[en] OBJECTIVE: This study aims to investigate the efficacy and safety of oral fixed-dose combination of strontium ranelate 2 g/vitamin D3 1000 IU daily vs strontium ranelate 2 g daily for correcting vitamin D insufficiency in osteoporosis. DESIGN: A 6-month international, randomized, double-blind, parallel-group, phase 3 study. METHODS: A total of 518 men and postmenopausal women aged >/=50 years with primary osteoporosis (T-score </=-2.5 s.d.) and serum 25-hydroxyvitamin D (25(OH)D) >22.5 nmol/l were included. Patients were allocated to strontium ranelate 2 g/vitamin D3 1000 IU daily (n=413) or strontium ranelate 2 g daily (n=105). The participants received calcium 1 g daily. The primary endpoint was serum 25(OH)D at last post-baseline evaluation during 3 months. RESULTS: Both groups were comparable at baseline. Mean baseline of 25(OH)D was 44.1+/-14.6 nmol/l. After 3 months, the percentage of patients with 25(OH)D >/=50 nmol/l was higher with strontium ranelate/vitamin D3 vs strontium ranelate (84 vs 44%, P<0.001; adjusted between-group odds ratio=6.7; 95% CI, 4.2-10.9). The efficacy of the fixed-dose combination on 25(OH)D was maintained at 6 months (86 vs 40%, P<0.001). Mean 25(OH)D was 65.1 and 49.5 nmol/l, respectively, after 3 months and 66.9 and 45.4 nmol/l after 6 months. Physical performance improved in both groups. Falls were 17 and 20% in the strontium ranelate/vitamin D3 and strontium ranelate groups respectively. Parathyroid hormone levels were inversely correlated with 25(OH)D. No clinically relevant differences in safety were observed. CONCLUSIONS: This study confirms the efficacy and safety of fixed-dose combination of strontium ranelate 2 g/vitamin D3 1000 IU for correction of vitamin D insufficiency in osteoporotic patients.
Disciplines :
General & internal medicine
Author, co-author :
Rizzoli, R.
Dawson-Hughes, B.
Kaufman, J.-M.
Fardellone, P.
Brandi, M. L.
Vellas, B.
COLLETTE, Julien ; Centre Hospitalier Universitaire de Liège - CHU > Chimie médicale
Reginster, Jean-Yves ; Université de Liège - ULiège > Département des sciences de la santé publique > Santé publique, Epidémiologie et Economie de la santé
Language :
English
Title :
Correction of vitamin D insufficiency with combined strontium ranelate and vitamin D3 in osteoporotic patients.
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