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

Abstract

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.

• Authors: R Rizzoli, B Dawson-Hughes, J-M Kaufman, P Fardellone, M L Brandi, B Vellas, J Collette, J-Y Reginster
• Journal: European journal of endocrinology (Eur J Endocrinol) Vol. 170 Issue 3 Pg. 441-50 (Mar 2014) ISSN: 1479-683X [Electronic] England
• PMID: 24322182 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Thiophenes
• strontium ranelate
• Vitamin D
• Cholecalciferol
• 25-hydroxyvitamin D
• Strontium

Topics

• Aged
• Cholecalciferol (administration & dosage)
• Female
• Humans
• Male
• Middle Aged
• Osteoporosis (drug therapy)
• Osteoporosis, Postmenopausal (drug therapy)
• Strontium (administration & dosage)
• Thiophenes (administration & dosage, adverse effects)
• Vitamin D (analogs & derivatives, blood)
• Vitamin D Deficiency (drug therapy)