Accidental Falls/statistics & numerical data; Aged; Aged, 80 and over; Alendronate/administration & dosage/adverse effects; Algorithms; Bone Density/drug effects; Bone Density Conservation Agents/administration & dosage/adverse effects; Cholecalciferol/administration & dosage/adverse effects; Diphosphonates/adverse effects/therapeutic use; Drug Combinations; Female; Humans; Osteoporosis, Postmenopausal/complications/drug therapy; Postmenopause/drug effects/physiology; Standard of Care; Vitamin D Deficiency/complications/drug therapy
Abstract :
[en] Vitamin D insufficiency is common in patients with osteoporosis. We conducted a randomized trial comparing alendronate 70 mg combined with vitamin D(3) 5,600 IU in a single tablet (ALN/D5600, n = 257) with standard care chosen by the patients' personal physicians (n = 258) in patients with postmenopausal osteoporosis (BMD T score </=2.5 or </=1.5 and a prior fragility fracture) who had vitamin D insufficiency (serum 25[OH]D values 8-20 ng/ml) and who were at risk of falls. Virtually all patients randomized to standard care received bisphosphonate therapy, and in approximately 70% of cases this was combined with vitamin D supplements. However, only 24% took >/=800 IU/day of supplemental vitamin D. At 6 months the proportion of patients with vitamin D insufficiency was 8.6% in the ALN/D5600 group compared with 31.0% in the standard care group (P < 0.001). Those in the ALN/D5600 group also had a greater reduction in urinary NTX/creatinine ratio (-57% vs. -46%, P < 0.001) and bone-specific alkaline phosphatase (-47% vs. -40%, P < 0.001). In the ALN/5600 group, by 12 months the increase in BMD was greater at the lumbar spine (4.9% vs. 3.9%, P = 0.047) and the total hip (2.2% vs. 1.4%, P = 0.035), significantly fewer patients were vitamin D-insufficient (11.3% vs. 36.9%, P < 0.001), and bone turnover marker (BTM) results were similar to those at 6 months. There was no difference between groups in those who experienced falls or fractures, and adverse events were similar. Based on the finding that ALN/D5600 was more effective than standard care at correcting vitamin D insufficiency, increasing BMD, and reducing BTMs in this patient group, greater attention needs to be directed toward optimizing the treatment of osteoporosis and correcting vitamin D deficiency in postmenopausal women.
Disciplines :
General & internal medicine
Author, co-author :
Ralston, Stuart H
Binkley, Neil
Boonen, Steven
Kiel, Douglas P
Reginster, Jean-Yves ; Université de Liège - ULiège > Département des sciences de la santé publique > Santé publique, Epidémiologie et Economie de la santé
Roux, Christian
Chen, Liang
Rosenberg, Elizabeth
Santora, Arthur
Language :
English
Title :
Randomized trial of alendronate plus vitamin D3 versus standard care in osteoporotic postmenopausal women with vitamin D insufficiency.
Publication date :
2011
Journal title :
Calcified Tissue International
ISSN :
0171-967X
eISSN :
1432-0827
Publisher :
Springer Verlag, New York, United States - New York
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