tissue (p < 0.05). Using TEM/EDX we detected ZnO nanoparticles inside the cells in the lungs, kidney and liver. Inhaling ZnO NP at the higher concentration increased the levels of mRNA of the following genes in the lungs: Mt2 (2.56 fold), Slc30a1 (1.52 fold) and Slc30a5 (2.34 fold). At the lower ZnO nanoparticle concentration, only Slc30a7 mRNA levels in the lungs were up (1.74 fold). Thus the two air concentrations of ZnO nanoparticles produced distinct effects on the expression of the Zn-homeostasis related genes.. Until adverse health effects of ZnO nanoparticles deposited in organs such as lungs are further investigated and/or ruled out, the exposure to ZnO nanoparticles in aerosols should be avoided or minimised.

Topics: A549 Cells; Acetylmuramyl-Alanyl-Isoglutamine; Acinetobacter baumannii; Acute Lung Injury; Adaptor Proteins, Signal Transducing; Adenine; Adenocarcinoma; Adipogenesis; Administration, Cutaneous; Administration, Ophthalmic; Adolescent; Adsorption; Adult; Aeromonas hydrophila; Aerosols; Aged; Aged, 80 and over; Aging; Agriculture; Air Pollutants; Air Pollution; Airway Remodeling; Alanine Transaminase; Albuminuria; Aldehyde Dehydrogenase 1 Family; Algorithms; AlkB Homolog 2, Alpha-Ketoglutarate-Dependent Dioxygenase; Alzheimer Disease; Amino Acid Sequence; Ammonia; Ammonium Compounds; Anaerobiosis; Anesthetics, Dissociative; Anesthetics, Inhalation; Animals; Anti-Bacterial Agents; Anti-HIV Agents; Anti-Infective Agents; Anti-Inflammatory Agents; Antibiotics, Antineoplastic; Antibodies, Antineutrophil Cytoplasmic; Antibodies, Monoclonal, Humanized; Antifungal Agents; Antigens, Bacterial; Antigens, CD; Antigens, Differentiation, Myelomonocytic; Antimetabolites, Antineoplastic; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Antioxidants; Antitubercular Agents; Antiviral Agents; Apolipoproteins E; Apoptosis; Arabidopsis; Arabidopsis Proteins; Arsenic; Arthritis, Rheumatoid; Asthma; Atherosclerosis; ATP-Dependent Proteases; Attitude of Health Personnel; Australia; Austria; Autophagy; Axitinib; Bacteria; Bacterial Outer Membrane Proteins; Bacterial Proteins; Bacterial Toxins; Bacterial Typing Techniques; Bariatric Surgery; Base Composition; Bayes Theorem; Benzoxazoles; Benzylamines; beta Catenin; Betacoronavirus; Betula; Binding Sites; Biological Availability; Biological Oxygen Demand Analysis; Biomarkers; Biomarkers, Tumor; Biopsy; Bioreactors; Biosensing Techniques; Birth Weight; Blindness; Blood Chemical Analysis; Blood Gas Analysis; Blood Glucose; Blood Pressure; Blood Pressure Monitoring, Ambulatory; Blood-Brain Barrier; Blotting, Western; Body Mass Index; Body Weight; Bone and Bones; Bone Density; Bone Resorption; Borates; Brain; Brain Infarction; Brain Injuries, Traumatic; Brain Neoplasms; Breakfast; Breast Milk Expression; Breast Neoplasms; Bronchi; Bronchoalveolar Lavage Fluid; Buffaloes; Cadherins; Calcification, Physiologic; Calcium Compounds; Calcium, Dietary; Cannula; Caprolactam; Carbon; Carbon Dioxide; Carboplatin; Carcinogenesis; Carcinoma, Ductal; Carcinoma, Ehrlich Tumor; Carcinoma, Hepatocellular; Carcinoma, Non-Small-Cell Lung; Carcinoma, Pancreatic Ductal; Carcinoma, Renal Cell; Cardiovascular Diseases; Carps; Carrageenan; Case-Control Studies; Catalysis; Catalytic Domain; Cattle; CD8-Positive T-Lymphocytes; Cell Adhesion; Cell Cycle Proteins; Cell Death; Cell Differentiation; Cell Line; Cell Line, Tumor; Cell Movement; Cell Nucleus; Cell Phone Use; Cell Proliferation; Cell Survival; Cell Transformation, Neoplastic; Cell Transformation, Viral; Cells, Cultured; Cellulose; Chemical Phenomena; Chemoradiotherapy; Child; Child Development; Child, Preschool; China; Chitosan; Chlorocebus aethiops; Cholecalciferol; Chromatography, Liquid; Circadian Clocks; Circadian Rhythm; Circular Dichroism; Cisplatin; Citric Acid; Clinical Competence; Clinical Laboratory Techniques; Clinical Trials, Phase I as Topic; Clinical Trials, Phase II as Topic; Clostridioides difficile; Clostridium Infections; Coculture Techniques; Cohort Studies; Cold Temperature; Colitis; Collagen Type I; Collagen Type I, alpha 1 Chain; Collagen Type XI; Color; Connective Tissue Diseases; Copper; Coronary Angiography; Coronavirus 3C Proteases; Coronavirus Infections; Cost of Illness; Counselors; COVID-19; COVID-19 Testing; Creatine Kinase; Creatinine; Cross-Over Studies; Cross-Sectional Studies; Cryoelectron Microscopy; Cryosurgery; Crystallography, X-Ray; Cues; Cultural Competency; Cultural Diversity; Curriculum; Cyclic AMP Response Element-Binding Protein; Cyclin-Dependent Kinase Inhibitor p21; Cycloparaffins; Cysteine Endopeptidases; Cytokines; Cytoplasm; Cytoprotection; Databases, Factual; Denitrification; Deoxycytidine; Diabetes Complications; Diabetes Mellitus; Diabetes Mellitus, Experimental; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diagnosis, Differential; Diatoms; Diet; Diet, High-Fat; Dietary Exposure; Diffusion Magnetic Resonance Imaging; Diketopiperazines; Dipeptidyl Peptidase 4; Dipeptidyl-Peptidase IV Inhibitors; Disease Models, Animal; Disease Progression; Disease-Free Survival; DNA; DNA Damage; DNA Glycosylases; DNA Repair; DNA-Binding Proteins; DNA, Bacterial; DNA, Viral; Docetaxel; Dose Fractionation, Radiation; Dose-Response Relationship, Drug; Down-Regulation; Doxorubicin; Drosophila; Drosophila melanogaster; Drug Carriers; Drug Delivery Systems; Drug Liberation; Drug Repositioning; Drug Resistance, Bacterial; Drug Resistance, Multiple, Bacterial; Drug Resistance, Neoplasm; Drug Screening Assays, Antitumor; Drug Synergism; Drug Therapy, Combination; Edema; Edible Grain; Education, Graduate; Education, Medical, Graduate; Education, Pharmacy; Ehlers-Danlos Syndrome; Electron Transport Complex III; Electron Transport Complex IV; Electronic Nicotine Delivery Systems; Emergency Service, Hospital; Empathy; Emulsions; Endothelial Cells; Endurance Training; Energy Intake; Enterovirus A, Human; Environment; Environmental Monitoring; Enzyme Assays; Enzyme Inhibitors; Epithelial Cells; Epithelial-Mesenchymal Transition; Epoxide Hydrolases; Epoxy Compounds; Erythrocyte Count; Erythrocytes; Escherichia coli; Escherichia coli Infections; Escherichia coli Proteins; Esophageal Neoplasms; Esophageal Squamous Cell Carcinoma; Esophagectomy; Estrogens; Etanercept; Ethiopia; Ethnicity; Ethylenes; Exanthema; Exercise; Exercise Test; Exercise Tolerance; Extracellular Matrix; Extracorporeal Membrane Oxygenation; Eye Infections, Fungal; False Negative Reactions; Fatty Acids; Fecal Microbiota Transplantation; Feces; Female; Femur Neck; Fermentation; Ferritins; Fetal Development; Fibroblast Growth Factor-23; Fibroblast Growth Factors; Fibroblasts; Fibroins; Fish Proteins; Flavanones; Flavonoids; Focus Groups; Follow-Up Studies; Food Handling; Food Supply; Food, Formulated; Forced Expiratory Volume; Forests; Fractures, Bone; Fruit and Vegetable Juices; Fusobacteria; G1 Phase Cell Cycle Checkpoints; G2 Phase Cell Cycle Checkpoints; Gamma Rays; Gastrectomy; Gastrointestinal Microbiome; Gastrointestinal Stromal Tumors; Gefitinib; Gels; Gemcitabine; Gene Amplification; Gene Expression; Gene Expression Regulation; Gene Expression Regulation, Bacterial; Gene Expression Regulation, Neoplastic; Gene Expression Regulation, Plant; Gene Knockdown Techniques; Gene-Environment Interaction; Genotype; Germany; Glioma; Glomerular Filtration Rate; Glucagon; Glucocorticoids; Glycemic Control; Glycerol; Glycogen Synthase Kinase 3 beta; Glycolipids; Glycolysis; Goblet Cells; Gram-Negative Bacterial Infections; Granulocyte Colony-Stimulating Factor; Graphite; Greenhouse Effect; Guanidines; Haemophilus influenzae; HCT116 Cells; Health Knowledge, Attitudes, Practice; Health Personnel; Health Services Accessibility; Health Services Needs and Demand; Health Status Disparities; Healthy Volunteers; Heart Failure; Heart Rate; Heart Transplantation; Heart-Assist Devices; HEK293 Cells; Heme; Heme Oxygenase-1; Hemolysis; Hemorrhage; Hepatitis B; Hepatitis B e Antigens; Hepatitis B Surface Antigens; Hepatitis B virus; Hepatitis B, Chronic; Hepatocytes; Hexoses; High-Throughput Nucleotide Sequencing; Hippo Signaling Pathway; Histamine; Histamine Agonists; Histidine; Histone Deacetylase 2; HIV Infections; HIV Reverse Transcriptase; HIV-1; Homebound Persons; Homeodomain Proteins; Homosexuality, Male; Hospice and Palliative Care Nursing; HSP70 Heat-Shock Proteins; Humans; Hyaluronan Receptors; Hydrogen; Hydrogen Peroxide; Hydrogen-Ion Concentration; Hydrolysis; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Hypoglycemia; Hypoglycemic Agents; Hypoxia; Idiopathic Interstitial Pneumonias; Imaging, Three-Dimensional; Imatinib Mesylate; Immunotherapy; Implementation Science; Incidence; INDEL Mutation; Induced Pluripotent Stem Cells; Industrial Waste; Infant; Infant, Newborn; Inflammation; Inflammation Mediators; Infliximab; Infusions, Intravenous; Inhibitory Concentration 50; Injections; Insecticides; Insulin-Like Growth Factor Binding Protein 5; Insulin-Secreting Cells; Interleukin-1; Interleukin-17; Interleukin-8; Internship and Residency; Intestines; Intracellular Signaling Peptides and Proteins; Ion Transport; Iridaceae; Iridoid Glucosides; Islets of Langerhans Transplantation; Isodon; Isoflurane; Isotopes; Italy; Joint Instability; Ketamine; Kidney; Kidney Failure, Chronic; Kidney Function Tests; Kidney Neoplasms; Kinetics; Klebsiella pneumoniae; Knee Joint; Kruppel-Like Factor 4; Kruppel-Like Transcription Factors; Lactate Dehydrogenase 5; Laparoscopy; Laser Therapy; Lasers, Semiconductor; Lasers, Solid-State; Laurates; Lead; Leukocyte L1 Antigen Complex; Leukocytes, Mononuclear; Light; Lipid Peroxidation; Lipopolysaccharides; Liposomes; Liver; Liver Cirrhosis; Liver Neoplasms; Liver Transplantation; Locomotion; Longitudinal Studies; Lopinavir; Lower Urinary Tract Symptoms; Lubricants; Lung; 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Oocytes; Open Reading Frames; Osteoclasts; Osteogenesis; Osteoporosis; Osteoporosis, Postmenopausal; Outpatients; Ovarian Neoplasms; Ovariectomy; Overweight; Oxazines; Oxidants; Oxidation-Reduction; Oxidative Stress; Oxides; Oxidoreductases; Oxygen; Oxygen Inhalation Therapy; Oxygenators, Membrane; Ozone; Paclitaxel; Paenibacillus; Pain Measurement; Palliative Care; Pancreatic Neoplasms; Pandemics; Parasympathetic Nervous System; Particulate Matter; Pasteurization; Patient Preference; Patient Satisfaction; Pediatric Obesity; Permeability; Peroxiredoxins; Peroxynitrous Acid; Pharmaceutical Services; Pharmacists; Pharmacy; Phaseolus; Phenotype; Phoeniceae; Phosphates; Phosphatidylinositol 3-Kinases; Phospholipid Transfer Proteins; Phospholipids; Phosphorus; Phosphorylation; Photoperiod; Photosynthesis; Phylogeny; Physical Endurance; Physicians; Pilot Projects; Piperidines; Pituitary Adenylate Cyclase-Activating Polypeptide; Plant Extracts; Plant Leaves; Plant Proteins; Plant Roots; Plaque, Atherosclerotic; Pneumonia; Pneumonia, Viral; Point-of-Care Testing; Polyethylene Glycols; Polymers; Polysorbates; Pore Forming Cytotoxic Proteins; Positron Emission Tomography Computed Tomography; Positron-Emission Tomography; Postprandial Period; Poverty; Pre-Exposure Prophylaxis; Prediabetic State; Predictive Value of Tests; Pregnancy; Pregnancy Trimester, First; Pregnancy, High-Risk; Prenatal Exposure Delayed Effects; Pressure; Prevalence; Primary Graft Dysfunction; Primary Health Care; Professional Role; Professionalism; Prognosis; Progression-Free Survival; Prolactin; Promoter Regions, Genetic; Proof of Concept Study; Proportional Hazards Models; Propylene Glycol; Prospective Studies; Prostate; Protein Binding; Protein Biosynthesis; Protein Isoforms; Protein Kinase Inhibitors; Protein Phosphatase 2; Protein Processing, Post-Translational; Protein Serine-Threonine Kinases; Protein Structure, Tertiary; Protein Transport; Proteoglycans; Proteome; Proto-Oncogene Proteins c-akt; Proto-Oncogene Proteins c-myc; Proto-Oncogene Proteins c-ret; Proto-Oncogene Proteins p21(ras); Proton Pumps; Protons; Protoporphyrins; Pseudomonas aeruginosa; Pseudomonas fluorescens; Pulmonary Artery; Pulmonary Disease, Chronic Obstructive; Pulmonary Gas Exchange; Pulmonary Veins; Pyrazoles; Pyridines; Pyrimidines; Qualitative Research; Quinoxalines; Rabbits; Random Allocation; Rats; Rats, Sprague-Dawley; Rats, Wistar; Receptors, Histamine H3; Receptors, Immunologic; Receptors, Transferrin; Recombinant Proteins; Recurrence; Reference Values; Referral and Consultation; Regional Blood Flow; Registries; Regulon; Renal Insufficiency, Chronic; Reperfusion Injury; Repressor Proteins; Reproducibility of Results; Republic of Korea; Research Design; Resistance Training; Respiration, Artificial; Respiratory Distress Syndrome; Respiratory Insufficiency; Resuscitation; Retinal Dehydrogenase; Retreatment; Retrospective Studies; Reverse Transcriptase Inhibitors; Rhinitis, Allergic; Ribosomal Proteins; Ribosomes; Risk Assessment; Risk Factors; Ritonavir; Rivers; RNA Interference; RNA-Seq; RNA, Messenger; RNA, Ribosomal, 16S; RNA, Small Interfering; Rosuvastatin Calcium; Rural Population; Saccharomyces cerevisiae; Saccharomyces cerevisiae Proteins; Salivary Ducts; Salivary Gland Neoplasms; San Francisco; SARS-CoV-2; Satiation; Satiety Response; Schools; Schools, Pharmacy; Seasons; Seawater; Selection, Genetic; Sequence Analysis, DNA; Serine-Threonine Kinase 3; Sewage; Sheep; Sheep, Domestic; Shock, Hemorrhagic; Signal Transduction; Silver; Silymarin; Single Photon Emission Computed Tomography Computed Tomography; Sirolimus; Sirtuin 1; Skin; Skin Neoplasms; Skin Physiological Phenomena; Sleep Initiation and Maintenance Disorders; Social Class; Social Participation; Social Support; Soil; Soil Microbiology; Solutions; Somatomedins; Soot; Specimen Handling; Spectrophotometry, Ultraviolet; Spectroscopy, Fourier Transform Infrared; Spectrum Analysis; Spinal Fractures; Spirometry; Staphylococcus aureus; STAT1 Transcription Factor; STAT3 Transcription Factor; Streptomyces coelicolor; Stress, Psychological; Stroke; Stroke Volume; Structure-Activity Relationship; Students, Medical; Students, Pharmacy; Substance Abuse Treatment Centers; Sulfur Dioxide; Surface Properties; Surface-Active Agents; Surveys and Questionnaires; Survival Analysis; Survival Rate; Survivin; Sweden; Swine; Swine, Miniature; Sympathetic Nervous System; T-Lymphocytes, Regulatory; Talaromyces; Tandem Mass Spectrometry; tau Proteins; Telemedicine; Telomerase; Telomere; Telomere Homeostasis; Temperature; Terminally Ill; Th1 Cells; Thiamethoxam; Thiazoles; Thiophenes; Thioredoxin Reductase 1; Thrombosis; Thulium; Thyroid Cancer, Papillary; Thyroid Carcinoma, Anaplastic; Thyroid Neoplasms; Time Factors; Titanium; Tomography, Emission-Computed, Single-Photon; Tomography, X-Ray Computed; TOR Serine-Threonine Kinases; Transcription Factor AP-1; Transcription Factors; Transcription, Genetic; Transcriptional Activation; Transcriptome; Transforming Growth Factor beta1; 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YAP-Signaling Proteins; Yogurt; Young Adult; Zebrafish; Zebrafish Proteins; Ziziphus

Observational studies have shown that low vitamin D status is associated with an increased risk of cardiovascular disease, acute respiratory infection, falls and non-vertebral fractures. We recruited 5110 Auckland adults, aged 50-84 years, into a randomized, double-blind, placebo-controlled trial to test whether vitamin D supplementation protects against these four major outcomes. The intervention is a monthly cholecalciferol dose of 100,000IU (2.5mg) for an estimated median 3.3 years (range 2.5-4.2) during 2011-2015. Participants were recruited primarily from family practices, plus community groups with a high proportion of Maori, Pacific, or South Asian individuals. The baseline evaluation included medical history, lifestyle, physical measurements (e.g. blood pressure, arterial waveform, lung function, muscle function), and a blood sample (stored at -80°C for later testing). Capsules are being mailed to home addresses with a questionnaire to collect data on non-hospitalized outcomes and to monitor adherence and potential adverse effects. Other data sources include New Zealand Ministry of Health data on mortality, hospitalization, cancer registrations and dispensed pharmaceuticals. A random sample of 438 participants returned for annual collection of blood samples to monitor adherence and safety (hypercalcemia), including repeat physical measurements at 12 months follow-up. The trial will allow testing of a priori hypotheses on several other endpoints including: weight, blood pressure, arterial waveform parameters, heart rate variability, lung function, muscle strength, gait and balance, mood, psoriasis, bone density, and chronic pain.

Topics: Accidental Falls; Affect; Aged; Aged, 80 and over; Blood Pressure; Cardiovascular Diseases; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Fractures, Bone; Gait; Heart Rate; Humans; Male; Middle Aged; Muscle Strength; Patient Compliance; Postural Balance; Research Design; Respiratory Function Tests; Respiratory Tract Infections; Surveys and Questionnaires

Although vitamin D is widely used to promote skeletal health, definitive data on benefits and risks of supplemental vitamin D alone on bone are lacking. Results from large, randomized controlled trials in the general population are sparse. Data on the effects of supplemental omega-3 fatty acids (FAs) on bone are also limited.. The VITamin D and OmegA-3 TriaL (VITAL) is a double-blind, placebo-controlled trial assessing the role of vitamin D3 (2000 IU/d) and omega-3 FA (1g/d) supplements in reducing risks of cancer and cardiovascular disease among U.S. men aged ≥50 and women aged ≥55. To comprehensively test effects of supplemental vitamin D and/or omega-3 FAs on skeletal health, the VITAL: Effects on Fractures ancillary study is determining the effects of these supplements on incident fractures among 25,875 participants enrolled in the parent trial. Study investigators adjudicate fractures through a detailed review of medical records and radiological images (hip and femur). In a complementary ancillary, VITAL: Effects on Structure and Architecture is determining the effects of supplemental vitamin D and/or omega-3 FAs on bone with detailed phenotyping during in-person visits. Comprehensive assessments of bone density, turnover, structure/architecture, body composition, and physical performance are being performed at baseline and 2 years post-randomization.. Results from these studies will clarify the relationship between supplemental vitamin D and/or omega-3 FAs on bone health outcomes, and inform clinical care and public health guidelines on the use of supplemental vitamin D for the primary prevention of fractures in women and men.

Topics: Absorptiometry, Photon; Aged; Bone Density; Bone Density Conservation Agents; Cholecalciferol; Dietary Supplements; Double-Blind Method; Fatty Acids, Omega-3; Female; Femur; Fractures, Bone; Hip Joint; Humans; Male; Middle Aged; Tomography, X-Ray Computed

Previous large trials of vitamin D for prevention of fractures and other disease outcomes have reported conflicting results, possibly because the doses tested were insufficient to maintain optimum blood levels of vitamin D (25[OH]D) predicted by the observational studies. This report describes the design and baseline characteristics of the BEST-D (Biochemical Efficacy and Safety Trial of vitamin D) trial which aims to establish the best dose of vitamin D to assess in a future large outcome trial.. The BEST-D trial will compare the biochemical and other effects of daily dietary supplementation with 100 μg or 50 μg vitamin D3 or placebo, when administered for 12 months, in 305 ambulant community-dwelling older people living in Oxfordshire, England. The primary analyses will compare 12-month mean plasma concentrations of 25(OH)D as well as the proportion of participants with a 12-month concentration >90 nmol/L between participants allocated 100 μg and participants allocated 50 μg daily. Secondary analyses will compare the two active doses (both separately and when combined) with placebo. Additional end-points include biochemical assessments of safety, blood pressure, arterial stiffness, falls, fractures, heel and wrist bone density, grip strength and physical performance and echocardiographic assessments of cardiac function in a random sample of participants.. About one-third of eligible participants agreed to participate in the trial. The mean age was 72 (SD 6) years with equal numbers of men and women. About one third reported a prior history of fracture or hypertension, one-fifth reported a prior cardiovascular event, and one tenth reported diabetes or a fall in the previous 6 months.. The results of this trial will help determine the optimum dose of vitamin D to test in a larger trial investigating whether vitamin D supplementation can reduce the risk of fractures, cardiovascular disease or cancer.

Topics: Accidental Falls; Aged; Blood Pressure; Bone Density; Bone Density Conservation Agents; Cholecalciferol; Dietary Supplements; Echocardiography; Female; Fractures, Bone; Hand Strength; Heart; Humans; Male; Research Design; Vascular Stiffness; Vitamin D

Bone health is influenced by the intake of both calcium and vitamin D.. Our objective was to evaluate the influence of calcium and vitamin D supplementation on PTH and bone turnover. SETTING, PATIENTS, AND DESIGN: At an ambulatory research center, 159 postmenopausal healthy white women participated in this double-blind, placebo-controlled parallel, longitudinal factorial study that was 6 months in duration.. Subjects were randomly allocated to 4 groups: 1) double placebo, 2) calcium (1200 mg daily) plus placebo, 3) vitamin D3 (100 μg) plus placebo, and 4) vitamin D3 and calcium. Serum and urine were collected fasting and 2 hours after a calcium load at baseline and at 3 and 6 months.. Serum PTH, cross-linked C-telopeptide (CTX), and procollagen type I N-terminal propeptide (P1NP) were measured.. Before study medication, a calcium load resulted in a decline in PTH and CTX and an increase in urinary calcium excretion. Serum CTX and P1NP declined over time with calcium supplementation but did not change with increased vitamin D intake. There was a decline in PTH in the vitamin D groups in the fasting state compared with placebo. Suppression of PTH was greater after a calcium load in the vitamin D groups. A calcium load decreased PTH and CTX and raised urinary calcium.. Fasting PTH declines with vitamin D supplementation. PTH declines after calcium intake. Supplementation of the diet with 1200 mg calcium/d reduces bone turnover markers, whereas supplementation with up to100 μg vitamin D3/d does not.

Topics: Aged; Bone and Bones; Bone Remodeling; Calcium; Calcium, Dietary; Cholecalciferol; Collagen Type I; Dietary Supplements; Female; Fractures, Bone; Humans; Longitudinal Studies; Middle Aged; Osteomalacia; Osteoporosis; Parathyroid Hormone; Peptide Fragments; Peptides; Placebos; Postmenopause; Procollagen; Vitamins

To compare the effect of calcium and cholecalciferol alone and along with additional sodium fluoride or ibandronate on bone mineral density (BMD) and fractures in patients with Crohn's disease (CD).. Patients (n =148) with reduced BMD (T-score < -1) were randomized to receive cholecalciferol (1000 IU) and calcium citrate (800 mg) daily alone(group A, n = 32) or along with additional sodium fluoride (25 mg bid) (group B, n = 62) or additional ibandronate (1 mg iv/3-monthly) (group C, n = 54). Dual energy X-ray absorptiometry of the lumbar spine (L1-L4) and proximal right femur and X-rays of the spine were performed at baseline and after 1.0, 2.25 and 3.5 years. Fracture-assessment included visual reading of X-rays and quantitative morphometry of vertebral bodies (T4-L4).. One hundred and twenty three (83.1%) patients completed the first year for intention-to-treat (ITT) analysis. Ninety two (62.2%) patients completed the second year and 71 (47.8%) the third year available for per-protocol (PP) analysis. With a significant increase in T-score of the lumbar spine by +0.28 ± 0.35 [95% confidence interval (CI): 0.162-0.460, P < 0.01], +0.33 ± 0.49 (95% CI: 0.109-0.558, P < 0.01), +0.43 ± 0.47 (95% CI: 0.147-0.708, P < 0.01) in group A, +0.22 ± 0.33 (95% CI: 0.125-0.321, P < 0.01); +0.47 ± 0.60 (95% CI: 0.262-0.676, P < 0.01), +0.51 ± 0.44 (95% CI: 0.338-0.682, P < 0.01) in group B and +0.22 ± 0.38 (95% CI: 0.111-0.329, P < 0.01), +0.36 ± 0.53 (95% CI: 0.147-0.578, P < 0.01), +0.41 ± 0.48 (95% CI: 0.238-0.576, P < 0.01) in group C, respectively, during the 1.0, 2.25 and 3.5 year periods (PP analysis), no treatment regimen was superior in any in- or between-group analyses. In the ITT analysis, similar results in all in- and between-group analyses with a significant in-group but non-significant between-group increase in T-score of the lumbar spine by 0.38 ± 0.46 (group A, P < 0.01), 0.37 ± 0.50 (group B, P < 0.01) and 0.35 ± 0.49 (group C, P < 0.01) was observed. Follow-up in ITT analysis was still 2.65 years. One vertebral fracture in the sodium fluoride group was detected. Study medication was safe and well tolerated.. Additional sodium fluoride or ibandronate had no benefit over calcium and cholecalciferol alone in managing reduced BMD in CD.

Topics: Absorptiometry, Photon; Adult; Bone Density; Bone Density Conservation Agents; Calcium Citrate; Cholecalciferol; Crohn Disease; Diphosphonates; Female; Fractures, Bone; Humans; Ibandronic Acid; Male; Middle Aged; Sodium Fluoride; Vitamin D; Young Adult

Epidemiological evidence supports a relationship between vitamin D and mental well-being, although evidence from large-scale placebo-controlled intervention trials is lacking.. To examine if vitamin D supplementation has a beneficial effect on mood in community-dwelling older women; if a single annual large dose of vitamin D has a role in the prevention of depressive symptoms; and if there is an association between serum 25-hydroxyvitamin D levels and mental health.. A double-blind, randomised, placebo-controlled trial of women aged 70 or older (the Vital D Study: ISRCTN83409867 and ACTR12605000658617). Participants were randomly assigned to receive 500 000 IU vitamin D(3) (cholecalciferol) orally or placebo every autumn/winter for 3-5 consecutive years. The tools utilised at various time points were the General Health Questionnaire, the 12-item Short Form Health Survey, the Patient Global Impression-Improvement scale and the WHO Well-Being Index. Serum 25-hydroxyvitamin D levels were measured in a subset of 102 participants.. In this non-clinical population, no significant differences between the vitamin D and placebo groups were detected in any of the measured outcomes of mental health. Serum 25-hydroxyvitamin D levels in the vitamin D group were 41% higher than the placebo group 12 months following their annual dose. Despite this difference, scores from the questionnaires did not differ. Furthermore, there was no interaction between those on antidepressant/anxiety medication at baseline and the treatment groups.. The lack of improvement in indices of mental well-being in the vitamin D group does not support the hypothesis that an annual high dose of vitamin D(3) is a practical intervention to prevent depressive symptoms in older community-dwelling women.

Topics: Aged; Aged, 80 and over; Anxiety; Cholecalciferol; Data Interpretation, Statistical; Depression; Double-Blind Method; Female; Fractures, Bone; Health Status; Humans; Intention to Treat Analysis; Mental Health; Middle Aged; Osteoporosis; Outcome Assessment, Health Care; Placebos; Risk Factors; Time Factors; Vitamin D; Vitamin D Deficiency; Vitamins

Vitamin D insufficiency was shown to be associated with adverse musculoskeletal and nonskeletal outcomes in numerous observational studies. However, some studies did not control for confounding factors such as age or seasonal variation of 25-hydroxyvitamin D [25(OH)D].. We sought to determine the effect of vitamin D status on health outcomes.. Healthy community-dwelling women (n = 1471) with a mean age of 74 y were followed in a 5-y trial of calcium supplementation. 25(OH)D was measured at baseline in all women. Skeletal and nonskeletal outcomes were evaluated according to seasonally adjusted vitamin D status at baseline.. Fifty percent of women had a seasonally adjusted 25(OH)D concentration <50 nmol/L. These women were significantly older, heavier, and less physically active and had more comorbidities than women with a seasonally adjusted 25(OH)D concentration > or =50 nmol/L. Women with a seasonally adjusted 25(OH)D concentration <50 nmol/L had an increased incidence of stroke and cardiovascular events that did not persist after adjustment for between-group differences in age or comorbidities. Women with a seasonally adjusted 25(OH)D concentration <50 nmol/L were not at increased risk of adverse consequences for any musculoskeletal outcome, including fracture, falls, bone density, or grip strength or any nonskeletal outcomes, including death, myocardial infarction, cancer, heart failure, diabetes, or adverse changes in blood pressure, weight, body composition, cholesterol, or glucose.. Vitamin D insufficiency is more common in older, frailer women. Community-dwelling older women with a seasonally adjusted 25(OH)D concentration <50 nmol/L were not at risk of adverse outcomes over 5 y after control for comorbidities. Randomized placebo-controlled trials are needed to determine whether vitamin D supplementation in individuals with vitamin D insufficiency influences health outcomes. This trial was registered at www.anzctr.org.au as ACTRN 012605000242628.

Topics: Aged; Aged, 80 and over; Blood Pressure; Bone Density; Calcium; Cholecalciferol; Dietary Supplements; Female; Fractures, Bone; Hand Strength; Health Status; Humans; Hydroxycholecalciferols; Incidence; Lipids; Middle Aged; Phosphates; Postmenopause; Vitamin D Deficiency

Antifracture efficacy of high-dose vitamin D (800 IU) and calcium (1000 mg) remains controversial. To determine whether daily 800 IU of vitamin D and 1000 mg of calcium supplementation prevents fractures, we randomized 3432 women of the population-based Osteoporosis Risk Factor and Prevention (OSTPRE) Study cohort (ages 65 to 71 years) living in the region of northern Savonia, Finland (latitude 62 degrees to 64 degrees N) for 3 years to receive 800 IU of cholecalciferol and 1000 mg of calcium as calcium carbonate or to a control group that did not receive placebo. The main outcome measure was incident fractures. Fracture data were collected in telephone interviews and validated. Data on 3195 women, 1586 in the intervention group and 1609 in the control group, were available for analysis. In adjusted Cox proportional hazards models, the risk of any fracture decreased in the vitamin D and calcium group by 17% [adjusted hazard ratio (aHR) = 0.83; 95% confidence interval (CI) 0.61-1.12], and the risk of any nonvertebral fracture decreased by 13% (aHR = 0.87; 95% CI 0.63-1.19). The risk of distal forearm fractures decreased by 30% (aHR = 0.70; 95% CI 0.41-1.20), and the risk of any upper extremity fractures decreased by 25% (aHR = 0.75; 95% CI 0.49-1.16), whereas the risk of lower extremity fractures remained essentially equal (aHR = 1.02; 95% CI 0.58-1.80). None of these effects reached statistical significance. In conclusion, this study did not produce statistically significant evidence that vitamin D and calcium supplementation prevents fractures in a 65- to 71-year-old general population of postmenopausal women.

Topics: Aged; Calcium; Cholecalciferol; Dietary Supplements; Female; Finland; Fractures, Bone; Humans; Osteoporosis, Postmenopausal; Risk Factors

Improving vitamin D status may be an important modifiable risk factor to reduce falls and fractures; however, adherence to daily supplementation is typically poor.. To determine whether a single annual dose of 500,000 IU of cholecalciferol administered orally to older women in autumn or winter would improve adherence and reduce the risk of falls and fracture.. A double-blind, placebo-controlled trial of 2256 community-dwelling women, aged 70 years or older, considered to be at high risk of fracture were recruited from June 2003 to June 2005 and were randomly assigned to receive cholecalciferol or placebo each autumn to winter for 3 to 5 years. The study concluded in 2008.. 500,000 IU of cholecalciferol or placebo.. Falls and fractures were ascertained using monthly calendars; details were confirmed by telephone interview. Fractures were radiologically confirmed. In a substudy, 137 randomly selected participants underwent serial blood sampling for 25-hydroxycholecalciferol and parathyroid hormone levels.. Women in the cholecalciferol (vitamin D) group had 171 fractures vs 135 in the placebo group; 837 women in the vitamin D group fell 2892 times (rate, 83.4 per 100 person-years) while 769 women in the placebo group fell 2512 times (rate, 72.7 per 100 person-years; incidence rate ratio [RR], 1.15; 95% confidence interval [CI], 1.02-1.30; P = .03). The incidence RR for fracture in the vitamin D group was 1.26 (95% CI, 1.00-1.59; P = .047) vs the placebo group (rates per 100 person-years, 4.9 vitamin D vs 3.9 placebo). A temporal pattern was observed in a post hoc analysis of falls. The incidence RR of falling in the vitamin D group vs the placebo group was 1.31 in the first 3 months after dosing and 1.13 during the following 9 months (test for homogeneity; P = .02). In the substudy, the median baseline serum 25-hydroxycholecalciferol was 49 nmol/L. Less than 3% of the substudy participants had 25-hydroxycholecalciferol levels lower than 25 nmol/L. In the vitamin D group, 25-hydroxycholecalciferol levels increased at 1 month after dosing to approximately 120 nmol/L, were approximately 90 nmol/L at 3 months, and remained higher than the placebo group 12 months after dosing.. Among older community-dwelling women, annual oral administration of high-dose cholecalciferol resulted in an increased risk of falls and fractures.. anzctr.org.au Identifier: ACTRN12605000658617; isrctn.org Identifier: ISRCTN83409867.

Topics: Accidental Falls; Administration, Oral; Aged; Aged, 80 and over; Bone Density Conservation Agents; Cholecalciferol; Double-Blind Method; Drug Administration Schedule; Female; Fractures, Bone; Humans; Male; Risk Factors; Seasons; Treatment Failure

Given the high risk of subsequent fracture among elderly persons with fracture, it is important to initiate secondary treatment for osteoporosis. Acute rehabilitation centers may offer a unique opportunity to introduce treatment. Therefore, we evaluated willingness-to-participate and compliance with evidence-based interventions for the secondary prevention of osteoporotic fracture in a non-randomized study conducted in the acute rehabilitation setting. We also described differences in baseline characteristics between study participants and non-participants.. All consecutive, community dwelling admissions to an acute rehabilitation unit (Boston, MA) with the diagnosis of fracture were screened for enrollment. Eligible subjects were offered a free, 6-month supply of alendronate/cholecalciferol (70 mg/2800 IU weekly), calcium and vitamin D supplements, and fall prevention strategies. Six-month compliance (> or =75% consumption of medication or supplement) with the interventions was determined at a home visit.. Among 62 eligible subjects, 25 agreed to participate. Non-participants were older than participants (86 vs 80 yrs, p<0.01). There was no significant difference between other characteristics of participants and non-participants including sex, weight, type of fracture, cognitive status, and functional status. The most common reason for non-participation was reluctance to take another medication. Among participants, only 52% were compliant with alendronate and 58% were compliant with calcium and vitamin D supplementation at 6 months.. Willingness- to-participate and compliance with secondary prevention strategies for osteoporosis was low in the acute rehabilitation setting, even when medications were provided free of cost. Educating individuals with fracture and their families on the consequences and treatment of osteoporosis may help to decrease the risk of sustaining a second fracture by accepting secondary preventive measures.

Topics: Acute Disease; Aged; Aged, 80 and over; Alendronate; Bone Density Conservation Agents; Calcium; Cholecalciferol; Female; Fractures, Bone; Humans; Male; Medication Adherence; Osteoporosis; Patient Acceptance of Health Care; Refusal to Participate; Rehabilitation Centers; Vitamin D; Vitamins

We aimed to optimize calcium intake among the 2,000+ older women taking part in the Vital D study. Calcium supplementation was not included in the study protocol. Our hypothesis was that annual feedback of calcium intake and informing women of strategies to improve calcium intake can lead to a sustained increase in the proportion of women who consume adequate levels of the mineral. Calcium intake was assessed on an annual basis using a validated short food frequency questionnaire (FFQ). Supplemental calcium intake was added to the dietary estimate. Participants and their nominated doctor were sent a letter that the participant's estimated daily calcium intake was adequate or inadequate based on a cutoff threshold of 800 mg/day. General brief statements outlining the importance of an adequate calcium intake and bone health were included in all letters. At baseline, the median daily consumption of calcium was 980 mg/day and 67 percent of 1,951 participants had calcium intake of at least 800 mg per day. Of the 644 older women advised of an inadequate calcium intake at baseline (<800 mg/day), 386 (60%) had increased their intake by at least 100 mg/day when re-assessed twelve months later. This desirable change was sustained at 24 months after baseline with almost half of these women (303/644) consuming over 800 mg calcium per day. This study devised an efficient method to provide feedback on calcium intake to over 2,000 older women. The improvements were modest but significant and most apparent in those with a low intake at baseline. The decreased proportion of these women with an inadequate intake of calcium 12- and 24-months later, suggests this might be a practical, low cost strategy to maintain an adequate calcium intake among older women.

Topics: Accidental Falls; Aged; Aged, 80 and over; Calcium, Dietary; Cholecalciferol; Diet; Dietary Supplements; Double-Blind Method; Feedback, Psychological; Female; Fractures, Bone; Humans; Placebos; Seasons

Randomised, placebo-controlled trials are needed to provide evidence demonstrating safe, effective interventions that reduce falls and fractures in the elderly. The quality of a clinical trial is dependent on successful recruitment of the target participant group. This paper documents the successes and failures of recruiting over 2,000 women aged at least 70 years and at higher risk of falls or fractures onto a placebo-controlled trial of six years duration. The characteristics of study participants at baseline are also described for this study.. The Vital D Study recruited older women identified at high risk of fracture through the use of an eligibility algorithm, adapted from identified risk factors for hip fracture. Participants were randomised to orally receive either 500,000 IU vitamin D3 (cholecalciferol) or placebo every autumn for five consecutive years. A variety of recruitment strategies were employed to attract potential participants.. Of the 2,317 participants randomised onto the study, 74% (n = 1716/2317) were consented onto the study in the last five months of recruiting. This was largely due to the success of a targeted mail-out. Prior to this only 541 women were consented in the 18 months of recruiting. A total of 70% of all participants were recruited as a result of targeted mail-out. The response rate from the letters increased from 2 to 7% following revision of the material by a public relations company. Participant demographic or risk factor profile did not differ between those recruited by targeted mail-outs compared with other methods.. The most successful recruitment strategy was the targeted mail-out and the response rate was no higher in the local region where the study had extensive exposure through other recruiting strategies. The strategies that were labour-intensive and did not result in successful recruitment include the activities directed towards the GP medical centres. Comprehensive recruitment programs employ overlapping strategies simultaneously with ongoing assessment of recruitment rates. In our experience, and others direct mail-outs work best although rights to privacy must be respected.. ISRCTN83409867 and ACTR12605000658617.

Topics: Accidental Falls; Aged; Aged, 80 and over; Bone Density Conservation Agents; Cholecalciferol; Female; Fractures, Bone; Health Knowledge, Attitudes, Practice; Humans; Mass Media; Patient Dropouts; Patient Selection; Planning Techniques; Postal Service; Randomized Controlled Trials as Topic

Topics: Absorptiometry, Photon; Adult; Biomarkers; Body Mass Index; Bone Density Conservation Agents; Bone Diseases, Metabolic; Calcium Carbonate; Cholecalciferol; Diphosphonates; Female; Fractures, Bone; Humans; Imidazoles; Liver Transplantation; Male; Middle Aged; Prospective Studies; Treatment Outcome; Zoledronic Acid

Low-energy fractures of the hip, forearm, shoulder, and spine are known consequences of osteoporosis.. We evaluated the effect of 1 y of treatment with calcium and vitamin D on bone mineral density (BMD) and bone markers in patients with a recent low-energy fracture.. In a double-blinded design, patients with fracture of the hip (lower-extremity fracture, or LEF) or upper extremity (UEF) were randomly assigned to receive 3000 mg calcium carbonate + 1400 IU cholecalciferol or placebo (200 IU cholecalciferol). BMD of the hip (HBMD) and lumbar spine (LBMD) were evaluated by dual-energy X-ray absorptiometry, and physical performance was assessed by the timed Up & Go test. Serum concentrations of 25-hydroxycholecalciferol, parathyroid hormone (PTH), telepeptide of type I collagen (ICTP), osteocalcin, and N-terminal propeptide of collagen type I were measured.. A total of 122 patients were included (84% women; x +/- SD age: 70 +/- 11 y); 68% completed the study. In an intention-to-treat analysis, LBMD increased in the intervention group and decreased in the placebo group, and the difference between the groups was significant after 12 mo: 0.931 +/- 0.211 compared with 0.848 +/- 0.194 (P<0.05). No significant change was shown for HBMD. The effect of treatment was more pronounced in patients aged <70 y. The intervention decreased bone turnover. PTH was significantly lower in the intervention group (P<0.01) for the LEF patients. ICTP and change in LBMD were significantly related to physical performance.. A 1-y intervention with calcium and vitamin D reduced bone turnover, significantly increased BMD in patients younger than 70 y, and decreased bone loss in older patients. The effect of treatment was related to physical performance.

Topics: Absorptiometry, Photon; Aged; Biomarkers; Bone and Bones; Bone Density; Bone Remodeling; Calcium Carbonate; Cholecalciferol; Collagen Type I; Double-Blind Method; Female; Fractures, Bone; Humans; Linear Models; Male; Middle Aged; Osteocalcin; Parathyroid Hormone; Peptide Fragments; Peptides; Procollagen; Prospective Studies

In women, the influence of androgens on bone health is not clear. It has been suggested that the androgen receptor (AR) genotype is associated with bone mineral density and serum androgen levels in pre- and perimenopausal women, but the association between AR genotype, bone mineral density, and fracture risk has not been studied in postmenopausal women. Therefore, we studied whether AR polymorphism affects bone mineral density, bone mineral density change, or fracture risk in a 5-year randomized hormone replacement therapy (HRT) trial on 331 early postmenopausal women (mean baseline age, 52.7 +/- 2.3 years). The participants consisted of two treatment groups: the HRT group (n = 151) received a sequential combination of 2 mg estradiol valerate and 1 mg cyproterone acetate with or without vitamin D3, 100-300 IU + 93 mg calcium as lactate/day, and the non-HRT group (n = 180) received 93 mg calcium alone or in combination with vitamin D3, 100-300 IU/day for 5 years. Bone mineral density was measured from lumbar spine and proximal femur (DXA) before and after the 5-year trial. All new symptomatic, radiographically defined fractures were recorded during the follow-up. The length of CAG repeat in exon 1 of AR gene was evaluated after polymerase chain reaction (PCR) amplification. The subjects were divided into three repeat groups according to AR alleles. None of the baseline characteristics were associated with AR gene polymorphism and HRT treatment. The polymorphism did not influence the calculated annual changes of lumbar or femoral neck bone mineral density during the 5-year follow-up in the HRT (p = 0.926 and 0.146, respectively) or non-HRT (p = 0.818 and 0.917, respectively) groups. In all, 28 women sustained 33 fractures during the follow-up. Thus, the numbers of fractures were limited. The AR repeat length variation was not significantly associated with fracture risk in the HRT or non-HRT groups (p = 0.632 and 0.459, respectively; Cox proportional hazards model). In conclusion, AR gene polymorphism was not associated with baseline bone mineral density, 5-year bone mineral density change, or fracture risk in early postmenopausal Finnish women.

Topics: Aged; Alleles; Bone Density; Cholecalciferol; Cyproterone Acetate; Estradiol; Exons; Female; Fractures, Bone; Genotype; Hormone Replacement Therapy; Humans; Middle Aged; Polymorphism, Genetic; Postmenopause; Random Allocation; Receptors, Androgen; Time Factors

To determine the effect of four monthly vitamin D supplementation on the rate of fractures in men and women aged 65 years and over living in the community.. Randomised double blind controlled trial of 100 000 IU oral vitamin D3 (cholecalciferol) supplementation or matching placebo every four months over five years.. 2686 people (2037 men and 649 women) aged 65-85 years living in the general community, recruited from the British doctors register and a general practice register in Suffolk.. Fracture incidence and total mortality by cause.. After five years 268 men and women had incident fractures, of whom 147 had fractures in common osteoporotic sites (hip, wrist or forearm, or vertebrae). Relative risks in the vitamin D group compared with the placebo group were 0.78 (95% confidence interval 0.61 to 0.99, P=0.04) for any first fracture and 0.67 (0.48 to 0.93, P=0.02) for first hip, wrist or forearm, or vertebral fracture. 471 participants died. The relative risk for total mortality in the vitamin D group compared with the placebo group was 0.88 (0.74 to 1.06, P=0.18). Findings were consistent in men and women and in doctors and the general practice population.. Four monthly supplementation with 100 000 IU oral vitamin D may prevent fractures without adverse effects in men and women living in the general community.

Topics: Administration, Oral; Aged; Aged, 80 and over; Calcifediol; Cholecalciferol; Double-Blind Method; Female; Fractures, Bone; Heel; Humans; Incidence; Male; Parathyroid Hormone; Risk Factors; Ultrasonography

After the menopause, estrogen synthesis from androgens and androgen precursors by aromatase is the main source of circulating estrogens.. To evaluate whether aromatase gene (CYP19)polymorphism affects circulating estradiol (E2) levels, bone mineral density (BMD), BMD change or fracture risk.. A 5-year randomized hormone replacement therapy (HRT) trial on 331 early postmenopausal women (mean baseline age 52.7 +/- 2.3 years). The participants consisted of two treatment groups: the HRT group (n = 151) received a sequential combination of 2 mg estradiol valerate and 1 mg cyproterone acetate with or without vitamin D3, 100-300 IU + 93 mg calcium as lactate/day, and the non-HRT group (n = 180) received 93 mg calcium alone or in combination with vitamin D3, 100-300 IU/day for 5 years. BMD was measured from lumbar spine and proximal femur (DXA) before and after the 5-year trial. All new symptomatic, radiographically defined fractures were recorded during the follow-up. The polymorphism (intron 4 TTTA repeat) of CYP19 was evaluated after PCR amplification of the polymorphic site. CYP19 polymorphism was divided into three repeat groups: short (length of 7 or 8 in both alleles; n = 135), long (length of 11 or higher in both alleles; n = 47), and medium (rest of the values; n = 149).. Of the baseline characteristics, only physical activity was associated with CYP19 polymorphism (P = 0.04) and a borderline significance was observed with previous fractures (P = 0.05). In the HRT or non-HRT groups, the 5-year serum E2 change was not associated with CYP19 polymorphism (P = 0.87 and 0.74, respectively). Further, the polymorphism did not influence the calculated annual changes of lumbar or femoral neck BMD during the 5-year follow-up in the HRT (P = 0.60 and 0.17, respectively) or non-HRT (P = 0.92 and 0.80, respectively) groups. In all, 28 women sustained 33 fractures during the follow-up. The CYP19 polymorphism was not significantly associated with fracture risk (P = 0.89 and 0.23 respectively; Cox proportional hazards model) in the HRT or non-HRT groups.. CYP19 polymorphism was not associated with circulating E2 levels, BMD values, or fracture risk in these early postmenopausal Finnish women. If such an association exists in women, it may become apparent in older age groups.

Topics: Aromatase; Bone Density; Cholecalciferol; Cyproterone; Estradiol; Female; Follow-Up Studies; Fractures, Bone; Genotype; Hormone Replacement Therapy; Humans; Middle Aged; Polymorphism, Genetic; Postmenopause; Risk Factors

The therapeutic effect of 1,25-dihydroxycholecalciferol (1,25(OH)2D3) in postmenopausal osteoporosis was tested in a single blind, randomized prospective study. Thirty-nine women, 50-65 years of age, were treated for three years with 0.5 microgram 1,25(OH)2D3 daily. In a control group, 37 women were given 400 IU vitamin D3 daily. There was no significant difference in annual bone loss from the distal or proximal forearm between the groups. New vertebral fractures were evaluated, and in the treatment group, the annual increase in vertebral fractures was 0.18 +/- 0.387 and in the control group 0.13 +/- 0.330. New long bone fractures were 7 and 5, respectively. None of the observed differences were statistically significant. In the 1,25(OH)2D3 group, 28% had to reduce the dose because of slight hypercalcaemia. We conclude that 1,25(OH)2D3 as used in this study is not effective in the treatment of osteoporosis.

Topics: Aged; Calcitriol; Cholecalciferol; Clinical Trials as Topic; Female; Fractures, Bone; Humans; Menopause; Middle Aged; Osteoporosis; Prospective Studies; Random Allocation; Time Factors

Topics: Cholecalciferol; Fractures, Bone; Humans

LeBoff MS, Chou SH, Ratliff KA, et al.

Topics: Aged; Cholecalciferol; Dietary Supplements; Double-Blind Method; Fractures, Bone; Humans; Middle Aged; Vitamin D; Vitamins

Low bone mass is a frequent and early complication of girls with Rett syndrome. As a consequence of the low bone mass, Rett patients are at an increased risk of fragility fractures. This study aimed to investigate the long-term influences of mobility on bone status in girls with Rett syndrome.. In 58 girls with Rett syndrome, biochemical parameters and quantitative ultrasound parameters at phalanges (amplitude-dependent speed of sound: AD-SoS and bone transmission time: BTT) were measured at baseline and after 5 and 10 years. The subjects were divided into two groups: nonambulatory (n = 28) and ambulatory (n = 30).. In nonambulatory Rett subjects, the values of AD-SoS and BTT were significantly lower than in ambulatory Rett subjects at each time point. However, during the 10-year follow-up both ambulatory and nonambulatory Rett patients showed a similar worsening in their bone status.. This longitudinal study suggests that both ambulatory and nonambulatory Rett subjects present a progressive deterioration of bone status as assessed by quantitative ultrasound parameters, and the ambulatory impairment and the nutritional status seem to play a key role in the deterioration of bone status.

Topics: Absorptiometry, Photon; Adolescent; Bone and Bones; Bone Density; Child; Child Nutrition Sciences; Child, Preschool; Cholecalciferol; Disabled Persons; Female; Finger Phalanges; Follow-Up Studies; Fractures, Bone; Humans; Infant; Longitudinal Studies; Nutritional Status; Rett Syndrome; Surveys and Questionnaires; Ultrasonography; Vitamin D; Walking

Topics: Bone Density Conservation Agents; Calcium Citrate; Cholecalciferol; Female; Fractures, Bone; Humans; Hypocalcemia; Ibandronic Acid; Middle Aged; Osteoporosis; Pubic Bone; Sacrum; Vitamin D Deficiency

To determine the incidence of hypovitaminosis D and to evaluate a supplementation intervention. We hypothesized that patients would exhibit high adherence with a free sample, and levels would become sufficient.. Prospective observational study.. Level 1 trauma center.. One hundred forty-four consecutive, skeletally mature patients treated for acute fractures.. All were provided 600 mg calcium and 800 IU vitamin D3 capsules twice daily.. Serum 25(OH) D levels were obtained on presentation and after supplementation. Patient surveys determined adherence, vitamin D intake, and sun exposure.. Ninety-one men and 53 women, mean age 45 years, mean body mass index 28.1, were studied. Mean baseline 25(OH) D level was 20.2 ng/mL, including 9 patients taking vitamin D supplements before injury. All others (mean baseline 16.9 ng/mL) were prescribed calcium and vitamin D and were offered free supplements when discharged. Seventy-seven patients completed surveys, and mean 25(OH) D level was 36.7 ng/mL after a mean of 7.0 weeks of supplementation (P < 0.0001). Seventy-nine percent reported adherence to supplement recommendations. All adherent patients achieved normal levels. Sixteen patients were nonadherent, with 10 who forgot to take the supplement, 4 choosing not to use it, 1 choosing to sell the sample, and 1 losing the sample.. Hypovitaminosis D was present in 97% of orthopaedic trauma patients who were not already taking supplements. The intervention was effective in reducing hypovitaminosis D within several weeks, with all supplemented patients achieving normal levels. Seventy-nine percent of patients adhered to recommendations. Further study to determine the long-term cost-effectiveness of this strategy seems warranted.. Therapeutic, Level II. See Instructions for Authors for a complete description of levels of evidence.

Topics: Adult; Bone Density Conservation Agents; Calcium, Dietary; Cholecalciferol; Dietary Supplements; Female; Fractures, Bone; Humans; Incidence; Male; Medication Adherence; Middle Aged; Prospective Studies; Vitamin D Deficiency

The purpose of this study was to determine the effectiveness of our vitamin D treatment protocol in managing low serum vitamin D levels in orthopaedic trauma patients.. A retrospective review was conducted of all orthopaedic trauma patients at a university level I trauma center over 20 months. Patients were included if they had an initial and repeat 25-hydroxy (OH) vitamin D serum level available. Vitamin D deficiency was defined as serum 25-hydroxy vitamin D level with less than 20 ng/mL. Vitamin D insufficiency was defined as serum 25-hydroxy vitamin D level between 20 and 32 ng/mL. The standard regimen for all patients was over-the-counter vitamin D3 1000 IU and 1500 mg of calcium daily. Patients with vitamin D deficiency or insufficiency also received 50,000 IU of ergocalciferol (D2) weekly until their 25-hydroxyvitamin D level normalized or their fracture healed. No compliance monitoring was performed except for questioning at each clinic visit.. A total of 201 patients met the inclusion criteria. Thirty-two patients had a normal initial 25-hydroxyvitamin D level, and 84% maintained their normal level, whereas 16% became insufficient or deficient. There were 88 patients insufficient initially and 54.5% improved to normal and 8% became deficient. In the vitamin D deficiency group (81), 26% remained deficient and 74% improved to insufficient. The average increase in serum 25-OH vitamin D with treatment (in nanograms per milliliter) was statistically significant for both the insufficient and deficient groups.. Vitamin D therapy improved the majority of the patients' vitamin D-25-OH level but did not normalize most. Patients with initial deficiency had the largest improvement. This study indicates that vigilance is required to adequately treat a low serum vitamin D-25-OH level.

Topics: Calcium; Cholecalciferol; Fractures, Bone; Humans; Hydroxycholecalciferols; Retrospective Studies; Vitamin D Deficiency

Topics: Aged, 80 and over; Bone Density Conservation Agents; Calcitriol; Calcium Carbonate; Cholecalciferol; Denosumab; Female; Fractures, Bone; Humans; Hypercalcemia; Hypocalcemia; Medication Errors; Renal Insufficiency, Chronic; Tetany

Topics: Basal Cell Nevus Syndrome; Biomarkers; Cholecalciferol; Dietary Supplements; Fractures, Bone; Humans; Iatrogenic Disease; Male; Middle Aged; Neoplasms, Radiation-Induced; Protective Clothing; Radiation Protection; Risk Factors; Skin Neoplasms; Sunlight; Sunscreening Agents; Time Factors; Treatment Outcome; Vitamin D; Vitamin D Deficiency

People with intellectual disabilities have a high risk of osteoporosis and fractures, which could partly be as a result of vitamin D deficiency.. To compare the serum vitamin D (25(OH)D) levels of 155 patients with intellectual disabilities under psychiatric care and 192 controls, investigate potential risk factors for vitamin D deficiency in people with intellectual disabilities and assess available treatments.. Cross-sectional observational study followed by treatment evaluation. Results Almost twice as many patients with intellectual disabilities had vitamin D deficiency (25(OH)D <50 nmol/l) compared with controls (77.3% v. 39.6%, P<0.0001). In the intellectual disabilities group, winter season (P<0.0001), dark skin pigmentation (P<0.0001), impaired mobility (P = 0.002) and obesity (P = 0.001) were independently associated with lower serum 25(OH)D. In most patients, 800 IU colecalciferol daily normalised 25(OH)D levels.. Vitamin D deficiency is highly prevalent in people with intellectual disabilities, partly because of insufficient exposure to sunlight. Screening and treatment strategies, aiming to reduce these patients' high fracture risk, should be introduced. Similar strategies may be required in other psychiatric populations at risk for fractures and with a tendency to spend excessive time indoors.

Topics: Adult; Bone Density Conservation Agents; Cholecalciferol; Cross-Sectional Studies; Drug Administration Schedule; Female; Fractures, Bone; Humans; Intellectual Disability; Male; Middle Aged; Mobility Limitation; Obesity; Osteoporosis; Risk Factors; Sunlight; Treatment Outcome; Vitamin D; Vitamin D Deficiency

Guidelines on the need for dose adaptation of vitamin D3 supplementation according to baseline serum 25(OH)D are inconclusive. The effects of increasing doses of vitamin D3 at lower baseline serum 25(OH)D values on the serum 25(OH)D after 4.2 and 11 months were determined in an observational study.. A prospective observational study.. Out of 1481 consecutive women and men with a recent clinical fracture, 707 had a baseline 25(OH)D level <50 nmol/l and were supplemented with increasing doses of vitamin D3 (400, 800, 1700, and ≥3500 IU/day) according to the lower baseline 25(OH)D. Final analysis was restricted to the 221 participants who had full follow-up data available for 11 months.. Serum 25(OH)D ≥50 nmol/l was achieved in 57-76% of patients after 4.2 months and in 73-79% after 11 months. These percentages were similar for all doses (P=0.06 and P=0.91 respectively). The mean achieved 25(OH)D was similar for all dose groups (56.1-64.0 nmol/l after 4.2 months and 60.2-76.3 nmol/l after 11 months). With multivariate analysis, the increase in 25(OH)D (17±32.0 after 4.2 months and 24.3±34.0 nmol/l after 11 months) was dependent on the baseline 25(OH)D (P<0.001), not on supplementation dose, season, age, BMI, or gender.. The increase in serum 25(OH)D was significantly larger with higher vitamin D3 supplementation doses. However, this dose-effect response was mainly explained by the baseline 25(OH)D, not the supplementation dose, with a greater magnitude of response at lower baseline 25(OH)D concentrations. In 21-27% of patients, serum 25(OH)D3 levels did not reach 50 nmol/l after 11 months, at any dose. Further studies are needed to identify possible causes of suboptimal response such as non-compliance, undiagnosed malabsorption syndromes, or variability in cholecalciferol content of the vitamin D supplements.

Topics: Absorptiometry, Photon; Aged; Bone Density; Cholecalciferol; Dietary Supplements; Dose-Response Relationship, Drug; Female; Fractures, Bone; Hormones; Humans; Hydroxycholecalciferols; Linear Models; Male; Middle Aged; Prospective Studies; Vitamins; White People

Osteopenia and osteoporosis are diseases frequently occurring after liver transplantation (OLT).. In a prospective study, we have investigated the effect of ibandronate, vitamin D(3), and calcium on the prevention and treatment of posttransplant osteopenia and osteoporosis.. The bone mineral density (BMD) of the lumbar spine (LS) and of the femoral neck (FN) were measured in 74 patients prospectively pre- and post-OLT.. Postoperatively the study group showed a consistent percentage increase in BMD (g/cm(2)) and a significantly increased BMD after 12 and 24 months in the LS (12 months: 1.05 ± 0.21 g/cm(2); P < .001 24 months: 1.11 ± 0.19 g/cm(2); P < .001) and the FN (12 months: 0.88 ± 0.16 g/cm(2); P < .002 24 months: 0.90 ± 0.15 g/cm(2); P < .001) in comparison with baseline pre-OLT (LS pre-OLT 0.98 ± 0.19 g/cm(2), FN 0.86 ± 0.14 g/cm(2)). The overall bone fracture rate was 5.4% up to 24 months.. Ibandronate once monthly per os significantly increased the BMD in the LS and FN after OLT at 12 and 24 months. The increased BMD limits the risk of fracture.

Topics: Absorptiometry, Photon; Administration, Oral; Alkaline Phosphatase; Amino Acids; Biomarkers; Bone Density; Bone Density Conservation Agents; Bone Diseases, Metabolic; Calcium; Chi-Square Distribution; Cholecalciferol; Creatinine; Dietary Supplements; Diphosphonates; Drug Administration Schedule; Femur Neck; Fractures, Bone; Germany; Humans; Ibandronic Acid; Liver Transplantation; Lumbar Vertebrae; Osteoporosis; Prospective Studies; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome

Hereditary Sensory and Autonomic Neuropathies comprise a set of 5 rare neurologic conditions, little known to radiologists as the neurologic and skin abnormalities precede the radiographic changes by months or even years. We report a Caucasian patient with a clinical history of HSAN, most consistent with subtype 1, whose progressive, destructive bone changes of the foot were not only controlled but to a degree reversed by the administration of bisphosphonates (Alendronate ) and vitamin D (Colecalciferol). The authors believe that combined bisphosphonate and vitamin D therapy is the treatment of choice for progressive bony changes in HSAN1. This therapy may be beneficial in other neuropathic osteoarthropathies and possibly osteolytic bone disorders.

Topics: Alendronate; Cholecalciferol; Diphosphonates; Female; Fractures, Bone; Hereditary Sensory and Autonomic Neuropathies; Humans; Vitamin D

Polyostotic fibrous dysplasia (PFD) is characterized by developmental failure in the remodeling of primitive bone to mature lamellar bone. PFD presents with bone pain, increased bone fragility, deformities, and fractures. Bisphosphonates are the only agents available for medical management.1,2 Intravenous (IV) pamidronate is the established treatment for symptomatic bone involvement in PFD.3,4 Oral alendronate holds promise because of its comparable outcomes, lower cost, and ease of administration.5 The patient described in this case report provided written informed consent for its print and electronic publication after reviewing the complete manuscript and skeletal radiographic images.

Topics: Adolescent; Alendronate; Bone Density; Bone Density Conservation Agents; Calcium Carbonate; Cholecalciferol; Diagnosis, Differential; Drug Therapy, Combination; Female; Fibrous Dysplasia, Polyostotic; Fractures, Bone; Humans; Radiography; Treatment Outcome

To report a case of hypervitaminosis D resulting in hypercalcemia and acute kidney injury in a 70-year-old female who was prescribed a standard dose of vitamin D but given a toxic dose of vitamin D 50,000 IU (1.25 mg) daily resulting from a dispensing error.. A 70-year-old female in her usual state of health was instructed to begin supplementation with vitamin D 1000 IU daily. Three months later she developed confusion, slurred speech, unstable gait, and increased fatigue. She was hospitalized for hypercalcemia and acute kidney injury secondary to hypervitaminosis D. All vitamin D supplementation was discontinued and 5 months after discharge, the patient's serum calcium and vitamin D concentrations, as well as renal function, had returned to baseline values. Upon review of the patient's records, it was discovered that she had been taking vitamin D 50,000 IU daily.. There is an increased interest in vitamin D, resulting in more health care providers recommending--and patients taking--supplemental vitamin D. Hypervitaminosis D is rarely reported and generally only in the setting of gross excess of vitamin D. This report highlights a case of hypervitaminosis D in the setting of a prescribed standard dose of vitamin D that resulted in toxic ingestion of vitamin D 50,000 IU daily due to a dispensing error. As more and more people use vitamin D supplements, it is important to recognize that, while rare, hypervitaminosis D is a possibility and dosage conversion of vitamin D units can result in errors.. Health care providers and patients should be educated on the advantages and risks associated with vitamin D supplementation and be informed of safety measures to avoid hypervitaminosis D. In addition, health care providers should understand dosage conversion regarding vitamin D and electronic prescribing and dispensing software should be designed to detect such errors.

Topics: Acute Kidney Injury; Aged; Cholecalciferol; Confusion; Drug Dosage Calculations; Ergocalciferols; Female; Fractures, Bone; Humans; Hypercalcemia; Medication Errors; Treatment Outcome

Many studies have demonstrated the prevalence of vitamin D insufficiency in the older population.. This study sought to determine whether supplementation with intramuscular vitamin D improved 25OH vitamin D levels significantly.. Ninety female inpatients aged over 65 years were assigned to receive 300,000 IU of intramuscular vitamin D3 (cholecalciferol) or no intervention.. Baseline 25OH vitamin D and intact parathyroid hormone (iPTH) levels were taken and repeated 3 months after supplementation.. Patients who received treatment showed a significant improvement in 25OH vitamin D levels, from 25.5 to 81 nmol/L with 11% remaining deficient. No patient became hypercalcaemic after treatment.. Vitamin D deficiency is common throughout all age groups in the Irish population and particularly the older female population who have increased risk of osteoporosis and fractures. Intramuscular vitamin D significantly improves 25OH vitamin D levels compared to no treatment and may combat non-compliance with oral medication.

Topics: Age Factors; Aged; Aged, 80 and over; Bone Density Conservation Agents; Bone Diseases, Metabolic; Cholecalciferol; Dietary Supplements; Feasibility Studies; Female; Fractures, Bone; Hospitalization; Humans; Injections, Intramuscular; Ireland; Parathyroid Hormone; Prevalence; Risk Assessment; Vitamin D Deficiency

Topics: Accidental Falls; Aged, 80 and over; Algorithms; Biomarkers; Black or African American; Blood Chemical Analysis; Bone and Bones; Cholecalciferol; Decision Making; Drug Monitoring; Ergocalciferols; Female; Fractures, Bone; Hip Fractures; Humans; Osteoporosis; Practice Guidelines as Topic; Vitamin D; Vitamin D Deficiency

Topics: Accidental Falls; Aged; Bone Density Conservation Agents; Cholecalciferol; Chronic Disease; Drug Administration Schedule; Female; Fractures, Bone; Humans; Randomized Controlled Trials as Topic; Risk; Treatment Outcome

Topics: Accidental Falls; Aged; Bone Density Conservation Agents; Bone Resorption; Cell Differentiation; Cholecalciferol; Female; Fractures, Bone; Humans; Osteoclasts

Topics: Accidental Falls; Aged; Bone Density Conservation Agents; Calcifediol; Cholecalciferol; Dose-Response Relationship, Drug; Female; Fractures, Bone; Hip Fractures; Humans

Topics: Accidental Falls; Aged; Bone Density Conservation Agents; Calcitriol; Cholecalciferol; Female; Fractures, Bone; Humans; Kidney Diseases; Vitamin D Deficiency

This study intended to determine whether the replacement of vitamin D3 with alfacalcidol results in any bone mineral density (BMD) increase in 76 patients unresponsive to the combination of alendronate and conventional vitamin D3 treatment. In these patients the conventional vitamin D3 had been replaced with alfacalcidol (0.5 μg/day), and then the patients were followed up for a year. After treatment for 1 year, Wilcoxon test revealed a small but statistically significant (P < 0.001) increase in the BMD values of the forearm and lumbar vertebrae, in the serum calcium and urinary calcium/creatinine ratio in first-voided morning urine. However, the serum alkaline phosphatase activity, phosphorus, parathormone, osteocalcin levels and the urinary d-pyr/creatinine ratio decreased significantly (P < 0.001). As suggested by our results, combination therapy with alendronate and alfacalcidol increases bone density and improves the biochemical markers of bone turnover, without any substantial increase in the incidence of adverse effects.

Topics: Absorptiometry, Photon; Aged; Alendronate; Biomarkers; Bone Density; Bone Density Conservation Agents; Bone Remodeling; Cholecalciferol; Diphosphonates; Drug Resistance; Drug Therapy, Combination; Female; Follow-Up Studies; Fractures, Bone; Humans; Hungary; Hydroxycholecalciferols; Male; Middle Aged; Osteoporosis; Time Factors; Treatment Outcome

Topics: Adult; Ascorbic Acid; Calcium; Cholecalciferol; Female; Fractures, Bone; Humans; Hypocalcemia; Osteomalacia; Pregnancy; Pregnancy Complications; Vitamin D Deficiency

Chondrocytes express RANKL, but their role in osteoclastogenesis is not clear. We report that hypertrophic chondrocytes induce osteoclast formation through RANKL production stimulated by BMP2 and Runx2/Smad1 and thus they may regulate resorption of calcified matrix by osteoclasts at growth plates.. Bone morphogenetic protein (BMP) signaling and Runx2 regulate chondrogenesis during bone development and fracture repair and RANKL expression by osteoblast/stromal cells. Chondrocytes express RANKL, and this expression is stimulated by vitamin D3, but it is not known if chondrocytes directly support osteoclast formation or if BMPs or Runx2 is involved in this potential regulation of osteoclastogenesis.. The chondrocyte cell line, ATDC5, primary mouse sternal chondrocytes, and chick sternal chondrocytes were used. Cells were treated with BMP2, and expression of RANKL and chondrocyte marker genes was determined by real-time RT-PCR and Western blot. Chondrocytes and spleen-derived osteoclast precursors +/- BMP2 were co-cultured to examine the effect of chondrocyte-produced RANKL on osteoclast formation. A reporter assay was used to determine whether BMP2-induced RANKL production is through transcriptional regulation of the RANKL promoter and whether it is mediated by Runx2.. BMP2 significantly increased expression of RANKL mRNA and protein in all three types of chondrocytes, particularly by Col X-expressing and upper sternal chondrocytes. Chondrocytes constitutively induced osteoclast formation. This effect was increased significantly by BMP2 and prevented by RANK:Fc. BMP2 significantly increased luciferase activity of the RANKL-luc reporter, and Smad1 increased this effect. Deletion or mutation of Runx2 binding sites within the RANKL promoter or overexpression of a dominant negative Runx2 abolished BMP2- and Smad1-mediated activation of RANKL promoter activity.. Hypertrophic chondrocytes may regulate osteoclastogenesis at growth plates to remove calcified matrix through BMP-induced RANKL expression.

Topics: Animals; Bone Development; Bone Morphogenetic Protein 2; Bone Morphogenetic Proteins; Cell Differentiation; Cell Line, Tumor; Chickens; Cholecalciferol; Chondrocytes; Collagen Type IX; Core Binding Factor Alpha 1 Subunit; Extracellular Matrix; Fractures, Bone; Gene Expression Regulation; Growth Plate; Humans; Mice; Osteoclasts; RANK Ligand; Response Elements; RNA, Messenger; Smad1 Protein; Spleen; Stem Cells; Transforming Growth Factor beta; Vitamins

To evaluate the cost-effectiveness of a fixed dose combination of alendronate 70 mg and cholecalciferol 2800 IU (alendronate/vitamin D3; Fosavance) versus no treatment, alendronate with dietary vitamin D supplements and ibandronate in the treatment of osteoporosis in the UK and Netherlands.. A patient simulation model was developed. One-year cycles included health states related to hip, vertebral, wrist and proximal humerus fractures, as well as death due to hip fractures and other causes. Effect of treatment was extracted from alendronate and ibandronate clinical trials. Direct costs and utilities were derived from other literature. Analyses were performed for women with a history of vertebral fractures and osteoporosis aged 50, 60, 70 and 80 years. Probabilistic sensitivity analyses were undertaken to estimate the uncertainty of outcomes.. In the UK, alendronate/vitamin D3 was cost-effective compared to no treatment in women 70 years and older with osteoporosis ( pound17 439 per quality-adjusted life year [QALY] gained) and women 60 years and older with a history of vertebral fractures ( pound29 283 per QALY gained). For women 80 years of age alendronate/vitamin D3 was cost-saving combined with QALY gains. Alendronate/vitamin D3 was cost-saving relative to alendronate with dietary supplements. Relative to ibandronate, alendronate/vitamin D3 was cost-effective in women 50 years ( pound19 095 per QALY gained) and economically dominant in women 60 years or older. Comparable results were observed for the Netherlands.. Given the underlying assumptions and data used, this economic modelling study showed that alendronate/vitamin D3 is cost-effective in women 70 years or older with osteoporosis and in women 60 years or older with a history of vertebral fractures in the UK and Netherlands. Alendronate/vitamin D3 is economically dominant over ibandronate in women with a history of vertebral fractures aged 60 and over and cost-saving relative to alendronate with dietary supplements.

Topics: Aged; Aged, 80 and over; Alendronate; Bone Density Conservation Agents; Cholecalciferol; Cost-Benefit Analysis; Diphosphonates; Drug Combinations; Drug Costs; Female; Fractures, Bone; Humans; Ibandronic Acid; Middle Aged; Models, Economic; Netherlands; Osteoporosis; Patient Compliance; Patient Simulation; Quality-Adjusted Life Years; United Kingdom

Osteoporosis is a frequent complication in patients with inflammatory bowel disease. Recent studies have shown bisphosphonates to considerably reduce fracture risk in patients with osteoporosis, and preventing fractures with bisphosphonates has been reported to be cost effective in older populations. However, no studies of the cost effectiveness of these agents in preventing fractures in patients with inflammatory bowel disease are available.. To investigate the cost effectiveness of the bisphosphonate ibandronate combined with calcium/colecalciferol ('ibandronate') in patients with osteopenia or osteoporosis due to inflammatory bowel disease in Germany. Treatment strategies used for comparison were sodium fluoride combined with calcium/colecalciferol ('fluoride') and calcium/colecalciferol ('calcium') alone.. A cost-utility analysis was conducted using data from a randomized controlled trial (RCT). Changes in bone mineral density (BMD) were adjusted and predicted for a standardized population receiving each respective treatment. A Markov model was developed, with probabilities of transition to fracture states consisting of BMD-dependent and -independent components. The BMD-dependent component was assessed using predicted change in BMD from the RCT. The independent component captured differences in bone quality and micro-architecture resulting from prevalent fractures or treatment with anti-resorptive drugs. The analysis was conducted for a population with a mean age of the RCT patients (women aged 36 years, men aged 38 years) with osteopenia (T-score about -2.0 at baseline), a population of the same age with osteoporosis (T-score of -3.0 at baseline) and for an older population (both sexes aged 65 years) with osteoporosis (T-score of -3.0). Outcomes were measured as costs per QALY gained from a societal perspective. The treatment duration in the RCT was 42 months. A 5-year period was assumed to follow, during which the treatment effects linearly declined to 0. The simulation time was 10 years. Prices for medication and treatment were presented as year 2004 values; costs and effects were discounted at 5%. To test the robustness of the results, univariate and probabilistic sensitivity analyses (Monte Carlo simulation) were conducted.. The calcium strategy dominated the fluoride strategy. When the ibandronate strategy was compared with the calcium strategy, the base-case cost-effectiveness ratios (costs per QALY gained) were between euro 407 375 for an older female population with osteoporosis and euro 6 516 345 for a younger female population with osteopenia. Univariate sensitivity analyses resulted in variations between 4% of base-case results and dominance of calcium. In Monte Carlo simulations, conducted for the various populations, the probability of an ICER of ibandronate below euro 50 000 per QALY was never greater than 20.2%.. The ibandronate strategy is unlikely to be considered cost effective by decision makers in men or women with characteristics of those in the target population of the RCT, or in older populations with osteoporosis.

Topics: Adult; Aged; Bone Density; Bone Density Conservation Agents; Calcium; Cholecalciferol; Cost-Benefit Analysis; Diphosphonates; Drug Therapy, Combination; Female; Fractures, Bone; Germany; Humans; Ibandronic Acid; Inflammatory Bowel Diseases; Male; Markov Chains; Models, Economic; Osteoporosis; Quality-Adjusted Life Years; Sodium Fluoride

Topics: Aged; Blood Glucose; Cholecalciferol; Fractures, Bone; Humans; Mass Screening; Middle Aged; Neoplasms; Risk Factors; Ultraviolet Rays; Vitamin D; Vitamin D Deficiency; Vitamins

Vitamin D insufficiency is widespread, regardless of geographical location. It is particularly prevalent in the elderly and has far-ranging health consequences including: osteoporosis, falls, increased risk of cancer, and altered glucose and lipid metabolism. Increasing evidence strongly supports the benefits of vitamin D supplementation and also reveals that present recommendations are inadequate, especially for older individuals. Although additional studies are still needed to further optimize diagnostic and therapeutic approaches, physicians should consider prescribing cholecalciferol--at least 2000 international units (IU) per day--to all elderly patients. Oral cholecalciferol supplementation at that level is inexpensive, safe, and effective, and has great potential to improve the quality of life of the elderly.

Topics: Accidental Falls; Aged; Cholecalciferol; Fractures, Bone; Humans; Inflammation; Metabolic Syndrome; Neoplasms; Osteoporosis; Ultraviolet Rays; Vitamin D; Vitamin D Deficiency; Vitamins

The aim of the present study was to clarify if patients with osteoporotic bone fractures have exocrine pancreatic insufficiency, especially reduced fecal elastase 1, connected with lowered serum levels of vitamin D3 that could be relevant for predominant osteoporosis.. Between October 1999 and September 2001, we investigated on 167 patients with an average age of approx. 69 years suffering from typical osteoporotic bone fractures, as well as 20 healthy controls with an average age of 53 years. A standardized osteodensitometry via dual energy X-ray absorptiometry (DEXA) was performed in all participants. Levels of PTH, 1,25(OH)(2) Vitamin D(3), 25(OH) Vitamin D(3), calcium and phosphate in serum, elastase 1 in feces as well as the body mass index were determined in all patients and controls.. In patients 25(OH)D3 was more than 60% and 1,25(OH)(2)D(3) was more than 53% decreased compared to controls. Fecal elastase 1 was lower than the lowest reference of 200 microg/g feces in more than 34% of the patients and it was more than 65% reduced in comparison to healthy controls (fecal elastase 1 patients: 240.7 +/- 96.3 microg/g; controls 694.9 +/- 138.6 microg/g). Separation of the patients in accordance with the elastase 1 contend in feces into four groups (below 100 microg/g, between 100 and 200 microg/g, between 201 and 300 microg/g and above 300 microg/g) resulted in significant variations for 25(OH)D(3), 1,25(OH)(2)D(3), calcium and PTH between these groups (p < 0.01). Furthermore 25(OH)D(3), 1,25(OH)(2)D(3), calcium and PTH correlated significantly with elastase 1 in feces (p < 0.01) the way, that lower fecal elastase 1 was connected with lower levels of the other parameters. BMI shows no relevant differences within the patients or between patients and controls.. Exocrine pancreatic insufficiency, especially lowered fecal elastase 1, may be much more frequent in patients with osteoporotic bone fractures than suggested so far. Lowered exocrine pancreatic function with lowered fecal elastase 1 seems to be relevant as a reason for reduced levels of circulating vitamin D3 metabolites being an appropriate additional cause for predominant osteoporosis.

Topics: Absorptiometry, Photon; Adult; Aged; Aged, 80 and over; Case-Control Studies; Cholecalciferol; Feces; Fractures, Bone; Humans; Middle Aged; Osteoporosis; Pancreatic Elastase

Vitamin D is essential for intestinal calcium absorption, bone mineralisation and plays an important role in neuromuscular functions. Vitamin D insufficiency is highly prevalent among postmenopausal women with osteoporosis and in the elderly. In turn, supplements of vitamin D3 (cholecalciferol), and to a lesser extent vitamin D2 (ergocalciferol), may decrease falls and fracture risk by 25%. Despite some recent negative studies, the actual question is not to know whether vitamin D is necessary, but rather how much vitamin D is sufficient to prevent secondary hyperparathyroidism, falls and fractures. Moreover, the risk of osteoporosis and of fragility fractures may be influenced by genetic variation in the vitamin D receptor (VDR).

Topics: Accidental Falls; Aged; Bone Density Conservation Agents; Calcification, Physiologic; Calcium; Cholecalciferol; Ergocalciferols; Female; Fractures, Bone; Humans; Hyperparathyroidism, Secondary; Intestinal Absorption; Neuromuscular Junction; Osteoporosis; Osteoporosis, Postmenopausal; Receptors, Calcitriol; Vitamin D; Vitamins

Topics: Cholecalciferol; Fractures, Bone; Humans; South Dakota; Vitamin D Deficiency

Topics: Bone Density Conservation Agents; Cholecalciferol; Ergocalciferols; Fractures, Bone; Humans; Vitamin D

Topics: Adult; Arthralgia; Bone Density Conservation Agents; Calcium; Celiac Disease; Cholecalciferol; Diagnosis, Differential; Drug Therapy, Combination; Female; Fractures, Bone; Humans; Hyperparathyroidism, Secondary; Neoplasms; Obesity; Treatment Outcome; Weight Loss

In postmenopausal osteoporosis, the administration of alfacalcidol to women resulted in an increase in trabecular bone mineral density (BMD), prevention of cortical bone loss, and a significant reduction in the incidence of further vertebral fractures. There is now robust evidence that alfacalcidol may be particularly active in conditions characterized by an increased rate of bone loss. Alfacalcidol 1 microg/day fully prevented vertebral bone loss over 3 years in women after the first year of menopause. In a large cohort of individuals starting treatment with high dose corticosteroid (CS, 46.6 mg equivalent prednisolone per day), the spinal bone loss observed in untreated patients was fully prevented by administration of 1 microg/day alfacalcidol. In patients with established CS-induced osteoporosis, with or without prevalent vertebral fractures, 1 microg/day of alfacalcidol, given for 3 years, increased lumbar spine density, reduced back pain, and showed a significant reduction in the rate of new vertebral fractures, compared to native vitamin D. In cardiac transplant recipients, alfacalcidol and calcium reduced spinal and femoral bone loss, compared to a control group treated with etidronate and calcium. Alfacalcidol-treated patients experienced fewer new vertebral fractures over the 2-year followup. When alfacalcidol and vitamin D3 were compared in elderly women with radiologic evidence of vertebral fracture, fractional calcium absorption was increased after 3 months with alfacalcidol but was unchanged with vitamin D3. In a recent metaanalysis of 14 studies of native vitamin D and 19 studies of D-hormone analogs (alfacalcidol and calcitriol), the D-analogs exerted a higher preventive effect on bone loss and fracture rates in patients with no exposure to CS. In head-to-head studies comparing D-analogs and native vitamin D in patients receiving CS, this metaanalysis identified significant effects favoring D-analogs for femoral neck BMD and spinal fractures. In conclusion, improvement in bone turnover, increase in BMD, and reduction in fracture rates have been described during alfacalcidol treatment in situations characterized by a high rate of bone loss, including CS-induced osteoporosis, early postmenopausal bone loss, and organ transplant. Compared to plain vitamin D, alfacalcidol exerts higher bone-protective effects, thus allowing the doses to be minimized and lowering the risk of adverse effects, including hypercalcemia.

Topics: Adrenal Cortex Hormones; Animals; Bone Density; Bone Density Conservation Agents; Bone Remodeling; Cholecalciferol; Clinical Trials as Topic; Female; Fractures, Bone; Humans; Hydroxycholecalciferols; Osteoporosis; Osteoporosis, Postmenopausal; Spinal Fractures; Transplantation

The aim of the present study was to survey the interest of Japanese orthopedists in preventing fractures in the elderly, and investigate their awareness with regard to main prevention strategies such as medications and hip protectors. From the list of 20,899 members of the Japanese Orthopedic Association, we randomly selected a sample of 2035 people. Each orthopedist was sent an anonymous survey consisting of 12 questions during July to August 2001. At that time, risedronate, raloxifene, and parathyroid hormone had not been approved for clinical use in Japan, and even alendronate had just been approved. Of the survey forms sent, 1011 responses were received, for a response rate of 50%. Analysis of these responses showed a very high interest in osteoporosis, fractures in the elderly from falls, and the prevention of such fractures. This interest was associated with physician age, with those above the age of 50 years being 2.3 times more likely to have an interest in each of these than physicians below that age. The respondents considered the most promising measure for the prevention of fractures in the elderly from falls to be fall prevention, followed by exercise and osteoporosis medications. The medication considered to be effective as a monotherapy by the overwhelming number of respondents was bisphosphonates, followed by vitamin D3 and calcitonin. Combination agents cited were vitamin D3, bisphosphonates, and calcitonin, in that order. Forty-two percent of respondents had some knowledge of hip protectors, but confidence in them as a means to prevent fractures was still low. The practical information from our survey should serve as a starting point for comparison to periods when new bisphosphonates or hip protectors become commonly available to Japanese orthopedists. The overall results indicate that Japanese orthopedists are very positive toward fracture prevention.

Topics: Accidental Falls; Adult; Age Factors; Aged; Attitude of Health Personnel; Calcitriol; Calcium; Calcium Channel Agonists; Cholecalciferol; Diphosphonates; Drug Therapy, Combination; Female; Fractures, Bone; Hip; Humans; Japan; Male; Middle Aged; Orthopedics; Osteoporosis; Protective Devices

Topics: Alendronate; Bone Density; Calcium, Dietary; Cholecalciferol; Dietary Supplements; Female; Fractures, Bone; Humans; Osteoporosis, Postmenopausal

Topics: Age Factors; Aged; Aged, 80 and over; Cholecalciferol; Clinical Trials as Topic; Female; Femoral Fractures; Fractures, Bone; Humans; Male; Osteoporosis; Risk Factors; Time Factors; Vitamin D; Vitamin D Deficiency

Topics: Cholecalciferol; Fractures, Bone; Humans; Osteoporosis; Xanthomatosis

Treatment of patients with osteoporosis includes drugs to influence bone metabolism but also gymnastics for pain relief and in order to improve mobility in general. Fluorides (20 to 25 mg ions/day) are used in patients, where reduction in bone mass caused vertebral fractures. Their beneficial effects were proven in clinical studies; recent studies, however, did not confirm this. Calcium (1000 mg/day) and Vitamin D3 (3000 units/day) complete therapy. Calcitonins (3 x 100 units/week) are given to patients during progressioning fracturing and in painful disease. Diphosphonates have been used as experimental therapy, but they are still not available for general use.

Topics: Aged; Calcitonin; Calcium; Cholecalciferol; Exercise Therapy; Fluorides; Fractures, Bone; Humans; Osteoporosis; Self-Help Groups

The available methods to quantitate vertebral deformity in osteoporotics are not satisfactory in comparing follow-up measurements in patients. This paper describes a newly developed 'spine deformity index' (SDI) which allows the quantitation of the extent of vertebral fractures. It is based on the observation that, in 110 normal persons, the heights of all vertebral bodies were related to each other in a predictable and constant manner. This relation was independent of the body height of the individual and was preserved despite growth acceleration during the last century. Since in all but one of our osteoporotic patients the 4th thoracic vertebra was unfractured we were able to compare the actual size of their fractured vertebrae to the calculated presumable original heights. The differences between presumable original and actual heights gave a measure of the extent of vertebral compression and allowed to define an index representing the sum of all spinal fractures in osteoporotics. The method was applied retrospectively to X-rays of 39 patients with idiopathic osteoporosis. Thirty-two of them were treated orally with 80 mg sodium fluoride, 1,000 mg calcium and 3000 IE vitamin D daily. Treatment resulted in a reduction of the progression of vertebral deformity. Seven inadequately treated patients had more pronounced progression of vertebral deformity.

Topics: Adult; Aged; Anthropometry; Body Height; Calcium; Cholecalciferol; Female; Fractures, Bone; Humans; Male; Middle Aged; Osteoporosis; Sodium Fluoride; Thoracic Vertebrae

The metabolism of vitamin D3 was studied in chicks after experimental fractures were performed on their tibiae. The chicks were fed for 3 weeks a vitamin D-deficient diet but were supplemented with radioactive labeled vitamin D3. The chicks were then divided into two groups. In the first group the right tibia was fractured, whereas the second group served as nonfractured control group. During the following days of fracture healing, the metabolites of [3H]vitamin D3 were measured in callus, epiphysis, diaphysis, plasma, duodenum, and kidney. Histological examination of calluses and bones, measurements of intestinal absorption of calcium, and renal production of dihydroxylated metabolites of vitamin D3 were performed as well. The levels of the dihydroxylated metabolites were increased in the calluses and the levels of [3H]24,25-dihydroxyvitamin D3 were found to coincide with the formation of cartilaginous tissue and with the renal production of this steroid. In the duodenum of the fractured chicks, the levels of [3H]1,25-dihydroxyvitamin D3 dropped significantly during the first week after fracture, coinciding with reduction in the intestinal absorption of calcium. In the plasma during those 3 weeks of healing process the levels of [3H]1,25-dihydroxyvitamin D3 were far below normal. These findings indicate that during the process of fracture repair, changes in the metabolism and expression of vitamin D are taking place in order to meet the new requirements of the body under stress condition of skeletal fracture.

Topics: Animals; Bone and Bones; Calcium; Chickens; Cholecalciferol; Duodenum; Fractures, Bone; Kidney; Wound Healing

The levels of the active metabolites of vitamin D were measured in the callus and in the epiphyseal growth plate of chicks given radioactive cholecalciferol during fracture healing. Those levels were correlated with the histological findings. Three groups of chicks were studied: a control group with no fracture, chicks with fractures fixed by Kirschner wire, and chicks with unfixed fractures. A significant increase in the levels of the active metabolites was found in the callus during the first few days after fracture. The levels of 25-hydroxycholecalciferol [25(OH)D3] and of 24,25-dihydroxycholecalciferol [24,25(OH)2D3] were higher when there was no fixation, while those of 1,25-dihydroxycholecalciferol [1,25(OH)2D3] were higher after fixation. The concentrations of these metabolites in the proximal epiphysis of the tibia were similar to those found in the callus. Based on these findings it is suggested that the active metabolites of vitamin D are directly involved in the process of fracture repair.

Topics: Animals; Bony Callus; Calcifediol; Calcitriol; Chickens; Cholecalciferol; Dihydroxycholecalciferols; Fractures, Bone; Growth Plate; Wound Healing

Topics: Adult; Aged; Aging; Calcium; Cholecalciferol; Dihydroxycholecalciferols; Estradiol; Female; Fractures, Bone; Humans; Hydroxycholecalciferols; Male; Middle Aged; Osteoporosis; Parathyroid Hormone; Sex Factors; Testosterone

Topics: Animals; Bone and Bones; Bony Callus; Calcium; Cartilage; Chickens; Cholecalciferol; Fractures, Bone; Hydroxycholecalciferols; Intestinal Absorption; Male; Osteogenesis; Phosphorus; Wound Healing

Severe osteomalacia with secondary hyperparathyroidism was observed in a 19-year-old mentally retarded girl, who had been treated for several years with antiepileptic drugs. Vitamin D3 orally administered in low doses led to complete reversal of all symptoms and normalization of blood chemistry, X-ray pictures demonstrated healing of all lesions. It is suggested that the alterations of vitamin-D metabolism occuring during the administration of phenobarbital and hydantion are of importance only in patients with an already lowered intake of vitamin D3 or reduced exposure to ultraviolet rays.

Topics: Adult; Anticonvulsants; Bicarbonates; Blood Proteins; Calcium; Cholecalciferol; Cholesterol; Creatinine; Female; Fractures, Bone; Hematocrit; Hemoglobins; Humans; Hyperparathyroidism; Osteomalacia; Vitamin B 12

Topics: Alkaline Phosphatase; Animals; Calcification, Physiologic; Cholecalciferol; Drug Synergism; Fractures, Bone; Hindlimb; Injections, Intravenous; Iron-Dextran Complex; Potassium Permanganate; Pyrophosphatases; Rabbits; Wound Healing