Women's Health Initiative clinical trials

Interaction of calcium and vitamin D with hormone therapy

John A. Robbins, Aaron Aragaki, Carolyn J. Crandall, Joann E. Manson, Laura D Carbone, Rebecca Jackson, Cora Elizabeth Lewis, Karen C. Johnson, Gloria Sarto, Marcia L. Stefanick, Jean Wactawski-Wende

Research output: Contribution to journalArticle

21 Citations (Scopus)

Abstract

OBJECTIVE: This study aims to test the added value of calcium and vitamin D (CaD) in fracture prevention among women taking postmenopausal hormone therapy (HT). METHODS: This is a prospective, partial-factorial, randomized, controlled, double-blind trial among Women's Health Initiative postmenopausal participants aged 50 to 79 years at 40 centers in the United States with a mean follow-up of 7.2 years. A total of 27,347 women were randomized to HT (0.625 mg of conjugated estrogens alone, or 0.625 mg of conjugated equine estrogens plus 2.5 mg of medroxyprogesterone acetate daily), and 36,282 women were randomized to 1,000 mg of elemental calcium (carbonate) plus 400 IU of vitamin D3 daily, each compared with placebo. A total of 16,089 women participated in both arms. The predefined outcomes were adjudicated hip fractures and measured bone mineral density. RESULTS: 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 (hazard ratio [HR], 0.59; 95% CI, 0.38-0.93) than among women assigned to 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; 95% CI, 0.28-0.66) than among women assigned to placebo (HR, 0.87; 95% CI, 0.60-1.26). CaD supplementation enhanced the antifracture effect of HT at all levels of personal calcium intake. There was no interaction between HT and CaD on change in hip or spine bone mineral density. CONCLUSIONS: Postmenopausal women at normal risk for hip fracture who are on CaD supplementation experience significantly reduced incident hip fractures beyond HT alone at all levels of personal baseline total calcium intake.

Original languageEnglish (US)
Pages (from-to)116-123
Number of pages8
JournalMenopause
Volume21
Issue number2
DOIs
StatePublished - Feb 1 2014

Fingerprint

Women's Health
Vitamin D
Clinical Trials
Hormones
Calcium
Hip Fractures
Conjugated (USP) Estrogens
Therapeutics
Placebos
Bone Density
Medroxyprogesterone Acetate
Calcium Carbonate
Cholecalciferol
Hip
Spine
Arm

Keywords

  • Calcium
  • Estrogens
  • Hormone therapy
  • Vitamin D

ASJC Scopus subject areas

  • Obstetrics and Gynecology

Cite this

Robbins, J. A., Aragaki, A., Crandall, C. J., Manson, J. E., Carbone, L. D., Jackson, R., ... Wactawski-Wende, J. (2014). Women's Health Initiative clinical trials: Interaction of calcium and vitamin D with hormone therapy. Menopause, 21(2), 116-123. https://doi.org/10.1097/GME.0b013e3182963901

Women's Health Initiative clinical trials : Interaction of calcium and vitamin D with hormone therapy. / Robbins, John A.; Aragaki, Aaron; Crandall, Carolyn J.; Manson, Joann E.; Carbone, Laura D; Jackson, Rebecca; Lewis, Cora Elizabeth; Johnson, Karen C.; Sarto, Gloria; Stefanick, Marcia L.; Wactawski-Wende, Jean.

In: Menopause, Vol. 21, No. 2, 01.02.2014, p. 116-123.

Research output: Contribution to journalArticle

Robbins, JA, Aragaki, A, Crandall, CJ, Manson, JE, Carbone, LD, Jackson, R, Lewis, CE, Johnson, KC, Sarto, G, Stefanick, ML & Wactawski-Wende, J 2014, 'Women's Health Initiative clinical trials: Interaction of calcium and vitamin D with hormone therapy', Menopause, vol. 21, no. 2, pp. 116-123. https://doi.org/10.1097/GME.0b013e3182963901
Robbins, John A. ; Aragaki, Aaron ; Crandall, Carolyn J. ; Manson, Joann E. ; Carbone, Laura D ; Jackson, Rebecca ; Lewis, Cora Elizabeth ; Johnson, Karen C. ; Sarto, Gloria ; Stefanick, Marcia L. ; Wactawski-Wende, Jean. / Women's Health Initiative clinical trials : Interaction of calcium and vitamin D with hormone therapy. In: Menopause. 2014 ; Vol. 21, No. 2. pp. 116-123.
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