کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
5892620 | 1153329 | 2009 | 9 صفحه PDF | دانلود رایگان |
Although vitamin D supplementation is a fundamental part of osteoporosis treatment, many patients do not regularly take adequate amounts. A once-weekly (OW) alendronate (ALN) preparation that includes 2800Â IU of vitamin D3 in a single combination tablet (ALNÂ +Â D2800) is available for treating patients and ensuring intake of vitamin D that is consistent with existing guidelines.This randomized, double-blind study extension was conducted to evaluate the safety and tolerability of ALNÂ +Â D2800 and ALNÂ +Â D2800 plus an additional 2800Â IU vitamin D3 single tablet supplement (ALNÂ +Â D5600) administered for 24Â weeks in men and postmenopausal women with osteoporosis previously treated OW for 15Â weeks with either ALN or ALNÂ +Â D2800. The primary endpoint was the proportion of participants who developed hypercalciuria (defined as a 24-hour urine calcium >Â 300Â mg in women or >Â 350Â mg in men and an increase of >Â 25% versus randomization baseline) at week 39. The key secondary endpoint was the proportion of participants with vitamin D insufficiency (serum 25(OH)D <Â 15Â ng/mL [37.4Â nmol/L]) at the end of the study.Hypercalciuria incidence (4.2% [ALNÂ +Â D5600] vs. 2.8% [ALNÂ +Â D2800]), did not differ between groups (p = 0.354). No participants developed hypercalcemia. Among the participants with vitamin D insufficiency at the week 0 baseline, the prevalence of insufficiency at the end of the study was reduced by 92% in the ALNÂ +Â D5600 group and by 86% in the ALNÂ +Â D2800 group. The incidences of clinical adverse experiences, including drug-related adverse experiences, were similar in both groups.In subjects previously treated with ALNÂ +Â D2800 for 15Â weeks, the addition of 2800Â IU D3 for 24Â weeks did not produce hypercalcemia nor increase the risk of hypercalciuria.
Journal: Bone - Volume 44, Issue 4, April 2009, Pages 639-647