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Correction of vitamin D insufficiency with combined strontium ranelate and vitamin D₃ in osteoporotic patients

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Abstract
Objective: This study aims to investigate the efficacy and safety of oral fixed-dose combination of strontium ranelate 2 g/vitamin D-3 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 D-3 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 D-3 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 D-3 1000 IU for correction of vitamin D insufficiency in osteoporotic patients.
Keywords
EFFICACY, FRACTURE, MANAGEMENT, CALCIUM SUPPLEMENTATION, D SUPPLEMENTATION, RANDOMIZED CONTROLLED-TRIAL, POSTMENOPAUSAL WOMEN, SAFETY, FALLS, RISK

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Chicago
Rizzoli, R, B Dawson-Hughes, Jean Kaufman, P Fardellone, ML Brandi, B Vellas, J Collette, and J-Y Reginster. 2014. “Correction of Vitamin D Insufficiency with Combined Strontium Ranelate and Vitamin D₃ in Osteoporotic Patients.” European Journal of Endocrinology 170 (3): 441–450.
APA
Rizzoli, R., Dawson-Hughes, B., Kaufman, J., Fardellone, P., Brandi, M., Vellas, B., Collette, J., et al. (2014). Correction of vitamin D insufficiency with combined strontium ranelate and vitamin D₃ in osteoporotic patients. EUROPEAN JOURNAL OF ENDOCRINOLOGY, 170(3), 441–450.
Vancouver
1.
Rizzoli R, Dawson-Hughes B, Kaufman J, Fardellone P, Brandi M, Vellas B, et al. Correction of vitamin D insufficiency with combined strontium ranelate and vitamin D₃ in osteoporotic patients. EUROPEAN JOURNAL OF ENDOCRINOLOGY. 2014;170(3):441–50.
MLA
Rizzoli, R et al. “Correction of Vitamin D Insufficiency with Combined Strontium Ranelate and Vitamin D₃ in Osteoporotic Patients.” EUROPEAN JOURNAL OF ENDOCRINOLOGY 170.3 (2014): 441–450. Print.
@article{6850851,
  abstract     = {Objective: This study aims to investigate the efficacy and safety of oral fixed-dose combination of strontium ranelate 2 g/vitamin D-3 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 D-3 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 D-3 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 D-3 1000 IU for correction of vitamin D insufficiency in osteoporotic patients.},
  author       = {Rizzoli, R and Dawson-Hughes, B and Kaufman, Jean and Fardellone, P and Brandi, ML and Vellas, B and Collette, J and Reginster, J-Y},
  issn         = {0804-4643},
  journal      = {EUROPEAN JOURNAL OF ENDOCRINOLOGY},
  keywords     = {EFFICACY,FRACTURE,MANAGEMENT,CALCIUM SUPPLEMENTATION,D SUPPLEMENTATION,RANDOMIZED CONTROLLED-TRIAL,POSTMENOPAUSAL WOMEN,SAFETY,FALLS,RISK},
  language     = {eng},
  number       = {3},
  pages        = {441--450},
  title        = {Correction of vitamin D insufficiency with combined strontium ranelate and vitamin D₃ in osteoporotic patients},
  url          = {http://dx.doi.org/10.1530/EJE-13-0775},
  volume       = {170},
  year         = {2014},
}

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