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Bone fractures not reduced with 400 IU of Vitamin D plus Calcium (no surprise) WHI – strange RCT May 2024

The Women's Health Initiative Randomized Trials and Clinical Practice: A Review

JAMA. 2024 May 1. doi: 10.1001/jama.2024.6542
JoAnn E Manson 1, Carolyn J Crandall 2, Jacques E Rossouw 3, Rowan T Chlebowski 4, Garnet L Anderson 5, Marcia L Stefanick 6, Aaron K Aragaki 5, Jane A Cauley 7, Gretchen L Wells 8, Andrea Z LaCroix 9, Cynthia A Thomson 10, Marian L Neuhouser 5, Linda Van Horn 11, Charles Kooperberg 5, Barbara V Howard 12, Lesley F Tinker 5, Jean Wactawski-Wende 13, Sally A Shumaker 14, Ross L Prentice 5

Importance: Approximately 55 million people in the US and approximately 1.1 billion people worldwide are postmenopausal women. To inform clinical practice about the health effects of menopausal hormone therapy, calcium plus vitamin D supplementation, and a low-fat dietary pattern, the Women's Health Initiative (WHI) enrolled 161 808 postmenopausal US women (N = 68 132 in the clinical trials) aged 50 to 79 years at baseline from 1993 to 1998, and followed them up for up to 20 years.

Observations: The WHI clinical trial results do not support hormone therapy with oral conjugated equine estrogens plus medroxyprogesterone acetate for postmenopausal women or conjugated equine estrogens alone for those with prior hysterectomy to prevent cardiovascular disease, dementia, or other chronic diseases. However, hormone therapy is effective for treating moderate to severe vasomotor and other menopausal symptoms. These benefits of hormone therapy in early menopause, combined with lower rates of adverse effects of hormone therapy in early compared with later menopause, support initiation of hormone therapy before age 60 years for women without contraindications to hormone therapy who have bothersome menopausal symptoms. The WHI results do not support routinely recommending calcium plus vitamin D supplementation for fracture prevention in all postmenopausal women. However, calcium and vitamin D are appropriate for women who do not meet national guidelines for recommended intakes of these nutrients through diet. A low-fat dietary pattern with increased fruit, vegetable, and grain consumption did not prevent the primary outcomes of breast or colorectal cancer but was associated with lower rates of the secondary outcome of breast cancer mortality during long-term follow-up.

Conclusions and relevance: For postmenopausal women, the WHI randomized clinical trials do not support menopausal hormone therapy to prevent cardiovascular disease or other chronic diseases. Menopausal hormone therapy is appropriate to treat bothersome vasomotor symptoms among women in early menopause, without contraindications, who are interested in taking hormone therapy. The WHI evidence does not support routine supplementation with calcium plus vitamin D for menopausal women to prevent fractures or a low-fat diet with increased fruits, vegetables, and grains to prevent breast or colorectal cancer. A potential role of a low-fat dietary pattern in reducing breast cancer mortality, a secondary outcome, warrants further study.

Clipped from PDF
In this trial, 36 282 women were randomly assigned to 1000 mg/d of elemental calcium carbonate with 400 IU/d of vitamin D3 or placebo. Personal supplementation of calcium (up to an additional 1000 mg/d) and/or vitamin D (initially up to 600 IU/d; later up to 1000 IU/d)44 was permitted. The mean baseline intakes (diet and supplements) were 1150 mg/d of calcium and 370 IU/d of vitamin D
Gave 400 IU, but allowed any woman to take up to 1,000 IU. How can this possibly be considered a RCT?

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VitaminDWiki - 24 Meta-analyses of Falls and Fractures

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