补充钙加维生素D与骨折风险

Calcium plus vitamin D supplementation and the risk of fractures.

作者信息

Jackson Rebecca D, LaCroix Andrea Z, Gass Margery, Wallace Robert B, Robbins John, Lewis Cora E, Bassford Tamsen, Beresford Shirley A A, Black Henry R, Blanchette Patricia, Bonds Denise E, Brunner Robert L, Brzyski Robert G, Caan Bette, Cauley Jane A, Chlebowski Rowan T, Cummings Steven R, Granek Iris, Hays Jennifer, Heiss Gerardo, Hendrix Susan L, Howard Barbara V, Hsia Judith, Hubbell F Allan, Johnson Karen C, Judd Howard, Kotchen Jane Morley, Kuller Lewis H, Langer Robert D, Lasser Norman L, Limacher Marian C, Ludlam Shari, Manson JoAnn E, Margolis Karen L, McGowan Joan, Ockene Judith K, O'Sullivan Mary Jo, Phillips Lawrence, Prentice Ross L, Sarto Gloria E, Stefanick Marcia L, Van Horn Linda, Wactawski-Wende Jean, Whitlock Evelyn, Anderson Garnet L, Assaf Annlouise R, Barad David

机构信息

Division of Endocrinology, Ohio State University, 485 McCampbell, 1581 Dodd Dr., Columbus, OH 43210, USA.

出版信息

N Engl J Med. 2006 Feb 16;354(7):669-83. doi: 10.1056/NEJMoa055218.

DOI:10.1056/NEJMoa055218

PMID:16481635

Abstract

BACKGROUND

The efficacy of calcium with vitamin D supplementation for preventing hip and other fractures in healthy postmenopausal women remains equivocal.

METHODS

We recruited 36,282 postmenopausal women, 50 to 79 years of age, who were already enrolled in a Women's Health Initiative (WHI) clinical trial. We randomly assigned participants to receive 1000 mg of elemental [corrected] calcium as calcium carbonate with 400 IU of vitamin D3 daily or placebo. Fractures were ascertained for an average follow-up period of 7.0 years. Bone density was measured at three WHI centers.

RESULTS

Hip bone density was 1.06 percent higher in the calcium plus vitamin D group than in the placebo group (P<0.01). Intention-to-treat analysis indicated that participants receiving calcium plus vitamin D supplementation had a hazard ratio of 0.88 for hip fracture (95 percent confidence interval, 0.72 to 1.08), 0.90 for clinical spine fracture (0.74 to 1.10), and 0.96 for total fractures (0.91 to 1.02). The risk of renal calculi increased with calcium plus vitamin D (hazard ratio, 1.17; 95 percent confidence interval, 1.02 to 1.34). Censoring data from women when they ceased to adhere to the study medication reduced the hazard ratio for hip fracture to 0.71 (95 percent confidence interval, 0.52 to 0.97). Effects did not vary significantly according to prerandomization serum vitamin D levels.

CONCLUSIONS

Among healthy postmenopausal women, calcium with vitamin D supplementation resulted in a small but significant improvement in hip bone density, did not significantly reduce hip fracture, and increased the risk of kidney stones. (ClinicalTrials.gov number, NCT00000611.).

摘要

背景

补充钙和维生素D对预防健康绝经后女性髋部及其他骨折的疗效仍不明确。

方法

我们招募了36282名年龄在50至79岁之间、已参加妇女健康倡议（WHI）临床试验的绝经后女性。我们将参与者随机分配，使其每日接受1000毫克元素钙（碳酸钙形式）加400国际单位维生素D3或安慰剂。在平均7.0年的随访期内确定骨折情况。在三个WHI中心测量骨密度。

结果

钙加维生素D组的髋部骨密度比安慰剂组高1.06%（P<0.01）。意向性分析表明，接受钙加维生素D补充剂的参与者发生髋部骨折的风险比为0.88（95%置信区间为0.72至1.08），临床脊柱骨折的风险比为0.90（0.74至1.10），总骨折的风险比为0.96（0.91至1.02）。钙加维生素D会增加肾结石风险（风险比为1.17；95%置信区间为1.02至1.34）。当剔除未坚持服用研究药物女性的数据后，髋部骨折的风险比降至0.71（95%置信区间为0.52至0.97）。根据随机分组前的血清维生素D水平，效果无显著差异。