Laiz A, Malouf J, Marin A, Longobardi V, de Caso J, Farrerons J, Casademont J
Ana Laiz MD, PhD. Internal Medicine Department, C/Sant Antoni Mª Claret 167, Hospital de la Santa Creu I Sant Pau, 08025 Barcelona, Spain, e-mail:
J Nutr Health Aging. 2017;21(4):413-420. doi: 10.1007/s12603-016-0773-3.
To determine whether 3-monthly supplementation of an oral vitamin D widely used in Spain (calcifediol) plus daily exercise could influence survival at one and four years after surgery for osteoporotic hip fracture.
A pragmatic, randomized, partially single-blind placebo-controlled study.
Patients admitted to a tertiary university hospital for acute hip fracture.
675 healthy adult patients undergoing surgery for osteoporotic hip fracture were recruited from January 2004 to December 2007.
Patients were randomized to receive either 3-monthly oral doses of 3 mg calcifediol (Hidroferol Choque®) or placebo in the 12 months postsurgery. Patients who received calcifediol were also given an exercise programme. The placebo group received standard health recommendations only.
The primary endpoint was survival at 1 year and at 4 year follow-up. We also recorded new fractures, medical complications and anti-osteoporotic treatment compliance.
We included a total of 88 patients, aged 62 to 99 years. Mean age was 82 years and 88.6% were women. At 12 months, 10 (11.3%) patients had died, 9 of them, from the non-intervention group. At 4 years after surgery, 20 (22.7%) had died, 3 (3.4%) from the intervention group and 17 (19.3%) from the non-intervention group. At this time, survival curve analysis showed 93% survival in the intervention group and 62% in the non-intervention group (p=0.001). At 12-month follow up, there were 18 new fractures, 9 in each group. The non-intervention group had more medical complications, with significant differences at visit 2 (p = 0.04) and 3 (p = 0.02) but not at visit 4 (p = 0.18). No significant differences between groups were found regarding treatment compliance.
3-monthly, oral supplements of 3 mg calcifediol plus daily exercise improved survival at one-year and four-year follow up after surgery for an osteoporotic hip fracture.
确定在西班牙广泛使用的口服维生素D（骨化二醇）每3个月补充一次并结合日常锻炼，是否会影响骨质疏松性髋部骨折手术后1年和4年的生存率。
一项实用、随机、部分单盲、安慰剂对照研究。
一家三级大学医院收治急性髋部骨折患者。
2004年1月至2007年12月招募了675例接受骨质疏松性髋部骨折手术的健康成年患者。
患者被随机分为两组，术后12个月内，一组每3个月口服3毫克骨化二醇（Hidroferol Choque®），另一组口服安慰剂。接受骨化二醇的患者还接受了一项锻炼计划。安慰剂组仅接受标准健康建议。
主要终点是1年和4年随访时的生存率。我们还记录了新发骨折、医疗并发症和抗骨质疏松治疗依从性。
我们共纳入88例患者，年龄在62至99岁之间。平均年龄为82岁，女性占88.6%。12个月时，10例（11.3%）患者死亡，其中9例来自非干预组。术后4年，20例（22.7%）患者死亡，干预组3例（3.4%），非干预组17例（19.3%）。此时，生存曲线分析显示干预组生存率为93%，非干预组为62%（p = 0.001）。12个月随访时，有18例新发骨折，每组9例。非干预组有更多医疗并发症，在第2次随访（p = 0.04）和第3次随访（p = 0.02）时有显著差异，但在第4次随访时无显著差异（p = 0.18）。两组在治疗依从性方面未发现显著差异。
每3个月口服3毫克骨化二醇并结合日常锻炼，可提高骨质疏松性髋部骨折手术后1年和4年随访时的生存率。
