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 greater than or equal to 50 years with primary osteoporosis (T-score less than or equal to −2.5 s.d.)
and serum 25-hydroxyvitamin D (25(OH)D)greater than 22.5 nmol/l (9 ng/mL) 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 plus or minus 14.6 nmol/l (17.6 ng/mL plus or minus 5.8 ng/mL). After 3 months, the percentage of
patients with 25(OH)D greater than or equal to 50 nmol/l (20 ng/mL) was higher with strontium ranelate/vitamin D3 vs strontium ranelate (84 vs 44%, P less than 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 less than 0.001).
Mean 25(OH)D was 65.1nmol/l (26 ng/mL) and 49.5 nmol/l (19.8 ng/mL), respectively, after 3 months and
66.9 nmol/l (26.8
ng/mL) and 45.4 nmol/l (18.2 ng/mL) 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.
http://www.eje-online.org/content/170/3/441.short