First- and second-generation immunometric PTH assays during treatment of hyperparathyroidism with cinacalcet HCl

Martin, Kévin; Jüppner, Harald; Sherrard, Donald J.; Goodman, William G.; Kaplan, Mark; Nassar, George M.; Campbell, Patricia; Curzi, Mario P.; Harytan, Chaim C.; McCary, Laura C.; Guo, Matthew; Turner, Stewart A.; Bushinsky, David A.

doi:10.1111/j.1523-1755.2005.00517.x

Cited by 53 publications

(58 citation statements)

References 37 publications

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“…The use of CART also identified the relationship between serum calcium concentrations and defective mineralization. Indeed, low serum calcium levels and high serum PTH values were the strongest predictors of mineralization defect in patients with bone turnover within the normal range, a finding that should be taken into consideration in view of the availability of therapeutic agents, such as calcium-free phosphate binders (10,27) and calcimimetic agents (28), which maintain serum calcium levels within the lower normal range. None of the patients included in this analysis received any of these agents before bone biopsy.…”

Section: Discussionmentioning

confidence: 99%

Value of the New Bone Classification System in Pediatric Renal Osteodystrophy

Bakkaloğlu

Wesseling‐Perry²,

Pereira³

et al. 2010

Clinical Journal of the American Society of Nephrology

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Background and objectives: Although lesions of renal osteodystrophy have traditionally been defined by bone turnover, alterations in skeletal mineralization and volume are also prevalent and may contribute to significant morbidity in patients with chronic kidney disease (CKD). The study presented here was undertaken to compare the traditional spectrum of renal osteodystrophy defined by bone turnover to a new classification system that includes T (turnover), M (mineralization), and V (volume) and to determine the value of biochemical parameters as predictors of specific TMV lesions.Design, setting, participants, & measurements: Pediatric patients (n ‫؍‬ 161) treated with peritoneal dialysis were enrolled into the study.Results: Increased bone turnover and abnormal mineralization were prevalent (57% and 48%, respectively); bone volume was normal or increased in all subjects. Predictive algorithms for different skeletal diagnoses were established by Classification and regression tree analysis. Serum parathyroid hormone (PTH) less than 400 pg/ml in combination with alkaline phosphatase values less than 400 IU/L provided the highest correct prediction rate for patients with both normal bone turnover and normal mineralization. Levels of PTH were higher and serum calcium levels were lower in patients with defective mineralization, irrespective of bone turnover.Conclusions: Although no single biochemical marker is able to provide a complete assessment of renal osteodystrophy, a combination of serum calcium, alkaline phosphatase, and PTH levels may lead to a more precise noninvasive assessment of turnover and mineralization abnormalities in this population.

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Section: Discussionmentioning

confidence: 99%

Value of the New Bone Classification System in Pediatric Renal Osteodystrophy

Bakkaloğlu

Wesseling‐Perry²,

Pereira³

et al. 2010

Clinical Journal of the American Society of Nephrology

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“…The means of the biochemical parameters (PTH, calcium, and phosphorus) during the 7-wk efficacy assessment period were used to evaluate efficacy. PTH levels measured with the bio-intact assay were multiplied by 1.95 for conversion to iPTH values (29). A last value carried forward method was used for patients who did not have laboratory values measured during the efficacy assessment period.…”

Section: Statistical Analysesmentioning

confidence: 99%

The OPTIMA Study

Messa¹,

Macário²,

Yaqoob³

et al. 2008

Clinical Journal of the American Society of Nephrology

207

164

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Background and objectives: Cinacalcet, a novel calcimimetic, targets the calcium-sensing receptor to lower parathyroid hormone (PTH), calcium, and phosphorus levels in dialysis patients with secondary hyperparathyroidism (SHPT). This study compared the efficacy of a cinacalcet-based regimen with unrestricted conventional care (vitamin D and phosphate binders) for achieving the stringent National Kidney Foundation Kidney Disease Outcomes Quality Initiative (KDOQI) targets for dialysis patients.Study design: In this multicenter, open-label study, hemodialysis patients with poorly controlled SHPT were randomized to receive conventional care (n ‫؍‬ 184) or a cinacalcet-based regimen (n ‫؍‬ 368). Doses of cinacalcet, vitamin D sterols, and phosphate binders were adjusted during a 16-wk dose-optimization phase with the use of algorithms that allowed cinacalcet to be used with adjusted doses of vitamin D. The primary end point was the proportion of patients with mean intact PTH <300 pg/ml during a 7-wk efficacy assessment phase.Results: A higher proportion of patients receiving the cinacalcet-based regimen versus conventional care achieved the targets for PTH (71% versus 22%, respectively; P < 0.001), Ca ؋ P (77% versus 58%, respectively; P < 0.001), calcium (76% versus 33%, respectively; P < 0.001), phosphorus (63% versus 50%, respectively; P ‫؍‬ 0.002), and PTH and Ca ؋ P (59% versus 16%, respectively, P < 0.001), and allowed a 22% reduction in vitamin D dosage in patients receiving vitamin D at baseline. Achievement of targets was greatest in patients with less severe disease (intact PTH range, 300 to 500 pg/ml) and the cinacalcet dose required was lower in these patients (median ‫؍‬ 30 mg/d).Conclusions: Compared with conventional therapy, a cinacalcet-based treatment algorithm increased achievement of KDOQI treatment targets in dialysis patients in whom conventional therapy was no longer effective in controlling this disease.

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“…The bone isoform of ALP is produced by osteoblasts and may be a more specific indicator of bone turnover than is PTH, which originates from the parathyroid glands and is influenced by age, race, suboptimal assays, inflammation, and nutrition and anthropometric status (19)(20)(21)(22)(23). Experimental data suggest that ALP may be causally associated with vascular calcification via hydrolysis of pyrophosphate, a potent calcification inhibitor (18,24,25).…”

mentioning

confidence: 99%

Comparative Mortality–Predictability Using Alkaline Phosphatase and Parathyroid Hormone in Patients on Peritoneal Dialysis and Hemodialysis

et al. 2014

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25 (1.12 to 1.41), 1.12 (1.02 to 1.23), 1.06 (0.96 to 1.18), 1.09 (0.97 to 1.24), 1.12 (0.97 to 1.29), 1.18 (0.99 to 1.40), and 1.23 (1.09 to 1.38) for PTH concentrations of <100 pg/mL, 100 to <200 pg/mL, 300 to <400 pg/mL, 400 to <500 pg/mL, 500 to <600 pg/mL, 600 to <700 pg/mL, and ≥700 pg/mL respectively. Compared with PD patients having serum concentrations of ALP and PTH within reference ranges, patients on HD experienced increased mortality across all ALP and PTH concentrations, particularly those in the lowest and highest categories. ♦ Conclusions: In summary, higher ALP concentrations are associated with increased mortality, and lower and higher PTH concentrations are both associated with death risk in PD patients. The utility of ALP in the management of chronic kidney disease mineral bone disorders in PD patients warrants further study.Perit Dial Int 2014; 34(7):732-748 www.PDIConnect.com epub ahead of print:

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First- and second-generation immunometric PTH assays during treatment of hyperparathyroidism with cinacalcet HCl

Abstract: These data show that PTH can be monitored with either iPTH or biPTH assays during therapy with cinacalcet, and that cinacalcet therapy does not exert a major influence on the ratio between PTH(1-84) and large, N-terminally truncated PTH fragments.

Cited by 53 publications

References 37 publications

Value of the New Bone Classification System in Pediatric Renal Osteodystrophy

Value of the New Bone Classification System in Pediatric Renal Osteodystrophy

The OPTIMA Study

Comparative Mortality–Predictability Using Alkaline Phosphatase and Parathyroid Hormone in Patients on Peritoneal Dialysis and Hemodialysis

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