Vitamin D insufficiency is common in patients with osteoporosis. We conducted a randomized trial comparing alendronate 70 mg combined with vitamin D3 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. © 2011 Springer Science+Business Media, LLC.
Randomized trial of alendronate plus vitamin D3 versus standard care in osteoporotic postmenopausal women with vitamin D insufficiency / Stuart H., Ralston; Neil, Binkley; S., Boonen; Douglas P., Kiel; Jean Yves, Reginster; Christian, Roux; Liang, Chen; Elizabeth, Rosenberg; Arthur, Santora; T. Focus D., Trial Coughlan; A., Arabi; A., Kucukdeveci; N., Savani; R., Kausiene; B., Pornel; T., Price; C. l., Benhamou; M., Aguilar; M., Abello; E., Tobias; N., Rais; O., Ershova; R., Martz; S., Linjawi; S., Kramer; J., Walliser; S., Hepguler; J., Gimble; O., Lesnyak; P., Chalem; J., Aramburu; H., De Basurto; J., Foldes; Y., Yaghi; C., Roux; C., Abud; M. m., Torres; G., Gonzalez; G., Weryha; E. m., Mola; M., Shargordsky; N., Patel; K., Lippuner; R., Moericke; B., Masri; I., Stura; R., Theiler; N., Dursun; V., Thompson; D., Andersone; M., Arya; C. p., Anderberg; M., Pfeifer; H., Goldstraj; V., Alekna; B., Wieskopf; T., De Villiers; Minisola, Salvatore; J. y., Reginster; K., Heil; K., Heil; V., Herkt; V., Herkt; J., Rohlf; A. d., Weerd; S., Ish Shalom; L., Bukauskiene; L., Benevolenskaya; R., Mantilla; A., Woolf; W., Otero; S., Nayiager; B., Walsh; S., Newman; N., Bagul; E., Abdulhakim; S., Govindraj; R., Sarmiento; R., Ellahbadi; H., Shaw; H., Thomas; S., Lipschitz; S., Gutierrez; N., Binkley; S., Ralston; M., Davey; R., Lauro; H., Rodriguez; M., Al Ramahi. - In: CALCIFIED TISSUE INTERNATIONAL. - ISSN 0171-967X. - ELETTRONICO. - 88:6(2011), pp. 485-494. [10.1007/s00223-011-9482-4]
Randomized trial of alendronate plus vitamin D3 versus standard care in osteoporotic postmenopausal women with vitamin D insufficiency
MINISOLA, Salvatore;
2011
Abstract
Vitamin D insufficiency is common in patients with osteoporosis. We conducted a randomized trial comparing alendronate 70 mg combined with vitamin D3 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. © 2011 Springer Science+Business Media, LLC.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
