Establishing a Reference Interval for Bone Turnover Markers in 637 Healthy, Young, Premenopausal Women From the United Kingdom, France, Belgium, and the United States

Glover, Sarah; Gall, Martin; Schoenborn-Kellenberger, Oliver; Wagener, Michael; Garnero, Patrick; Boonen, Steven; Cauley, Jane A.; Black, Dennis M.; Delmas, Pierre D.; Eastell, Richard

doi:10.1359/jbmr.080703

Cited by 145 publications

(105 citation statements)

References 28 publications

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“…Surprisingly, Spanish values for bone ALP, PINP and serum CTX-I were quite similar to UKreported values, instead of those of French women from our neighboring country. Indeed, PINP and CTX-I, higher in France than in UK have been attributed to different lifestyle factors and BMI [11]. In addition, we found similar PINP and serum CTX-I values to those published by other authors in Italian and in German premenopausal women aged 35-45 years, particularly for total and intact PINP [13,24].…”

Section: Discussionsupporting

confidence: 88%

“…This has been analyzed by Glover et al, comparing European data from UK, France and Belgium [11]. Surprisingly, Spanish values for bone ALP, PINP and serum CTX-I were quite similar to UKreported values, instead of those of French women from our neighboring country.…”

Section: Discussionmentioning

confidence: 71%

“…In the last few years, reference intervals in premenopausal women from different countries in Europe (UK, France, Belgium and Denmark) [10,11] and the US [11,12] have been reported. In addition, data from Germany on men and women have been recently published [13].…”

Section: Introductionmentioning

confidence: 99%

“…In Spain, there are data on PINP and CTX-I in older men and in postmenopausal women [14][15][16], as well as on CTX-I in a subset of 50 premenopausal women [17]. As our aim was to establish reliable BTM intervals, it was tempting to use the reference intervals for BTMs in premenopausal women from a country with a geographical proximity, such as France [11]. However, we could not assume that the environmental and lifestyle factors are the same in French and in Spanish women.…”

Section: Introductionmentioning

confidence: 99%

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Reference intervals for bone turnover markers in Spanish premenopausal women

Guañabens¹,

Filella²,

Monegal³

et al. 2016

Clinical Chemistry and Laboratory Medicine (CCLM)

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Section: Discussionsupporting

confidence: 88%

Section: Discussionmentioning

confidence: 71%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Reference intervals for bone turnover markers in Spanish premenopausal women

Guañabens¹,

Filella²,

Monegal³

et al. 2016

Clinical Chemistry and Laboratory Medicine (CCLM)

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“…Clinical fracture incidence was significantly lower in the combination group than in the zoledronic acid-alone group ( p ¼ .04; risk ratio [95% CI]: 0.31 [0.10, 0.92]) but was not significantly different for combination versus teriparatide alone. Because of the slight difference in baseline fracture history between the groups, fracture rates during the trial were compared between the combination and (33) zoledronic acid groups using logistic regression adjusted for baseline prevalent vertebral fracture and history of clinical fracture. The difference remained significant ( p ¼ .04).…”

Section: Fracturesmentioning

confidence: 99%

Effects of intravenous zoledronic acid plus subcutaneous teriparatide [rhPTH(1–34)] in postmenopausal osteoporosis

Cosman

Eriksen

Recknor

et al. 2010

Journal of Bone and Mineral Research

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303

173

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Clinical data suggest concomitant therapy with bisphosphonates and parathyroid hormone (PTH) may blunt the anabolic effect of PTH; rodent models suggest that infrequently administered bisphosphonates may interact differently. To evaluate the effects of combination therapy with an intravenous infusion of zoledronic acid 5 mg and daily subcutaneous recombinant human (rh)PTH(1-34) (teriparatide) 20 mg versus either agent alone on bone mineral density (BMD) and bone turnover markers, we conducted a 1-year multicenter, multinational, randomized, partial double-blinded, controlled trial. 412 postmenopausal women with osteoporosis (mean age 65 AE 9 years) were randomized to a single infusion of zoledronic acid 5 mg plus daily subcutaneous teriparatide 20 mg (n ¼ 137), zoledronic acid alone (n ¼ 137), or teriparatide alone (n ¼ 138). The primary endpoint was percentage increase in lumbar spine BMD (assessed by dual-energy X-ray absorptiometry [DXA]) at 52 weeks versus baseline. Secondary endpoints included change in BMD at the spine at earlier time points and at the total hip, trochanter, and femoral neck at all time points. At week 52, lumbar spine BMD had increased 7.5%, 7.0%, and 4.4% in the combination, teriparatide, and zoledronic acid groups, respectively ( p < .001 for combination and teriparatide versus zoledronic acid). In the combination group, spine BMD increased more rapidly than with either agent alone ( p < .001 versus both teriparatide and zoledronic acid at 13 and 26 weeks). Combination therapy increased total-hip BMD more than teriparatide alone at all times (all p < .01) and more than zoledronic acid at 13 weeks ( p < .05), with final 52-week increments of 2.3%, 1.1%, and 2.2% in the combination, teriparatide, and zoledronic acid groups, respectively. With combination therapy, bone formation (assessed by serum N-terminal propeptide of type I collagen [PINP]) increased from 0 to 4 weeks, declined minimally from 4 to 8 weeks, and then rose throughout the trial, with levels above baseline from 6 to 12 months. Bone resorption (assessed by serum b-C-telopeptide of type I collagen [b-CTX]) was markedly reduced with combination therapy from 0 to 8 weeks (a reduction of similar magnitude to that seen with zoledronic acid alone), followed by a gradual increase after week 8, with levels remaining above baseline for the latter half of the year. Levels for both markers were significantly lower with combination therapy versus teriparatide alone ( p < .002). Limitations of the study included its short duration, lack of endpoints beyond DXA-based BMD (e.g., quantitative computed tomography and finite-element modeling for bone strength), lack of teriparatide placebo, and insufficient power for fracture outcomes. We conclude that while teriparatide increases spine BMD more than zoledronic acid and zoledronic acid increases hip BMD more than teriparatide, combination therapy provides the largest, most rapid increments when both spine and hip sites are considered. ß

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The effect of 3 versus 6 years of Zoledronic acid treatment of osteoporosis: A randomized extension to the HORIZON-Pivotal Fracture Trial (PFT)

Black

Reid

Boonen

et al. 2011

Journal of Bone and Mineral Research

Self Cite

548

220

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Zoledronic acid 5 mg (ZOL) annually for 3 years reduces fracture risk in postmenopausal women with osteoporosis. To investigate long-term effects of ZOL on bone mineral density (BMD) and fracture risk, the Health Outcomes and Reduced Incidence with Zoledronic acid Once Yearly–Pivotal Fracture Trial (HORIZON-PFT) was extended to 6 years. In this international, multicenter, double-blind, placebo-controlled extension trial, 1233 postmenopausal women who received ZOL for 3 years in the core study were randomized to 3 additional years of ZOL (Z6, n = 616) or placebo (Z3P3, n = 617). The primary endpoint was femoral neck (FN) BMD percentage change from year 3 to 6 in the intent-to-treat (ITT) population. Secondary endpoints included other BMD sites, fractures, biochemical bone turnover markers, and safety. In years 3 to 6, FN-BMD remained constant in Z6 and dropped slightly in Z3P3 (between-treatment difference = 1.04%; 95% confidence interval 0.4 to 1.7; p = 0.0009) but remained above pretreatment levels. Other BMD sites showed similar differences. Biochemical markers remained constant in Z6 but rose slightly in Z3P3, remaining well below pretreatment levels in both. New morphometric vertebral fractures were lower in the Z6 (n = 14) versus Z3P3 (n = 30) group (odds ratio = 0.51; p = 0.035), whereas other fractures were not different. Significantly more Z6 patients had a transient increase in serum creatinine >0.5 mg/dL (0.65% versus 2.94% in Z3P3). Nonsignificant increases in Z6 of atrial fibrillation serious adverse events (2.0% versus 1.1% in Z3P3; p = 0.26) and stroke (3.1% versus 1.5% in Z3P3; p = 0.06) were seen. Postdose symptoms were similar in both groups. Reports of hypertension were significantly lower in Z6 versus Z3P3 (7.8% versus 15.1%, p < 0.001). Small differences in bone density and markers in those who continued versus those who stopped treatment suggest residual effects, and therefore, after 3 years of annual ZOL, many patients may discontinue therapy up to 3 years. However, vertebral fracture reductions suggest that those at high fracture risk, particularly vertebral fracture, may benefit by continued treatment. (ClinicalTrials.gov identifier: NCT00145327). © 2012 American Society for Bone and Mineral Research.

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Establishing a Reference Interval for Bone Turnover Markers in 637 Healthy, Young, Premenopausal Women From the United Kingdom, France, Belgium, and the United States

Cited by 145 publications

References 28 publications

Reference intervals for bone turnover markers in Spanish premenopausal women

Reference intervals for bone turnover markers in Spanish premenopausal women

Effects of intravenous zoledronic acid plus subcutaneous teriparatide [rhPTH(1–34)] in postmenopausal osteoporosis

The effect of 3 versus 6 years of Zoledronic acid treatment of osteoporosis: A randomized extension to the HORIZON-Pivotal Fracture Trial (PFT)

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