Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose: To assess the efficacy and safety over 1 year of a daily oral administration of the fixed combination of strontium ranelate (SrRan) 2 g/vitamin D3 (vitD3) 1000 IU on the correction of vitamin D insufficiency in the treatment of osteoporotic men and postmenopausal women.
Methods: Prospective, international study, with a 6-month double blind SrRan/vitD3 vs SrRan parallel group period (ratio 4:1), followed by a 6-month open-SrRan/vitD3 extension period in a subgroup of patients. All patients were supplemented with calcium 1 g/d during the whole study. Men and postmenopausal women included were osteoporotic (BMD T-score ≤ ‑2.5 SD). 80% of the patients had to present insufficient levels of 25-hydroxyvitamin D (25-OHD), i.e. ]22.5-50 nmol/L[, and 20% ≥50 nmol/L. 25-OHD level was assessed at 3 months (primary endpoint) and 6 months among assessable patients according to intent-to-treat principle, and in the group of patients treated 12 months with SrRan/vitD3. Other criteria were: BMD, falls, PTH, 1,25-(OH)2D and safety.
Results: 518 patients were randomized: 413 to SrRan/vitD3, 105 to SrRan. Of these, 257 patients continued at M6 in the 5 countries selected into the extension period M6-M12: 53 patients switched from SrRan to SrRan/vitD3 while 204 remained on SrRan/vitD3. 242 patients completed the study at M12. Baseline characteristics were similar between groups. At inclusion, mean age (±SD) was 66.8 ± 8.3 years, mean L1-L4 T-score BMD was -2.85 ± 0.86 and mean 25-OHD was 44.1 ± 14.6 nmol/L.
The proportion of patients with 25-OHD ≥ 50 nmol/L at END (i.e. last post-baseline value over M0-M3) was significantly higher in SrRan/vitD3 group than in SrRan group: 83.8% vs 44.2% (p<0.001). Adjusted odds ratio was 6.7 (95% CI [4.2; 10.9]). Mean 25-OHD reached 65.1 vs 49.5 nmol/L at M3, and 66.9 vs 45.4 nmol/L at M6, in SrRan/vit D3and SrRan groups respectively.
The correction of vitamin D insufficiency was maintained over 12 months of SrRan/vitD3treatment (N = 198) with an increase in the proportion of patients with 25-OHD ≥ 50 nmol/L from 21.2% at baseline to 81.1% at M12. The mean concentration of 25-OHD increased from baseline (44.3 ± 13.8 nmol/L) to M3 (64.3 ± 14.6 nmol/L), then remained stable until M12 (60.8 ± 13.9 nmol/L).
BMD significantly increased at all assessed sites in patients treated with SrRan/vitD3during one year (+5% at L1-L4, +4% at femoral neck and +3% at total hip), consistent with annual BMD changes reported with SrRan in previous studies.
There was a trend to fewer patients falling with SrRan/vitD3 (16.5%) as compared to SrRan (20.2%) at M6. PTH evolution over time was inversely correlated with 25-OHD. Increase in mean 1,25-(OH)2D was higher in SrRan/vitD3 than in SrRan group. Safety of SrRan/vitD3was good, comparable to that of SrRan over M0-M6 and in accordance to that expected with SrRan over M6-M12.
Conclusion: The study demonstrates the efficacy and safety of the fixed combination of SrRan 2 g and vitD3 1000 IU on the correction of vitamin D insufficiency in osteoporotic men and postmenopausal women aged ≥50 years. The efficacy observed after 3 months was maintained after 6 and 12 months of treatment.
Disclosure:
R. Rizzoli,
Merck Sharp and Dohme, Eli Lilly, Amgen, Wyeth, Novartis, Servier, Nycomed, Nestlé and Danone,
5,
Merck Sharp and Dohme, Eli Lilly, Amgen, Wyeth, Novartis, Servier, Nycomed, Nestlé and Danone,
9;
B. Dawson-Hughes,
Cytochroma, Danone, Eli Lilly, Merck, Pfizer, Wright Medical, and Servier.,
5;
J. M. Kaufman,
Amgen, Eli Lilly, Glaxo Smith Kline, Merck Sharp & Dohme, Novartis, Roche, Sanofi Aventis, Servier, Warner Chilcott,
5,
Amgen, Eli Lilly, Glaxo Smith Kline, Merck Sharp & Dohme, Novartis, Roche, Sanofi Aventis, Servier, Warner Chilcott,
2,
Amgen, Eli Lilly, Glaxo Smith Kline, Merck Sharp & Dohme, Novartis, Roche, Sanofi Aventis, Servier, Warner Chilcott,
9;
P. Fardellone,
None;
M. L. Brandi,
Servier, Amgen, MSD,
5,
Servier, Stroder, Amgen, MSD, Novartis, NPS, SPA, Eli Lilly, Roche,
2,
Servier, Stroder, Amgen, MSD, Novartis, NPS, SPA, Eli Lilly, Roche,
9;
B. Vellas,
None;
J. Collette,
None;
J. Y. Reginster,
Servier, Novartis, Negma, Lilly, Wyeth, Amgen, GlaxoSmithKline, Roche, Merckle, Nycomed, NPS, Theramex, UCB,
5,
Merck Sharp and Dohme, Lilly, Rottapharm, IBSA, Genevrier, Novartis, Servier, Roche, GlaxoSmithKline, Teijin, Teva, Ebewee Pharma, Zodiac, Analis, Theramex, Nycomed, Novo-Nordisk,
,
Bristol Myers Squibb, Merck Sharp and Dohme, Rottapharm, Teva, Lilly, Novartis, Roche, GlaxoSmithKline, Amgen, Servier,
2.
« Back to 2012 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/correction-of-vitamin-d-insufficiency-with-the-fixed-daily-combination-strontium-ranelate-2-gvitamin-d3-1000-iu-over-12-months/