Women's Health Initiative clinical trials: interaction of calcium and vitamin D with hormone therapy.
Women's Health Initiative clinical trials: interaction of calcium and vitamin D with hormone therapy.
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DOI：
10.1097/gme.0b013e3182963901
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发表时间：
2014-02
期刊：
影响因子：
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通讯作者：
Wactawski-Wende J
中科院分区：
文献类型：
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作者：
Robbins JA;Aragaki A;Crandall CJ;Manson JE;Carbone L;Jackson R;Lewis CE;Johnson KC;Sarto G;Stefanick ML;Wactawski-Wende J
To test the added value of Calcium and vitamin D (CaD) for fracture prevention among women taking postmenopausal hormone therapy (HT). A prospective, partial-factorial design, randomized controlled double blind trial amongst Women’s Health Initiative post-menopausal participants, ages 50–79, at 40 centers in the US, with 7.1 years average follow-up. 27,347 women were randomized to HT (conjugated estrogen 0.625 mg alone, or CEE 0.625 mg daily plus medroxyprogesterone acetate 2.5mg) and 36,282 women randomized to either 1000mg elemental calcium (carbonate) plus 400 IU of vitamin D3 daily each compared to placebo. A total of 16,089 women were in both arms. The predefined outcomes were adjudicated hip fractures and measured bone mineral density. Interaction between HT and CaD on hip fracture (P-interaction = 0.01) was shown. The effect of CaD was stronger among women assigned to HT (HR, 0.59; 95%CI, 0.38–0.93) than placebo (HR, 1.20; 95%CI, 0.85, 1.69). The effect of HT on hip fracture was stronger among women assigned to active CaD (HR, 0.43; 0.28–0.66) than placebo (HR, 0.87; 95%CI, 0.60–1.26). CaD supplementation enhanced the anti-fracture effect of the HT at all levels of personal calcium intake. There was no interaction of HT and CaD on change in hip or spine BMD. Postmenopausal women at normal risk of hip fracture on HT, supplementation with CaD significantly reduced incident hip fracture beyond HT alone; at all levels of personal baseline total calcium intake.
