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See detailPerspective and priorities for improvement of parathyroid hormone (PTH) measurement - A view from the IFCC Working Group for PTH.
Sturgeon, Catharine M.; Sprague, Stuart; Almond, Alison et al

in Clinica Chimica Acta (2017), 467

Parathyroid hormone (PTH) measurement in serum or plasma is a necessary tool for the exploration of calcium/phosphate disorders, and is widely used as a surrogate marker to assess skeletal and mineral ... [more ▼]

Parathyroid hormone (PTH) measurement in serum or plasma is a necessary tool for the exploration of calcium/phosphate disorders, and is widely used as a surrogate marker to assess skeletal and mineral disorders associated with chronic kidney disease (CKD), referred to as CKD-bone mineral disorders (CKD-MBD). CKD currently affects >10% of the adult population in the United States and represents a major health issue worldwide. Disturbances in mineral metabolism and fractures in CKD patients are associated with increased morbidity and mortality. Appropriate identification and management of CKD-MBD is therefore critical to improving clinical outcome. Recent increases in understanding of the complex pathophysiology of CKD, which involves calcium, phosphate and magnesium balance, and is also influenced by vitamin D status and fibroblast growth factor (FGF)-23 production, should facilitate such improvement. Development of evidence-based recommendations about how best to use PTH is limited by considerable method-related variation in results, of up to 5-fold, as well as by lack of clarity about which PTH metabolites these methods recognise. This makes it difficult to compare PTH results from different studies and to develop common reference intervals and/or decision levels for treatment. The implications of these method-related differences for current clinical practice are reviewed here. Work being undertaken by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) to improve the comparability of PTH measurements worldwide is also described. [less ▲]

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See detailBiomarkers of osteoarthritis : practical considerations.
CAVALIER, Etienne ULiege; Reginster, Jean-Yves ULiege

in Osteoporosis International (2017, March), 28 Suppl 1

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See detailAnalytical and clinical validation of the new Abbot Architect 25(OH)D assay: fit for purpose?
Cavalier, Etienne ULiege; LUKAS, Pierre ULiege; BEKAERT, Anne-Catherine ULiege et al

in Clinical Chemistry & Laboratory Medicine (2017), 55(3), 378-384

BACKGROUND: We provide a clinical and analytical evaluation of the reformulated version of the Abbott Architect 25-hydroxyvitamin D assay. We compared this assay with three commercial automated ... [more ▼]

BACKGROUND: We provide a clinical and analytical evaluation of the reformulated version of the Abbott Architect 25-hydroxyvitamin D assay. We compared this assay with three commercial automated immunoassays and against a VDSP-traceable liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) in six different populations. We also supplemented 40 healthy volunteers with either 600,000 IU of vitamin D2 or 100,000 of vitamin D3 to evaluate the performance of the immunoassays vs. the LC-MS/MS. METHODS: Precision and limit of quantification were assessed, 25(OH)D2 and C3-epimer recovery were calculated. Two hundred and forty samples obtained in healthy Caucasians and Africans, osteoporotic, hemodialyzed and intensive care patients and 3rd trimester pregnant women were analyzed by all methods. Correlation was studied using Passing-Bablok and Bland-Altman analysis. Concordance correlation coefficient (CCC) was calculated to evaluate agreement between immunoassays and LC-MS/MS. We verified if patients were homogeneously classified with the immunoassays when they took vitamin D2 or vitamin D3 after 1, 7 and 28 days. RESULTS: We observed excellent analytical features and showed a very good correlation to the LC-MS/MS results in the overall population. Compared to the other immunoassays, concordance of the new Abbott assay with the LC-MS/MS was at least similar, and often better in diseased populations. Althought the cross-reactivity with 25(OH)D2 was not of 100%, there was no significant difference in the classifications of the patients, either supplemented with D2 or D3 or after 7 or 28 days. CONCLUSIONS: This modified version of the Abbott Architect assay is clearly improved compared to the previous one and presents a better agreement with the LC-MS/MS. [less ▲]

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See detailHow the reference values for serum parathyroid hormone concentration are (or should be) established?
Souberbielle, J.-C.; Brazier, F.; Piketty, M.-L. et al

in Journal of Endocrinological Investigation (2017), 40(3), 241-256

Well-validated reference values are necessary for a correct interpretation of a serum PTH concentration. Establishing PTH reference values needs recruiting a large reference population. Exclusion criteria ... [more ▼]

Well-validated reference values are necessary for a correct interpretation of a serum PTH concentration. Establishing PTH reference values needs recruiting a large reference population. Exclusion criteria for this population can be defined as any situation possibly inducing an increase or a decrease in PTH concentration. As recommended in the recent guidelines on the diagnosis and management of asymptomatic primary hyperparathyroidism, PTH reference values should be established in vitamin D-replete subjects with a normal renal function with possible stratification according to various factors such as age, gender, menopausal status, body mass index, and race. A consensus about analytical/pre-analytical aspects of PTH measurement is also needed with special emphasis on the nature of the sample (plasma or serum), the time and the fasting/non-fasting status of the blood sample. Our opinion is that blood sample for PTH measurement should be obtained in the morning after an overnight fast. Furthermore, despite longer stability of the PTH molecule in EDTA plasma, we prefer serum as it allows to measure calcium, a prerequisite for a correct interpretation of a PTH concentration, on the same sample. Once a consensus is reached, we believe an important international multicentre work should be performed to recruit a very extensive reference population of apparently healthy vitamin D-replete subjects with a normal renal function in order to establish the PTH normative data. Due to the huge inter-method variability in PTH measurement, a sufficient quantity of blood sample should be obtained to allow measurement with as many PTH kits as possible. [less ▲]

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See detailImpact of an ultra-marathon of 330km on plasma levels of cardiac biomarkers
Le Goff, Caroline ULiege; Kaux, Jean-François ULiege; Gergelé, Laurent et al

in British Journal of Sports Medicine (2017, February), 51(4), 347

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See detailThe added value of plasma or urinary NGAL concentrations in clinical practice
Gregoire, Emilien ULiege; Claisse, Guillaume; GUIOT, Julien ULiege et al

Poster (2017, January 13)

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See detailEtude rétrospective du bilan thyroïdien: définition de valeurs de référence pédiatriques
LADANG, Aurélie ULiege; VRANKEN, Laura ULiege; LUYCKX, Françoise ULiege et al

in Revue Médicale de Liège (2017)

Defining reference range is an essential tool for diagnostic. Age and sexe influences on thyroid hormone levels have been already discussed. In this study, we are defining a new pediatric reference range ... [more ▼]

Defining reference range is an essential tool for diagnostic. Age and sexe influences on thyroid hormone levels have been already discussed. In this study, we are defining a new pediatric reference range for TSH, FT3 and FT4 for Cobas C6000 analyzer. To do so, we have taken in account 0 to 18 year old outclinic patients. During the first year of life, thyroid hormone levels change dramatically before getting stabilized around 3 years old. We also compared our results to those obtained in a Canadian large-scale prospective study (the CALIPER initiative). [less ▲]

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See detailAssessment of vitamin D status - a changing landscape.
Herrmann, Markus; Farrell, Christopher-John L.; Pusceddu, Irene et al

in Clinical Chemistry & Laboratory Medicine (2017)

In recent years it has been shown that vitamin D deficiency is associated with an increased incidence as well as the progression of a broad range of diseases including osteoporosis, rickets ... [more ▼]

In recent years it has been shown that vitamin D deficiency is associated with an increased incidence as well as the progression of a broad range of diseases including osteoporosis, rickets, cardiovascular disease, autoimmune disease, multiple sclerosis and cancer. Consequently, requests for the assessment of vitamin D status have increased dramatically. Despite significant progress in the analysis of vitamin D metabolites and an expansion of our pathophysiological knowledge of vitamin D, the assessment of vitamin D status remains a challenging and partially unresolved issue. Current guidelines from scientific bodies recommend the measurement of 25-hydroxy vitamin D (25-OHD) in blood as the preferred test. However, growing evidence indicates significant limitations of this test, including analytical aspects and interpretation of results. In addition, the relationships between 25-OHD and various clinical indices, such as bone mineral density and fracture risk, are rather weak and not consistent across races. Recent studies have systematically investigated new markers of vitamin D status including the vitamin D metabolite ratio (VMR) (ratio between 25-OHD and 24,25-dihydroxy vitamin D), bioavailable 25-OHD [25-OHD not bound to vitamin D binding protein (DBP)], and free 25-OHD [circulating 25-OHD bound to neither DBP nor albumin (ALB)]. These parameters may potentially change how we will assess vitamin D status in the future. Although these new biomarkers have expanded our knowledge about vitamin D metabolism, a range of unresolved issues regarding their measurement and the interpretation of results prevent their use in daily practice. It can be expected that some of these issues will be overcome in the near future so that they may be considered for routine use (at least in specialized centers). In addition, genetic studies have revealed several polymorphisms in key proteins of vitamin D metabolism that affect the circulating concentrations of vitamin D metabolites. The affected proteins include DBP, 7-dehydrocholesterol synthase and the vitamin D receptor (VDR). Here we aim to review existing knowledge regarding the biochemistry, physiology and measurement of vitamin D. We will also provide an overview of current and emerging biomarkers for the assessment of vitamin D status, with particular attention methodological aspects and their usefulness in clinical practice. [less ▲]

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See detailRelevance of vitamin D in the pathogenesis and therapy of frailty.
Bruyère, Olivier ULiege; Cavalier, Etienne ULiege; Buckinx, Fanny ULiege et al

in Current Opinion in Clinical Nutrition & Metabolic Care (2017), 20(1), 26-29

PURPOSE OF REVIEW: This article reviews recently published evidence regarding the role of vitamin D in the physiopathology of physical frailty in elderly populations and its role in the management of this ... [more ▼]

PURPOSE OF REVIEW: This article reviews recently published evidence regarding the role of vitamin D in the physiopathology of physical frailty in elderly populations and its role in the management of this geriatric condition. RECENT FINDINGS: Some recent studies have found a low level of 25-hydroxyvitamin D, considered the best marker of vitamin D status, in frail individuals. All prospective studies consistently report that low vitamin D status is associated with an increased risk of becoming frail. Recent studies also suggest that the relationship between vitamin D status and frailty is largely mediated by the development of sarcopenia. Very few well designed randomized controlled trials are available that assess the effectiveness of vitamin D supplementation in the prevention or management of frailty. In the absence of specific guidelines, a minimal serum 25-hydroxyvitamin D level of 75 nmol/l is proposed for frail elderly patients by some scientific societies. The doses necessary to reach this target are between 800 and 2000 IU/day. SUMMARY: Several studies suggest a potential effect of vitamin D on physical frailty but large clinical trials are lacking at this time to provide solid evidence of clinical benefit. [less ▲]

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See detailSkeletal health in breast cancer survivors
Bruyère, Olivier ULiege; Bergmann, Pierre; CAVALIER, Etienne ULiege et al

in Maturitas (2017), 105

Although some risk factors for breast cancer might be protective for osteoporosis, several cross-sectional studies have reported, nevertheless, that patients with breast cancer have a lower bone mass and ... [more ▼]

Although some risk factors for breast cancer might be protective for osteoporosis, several cross-sectional studies have reported, nevertheless, that patients with breast cancer have a lower bone mass and potentially a higher incidence of fractures than expected. In any case, it appears that patients with breast cancer are not protected from osteoporosis, which provides further support for the recommendation that bone health is assessed after a diagnosis of breast cancer. Most adjuvant therapies will lead to increased bone loss and a higher fracture rate. Among the adjuvant therapy options for premenopausal patients with breast cancer, endocrine therapy (ovarian suppression) and chemotherapy can result in cancer treatment-induced bone loss (CTIBL) of up to 10% at the lumbar spine after one year. Antiresorptive therapies prevent CTIBL in premenopausal women with breast cancer. Most of the evidence demonstrating the efficacy of bisphosphonates in the prevention of CTIBL is derived from clinical trials with zoledronic acid. The addition of zoledronic acid 4 mg per six months to adjuvant endocrine therapy maintained and even increased bone mass during a 3-year treatment period and significantly improved disease-free survival in a population of young women who underwent menopause due to the adjuvant treatment. The major contributor to bone loss in the adjuvant treatment of breast cancer in postmenopausal women is the use of aromatase inhibitors (AIs). Oncology trials have underestimated the fracture risk in the setting of AI-induced bone loss. In the ABCSG-18 study, the only trial in which fracture incidence was the primary endpoint, the rate of clinical fractures was close to 10% after 3 years in the placebo group on AIs only. Bisphosphonates and denosumab at osteoporosis treatment doses can counteract AI-induced bone loss. In the ABCSG-18 trial, treatment with denosumab 60 mg injection every 6 months reduced the risk of first clinical fracture relative to placebo by 50%. Current guidelines recommend antiresorptive therapy in patients with a baseline T score of<−2.0 or with two or more clinical risk factors for fracture. These recent guidelines will need to be updated, as similar significant protective effects were seen in women with either normal or low bone mass. Moreover, a formal meta-analysis of individual patient data from more than 18,000 women in 26 randomized trials of adjuvant zoledronic acid or clodronate treatment for early breast cancer revealed that bisphosphonates significantly reduced the risk of first distant recurrence in bone and the risk of breast cancer mortality, at least in postmenopausal women. Even though the increased risk of fracture during adjuvant treatment for breast cancer in postmenopausal women is notable, an enhanced risk of fracture in long-term survivors of breast cancer remains under debate. The most recent studies suggest that Caucasian breast cancer survivors do not have a significantly increased risk of osteoporotic fracture over the long term. [less ▲]

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See detailParathormone stability in hemodialyzed patients and healthy subjects: comparison on non-centrifuged EDTA and serum samples with second- and third-generation assays.
SCHLECK, Marie-Louise ULiege; Souberbielle, Jean-Claude; DELANAYE, Pierre ULiege et al

in Clinical Chemistry & Laboratory Medicine (2017), 55(8), 1152-1159

BACKGROUND: Parathyroid hormone (PTH) stability is important. Many studies have shown divergent results between EDTA and serum, which are mainly linked to differences in protocols or cut-offs used to ... [more ▼]

BACKGROUND: Parathyroid hormone (PTH) stability is important. Many studies have shown divergent results between EDTA and serum, which are mainly linked to differences in protocols or cut-offs used to determine whether or not PTH remained stable. No studies have yet compared PTH stability as measured by second- and third-generation assays on the same samples in hemodialyzed patients and healthy subjects. METHODS: Five pairs of samples (EDTA and gel tubes) were obtained in 10 hemodialyzed patients before a dialysis session and in 10 healthy subjects. One pair was centrifuged and run directly to define the "T0". Two pairs were kept at +4 degrees C and two pairs were kept at +25 degrees C. They were centrifuged after 4 and 18 h. Supernatant was kept at -80 degrees C for 1 week. All samples were measured in a single batch, on Roche Cobas and DiaSorin XL second- and third-generation PTH assays. We used three different approaches to evaluate PTH stability: Wilcoxon test, an Acceptable Change Limit (ACL) according to ISO Guide 5725-6 and a Total Change Limit (TCL) derived from the sum of biological and technical variability according to WHO. RESULTS: PTH decreased in all samples. Stability of PTH was mainly dependent on the way it was evaluated. Percentages of decrease were systematically lower in EDTA vs. serum. Wilcoxon and ACL showed that PTH was no more stable after 4 h at +4 degrees C in EDTA or serum gel tubes. None of the subjects presented a PTH decrease higher than the TCL with EDTA plasma. In serum gel tubes, PTH was unstable only when kept at 25 degrees C for 18 h. CONCLUSIONS: PTH seems more stable in EDTA than in serum gel tubes but only when samples have to stay unprocessed for a long period (18 h) at room temperature (25 degrees C), which can happen when samples are delivered from external care centers. For all the other conditions, using serum gel tubes is recommended since calcium measurement, which is necessary for a good PTH results interpretation, can be achieved on the same tube. [less ▲]

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See detailOsteoporosis in Frail Patients: A Consensus Paper of the Belgian Bone Club.
Gielen, Evelien; Bergmann, Pierre; Bruyère, Olivier ULiege et al

in Calcified Tissue International (2017), 101(2), 111-31

In this consensus paper, the Belgian Bone Club aims to provide a state of the art on the epidemiology, diagnosis, and management of osteoporosis in frail individuals, including patients with anorexia ... [more ▼]

In this consensus paper, the Belgian Bone Club aims to provide a state of the art on the epidemiology, diagnosis, and management of osteoporosis in frail individuals, including patients with anorexia nervosa, patients on dialysis, cancer patients, persons with sarcopenia, and the oldest old. All these conditions may indeed induce bone loss that is superimposed on physiological bone loss and often remains under-recognized and under-treated. This is of particular concern because of the major burden of osteoporotic fractures in terms of morbidity, mortality, and economic cost. Therefore, there is an urgent need to appreciate bone loss associated with these conditions, as this may improve diagnosis and management of bone loss and fracture risk in clinical practice. [less ▲]

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See detailDistinction between urine crystals by automated urine analyzer SediMAX conTRUST is specific but lacks of sensitivity.
Castiglione, Vincent ULiege; CAVALIER, Etienne ULiege; Diop, Coumba Souley ULiege et al

in Clinical Chemistry & Laboratory Medicine (2017)

Urine crystals are commonly encountered but few papers have been published about it while it is useful for patient’s follow-up, particularly the stone-formers. For the first time to our knowledge, we have ... [more ▼]

Urine crystals are commonly encountered but few papers have been published about it while it is useful for patient’s follow-up, particularly the stone-formers. For the first time to our knowledge, we have assessed the performance of an automated urine analyzer to identify and distinguish several types of crystals in a very large cohort of samples. We share in this report the results of method comparison of the SediMAX conTRUST with the polarized light microscopy which is the gold standard. We showed that the distinction between crystals and other urine elements was accurate. Negative predictive value was very good, but the positive predictive value was poor for most of crystals. The discrimination of different types of crystals between them by the automated urine analyzer still requires improvement to decrease reviewing rate and help clinician. [less ▲]

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See detailGuidelines for the conduct of pharmacological clinical trials in hand osteoarthritis: Consensus of a Working Group of the European Society on Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO).
Reginster, Jean-Yves ULiege; Arden, Nigel K.; Haugen, Ida K. et al

in Seminars in Arthritis & Rheumatism (2017)

OBJECTIVES: To gather expert opinion on the conduct of clinical trials that will facilitate regulatory review and approval of appropriate efficacious pharmacological treatments for hand osteoarthritis (OA ... [more ▼]

OBJECTIVES: To gather expert opinion on the conduct of clinical trials that will facilitate regulatory review and approval of appropriate efficacious pharmacological treatments for hand osteoarthritis (OA), an area of high unmet clinical need. METHODS: The European Society on Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal diseases (ESCEO) organized a working group under the auspices of the International Osteoporosis Foundation (IOF) and the World Health Organization (WHO). RESULTS: This consensus guideline is intended to provide a reference tool for practice, and should allow for better standardization of the conduct of clinical trials in hand OA. Hand OA is a heterogeneous disease affecting different, and often multiple, joints of the thumb and fingers. It was recognized that the various phenotypes and limitations of diagnostic criteria may make the results of hand OA trials difficult to interpret. Nonetheless, practical recommendations for the conduct of clinical trials of both symptom and structure modifying drugs are outlined in this consensus statement, including guidance on study design, execution, and analysis. CONCLUSIONS: While the working group acknowledges that the methodology for performing clinical trials in hand OA will evolve as knowledge of the disease increases, it is hoped that this guidance will support the development of new pharmacological treatments targeting hand OA. [less ▲]

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See detailMeasured (and estimated) glomerular filtration rate: reference values in West Africa.
Yayo, Eric; Aye, Mireille; Yao, Carine et al

in Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association (2017)

Background: Establishment of normal reference values for glomerular filtration rate (GFR) is mandatory in nephrology. However, no data are available for measured GFR (mGFR) in Africa. Methods: GFR was ... [more ▼]

Background: Establishment of normal reference values for glomerular filtration rate (GFR) is mandatory in nephrology. However, no data are available for measured GFR (mGFR) in Africa. Methods: GFR was measured in 237 healthy adult subjects (103 women and 134 men, mean age 34 +/- 10 years) by iohexol plasma clearance. Results: The mean mGFR was 103 +/- 17 mL/min/1.73 m 2 and the median value was 103 mL/min/1.73 m 2 (2.5th and 97.5th percentiles are 76 and 137 mL/min/1.73 m 2 , respectively). No significant difference in mGFR results was observed in patients < 40 years of age, whereas a significant decline in mGFR was observed after 40 years of age. There was no significant difference between mGFR in men and women. Conclusions: Normal GFR values and descriptions of percentiles are now available for West Africa. As in Caucasians, no significant difference was observed between men and women. Moreover, the same age-associated decline in mGFR is also observed after 40 years of age, as in Caucasians. [less ▲]

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