ObjectiveThis study aims to investigate the efficacy and safety of oral fixed-dose combination of strontium ranelate 2 g/vitamin D31000 IU daily vs strontium ranelate 2 g daily for correcting vitamin D insufficiency in osteoporosis.DesignA 6-month international, randomized, double-blind, parallel-group, phase 3 study.MethodsA total of 518 men and postmenopausal women aged ≥50 years with primary osteoporosis (T-score ≤−2.5s.d.) and serum 25-hydroxyvitamin D (25(OH)D) >22.5 nmol/l were included. Patients were allocated to strontium ranelate 2 g/vitamin D31000 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.ResultsBoth 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 D3vs 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 D3and strontium ranelate groups respectively. Parathyroid hormone levels were inversely correlated with 25(OH)D. No clinically relevant differences in safety were observed.ConclusionsThis study confirms the efficacy and safety of fixed-dose combination of strontium ranelate 2 g/vitamin D31000 IU for correction of vitamin D insufficiency in osteoporotic patients.
A randomized, double‐blind clinical trial to evaluate the efficacy and safety of a fixed‐dose combination of amlodipine/rosuvastatin in patients with dyslipidemia and hypertension
