Serum 25-hydroxy-vitamin D and the risk of fractures in the teriparatide versus risedronate VERO clinical trial

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023728%3A_____%2F19%3AN0000067" target="_blank" >RIV/00023728:_____/19:N0000067 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00216208:11110/19:10396081

Výsledek na webu

<a href="https://doi.org/10.1007/s11657-019-0561-x" target="_blank" >https://doi.org/10.1007/s11657-019-0561-x</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1007/s11657-019-0561-x" target="_blank" >10.1007/s11657-019-0561-x</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Serum 25-hydroxy-vitamin D and the risk of fractures in the teriparatide versus risedronate VERO clinical trial

Popis výsledku v původním jazyce

PurposeUsing data from the 2-year, randomized, double-dummy VERO trial, we examined the changes in 25-hydroxy-vitamin D (25[OH]D) concentrations over time, and whether the fracture risk reduction of teriparatide versus risedronate varies by baseline 25(OH)D sufficiency category.MethodsPostmenopausal women with established osteoporosis received subcutaneous daily teriparatide 20g or oral weekly risedronate 35mg, with concomitant 500-1000mg of elemental calcium and 400-800IU/day of vitamin D supplements. Fracture endpoints were analyzed by predefined subgroups of 25(OH)D insufficient and sufficient patients. Heterogeneity of the treatment effect on fractures was investigated by logistic and Cox proportional hazards regression models.ResultsAt baseline, mean serum 25(OH)D was 31.9ng/mL in the teriparatide group and 31.5ng/mL in the risedronate group, and 16.8% and 17.9% of patients, respectively, were 25(OH)D insufficient. At month 6, the mean serum 25(OH)D concentration decreased in teriparatide-treated patients to 24.5ng/mL (by approximately 23%) but remained relatively constant in risedronate-treated patients (32.2ng/mL) (p<0.001). Proportions of 25(OH)D insufficient patients at month 6 were 26.7% and 5.6%, respectively (p<0.001). The risk reduction with teriparatide versus risedronate for any of the fracture endpoints did not significantly differ between subgroups by 25(OH)D sufficiency status at baseline, with nonsignificant (p>0.1) treatment-by-25(OH)D interactions in all fracture analyses.ConclusionsSerum 25(OH)D concentration decreases during teriparatide treatment. Fracture risk reduction with teriparatide versus risedronate did not significantly differ between the two groups of patients defined by baseline 25(OH)D

Název v anglickém jazyce

Serum 25-hydroxy-vitamin D and the risk of fractures in the teriparatide versus risedronate VERO clinical trial

Popis výsledku anglicky

PurposeUsing data from the 2-year, randomized, double-dummy VERO trial, we examined the changes in 25-hydroxy-vitamin D (25[OH]D) concentrations over time, and whether the fracture risk reduction of teriparatide versus risedronate varies by baseline 25(OH)D sufficiency category.MethodsPostmenopausal women with established osteoporosis received subcutaneous daily teriparatide 20g or oral weekly risedronate 35mg, with concomitant 500-1000mg of elemental calcium and 400-800IU/day of vitamin D supplements. Fracture endpoints were analyzed by predefined subgroups of 25(OH)D insufficient and sufficient patients. Heterogeneity of the treatment effect on fractures was investigated by logistic and Cox proportional hazards regression models.ResultsAt baseline, mean serum 25(OH)D was 31.9ng/mL in the teriparatide group and 31.5ng/mL in the risedronate group, and 16.8% and 17.9% of patients, respectively, were 25(OH)D insufficient. At month 6, the mean serum 25(OH)D concentration decreased in teriparatide-treated patients to 24.5ng/mL (by approximately 23%) but remained relatively constant in risedronate-treated patients (32.2ng/mL) (p<0.001). Proportions of 25(OH)D insufficient patients at month 6 were 26.7% and 5.6%, respectively (p<0.001). The risk reduction with teriparatide versus risedronate for any of the fracture endpoints did not significantly differ between subgroups by 25(OH)D sufficiency status at baseline, with nonsignificant (p>0.1) treatment-by-25(OH)D interactions in all fracture analyses.ConclusionsSerum 25(OH)D concentration decreases during teriparatide treatment. Fracture risk reduction with teriparatide versus risedronate did not significantly differ between the two groups of patients defined by baseline 25(OH)D

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30226 - Rheumatology

Projekt

—

Návaznosti

V - Vyzkumna aktivita podporovana z jinych verejnych zdroju

Rok uplatnění

2019

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

ARCHIVES OF OSTEOPOROSIS

ISSN

1862-3522

e-ISSN

1862-3514

Svazek periodika

14

Číslo periodika v rámci svazku

1

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

8

Strana od-do

Art.Nr. 10

Kód UT WoS článku

000456141600001

EID výsledku v databázi Scopus

2-s2.0-85060172377