Has acted as a data safety monitoring board member and consultant compensated for, and has received research funding from GlaxoSmithKline. Secondary objectives are safety and tolerability of the treatment as well as efficacy in terms of survival. Irisin is a recently identified myokine, suggested to mediate the beneficial effects of exercise by inducing browning of white adipocytes and thus increasing energy expenditure. We compared whole-body and regional bone strength and skeletal muscle charac weiter
We found that trials with investigator sponsorship vs industry sponsorship and those with smaller planned sample sizes were at higher risk of discontinuation due to poor recruitment. Trial investigators rarely informed RECs about trial discontinuation and publication. A strength of our study was the full access to the files of all trials approved by the collaborating RECs during the study period.
We systematically searched all documents to capture any relevant information about the course of the RCT such as issues of recruitment, changes in design, or modification of target sample size. We published our own study protocol, 3 involved only trained methodologists in data abstraction, and, to minimize chance associations, considered only a limited number of variables in the statistical models.
Our results proved robust in sensitivity analyses applying alternate assumptions and statistical approaches. A limitation of our study was the low quality of the included RCT protocols, in particular those for RCTs with investigator sponsorship. Elements of trial methodology potentially associated with trial discontinuation due to poor recruitment, eg, recruitment projections, financial or nonfinancial incentives, and study piloting, were frequently not reported and thus limited our risk factor analysis.
In our regression analysis, we could not include some well-established factors associated with nonpublication of RCTs, such as results that are statistically nonsignificant or that did not confirm study hypotheses, because we did not ask investigators of unpublished RCTs for study results.
However, we used prepiloted extraction forms with detailed written instructions, conducted formal calibration exercises with all data extractors, and checked extractions from a random sample of protocols at several points during the process.
Agreement was good, with no more than 2 discrepancies in 30 extracted answers. All outcome data on discontinuation and publication of RCTs were verified by a second investigator. Last, we used a convenience sample of 6 RECs in 3 countries. We cannot say whether they are representative for other RECs in these or other countries; to our knowledge, they are not in any way particular.
Various studies suggest that poor recruitment is common and a major problem for clinical trials. Larger RCTs might be better organized from the outset eg, within established research networks including multiple centers and experienced investigators and better able to respond to recruitment challenges. This publication rate is higher than reported for most previous study cohorts.
Those RCTs discontinued for early apparent benefit are frequently published in highly ranked, peer-reviewed journals 18 ; all 9 RCTs from the present study that were stopped early for benefit were published as full journal articles. Our analysis suggests, however, that RCT discontinuation for other reasons is one of the major factors driving nonpublication of RCTs.
For investigator-sponsored RCTs, stakeholders including trial investigators, funding agencies, and RECs need to develop strategies to prevent trial discontinuation due to poor recruitment. Based on our data and a previous study, 19 retrospective or prospective screening of patients appears to hold little promise in estimating recruitment rates, but conducting a full pilot study including consent procedures might be effective. Further research is necessary to determine the optimal length of pilot studies and to develop reliable prediction models for recruitment performance.
Strategies to improve recruitment have been tested 21 , 22 and could possibly be combined, depending on the setting and area of investigation. The nonpublication of results from discontinued—or from completed—RCTs represents a waste of valid data that could contribute to systematic reviews and meta-analyses.
In this sample of trials based on RCT protocols from 6 RECs, discontinuation was common, with poor recruitment being the most frequently reported reason. Greater efforts are needed to make certain that trial discontinuation is reported to RECs and that results of discontinued trials are published.
Drs Kasenda and Briel had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Drs Kasenda and von Elm contributed equally to this article. Study concept and design: Drafting of the manuscript: Critical revision of the manuscript for important intellectual content: Administrative, technical, and material support: Conflict of Interest Disclosures: During study preparation, Dr von Elm was supported by the Brocher Foundation.
Role of the Sponsors: The Swiss National Science Foundation, the German Research Foundation, and the Brocher Foundation had no role in the design and conduct of the study; the collection, management, analysis, and interpretation of the data; the preparation, review, or approval of the manuscript; or the decision to submit the manuscript for publication. We would like to thank the presidents and staff of participating research ethics committees from Switzerland Basel, Lausanne, Zurich, Lucerne , Germany Freiburg , and Canada Hamilton, Ontario for their continuous support and cooperation.
This article was corrected online March 11, , for missing statement of equal contributorship. Standardized Survey Questionnaire eFigure. Frequencies of Specialties eTable 3. PubMed Google Scholar Crossref. Recruitment to randomised trials: Learning from failure—rationale and design for a study about discontinuation of randomized trials DISCO study.
What influences recruitment to randomised controlled trials? Preliminary evaluation of factors associated with premature trial closure and feasibility of accrual benchmarks in phase III oncology trials. Rheumatische Erkrankungen in der Schwangerschaft.
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Stellungnahme zum Einsatz von Mycophenolat-Mofetil beim systemischen Lupus erythematodes. Nonrenal disease activity following mycophenolate mofetil or intravenous cyclophosphamide as induction treatment for lupus nephritis: EULAR textbook on rheumatic diseases.
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Recommendations on screening for chloroquine and hydroxychloroquine retinopathy: A prospective analysis of the effects of enteric-coated mycophenolate sodium and mycophenolate mofetil co-medicated with a proton pump inhibitor in kidney transplant recipients at a single institute in China. Transplant Proc ; The potential negative impact of proton pump inhibitors on the immunopharmacologic effects of chloroquine and hydroxychloroquine.
Anders; Private practice in internal medicine and rheumatology, München: Current issue Upcoming issue All issues. Dermatology Nephrology Pediatrics and Neonatology Rheumatology.
Tea consumption may be beneficial to osteoporosis due to its antioxidant capability. This study was designed to test an intervention including green tea polyphenols GTP and TC exercise for feasibility, and to quantitatively assess their individual and interactive effects on postmenopausal women with osteopenia. The outcome measures were bone formation biomarker serum bone alkaline phosphatase , bone resorption biomarker serum tartrate resistant acid phosphatase , and oxidative DNA damage biomarker urinary 8-hydroxy-2'-deoxyguanosine.
All outcome measures were determined at baseline, 4, 12, and 24 weeks. This study presents the rationale, design, and methodology of a placebo-controlled randomized trial to investigate a new complementary and alternative medicine strategy featuring a dietary supplement and a mind-body exercise for alleviating bone loss in osteopenic postmenopausal women.
This study evaluated the effect of L-Arg and L-Lys on cultured human osteoblasts. Primary human osteoblast cultures were divided into four groups: Lys administration over the same time interval mainly affected cell proliferation, as evidenced by the MTT test and immunostaining for PDGF.
The same positive effects evidenced by the single administrations of the two amino acids resulted from their simultaneous administration. However, synergism could be demonstrated only for the decrease in the level of IL Arg and Lys show a positive effect on human osteoblasts, which is related partly to the production of those factors required for matrix synthesis, and partly to the direct or mediated activation of cell proliferation.
After analyzing the effect of two essential amino acids, L-arginine Arg and L-lysine Lys , in previous in vitro and in vivo studies, the present authors investigated the administration of Arg and Lys in osteoblasts derived from human osteopenic bone. Results were compared with those obtained from human healthy bone to verify the effect of the amino acids on osteoblasts derived from pathological tissue. In addition, a comparison was also made with the results obtained from rat osteopenic bone to assess reliability of the in vitro model.
The current results support previous findings and indicate that Arg and Lys stimulation has a positive effect on osteoblast proliferation, activation and differentiation. Therefore, administration of these amino acids may be useful in clinical treatment and prevention of osteoporosis. Osteoporos International ; 17 7: The aim of our study was to understand the distinctive posttranslational modifications of collagen in areas with different degrees of mineralization with and without hip fracture.
A sample of each femoral neck cortex was fractionated into low 1. The contents of enzymatic cross-links dihydroxylysinonorleucine, hydroxylysinonorleucine, lysinonorleucine, pyridinoline, and deoxypyridinoline and nonenzymatic cross-links pentosidine and the extent of lysine Lys hydroxylation were determined in each fraction. The results show that pentosidine content of low-mineralized bone was significantly higher in fracture cases than in controls p http: Collagen cross-links play important roles in the expression of bone strength and the proper biological function of bone.
The cross-links of collagen can be roughly divided into two types: Recently, the study showed that reduction in enzymatic cross-links and excessive formation of nonenzymatic cross-links, pentosidine in bone could be important for explaining the variation of fracture susceptibility in osteoporosis Osteoporos. In this review, the author summarizes the recent literatures regarding bone quality markers.
Osteoporosis International ; 17 7: Female rats were 6 weeks of age at the start of study. Femurs and tibias were also collected for mineral content analyses, micro-computerized tomography, histomorphometry, and immunohistochemical localization of substance P, TNFalpha, and IL-1beta at 3 and 6 months.
Journal of the American Geriatrics Society ; 53 The objective of this study was to determine whether magnesium intake from supplemental and dietary sources is associated with bone mineral density BMD in older men and women.
Two thousand thirty-eight older black and white men and women aged 70 to 79 at baseline enrolled in the Health, Aging and Body Composition Study.
Dietary intake of magnesium was assessed using a semiquantitative food frequency questionnaire, and supplement data were collected based on a medication inventory.
BMD of the whole body was obtained using a fan-beam densitometer. Additional covariates included age, body mass index BMI , smoking status, alcohol use, physical activity, estrogen use, and supplemental calcium Ca and vitamin D use. The study concludes that greater magnesium intake was significantly related to higher BMD in white women and men. The lack of association observed in black women and men may be related to differences in Ca regulation or in nutrient reporting.
Clinical Calcium ; 16 About half the total magnesium Mg of the body is existed in bone. Bone is one of the main Mg pools in the body. Epidemiologic studies have demonstrated a positive correlation between Mg intake and bone mineral density.
It is also reported that Mg deficiency induced a decrease in osteoblasts number, an increase in osteoclasts number and a decrease in bone strength in rats. In contrast, dietary Mg supplementation improved bone formation, bone resorption and bone strength in ovariectomized rats. Mg deficiency is known as a risk factor for osteoporosis, since Mg is essential mineral for normal bone growth.
However, the detail of effects of Mg on bone metabolism remains unclear. Further studies should be developed to clarify the details.
Biological Trace Element Research ; 3: The aim of this study was to explore whether the serum levels of magnesium Mg and calcium Ca differ between osteoporotic and nonosteoporotic elderly Chinese women. Using WHO classification criteria based on bone mineral density BMD , general healthy Chinese women older than 65 yr were classified as osteoporosis OP , osteopenia, and normal group according to the T-score of the femur neck.
Then their physical characteristics, serum levels of magnesium sMg , calcium sCa , and other biochemical measurements were analyzed.
Altogether, subjects were included in the final analysis with 77 in OP, in osteopenia, in normal group. The study concludes that high content of sMg and potentially low content of sCa could be a feature of the serum profile of elderly Chinese women with OP, the clinical significance of which needs further elucidation.
Supplementation of Mg for elderly Chinese women with OP did not appear to be necessary. The Journal of International Medical Research ; 35 5: Mean concentrations of magnesium and zinc were significantly lower in osteoporotic women than in both osteopenic women and normal women. In addition, magnesium and zinc concentrations in osteopenic women were significantly lower than in normal women. There were no statistically significant differences observed between the osteopenic, osteoporotic and control groups with respect to copper levels.
The clinical significance of these changes needs further elucidation, but trace element supplementation, especially with magnesium and zinc and perhaps copper, may have beneficial effects on bone density. This study reports a case of an year-old woman with a giant adenomatous goiter and severe osteoporosis with multiple vertebral fractures, whose clinical course indicated that her osteoporosis was probably due to Mg deficiency.
Laboratory data showed the existence of hypomagnesemia, hypocalcemia, hypokalemia, vitamin D deficiency, and slightly elevated intact PTH. Intravenous administration of Mg not only improved these electrolyte abnormalities but also increased serum levels of intact PTH, bone formation markers, 1,dihydroxyvitamin D, as well as bone resorption markers in the urine, and lowered urinary phosphate reabsorption. Mg deficiency in this case seemed to cause impaired secretion of PTH from the parathyroid and the refractoriness of bone and kidney to the hormone, which led to the suppression of both bone remodeling and renal vitamin D production.
These processes were probably linked to her severe osteoporosis, which was reversed by Mg supplementation. Annals of the Academy of Medicine, Singapore ; 37 7: The aim of the study was to assess the plasma and red blood concentrations of some elements in postmenopausal women with osteoporosis. Seventy-seven postmenopausal women with osteoporosis aged 61 years median interquartile range, 7. Element concentrations in plasma and red blood cells including magnesium Mg , zinc, copper, manganese, and selenium were measured by atomic absorption spectrophotometry in both postmenopausal women with osteoporosis and healthy postmenopausal women.
Only statistically significant difference between the osteoporotic However, no significant difference was found between patient and control groups, both in plasma and in red blood concentrations, for zinc, copper, manganese, and selenium. The study concludes that Mg levels in red blood cells are significantly lower in postmenopausal women with osteoporosis. It is concluded that Mg transport mechanism s into the cell could be affected in patients with osteoporosis.
Biological Trace Element Research June 2. In this study, the effects of daily oral magnesium supplementation on biochemical markers of bone turnover were investigated. Twenty postmenopausal women have been divided into two groups. Ten postmenopausal women of matching age, menopause duration, and BMI were recruited as the control group and followed without any medication.
Fasting blood and first-void urine samples were collected on days 0, 1, 5, 10, 20, and 30, respectively. Total magnesium, calcium, phosphorus, iPTH and osteocalcin were determined in blood samples. Deoxypyridinoline levels adjusted for creatinine were measured in urine samples. Thirty consecutive days of oral magnesium supplementation caused significantly decrease in serum iPTH levels in the Mg-supplemented group p http: Journal of the American College of Nutrition ; 28 2: The objective of this paper is to review the evidence for Mg deficiency-induced osteoporosis and potential reasons why this occurs, including a cumulative review of work in our laboratories and well as a review of other published studies linking Mg deficiency to osteoporosis.
Epidemiological studies have linked dietary Mg deficiency to osteoporosis. As diets deficient in Mg are also deficient in other nutrients that may affect bone, studies have been carried out with select dietary Mg depletion in animal models.
Severe Mg deficiency in the rat Mg at http: Bone strength is determined by bone mineral density and bone quality. Bone quality can be assessed by only bone turnover markers.
Nutrients that reduce bone resorption markers are calcium and isoflavone, nutrients that increase bone formation markers are vitamin C, vitamin D and vitamin K. These nutrients affect bone turnover and, as a result, improve bone density.
These nutrients might contribute to prevent the incidence of osteoporosis when they are taken from adolescence. European Journal of Epidemiology ; 23 3: The aim of this study was to analyze the association between hip fracture incidence in 12 regional blocks within Japan and dietary intake of four key nutrients: Using data from the national survey on the incidence of hip fracture and the National Nutritional Survey of Japan, a standardized incidence ratio of hip fracture was calculated, and the association between the standardized incidence ratio and each nutritional intake was assessed for each region using Pearson's correlation coefficient and partial correlation analysis.
There were significant correlations between the standardized incidence ratio by region and magnesium, vitamin D, and vitamin K in both men and women, and calcium in women. Journal of the American Dietetic Association ; 5: The goal of this study was to compare the equivalency of nutrient intakes assessed by diet records and the Arizona Food Frequency Questionnaire and the associations of these nutrients with bone mineral density BMD.
One-year dietary intakes were assessed using 8 days of diet records and the Arizona Food Frequency Questionnaire. Participants' BMD was measured at the lumbar spine L2-L4 , femur trochanter, femur neck, Ward's triangle, and total body using dual-energy x-ray absorptiometry.
Linear regression analyses P http: The aim of the present study was to evaluate bone health-related nutrients intake and its association with osteoporotic fractures in a representative sample of individuals aged 40 years or older in Brazil. In a transversal population-based study, a total of individuals over 40 years old were evaluated from March to April Participants were men and women from all socio-economic classes and education levels living around the Brazilian territory Individuals responded a questionnaire including self reported fractures as well a hour food recall.
Low trauma fracture was defined as that resulting of a fall from standing height or less. Women with fractures presented significantly higher calcium, phosphorus and magnesium intakes. However, in all regions and socio-economical levels mean intakes of bone related nutrients were below the recommended levels. All the components which constitute our body are reconstructed from the nutrients taken in as the foods. Bone is also the same and various nutrients are involving for the formation and maintenance.
Calcium, vitamin D, protein, vitamin K, magnesium, zinc, vitamin B groups, vitamin A, etc. Moreover, the importance of fruit and vegetables is also suggested. Neuropeptide Y NPY is a versatile neurotransmitter that has recently been shown to regulate bone metabolism in animal and in vitro studies. The participants were randomized into two treatment groups: At baseline, there were no significant differences in the lumbar or femoral neck BMD between the subjects who had Leu7Pro7 polymorphism and the normal subjects.
After 5 years, the BMD of the femoral neck remained unaltered and that of the lumbar spine increased by 1. Cumulative in vitro studies indicated that proline-rich tyrosine kinase 2 PYK2 is a positive mediator of osteoclast function and activity.
Consistent with the in vivo findings, mouse bone marrow cultures show that PYK2 deficiency enhances differentiation and activity of osteoprogenitor cells, as does expressing a PYK2-specific short hairpin RNA or dominantly interfering proteins in human mesenchymal stem cells.
Furthermore, the daily administration of a small-molecule PYK2 inhibitor increases bone formation and protects against bone loss in ovariectomized rats, an established preclinical model of postmenopausal osteoporosis.
In summary, the study finds that PYK2 regulates the differentiation of early osteoprogenitor cells across species and that inhibitors of the PYK2 have potential as a bone anabolic approach for the treatment of osteoporosis. Clinical Chemistry and Laboratory Medicine ; 46 Owing to the high correlation between the level of prolylhydroxyproline dipeptide in non-hydrolyzed urine and that of 4-hydroxyproline in hydrolyzed urine, we examined whether the dipeptide might function as a valuable marker of bone turnover.
Based on densitometric measurements, 68 postmenopausal women were divided into groups of non-osteopathic, osteopenic and osteoporotic subjects. The dipeptide and current urinary resorption markers were assayed in morning urine, the former using liquid chromatography, the others plus serum formation markers by means of immunoassay procedures.
Together with the assay of basal levels, diet-related changes and healing effect of yearly alendronate therapy were assessed.
The study concludes that ease of the dipeptide assay in non-hydrolyzed urine surpasses that of hydroxyproline, and the results present the compound as a real competition to other commonly assessed markers in osteopathies. Bioscience, Biotechnology and Biochemistry ; 68 5: To examine a potential role for soybean phytoestrogens in postmenopausal bone loss, twenty-four week-old Sprague-Dawley rats were divided randomly into 4 groups and given controlled diets for 16 weeks. The treatment groups were as followed: The results show that supplementation with isoflavone prevented the losses of bone density and mineral content caused by ovariectomized OVX p http: Journal of Medicinal Food ; 12 3: This study evaluated the protective effects of soy isoflavones SIF against osteoporosis in middle-aged ovariectomized OVX mice.
The biochemical markers of bone turnover, e. The bone mineral density BMD in femurs and lumbar vertebrae were also observed. In addition, the study examined trabecular bone and interstitial cells in the femur using hematoxylin and eosin staining. American Journal of Epidemiology ; 7: Although there is some epidemiologic evidence that soy may reduce risk of osteoporotic fracture in women, it is not known whether this risk reduction also occurs for men. The authors examined gender-specific associations between soy intake and hip fracture risk in the Singapore Chinese Health Study, a prospective cohort of 63, Chinese living in Singapore.
At recruitment between and , each subject was administered a food frequency questionnaire and questions on medical history and lifestyle factors. As of December 31, , incident cases of hip fracture in men and cases in women were identified via linkage with hospital discharge databases.
For both genders, hip fracture risk was positively associated with cigarette smoking and was inversely associated with body mass index. There was a statistically significant association of tofu equivalents, soy protein, and isoflavones with hip fracture risk among women but not among men. Compared with women in the lowest quartile of intakes for tofu equivalents http: The American Journal of Clinical Nutrition ; 90 5: Study subjects were tested annually and changes in whole-body and regional bone mineral density BMD , bone mineral content BMC , and T scores were assessed.
Changes in serum biochemical markers of bone metabolism were also assessed. The study concludes that daily supplementation with mg soy hypocotyl isoflavones reduces whole-body bone loss but does not slow bone loss at common fracture sites in healthy postmenopausal women. This trial was registered at clinicaltrials. Vitamin C depletion is responsible for structural collagen alterations, defective osteoid matrix formation, and increased bone resorption.
Trabecular and cortical osteoporosis is common. Children experience severe lower limb pain related to subperiosteal bleeding. Laboratory tests show nonspecific abnormalities including anemia and low levels of cholesterol and albumin. The finding of a serum ascorbic acid level lower than 2.
Vitamin C supplementation ensures prompt resolution of the symptoms. Journal of Bone and Mineral Research ; 20 9: Using a mouse mutant that fractures spontaneously and dies at a very young age, this study identified that a deletion of the GULO gene, which is involved in the synthesis of vitamin C, is the cause of impaired osteoblast differentiation, reduced bone formation, and development of spontaneous fractures. Skeletal phenotype of the spontaneous fractures sfx phenotype was evaluated by DXA using PIXImus instrumentation and by dynamic histomorphometry.
The sfx gene was identified using various molecular genetic approaches, including fine mapping and sequencing of candidate genes, whole genome microarray, and PCR amplification of candidate genes using cDNA and genomic DNA as templates. Gene expression of selected candidate genes was performed using real-time PCR analysis. Osteoblast differentiation was measured by bone marrow stromal cell nodule assay.
The results show that the sfx is a mutation of the GULO gene, which leads to ascorbic acid deficiency, impaired osteoblast cell function, and fractures in affected mice. Based on these and other findings, the study suggests that ascorbic acid is essential for the maintenance of differentiated functions of osteoblasts and other cell types.
Calcified Tissue International ; 76 2: Osteoporosis and femoral neck fractures FNF are uncommon in black Africans although osteoporosis accompanying iron overload from traditional beer brewed in iron containers associated with ascorbic acid deficiency oxidative catabolism by iron has been described from sub-Saharan Africa. This study describes histomorphometric findings of iliac crest bone biopsies and serum biochemical markers of iron overload and of alcohol abuse and ascorbic acid levels in 50 black patients with FNFs 29 M, 21 F , age 62 years years median [min-max] , and in age- and gender-matched black controls.
Ascorbic acid deficiency accounted significantly for decrease in bone volume and trabecular number, and increase in trabecular separation, osteoid surface, and eroded surface; iron overload accounted for a reduction in mineral apposition rate.
Alcohol markers correlated negatively with osteoblast surface and positively with eroded surface. Relative to reported data in white FNF patients, the osteoporosis was more severe, showed lower osteoid variables and greater eroded surface; FNFs occurred 12 years earlier and were more common among men.
The study concludes that the osteoporosis underlying FNFs in black Africans is severe, with marked uncoupling of resorption and formation in favor of resorption. All three factors--ascorbic acid deficiency, iron overload, and alcohol abuse--contributed to the osteoporosis, in that order. Journal of Women's Health ; 15 3:
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