Establishing a Reference Interval for Bone Turnover Markers in 637 Healthy,Young, Premenopausal Women From the United Kingdom,France, Belgium,and the United States |
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Authors: | Sarah J Glover Martin Gall Oliver Schoenborn‐Kellenberger Michael Wagener Patrick Garnero Steven Boonen Jane A Cauley Dennis M Black Pierre D Delmas Richard Eastell |
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Affiliation: | 1. University of Sheffield, Sheffield, United Kingdom;2. Novartis Pharmaceuticals, East Hanover, New Jersey, USA;3. Novartis Pharma AG, Basel, Switzerland;4. INSERM Unit 664, SYNARC, Lyon, France;5. Gerontology and Geriatrics Section and Musculoskeletal Research Unit, Leuven University Department of Experimental Medicine, Katholieke Universiteit Leuven, Leuven, Belgium;6. University of Pittsburgh, Pittsburgh, Pennsylvania, USA;7. Department of Epidemiology and Biostatistics, University of California, San Francisco, California, USA;8. INSERM Research Unit 831,University of Lyon, Lyon, France |
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Abstract: | Robust reference intervals are needed for the interpretation of bone turnover markers in large phase III fracture trials. The objectives of the study were to (1) estimate reference intervals for serum bone alkaline phosphatase (bone ALP), serum procollagen type I N propeptide (PINP), serum β cross‐linked C‐telopeptides of type I collagen (S‐βCTX), and urinary cross‐linked N‐telopeptides of type I collagen (U‐NTX) in healthy young premenopausal women; (2) examine geographical differences on bone turnover markers; and (3) assess factors known to influence bone turnover and test whether these explain any regional differences. We studied 637 eligible women from four countries that participated in the Horizon‐PFT study (United Kingdom, France, Belgium, United States). The women were 30–39 yr of age (mean, 34.6 yr), with regular cyclic menses. Subjects completed a medical and lifestyle questionnaire. Two‐sided 95% reference intervals were estimated on transformed values and transformed back to the original scale using the proposed methodology of the International Federation of Clinical Chemistry. S‐βCTX was significantly higher in France relative to the United Kingdom (p = 0.01), and PINP was higher in France (p < 0.001) and Belgium (p = 0.02) relative to the United Kingdom and significantly higher in France relative to the United States (p < 0.01) by ANOVA. Overall, one could associate low bone turnover markers with nonsmoking, use of a contraceptive pill, exercise, being close to the time of ovulation, and having high 25‐hydroxyvitamin D levels. Countries differed by these characteristics, and once allowed for in the statistical model, any country differences were attenuated or removed. |
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Keywords: | reference interval bone turnover markers postmenopausal osteoporosis cross‐linked C‐telopeptide of type I collagen cross‐linked N‐telopeptide of type I collagen |
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